HIV

Among the more than 320 million people in the United States, there was a prevalence estimate of 67.6 million sexually transmitted infections at the time of assessment in 2018, according to the results of an epidemiologic study using multiple data sources, including the National Health and Nutrition Examination Survey (NHANES).

In addition, almost half of the incident STIs occurred in the 15- to 24-year age bracket, according to a report published online in Sexually Transmitted Diseases. Researchers estimated the combined number of prevalent and incident infections of eight STIs in the United States in 2018: chlamydia, gonorrhea, trichomoniasis, syphilis, genital herpes (caused by herpes simplex virus type 2 [HSV-2]), human papillomavirus (HPV), sexually transmitted hepatitis B virus (HBV), and sexually transmitted HIV.

The estimated incidences of these STIs in this update, the first since 2008, were made using more recent data and improved estimation methods to provide updated STI prevalence and incidence estimates for 2018, both overall and by disease. “Having a combined estimate is crucial for policy purposes to illustrate the importance of STIs in the United States,” according to Kristen M. Kreisel, PhD, an epidemiologist at the Centers for Disease Control and Prevention, division of STD prevention, and colleagues.

The number of prevalent and incident infections were obtained by multiplying each STI’s updated per capita estimates by the 2018 full resident population estimates from the American Community Survey.
 

Detailed results

Chlamydia. The prevalence of chlamydia was estimated using 2015-2018 NHANES data, which was then used to create a modeled prevalence in 2018, according to the authors. There were an estimated 2.4 million prevalent urogenital chlamydial infections among persons aged 15-39 years in 2018; 1.1 and 1.3 million infections among men and women, respectively. Individuals aged 15-24 years comprised 56.7% and 75.8% of all infections in men and women respectively.

Gonorrhea. The prevalence of gonorrhea was estimated using ordinary differential equation based modeling. The number of prevalent urogenital gonococcal infections in 2018 among 15- to 39-year-olds was 209,000 overall; 50,000 in men and 155,000 in women. Of these, 113,000 (54.1%) occurred in 15- to 24-year-olds.

Trichomoniasis. The prevalence of trichomoniasis was estimated using 2015-2018 NHANES data, which was then used to create a modeled prevalence in 2018, according to the authors. The number of prevalent Trichomonas infections among 15- to 59-year-olds was 2.6 million, with 470,000 in men and 2.1 million in women. Persons aged 15-24 years comprised 15.6% of all prevalent infections, according to the authors.

Syphilis. The number of estimated prevalent syphilitic infections (all stages) among 14- to 49-year-old persons in 2018 was 156,000, with infections in men comprising 71.8% of all infections. Infections in both men and women aged 14-24 years accounted for about 25% of all infections, with 36,000 total prevalent syphilitic infections among 14- to 24-year-olds in 2018.

Genital herpes. The prevalence of genital herpes (caused by HSV-2) was estimated using 2015-2018 NHANES data, according to the authors. In persons aged 15-49 years in 2018, there were 18.6 million prevalent HSV-2 infections; 6.4 million among men and 12.2 million among women. Infections in 15- to 24-year-olds comprised 7.1% of all prevalent HSV-2 infections.

HPV. The prevalence of HPV was estimated using 2013-2016 NHANES data, which was assumed to reflect stable prevalence in 2018, according to the authors. Among 15- to 59-year-olds, the estimated number of persons, men, and women infected with one or more disease-associated HPV types in 2018 was 42.5, 23.4, and 19.2 million, respectively, with an estimated 9.0 million (21%) 15- to 24-year-olds infected,

HBV. NHANES 2013-2018 data were used to estimate the prevalence of sexually transmitted chronic HBV infections in 2018, according to the authors. The estimated number of infections among persons aged 15 years and older in 2018 was 103,000 (51,000 men and 52,000 women). There small sample size of individuals aged 15-24 years in the NHANES database made it impossible to obtain an accurate estimate for this group, according to the authors.

HIV. Data from the National HIV Surveillance System were used to estimate the prevalence and incidence of sexually transmitted HIV infections for persons aged 13 years and older in 2018. A total of 984,000 individuals aged 13 years and older were estimated to be living with sexually transmitted HIV at the end of 2018, according to the authors. Nearly 80% were men. In the 13- to 24-year-old age bracket, there were an estimated 45,400 living with sexually transmitted HIV.

Billions in costs

Commenting on the study by the CDC researchers, Raul Romaguera, acting director for CDC’s division of STD prevention, stated in a press release: “There are significant human and financial costs associated with these infections, and we know from other studies that cuts in STI prevention efforts result in higher costs down the road. Preventing STIs could save billions in medical costs, but more importantly, prevention would improve the health and lives of millions of people.”

“About 20% of the total U.S. population had an STI at a given point in 2018, while nearly half of all incident infections occurred in people aged 15-24 years. Focusing STI prevention efforts on the 15- to 24-year-old population may be key to lowering the STI burden in the U.S.,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

Among the more than 320 million people in the United States, there was a prevalence estimate of 67.6 million sexually transmitted infections at the time of assessment in 2018, according to the results of an epidemiologic study using multiple data sources, including the National Health and Nutrition Examination Survey (NHANES).

In addition, almost half of the incident STIs occurred in the 15- to 24-year age bracket, according to a report published online in Sexually Transmitted Diseases. Researchers estimated the combined number of prevalent and incident infections of eight STIs in the United States in 2018: chlamydia, gonorrhea, trichomoniasis, syphilis, genital herpes (caused by herpes simplex virus type 2 [HSV-2]), human papillomavirus (HPV), sexually transmitted hepatitis B virus (HBV), and sexually transmitted HIV.

The estimated incidences of these STIs in this update, the first since 2008, were made using more recent data and improved estimation methods to provide updated STI prevalence and incidence estimates for 2018, both overall and by disease. “Having a combined estimate is crucial for policy purposes to illustrate the importance of STIs in the United States,” according to Kristen M. Kreisel, PhD, an epidemiologist at the Centers for Disease Control and Prevention, division of STD prevention, and colleagues.

The number of prevalent and incident infections were obtained by multiplying each STI’s updated per capita estimates by the 2018 full resident population estimates from the American Community Survey.
 

Detailed results

Chlamydia. The prevalence of chlamydia was estimated using 2015-2018 NHANES data, which was then used to create a modeled prevalence in 2018, according to the authors. There were an estimated 2.4 million prevalent urogenital chlamydial infections among persons aged 15-39 years in 2018; 1.1 and 1.3 million infections among men and women, respectively. Individuals aged 15-24 years comprised 56.7% and 75.8% of all infections in men and women respectively.

Gonorrhea. The prevalence of gonorrhea was estimated using ordinary differential equation based modeling. The number of prevalent urogenital gonococcal infections in 2018 among 15- to 39-year-olds was 209,000 overall; 50,000 in men and 155,000 in women. Of these, 113,000 (54.1%) occurred in 15- to 24-year-olds.

Trichomoniasis. The prevalence of trichomoniasis was estimated using 2015-2018 NHANES data, which was then used to create a modeled prevalence in 2018, according to the authors. The number of prevalent Trichomonas infections among 15- to 59-year-olds was 2.6 million, with 470,000 in men and 2.1 million in women. Persons aged 15-24 years comprised 15.6% of all prevalent infections, according to the authors.

Syphilis. The number of estimated prevalent syphilitic infections (all stages) among 14- to 49-year-old persons in 2018 was 156,000, with infections in men comprising 71.8% of all infections. Infections in both men and women aged 14-24 years accounted for about 25% of all infections, with 36,000 total prevalent syphilitic infections among 14- to 24-year-olds in 2018.

Genital herpes. The prevalence of genital herpes (caused by HSV-2) was estimated using 2015-2018 NHANES data, according to the authors. In persons aged 15-49 years in 2018, there were 18.6 million prevalent HSV-2 infections; 6.4 million among men and 12.2 million among women. Infections in 15- to 24-year-olds comprised 7.1% of all prevalent HSV-2 infections.

HPV. The prevalence of HPV was estimated using 2013-2016 NHANES data, which was assumed to reflect stable prevalence in 2018, according to the authors. Among 15- to 59-year-olds, the estimated number of persons, men, and women infected with one or more disease-associated HPV types in 2018 was 42.5, 23.4, and 19.2 million, respectively, with an estimated 9.0 million (21%) 15- to 24-year-olds infected,

HBV. NHANES 2013-2018 data were used to estimate the prevalence of sexually transmitted chronic HBV infections in 2018, according to the authors. The estimated number of infections among persons aged 15 years and older in 2018 was 103,000 (51,000 men and 52,000 women). There small sample size of individuals aged 15-24 years in the NHANES database made it impossible to obtain an accurate estimate for this group, according to the authors.

HIV. Data from the National HIV Surveillance System were used to estimate the prevalence and incidence of sexually transmitted HIV infections for persons aged 13 years and older in 2018. A total of 984,000 individuals aged 13 years and older were estimated to be living with sexually transmitted HIV at the end of 2018, according to the authors. Nearly 80% were men. In the 13- to 24-year-old age bracket, there were an estimated 45,400 living with sexually transmitted HIV.

Billions in costs

Commenting on the study by the CDC researchers, Raul Romaguera, acting director for CDC’s division of STD prevention, stated in a press release: “There are significant human and financial costs associated with these infections, and we know from other studies that cuts in STI prevention efforts result in higher costs down the road. Preventing STIs could save billions in medical costs, but more importantly, prevention would improve the health and lives of millions of people.”

“About 20% of the total U.S. population had an STI at a given point in 2018, while nearly half of all incident infections occurred in people aged 15-24 years. Focusing STI prevention efforts on the 15- to 24-year-old population may be key to lowering the STI burden in the U.S.,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

Among the more than 320 million people in the United States, there was a prevalence estimate of 67.6 million sexually transmitted infections at the time of assessment in 2018, according to the results of an epidemiologic study using multiple data sources, including the National Health and Nutrition Examination Survey (NHANES).

In addition, almost half of the incident STIs occurred in the 15- to 24-year age bracket, according to a report published online in Sexually Transmitted Diseases. Researchers estimated the combined number of prevalent and incident infections of eight STIs in the United States in 2018: chlamydia, gonorrhea, trichomoniasis, syphilis, genital herpes (caused by herpes simplex virus type 2 [HSV-2]), human papillomavirus (HPV), sexually transmitted hepatitis B virus (HBV), and sexually transmitted HIV.

The estimated incidences of these STIs in this update, the first since 2008, were made using more recent data and improved estimation methods to provide updated STI prevalence and incidence estimates for 2018, both overall and by disease. “Having a combined estimate is crucial for policy purposes to illustrate the importance of STIs in the United States,” according to Kristen M. Kreisel, PhD, an epidemiologist at the Centers for Disease Control and Prevention, division of STD prevention, and colleagues.

The number of prevalent and incident infections were obtained by multiplying each STI’s updated per capita estimates by the 2018 full resident population estimates from the American Community Survey.
 

Detailed results

Chlamydia. The prevalence of chlamydia was estimated using 2015-2018 NHANES data, which was then used to create a modeled prevalence in 2018, according to the authors. There were an estimated 2.4 million prevalent urogenital chlamydial infections among persons aged 15-39 years in 2018; 1.1 and 1.3 million infections among men and women, respectively. Individuals aged 15-24 years comprised 56.7% and 75.8% of all infections in men and women respectively.

Gonorrhea. The prevalence of gonorrhea was estimated using ordinary differential equation based modeling. The number of prevalent urogenital gonococcal infections in 2018 among 15- to 39-year-olds was 209,000 overall; 50,000 in men and 155,000 in women. Of these, 113,000 (54.1%) occurred in 15- to 24-year-olds.

Trichomoniasis. The prevalence of trichomoniasis was estimated using 2015-2018 NHANES data, which was then used to create a modeled prevalence in 2018, according to the authors. The number of prevalent Trichomonas infections among 15- to 59-year-olds was 2.6 million, with 470,000 in men and 2.1 million in women. Persons aged 15-24 years comprised 15.6% of all prevalent infections, according to the authors.

Syphilis. The number of estimated prevalent syphilitic infections (all stages) among 14- to 49-year-old persons in 2018 was 156,000, with infections in men comprising 71.8% of all infections. Infections in both men and women aged 14-24 years accounted for about 25% of all infections, with 36,000 total prevalent syphilitic infections among 14- to 24-year-olds in 2018.

Genital herpes. The prevalence of genital herpes (caused by HSV-2) was estimated using 2015-2018 NHANES data, according to the authors. In persons aged 15-49 years in 2018, there were 18.6 million prevalent HSV-2 infections; 6.4 million among men and 12.2 million among women. Infections in 15- to 24-year-olds comprised 7.1% of all prevalent HSV-2 infections.

HPV. The prevalence of HPV was estimated using 2013-2016 NHANES data, which was assumed to reflect stable prevalence in 2018, according to the authors. Among 15- to 59-year-olds, the estimated number of persons, men, and women infected with one or more disease-associated HPV types in 2018 was 42.5, 23.4, and 19.2 million, respectively, with an estimated 9.0 million (21%) 15- to 24-year-olds infected,

HBV. NHANES 2013-2018 data were used to estimate the prevalence of sexually transmitted chronic HBV infections in 2018, according to the authors. The estimated number of infections among persons aged 15 years and older in 2018 was 103,000 (51,000 men and 52,000 women). There small sample size of individuals aged 15-24 years in the NHANES database made it impossible to obtain an accurate estimate for this group, according to the authors.

HIV. Data from the National HIV Surveillance System were used to estimate the prevalence and incidence of sexually transmitted HIV infections for persons aged 13 years and older in 2018. A total of 984,000 individuals aged 13 years and older were estimated to be living with sexually transmitted HIV at the end of 2018, according to the authors. Nearly 80% were men. In the 13- to 24-year-old age bracket, there were an estimated 45,400 living with sexually transmitted HIV.

Billions in costs

Commenting on the study by the CDC researchers, Raul Romaguera, acting director for CDC’s division of STD prevention, stated in a press release: “There are significant human and financial costs associated with these infections, and we know from other studies that cuts in STI prevention efforts result in higher costs down the road. Preventing STIs could save billions in medical costs, but more importantly, prevention would improve the health and lives of millions of people.”

“About 20% of the total U.S. population had an STI at a given point in 2018, while nearly half of all incident infections occurred in people aged 15-24 years. Focusing STI prevention efforts on the 15- to 24-year-old population may be key to lowering the STI burden in the U.S.,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

Cabenuva (cabotegravir and rilpivirine, a once-per-month injectable formulation) was approved by the Food and Drug Administration as a complete regimen for treatment of HIV-1 infection in adults. It is intended to replace current antiretroviral regimens in those patients who are virologically suppressed with no history of treatment failure and with no known or suspected resistance to either of the two component drugs.

Cabenuva is the first FDA-approved monthly injectable, complete regimen for HIV-infected adults, according to the agency’s announcement.

In addition, the FDA-approved Vocabria (cabotegravir, tablet formulation), a preparatory treatment intended to be taken in combination with oral rilpivirine (Edurant) for 1 month prior to starting treatment with Cabenuva to ensure the medications are well tolerated before switching to the extended-release injectable formulation. The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.

Cabotegravir is as an integrase strand transfer inhibitor that blocks HIV integrase by attaching to the active integrase site and inhibiting retroviral DNA integration, which is necessary in order for HIV to replicate. In contrast, rilpivirine acts as a diarylpyrimidine nonnucleoside reverse transcriptase inhibitor of HIV-1.

Approval of Cabenuva was based upon two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiation of treatment with Cabenuva. The two pivotal phase three clinical studies were: Antiretroviral Therapy as Long-Acting Suppression (ATLAS; NCT02951052) and First Long-Acting Injectable Regimen (FLAIR; NCT02938520). Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed, according to the FDA announcement.

Adverse reactions with Cabenuva included injection-site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The FDA warned that Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/mL).

Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA. Prescribing information for Cabenuva is available on the ViiV Healthcare website.

[email protected]

Cabenuva (cabotegravir and rilpivirine, a once-per-month injectable formulation) was approved by the Food and Drug Administration as a complete regimen for treatment of HIV-1 infection in adults. It is intended to replace current antiretroviral regimens in those patients who are virologically suppressed with no history of treatment failure and with no known or suspected resistance to either of the two component drugs.

Cabenuva is the first FDA-approved monthly injectable, complete regimen for HIV-infected adults, according to the agency’s announcement.

In addition, the FDA-approved Vocabria (cabotegravir, tablet formulation), a preparatory treatment intended to be taken in combination with oral rilpivirine (Edurant) for 1 month prior to starting treatment with Cabenuva to ensure the medications are well tolerated before switching to the extended-release injectable formulation. The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.

Cabotegravir is as an integrase strand transfer inhibitor that blocks HIV integrase by attaching to the active integrase site and inhibiting retroviral DNA integration, which is necessary in order for HIV to replicate. In contrast, rilpivirine acts as a diarylpyrimidine nonnucleoside reverse transcriptase inhibitor of HIV-1.

Approval of Cabenuva was based upon two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiation of treatment with Cabenuva. The two pivotal phase three clinical studies were: Antiretroviral Therapy as Long-Acting Suppression (ATLAS; NCT02951052) and First Long-Acting Injectable Regimen (FLAIR; NCT02938520). Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed, according to the FDA announcement.

Adverse reactions with Cabenuva included injection-site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The FDA warned that Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/mL).

Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA. Prescribing information for Cabenuva is available on the ViiV Healthcare website.

[email protected]

Cabenuva (cabotegravir and rilpivirine, a once-per-month injectable formulation) was approved by the Food and Drug Administration as a complete regimen for treatment of HIV-1 infection in adults. It is intended to replace current antiretroviral regimens in those patients who are virologically suppressed with no history of treatment failure and with no known or suspected resistance to either of the two component drugs.

Cabenuva is the first FDA-approved monthly injectable, complete regimen for HIV-infected adults, according to the agency’s announcement.

In addition, the FDA-approved Vocabria (cabotegravir, tablet formulation), a preparatory treatment intended to be taken in combination with oral rilpivirine (Edurant) for 1 month prior to starting treatment with Cabenuva to ensure the medications are well tolerated before switching to the extended-release injectable formulation. The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.

Cabotegravir is as an integrase strand transfer inhibitor that blocks HIV integrase by attaching to the active integrase site and inhibiting retroviral DNA integration, which is necessary in order for HIV to replicate. In contrast, rilpivirine acts as a diarylpyrimidine nonnucleoside reverse transcriptase inhibitor of HIV-1.

Approval of Cabenuva was based upon two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiation of treatment with Cabenuva. The two pivotal phase three clinical studies were: Antiretroviral Therapy as Long-Acting Suppression (ATLAS; NCT02951052) and First Long-Acting Injectable Regimen (FLAIR; NCT02938520). Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed, according to the FDA announcement.

Adverse reactions with Cabenuva included injection-site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The FDA warned that Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/mL).

Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA. Prescribing information for Cabenuva is available on the ViiV Healthcare website.

[email protected]

Several updates in the strategy for prevention of and treatment of sexually transmitted infections were recently published in the United States.

Among these are the U.S. Department of Health and Human Services’ first “Sexually Transmitted Infections (STIs) National Strategic Plan for the United States,” which has a strong encompassing vision.

• Prevent New STIs.
• Improve the health of people by reducing adverse outcomes of STIs.
• Accelerate progress in STI research, technology, and innovation.
• Reduce STI-related health disparities and health inequities.
• Achieve integrated, coordinated efforts that address the STI epidemic.¹

In my opinion, family physicians have important roles to play in order for each of these goals to be achieved.Unfortunately, there are approximately 20 million new cases of STIs each year, and the U.S. has seen increases in the rates of STIs in the past decade.

“Sexually transmitted infections are frequently asymptomatic, which may delay diagnosis and treatment and lead persons to unknowingly transmit STIs to others,” according to a new recommendation statement from the USPSTF.² STIs may lead to serious health consequences for patients, cause harms to a mother and infant during pregnancy, and lead to cases of cancer among other concerning outcomes. As such, following the HHS new national strategic plan is critical for us to address the needs of our communities.
 

Preventing new STIs

Family physicians can be vital in achieving the first goal of the plan by helping to prevent new STIs. In August 2020, the USPSTF updated its guideline on behavioral counseling interventions to prevent STIs. In my opinion, the USPSTF offers some practical improvements from the earlier version of this guideline.

The task force provides a grade B recommendation that all sexually active adolescents and adults at increased risk for STIs be provided with behavioral counseling to prevent STIs. The guideline indicates that behavioral counseling interventions reduce the likelihood of those at increased risk for acquiring STIs.²

The 2014 guideline had recommended intensive interventions with a minimum of 30 minutes of counseling. Many family physicians may have found this previous recommendation impractical to implement. These updated recommendations now include a variety of interventions, such as those that take less than 30 minutes.

Although interventions with more than 120 minutes of contact time had the most effect, those with less than 30 minutes still demonstrated statistically significant fewer acquisitions of STIs during follow-up. These options include in-person counseling, and providing written materials, websites, videos, and telephone and text support to patients. These interventions can be delivered directly by the family physician, or patients may be referred to other settings or the media interventions.

The task force’s updated recommendation statement refers to a variety of resources that can be used to identify these interventions. Many of the studies reviewed for this guideline were conducted in STI clinics, and the guideline authors recommended further studies in primary care as opportunities for more generalizability.

In addition to behavioral counseling for STI prevention, family physicians can help prevent STIs in their patients through HPV vaccination and HIV pre-exposure prophylaxis (PrEP provision) within their practices. As the first contact for health care for many patients, we have an opportunity to significantly impact this first goal of prevention.
 

Treating STIs

Within the second goal of the national strategic plan is treatment of STIs, which family physicians should include in their practices as well as the diagnosis of STIs.

In December 2020, an update to the CDC’s treatment guideline for gonococcal infection was released. Prior to the publishing of this updated recommendation, the CDC recommended combination therapy of 250 mg intramuscular (IM) dose of ceftriaxone and either doxycycline or azithromycin. This recommendation has been changed to a single 500-mg IM dose of ceftriaxone for uncomplicated urogenital, anorectal, and pharyngeal gonorrhea. If chlamydia cannot be excluded, then the addition of oral doxycycline 100 mg twice daily for 7 days is recommended for nonpregnant persons, and 1 g oral azithromycin for pregnant persons. The previous treatment was recommended based on a concern for gonococcal resistance.

This updated guideline reflects increasing concerns for antimicrobial stewardship and emerging azithromycin resistance. It does not recommend a test-of-cure for urogenital or rectal gonorrhea, though did recommend a test-of-cure 7-14 days after treatment of pharyngeal gonorrhea. The guideline also recommends testing for reinfection 3-12 months after treatment as the rate of reinfection ranges from 7% to 12% among those previously treated.³

For some offices, the provision of the IM injection may be challenging, though having this medication in stock with the possibility of provision can greatly improve access and ease of treatment for patients. Family physicians can incorporate these updated recommendations along with those for other STIs such as chlamydia and syphilis with standing orders for treatment and testing within their offices.
 

Accelerating progress in STI research

Family physicians can also support the national strategic plan by participating in studies looking at the impact of behavioral counseling in the primary care office as opposed to in STI clinics. In addition, by following the STI treatment and screening guidelines, family physicians will contribute to the body of knowledge of prevalence, treatment failure, and reinfection rates of STIs. We can also help advance the research by providing feedback on interventions that have success within our practices.

Reducing STI-related health disparities and inequities

Family physicians are also in important places to support the strategic plan’s fourth goal of reducing health disparities and health inequities.

If we continue to ask the questions to identify those at high risk and ensure that we are offering appropriate STI prevention, care, and treatment services within our clinics, we can expand access to all who need services and improve equity. By offering these services within the primary care office, we may be able to decrease the stigma some may feel going to an STI clinic for services.

By incorporating additional screening and counseling in our practices we may identify some patients who were not aware that they were at risk for an STI and offer them preventive services.
 

Achieving integrated and coordinated efforts

Finally, as many family physicians have integrated practices, we are uniquely poised to support the fifth goal of the strategic plan of achieving integrated and coordinated efforts addressing the STI epidemic. In our practices we can participate in, lead, and refer to programs for substance use disorders, viral hepatitis, STIs, and HIV as part of full scope primary care.

Family physicians and other primary care providers should work to support the entire strategic plan to ensure that we are fully caring for our patients and communities and stopping the past decade’s increase in STIs. We have an opportunity to use this strategy and make a large impact in our communities.
 

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].

References

1. U.S. Department of Health and Human Services. 2020. Sexually Transmitted Infections National Strategic Plan for the United States: 2021-2025. Washington.

2. U.S. Preventive Services Task Force. Behavioral counseling interventions to prevent sexually transmitted infections: U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2020;324(7):674-81. doi: 10.1001/jama.2020.13095.

3. St. Cyr S et al. Update to CDC’s Treatment Guideline for Gonococcal Infection, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1911-6. doi: 10.15585/mmwr.mm6950a6external_icon.

Several updates in the strategy for prevention of and treatment of sexually transmitted infections were recently published in the United States.

Among these are the U.S. Department of Health and Human Services’ first “Sexually Transmitted Infections (STIs) National Strategic Plan for the United States,” which has a strong encompassing vision.

• Prevent New STIs.
• Improve the health of people by reducing adverse outcomes of STIs.
• Accelerate progress in STI research, technology, and innovation.
• Reduce STI-related health disparities and health inequities.
• Achieve integrated, coordinated efforts that address the STI epidemic.¹

In my opinion, family physicians have important roles to play in order for each of these goals to be achieved.Unfortunately, there are approximately 20 million new cases of STIs each year, and the U.S. has seen increases in the rates of STIs in the past decade.

“Sexually transmitted infections are frequently asymptomatic, which may delay diagnosis and treatment and lead persons to unknowingly transmit STIs to others,” according to a new recommendation statement from the USPSTF.² STIs may lead to serious health consequences for patients, cause harms to a mother and infant during pregnancy, and lead to cases of cancer among other concerning outcomes. As such, following the HHS new national strategic plan is critical for us to address the needs of our communities.
 

Preventing new STIs

Family physicians can be vital in achieving the first goal of the plan by helping to prevent new STIs. In August 2020, the USPSTF updated its guideline on behavioral counseling interventions to prevent STIs. In my opinion, the USPSTF offers some practical improvements from the earlier version of this guideline.

The task force provides a grade B recommendation that all sexually active adolescents and adults at increased risk for STIs be provided with behavioral counseling to prevent STIs. The guideline indicates that behavioral counseling interventions reduce the likelihood of those at increased risk for acquiring STIs.²

The 2014 guideline had recommended intensive interventions with a minimum of 30 minutes of counseling. Many family physicians may have found this previous recommendation impractical to implement. These updated recommendations now include a variety of interventions, such as those that take less than 30 minutes.

Although interventions with more than 120 minutes of contact time had the most effect, those with less than 30 minutes still demonstrated statistically significant fewer acquisitions of STIs during follow-up. These options include in-person counseling, and providing written materials, websites, videos, and telephone and text support to patients. These interventions can be delivered directly by the family physician, or patients may be referred to other settings or the media interventions.

The task force’s updated recommendation statement refers to a variety of resources that can be used to identify these interventions. Many of the studies reviewed for this guideline were conducted in STI clinics, and the guideline authors recommended further studies in primary care as opportunities for more generalizability.

In addition to behavioral counseling for STI prevention, family physicians can help prevent STIs in their patients through HPV vaccination and HIV pre-exposure prophylaxis (PrEP provision) within their practices. As the first contact for health care for many patients, we have an opportunity to significantly impact this first goal of prevention.
 

Treating STIs

Within the second goal of the national strategic plan is treatment of STIs, which family physicians should include in their practices as well as the diagnosis of STIs.

In December 2020, an update to the CDC’s treatment guideline for gonococcal infection was released. Prior to the publishing of this updated recommendation, the CDC recommended combination therapy of 250 mg intramuscular (IM) dose of ceftriaxone and either doxycycline or azithromycin. This recommendation has been changed to a single 500-mg IM dose of ceftriaxone for uncomplicated urogenital, anorectal, and pharyngeal gonorrhea. If chlamydia cannot be excluded, then the addition of oral doxycycline 100 mg twice daily for 7 days is recommended for nonpregnant persons, and 1 g oral azithromycin for pregnant persons. The previous treatment was recommended based on a concern for gonococcal resistance.

This updated guideline reflects increasing concerns for antimicrobial stewardship and emerging azithromycin resistance. It does not recommend a test-of-cure for urogenital or rectal gonorrhea, though did recommend a test-of-cure 7-14 days after treatment of pharyngeal gonorrhea. The guideline also recommends testing for reinfection 3-12 months after treatment as the rate of reinfection ranges from 7% to 12% among those previously treated.³

For some offices, the provision of the IM injection may be challenging, though having this medication in stock with the possibility of provision can greatly improve access and ease of treatment for patients. Family physicians can incorporate these updated recommendations along with those for other STIs such as chlamydia and syphilis with standing orders for treatment and testing within their offices.
 

Accelerating progress in STI research

Family physicians can also support the national strategic plan by participating in studies looking at the impact of behavioral counseling in the primary care office as opposed to in STI clinics. In addition, by following the STI treatment and screening guidelines, family physicians will contribute to the body of knowledge of prevalence, treatment failure, and reinfection rates of STIs. We can also help advance the research by providing feedback on interventions that have success within our practices.

Reducing STI-related health disparities and inequities

Family physicians are also in important places to support the strategic plan’s fourth goal of reducing health disparities and health inequities.

If we continue to ask the questions to identify those at high risk and ensure that we are offering appropriate STI prevention, care, and treatment services within our clinics, we can expand access to all who need services and improve equity. By offering these services within the primary care office, we may be able to decrease the stigma some may feel going to an STI clinic for services.

By incorporating additional screening and counseling in our practices we may identify some patients who were not aware that they were at risk for an STI and offer them preventive services.
 

Achieving integrated and coordinated efforts

Finally, as many family physicians have integrated practices, we are uniquely poised to support the fifth goal of the strategic plan of achieving integrated and coordinated efforts addressing the STI epidemic. In our practices we can participate in, lead, and refer to programs for substance use disorders, viral hepatitis, STIs, and HIV as part of full scope primary care.

Family physicians and other primary care providers should work to support the entire strategic plan to ensure that we are fully caring for our patients and communities and stopping the past decade’s increase in STIs. We have an opportunity to use this strategy and make a large impact in our communities.
 

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].

References

1. U.S. Department of Health and Human Services. 2020. Sexually Transmitted Infections National Strategic Plan for the United States: 2021-2025. Washington.

2. U.S. Preventive Services Task Force. Behavioral counseling interventions to prevent sexually transmitted infections: U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2020;324(7):674-81. doi: 10.1001/jama.2020.13095.

3. St. Cyr S et al. Update to CDC’s Treatment Guideline for Gonococcal Infection, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1911-6. doi: 10.15585/mmwr.mm6950a6external_icon.

Several updates in the strategy for prevention of and treatment of sexually transmitted infections were recently published in the United States.

Among these are the U.S. Department of Health and Human Services’ first “Sexually Transmitted Infections (STIs) National Strategic Plan for the United States,” which has a strong encompassing vision.

• Prevent New STIs.
• Improve the health of people by reducing adverse outcomes of STIs.
• Accelerate progress in STI research, technology, and innovation.
• Reduce STI-related health disparities and health inequities.
• Achieve integrated, coordinated efforts that address the STI epidemic.¹

In my opinion, family physicians have important roles to play in order for each of these goals to be achieved.Unfortunately, there are approximately 20 million new cases of STIs each year, and the U.S. has seen increases in the rates of STIs in the past decade.

“Sexually transmitted infections are frequently asymptomatic, which may delay diagnosis and treatment and lead persons to unknowingly transmit STIs to others,” according to a new recommendation statement from the USPSTF.² STIs may lead to serious health consequences for patients, cause harms to a mother and infant during pregnancy, and lead to cases of cancer among other concerning outcomes. As such, following the HHS new national strategic plan is critical for us to address the needs of our communities.
 

Preventing new STIs

Family physicians can be vital in achieving the first goal of the plan by helping to prevent new STIs. In August 2020, the USPSTF updated its guideline on behavioral counseling interventions to prevent STIs. In my opinion, the USPSTF offers some practical improvements from the earlier version of this guideline.

The task force provides a grade B recommendation that all sexually active adolescents and adults at increased risk for STIs be provided with behavioral counseling to prevent STIs. The guideline indicates that behavioral counseling interventions reduce the likelihood of those at increased risk for acquiring STIs.²

The 2014 guideline had recommended intensive interventions with a minimum of 30 minutes of counseling. Many family physicians may have found this previous recommendation impractical to implement. These updated recommendations now include a variety of interventions, such as those that take less than 30 minutes.

Although interventions with more than 120 minutes of contact time had the most effect, those with less than 30 minutes still demonstrated statistically significant fewer acquisitions of STIs during follow-up. These options include in-person counseling, and providing written materials, websites, videos, and telephone and text support to patients. These interventions can be delivered directly by the family physician, or patients may be referred to other settings or the media interventions.

The task force’s updated recommendation statement refers to a variety of resources that can be used to identify these interventions. Many of the studies reviewed for this guideline were conducted in STI clinics, and the guideline authors recommended further studies in primary care as opportunities for more generalizability.

In addition to behavioral counseling for STI prevention, family physicians can help prevent STIs in their patients through HPV vaccination and HIV pre-exposure prophylaxis (PrEP provision) within their practices. As the first contact for health care for many patients, we have an opportunity to significantly impact this first goal of prevention.
 

Treating STIs

Within the second goal of the national strategic plan is treatment of STIs, which family physicians should include in their practices as well as the diagnosis of STIs.

In December 2020, an update to the CDC’s treatment guideline for gonococcal infection was released. Prior to the publishing of this updated recommendation, the CDC recommended combination therapy of 250 mg intramuscular (IM) dose of ceftriaxone and either doxycycline or azithromycin. This recommendation has been changed to a single 500-mg IM dose of ceftriaxone for uncomplicated urogenital, anorectal, and pharyngeal gonorrhea. If chlamydia cannot be excluded, then the addition of oral doxycycline 100 mg twice daily for 7 days is recommended for nonpregnant persons, and 1 g oral azithromycin for pregnant persons. The previous treatment was recommended based on a concern for gonococcal resistance.

This updated guideline reflects increasing concerns for antimicrobial stewardship and emerging azithromycin resistance. It does not recommend a test-of-cure for urogenital or rectal gonorrhea, though did recommend a test-of-cure 7-14 days after treatment of pharyngeal gonorrhea. The guideline also recommends testing for reinfection 3-12 months after treatment as the rate of reinfection ranges from 7% to 12% among those previously treated.³

For some offices, the provision of the IM injection may be challenging, though having this medication in stock with the possibility of provision can greatly improve access and ease of treatment for patients. Family physicians can incorporate these updated recommendations along with those for other STIs such as chlamydia and syphilis with standing orders for treatment and testing within their offices.
 

Accelerating progress in STI research

Family physicians can also support the national strategic plan by participating in studies looking at the impact of behavioral counseling in the primary care office as opposed to in STI clinics. In addition, by following the STI treatment and screening guidelines, family physicians will contribute to the body of knowledge of prevalence, treatment failure, and reinfection rates of STIs. We can also help advance the research by providing feedback on interventions that have success within our practices.

Reducing STI-related health disparities and inequities

Family physicians are also in important places to support the strategic plan’s fourth goal of reducing health disparities and health inequities.

If we continue to ask the questions to identify those at high risk and ensure that we are offering appropriate STI prevention, care, and treatment services within our clinics, we can expand access to all who need services and improve equity. By offering these services within the primary care office, we may be able to decrease the stigma some may feel going to an STI clinic for services.

By incorporating additional screening and counseling in our practices we may identify some patients who were not aware that they were at risk for an STI and offer them preventive services.
 

Achieving integrated and coordinated efforts

Finally, as many family physicians have integrated practices, we are uniquely poised to support the fifth goal of the strategic plan of achieving integrated and coordinated efforts addressing the STI epidemic. In our practices we can participate in, lead, and refer to programs for substance use disorders, viral hepatitis, STIs, and HIV as part of full scope primary care.

Family physicians and other primary care providers should work to support the entire strategic plan to ensure that we are fully caring for our patients and communities and stopping the past decade’s increase in STIs. We have an opportunity to use this strategy and make a large impact in our communities.
 

Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program at Humboldt Park, Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].

References

1. U.S. Department of Health and Human Services. 2020. Sexually Transmitted Infections National Strategic Plan for the United States: 2021-2025. Washington.

2. U.S. Preventive Services Task Force. Behavioral counseling interventions to prevent sexually transmitted infections: U.S. Preventive Services Task Force Recommendation Statement. JAMA. 2020;324(7):674-81. doi: 10.1001/jama.2020.13095.

3. St. Cyr S et al. Update to CDC’s Treatment Guideline for Gonococcal Infection, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1911-6. doi: 10.15585/mmwr.mm6950a6external_icon.

Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up.

Under his insurance plan, the former flight attendant and customer service instructor owed $500 in copayments every month for the drug and an additional $250 every three months for lab work and clinic visits.

Luckily for Howard, his doctor at Las Vegas’ Huntridge Family Clinic, which specializes in LGBTQ care, enrolled him in a clinical trial that covered his medication and other costs in full.

“If I hadn’t been able to get into the trial, I wouldn’t have kept taking PrEP,” said Howard, 68, using the shorthand term for “preexposure prophylaxis.” Taken daily, these drugs — like Truvada — are more than 90% effective at preventing infection with HIV.

Starting in January of 2021, most people with private insurance will no longer have to decide whether they can afford to protect themselves against HIV. Most health plans must begin to cover the drugs then without charging consumers anything out-of-pocket (some plans already began doing so last year).

Drugs in this category — Truvada, Descovy and, newly available, a generic version of Truvada — received an “A” recommendation by the U.S. Preventive Services Task Force. Under the Affordable Care Act, preventive services that receive an “A” or “B” rating by the task force, a group of medical experts in prevention and primary care, must be covered by most private health plans without making members share the cost, usually through copayments or deductibles. Only plans that are grandfathered under the health law are exempt.

The task force recommended PrEP for people at high risk of HIV infection, including men who have sex with men and injection drug users.

In the United States, more than 1 million people live with HIV, and nearly 40,000 new HIV cases are diagnosed every year. Yet fewer than 10% of people who could benefit from PrEP are taking it. One key reason is that out-of-pocket costs can exceed $1,000 annually, according to a study published in the American Journal of Public Health last year. Required periodic blood tests and doctor visits can add hundreds of dollars to the cost of the drug, and it’s not clear if insurers are required to pick up all those costs.

“Cost sharing has been a problem,” said Michael Crews, policy director at One Colorado, an advocacy group for the LGBTQ community. “It’s not just getting on PrEP and taking a pill. It’s the lab and clinical services. That’s a huge barrier for folks.”

Whether you’re shopping for a new plan during open enrollment or want to check out what your current plan covers, here are answers to questions you may have about the new preventive coverage requirement.
 

Q: How can people find out whether their health plan covers PrEP medications without charge?

The plan’s list of covered drugs, called a formulary, should spell out which drugs are covered, along with details about which drug tier they fall into. Drugs placed in higher tiers generally have higher cost sharing. That list should be online with the plan documents that give coverage details.

Sorting out coverage and cost sharing can be tricky. Both Truvada and Descovy can also be used to treat HIV, and if they are taken for that purpose, a plan may require members to pay some of the cost. But if the drugs are taken to prevent HIV infection, patients shouldn’t owe anything out-of-pocket, no matter which tier they are on.

In a recent analysis of online formularies for plans sold on the ACA marketplaces, Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, found that many plans seemed out of compliance with the requirement to cover PrEP without cost sharing this year.

But representatives for Oscar and Kaiser Permanente, two insurers that were called out in the analysis for lack of compliance, said the drugs are covered without cost sharing in plans nationwide if they are taken to prevent HIV. Schmid later revised his analysis to reflect Oscar’s coverage.

Coverage and cost-sharing information needs to be transparent and easy to find, Schmid said.

“I acted like a shopper of insurance, just like any person would do,” he said. “Even when the information is correct, [it’s so] difficult to find [and there’s] no uniformity.”

It may be necessary to call the insurer directly to confirm coverage details if information on the website is unclear.
 

Q: Are all three drugs covered without cost sharing?

Health plans have to cover at least one of the drugs in this category — Descovy and the brand and generic versions of Truvada — without cost sharing. People may have to jump through some hoops to get approval for a specific drug, however. For example, Oscar plans sold in 18 states cover the three PrEP options without cost sharing. The generic version of Truvada doesn’t require prior authorization by the insurer. But if someone wants to take the name-brand drug, that person has to go through an approval process. Descovy, a newer drug, is available without cost sharing only if people are unable to use Truvada or its generic version because of clinical intolerance or other issues.
 

Q: What about the lab work and clinical visits that are necessary while taking PrEP? Are those services also covered without cost sharing?

That is the thousand-dollar question. People who are taking drugs to prevent HIV infection need to meet with a clinician and have blood work every three months to test for HIV, hepatitis B and sexually transmitted infections, and to check their kidney function.

The task force recommendation doesn’t specify whether these services must also be covered without cost sharing, and advocates say federal guidance is necessary to ensure they are free.

“If you’ve got a high-deductible plan and you’ve got to meet it before those services are covered, that’s going to add up,” said Amy Killelea, senior director of health systems and policy at the National Alliance of State & Territorial AIDS Directors. “We’re trying to emphasize that it’s integral to the intervention itself.”

A handful of states have programs that help people cover their out-of-pocket costs for lab and clinical visits, generally based on income.

There is precedent for including free ancillary care as part of a recommended preventive service. After consumers and advocates complained, the Centers for Medicare & Medicaid Services (CMS) clarified that under the ACA removing a polyp during a screening colonoscopy is considered an integral part of the procedure and patients shouldn’t be charged for it.

CMS officials declined to clarify whether PrEP services such as lab work and clinical visits are to be covered without cost sharing as part of the preventive service and noted that states generally enforce such insurance requirements. “CMS intends to contact state regulators, as appropriate, to discuss issuer’s compliance with the federal requirements and whether issuers need further guidance on which services associated with PrEP must be covered without cost sharing,” the agency said in a statement.
 

Q: What if someone runs into roadblocks getting a plan to cover PrEP or related services without cost sharing?

If an insurer charges for the medication or a follow-up visit, people may have to go through an appeals process to fight it.

“They’d have to appeal to the insurance company and then to the state if they don’t succeed,” said Nadeen Israel, vice president of policy and advocacy at the AIDS Foundation of Chicago. “Most people don’t know to do that.”
 

Q: Are uninsured people also protected by this new cost-sharing change for PrEP?

Unfortunately, no. The ACA requirement to cover recommended preventive services without charging patients applies only to private insurance plans. People without insurance don’t benefit. Gilead, which makes both Truvada and Descovy, has a patient assistance program for the uninsured.
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up.

Under his insurance plan, the former flight attendant and customer service instructor owed $500 in copayments every month for the drug and an additional $250 every three months for lab work and clinic visits.

Luckily for Howard, his doctor at Las Vegas’ Huntridge Family Clinic, which specializes in LGBTQ care, enrolled him in a clinical trial that covered his medication and other costs in full.

“If I hadn’t been able to get into the trial, I wouldn’t have kept taking PrEP,” said Howard, 68, using the shorthand term for “preexposure prophylaxis.” Taken daily, these drugs — like Truvada — are more than 90% effective at preventing infection with HIV.

Starting in January of 2021, most people with private insurance will no longer have to decide whether they can afford to protect themselves against HIV. Most health plans must begin to cover the drugs then without charging consumers anything out-of-pocket (some plans already began doing so last year).

Drugs in this category — Truvada, Descovy and, newly available, a generic version of Truvada — received an “A” recommendation by the U.S. Preventive Services Task Force. Under the Affordable Care Act, preventive services that receive an “A” or “B” rating by the task force, a group of medical experts in prevention and primary care, must be covered by most private health plans without making members share the cost, usually through copayments or deductibles. Only plans that are grandfathered under the health law are exempt.

The task force recommended PrEP for people at high risk of HIV infection, including men who have sex with men and injection drug users.

In the United States, more than 1 million people live with HIV, and nearly 40,000 new HIV cases are diagnosed every year. Yet fewer than 10% of people who could benefit from PrEP are taking it. One key reason is that out-of-pocket costs can exceed $1,000 annually, according to a study published in the American Journal of Public Health last year. Required periodic blood tests and doctor visits can add hundreds of dollars to the cost of the drug, and it’s not clear if insurers are required to pick up all those costs.

“Cost sharing has been a problem,” said Michael Crews, policy director at One Colorado, an advocacy group for the LGBTQ community. “It’s not just getting on PrEP and taking a pill. It’s the lab and clinical services. That’s a huge barrier for folks.”

Whether you’re shopping for a new plan during open enrollment or want to check out what your current plan covers, here are answers to questions you may have about the new preventive coverage requirement.
 

Q: How can people find out whether their health plan covers PrEP medications without charge?

The plan’s list of covered drugs, called a formulary, should spell out which drugs are covered, along with details about which drug tier they fall into. Drugs placed in higher tiers generally have higher cost sharing. That list should be online with the plan documents that give coverage details.

Sorting out coverage and cost sharing can be tricky. Both Truvada and Descovy can also be used to treat HIV, and if they are taken for that purpose, a plan may require members to pay some of the cost. But if the drugs are taken to prevent HIV infection, patients shouldn’t owe anything out-of-pocket, no matter which tier they are on.

In a recent analysis of online formularies for plans sold on the ACA marketplaces, Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, found that many plans seemed out of compliance with the requirement to cover PrEP without cost sharing this year.

But representatives for Oscar and Kaiser Permanente, two insurers that were called out in the analysis for lack of compliance, said the drugs are covered without cost sharing in plans nationwide if they are taken to prevent HIV. Schmid later revised his analysis to reflect Oscar’s coverage.

Coverage and cost-sharing information needs to be transparent and easy to find, Schmid said.

“I acted like a shopper of insurance, just like any person would do,” he said. “Even when the information is correct, [it’s so] difficult to find [and there’s] no uniformity.”

It may be necessary to call the insurer directly to confirm coverage details if information on the website is unclear.
 

Q: Are all three drugs covered without cost sharing?

Health plans have to cover at least one of the drugs in this category — Descovy and the brand and generic versions of Truvada — without cost sharing. People may have to jump through some hoops to get approval for a specific drug, however. For example, Oscar plans sold in 18 states cover the three PrEP options without cost sharing. The generic version of Truvada doesn’t require prior authorization by the insurer. But if someone wants to take the name-brand drug, that person has to go through an approval process. Descovy, a newer drug, is available without cost sharing only if people are unable to use Truvada or its generic version because of clinical intolerance or other issues.
 

Q: What about the lab work and clinical visits that are necessary while taking PrEP? Are those services also covered without cost sharing?

That is the thousand-dollar question. People who are taking drugs to prevent HIV infection need to meet with a clinician and have blood work every three months to test for HIV, hepatitis B and sexually transmitted infections, and to check their kidney function.

The task force recommendation doesn’t specify whether these services must also be covered without cost sharing, and advocates say federal guidance is necessary to ensure they are free.

“If you’ve got a high-deductible plan and you’ve got to meet it before those services are covered, that’s going to add up,” said Amy Killelea, senior director of health systems and policy at the National Alliance of State & Territorial AIDS Directors. “We’re trying to emphasize that it’s integral to the intervention itself.”

A handful of states have programs that help people cover their out-of-pocket costs for lab and clinical visits, generally based on income.

There is precedent for including free ancillary care as part of a recommended preventive service. After consumers and advocates complained, the Centers for Medicare & Medicaid Services (CMS) clarified that under the ACA removing a polyp during a screening colonoscopy is considered an integral part of the procedure and patients shouldn’t be charged for it.

CMS officials declined to clarify whether PrEP services such as lab work and clinical visits are to be covered without cost sharing as part of the preventive service and noted that states generally enforce such insurance requirements. “CMS intends to contact state regulators, as appropriate, to discuss issuer’s compliance with the federal requirements and whether issuers need further guidance on which services associated with PrEP must be covered without cost sharing,” the agency said in a statement.
 

Q: What if someone runs into roadblocks getting a plan to cover PrEP or related services without cost sharing?

If an insurer charges for the medication or a follow-up visit, people may have to go through an appeals process to fight it.

“They’d have to appeal to the insurance company and then to the state if they don’t succeed,” said Nadeen Israel, vice president of policy and advocacy at the AIDS Foundation of Chicago. “Most people don’t know to do that.”
 

Q: Are uninsured people also protected by this new cost-sharing change for PrEP?

Unfortunately, no. The ACA requirement to cover recommended preventive services without charging patients applies only to private insurance plans. People without insurance don’t benefit. Gilead, which makes both Truvada and Descovy, has a patient assistance program for the uninsured.
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up.

Under his insurance plan, the former flight attendant and customer service instructor owed $500 in copayments every month for the drug and an additional $250 every three months for lab work and clinic visits.

Luckily for Howard, his doctor at Las Vegas’ Huntridge Family Clinic, which specializes in LGBTQ care, enrolled him in a clinical trial that covered his medication and other costs in full.

“If I hadn’t been able to get into the trial, I wouldn’t have kept taking PrEP,” said Howard, 68, using the shorthand term for “preexposure prophylaxis.” Taken daily, these drugs — like Truvada — are more than 90% effective at preventing infection with HIV.

Starting in January of 2021, most people with private insurance will no longer have to decide whether they can afford to protect themselves against HIV. Most health plans must begin to cover the drugs then without charging consumers anything out-of-pocket (some plans already began doing so last year).

Drugs in this category — Truvada, Descovy and, newly available, a generic version of Truvada — received an “A” recommendation by the U.S. Preventive Services Task Force. Under the Affordable Care Act, preventive services that receive an “A” or “B” rating by the task force, a group of medical experts in prevention and primary care, must be covered by most private health plans without making members share the cost, usually through copayments or deductibles. Only plans that are grandfathered under the health law are exempt.

The task force recommended PrEP for people at high risk of HIV infection, including men who have sex with men and injection drug users.

In the United States, more than 1 million people live with HIV, and nearly 40,000 new HIV cases are diagnosed every year. Yet fewer than 10% of people who could benefit from PrEP are taking it. One key reason is that out-of-pocket costs can exceed $1,000 annually, according to a study published in the American Journal of Public Health last year. Required periodic blood tests and doctor visits can add hundreds of dollars to the cost of the drug, and it’s not clear if insurers are required to pick up all those costs.

“Cost sharing has been a problem,” said Michael Crews, policy director at One Colorado, an advocacy group for the LGBTQ community. “It’s not just getting on PrEP and taking a pill. It’s the lab and clinical services. That’s a huge barrier for folks.”

Whether you’re shopping for a new plan during open enrollment or want to check out what your current plan covers, here are answers to questions you may have about the new preventive coverage requirement.
 

Q: How can people find out whether their health plan covers PrEP medications without charge?

The plan’s list of covered drugs, called a formulary, should spell out which drugs are covered, along with details about which drug tier they fall into. Drugs placed in higher tiers generally have higher cost sharing. That list should be online with the plan documents that give coverage details.

Sorting out coverage and cost sharing can be tricky. Both Truvada and Descovy can also be used to treat HIV, and if they are taken for that purpose, a plan may require members to pay some of the cost. But if the drugs are taken to prevent HIV infection, patients shouldn’t owe anything out-of-pocket, no matter which tier they are on.

In a recent analysis of online formularies for plans sold on the ACA marketplaces, Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, found that many plans seemed out of compliance with the requirement to cover PrEP without cost sharing this year.

But representatives for Oscar and Kaiser Permanente, two insurers that were called out in the analysis for lack of compliance, said the drugs are covered without cost sharing in plans nationwide if they are taken to prevent HIV. Schmid later revised his analysis to reflect Oscar’s coverage.

Coverage and cost-sharing information needs to be transparent and easy to find, Schmid said.

“I acted like a shopper of insurance, just like any person would do,” he said. “Even when the information is correct, [it’s so] difficult to find [and there’s] no uniformity.”

It may be necessary to call the insurer directly to confirm coverage details if information on the website is unclear.
 

Q: Are all three drugs covered without cost sharing?

Health plans have to cover at least one of the drugs in this category — Descovy and the brand and generic versions of Truvada — without cost sharing. People may have to jump through some hoops to get approval for a specific drug, however. For example, Oscar plans sold in 18 states cover the three PrEP options without cost sharing. The generic version of Truvada doesn’t require prior authorization by the insurer. But if someone wants to take the name-brand drug, that person has to go through an approval process. Descovy, a newer drug, is available without cost sharing only if people are unable to use Truvada or its generic version because of clinical intolerance or other issues.
 

Q: What about the lab work and clinical visits that are necessary while taking PrEP? Are those services also covered without cost sharing?

That is the thousand-dollar question. People who are taking drugs to prevent HIV infection need to meet with a clinician and have blood work every three months to test for HIV, hepatitis B and sexually transmitted infections, and to check their kidney function.

The task force recommendation doesn’t specify whether these services must also be covered without cost sharing, and advocates say federal guidance is necessary to ensure they are free.

“If you’ve got a high-deductible plan and you’ve got to meet it before those services are covered, that’s going to add up,” said Amy Killelea, senior director of health systems and policy at the National Alliance of State & Territorial AIDS Directors. “We’re trying to emphasize that it’s integral to the intervention itself.”

A handful of states have programs that help people cover their out-of-pocket costs for lab and clinical visits, generally based on income.

There is precedent for including free ancillary care as part of a recommended preventive service. After consumers and advocates complained, the Centers for Medicare & Medicaid Services (CMS) clarified that under the ACA removing a polyp during a screening colonoscopy is considered an integral part of the procedure and patients shouldn’t be charged for it.

CMS officials declined to clarify whether PrEP services such as lab work and clinical visits are to be covered without cost sharing as part of the preventive service and noted that states generally enforce such insurance requirements. “CMS intends to contact state regulators, as appropriate, to discuss issuer’s compliance with the federal requirements and whether issuers need further guidance on which services associated with PrEP must be covered without cost sharing,” the agency said in a statement.
 

Q: What if someone runs into roadblocks getting a plan to cover PrEP or related services without cost sharing?

If an insurer charges for the medication or a follow-up visit, people may have to go through an appeals process to fight it.

“They’d have to appeal to the insurance company and then to the state if they don’t succeed,” said Nadeen Israel, vice president of policy and advocacy at the AIDS Foundation of Chicago. “Most people don’t know to do that.”
 

Q: Are uninsured people also protected by this new cost-sharing change for PrEP?

Unfortunately, no. The ACA requirement to cover recommended preventive services without charging patients applies only to private insurance plans. People without insurance don’t benefit. Gilead, which makes both Truvada and Descovy, has a patient assistance program for the uninsured.
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Clinical encounters with female patients presenting with a STI offer a key opportunity for health care professionals to identify and prevent HIV through testing and prophylactic treatment, reported Kirk D. Henny, PhD, and colleagues of the Centers for Disease Control and Prevention.

In an effort to quantify HIV testing rates as well as the rate of pre-exposure prophylaxis (PrEP) among women with gonorrhea or syphilis, Dr. Henny and his colleagues performed a multivariate logistic regression analysis of 13,074 female patients aged 15-64 diagnosed with a STI in the absence of HIV. Data was pulled in 2017 from the IBM MarketScan commercial and Medicaid insurance databases, and the research was published in Obstetrics & Gynecology.
 

Medicaid patients were more likely to be tested for HIV

A total of 3,709 patients with commercial insurance were diagnosed with gonorrhea and 1,696 with syphilis. Among those with Medicaid, 6,172 were diagnosed with gonorrhea and 1,497 with syphilis. Medicaid patients diagnosed with either STI were more likely to be tested for HIV than the commercially insured patients. With an adjusted prevalence ratio, patients commercially insured with had either STI were more likely to be tested for HIV than patients who had no STI. Prophylactic treatment rates were similar in both insurance groups: 0.15% in the commercial insurance group and 0.26% in the Medicaid group. No patient from either group who was diagnosed with gonorrhea or syphilis and subsequently tested for HIV received pre-exposure prophylactic (PrEP) treatment.

STI diagnosis is a significant indicator of future HIV

Female patients diagnosed with either STI are more likely to contract HIV, the researchers noted. They cautioned that their findings of low HIV testing rates and the absence of prophylactic treatment means that “these missed opportunities for health care professionals to intervene with female patients diagnosed with gonorrhea or syphilis might have contributed to HIV infections that could have been averted.”

The researchers also pointed out that, in a recent analysis of pharmacy data, prophylactic prescribing for female patients with clinical indications for PrEP was 6.6%, less than one-third the coverage provided to male patients.

Future research should target understanding “individual and contextual factors associated with low HIV testing” and PrEP treatment in female patients, especially those with STIs, Dr. Henny and his colleagues advised.

In a separate interview, Constance Bohon, MD FACOG, observed: “The authors present data to document the low incidence of pre-exposure prophylaxis in women who are at substantial risk of acquiring HIV and possible causes for the low utilization of this treatment.” It is important to identify barriers to diagnosis, counseling, and treatment, she advised.

“Multicenter studies to determine the best methodologies to improve the identification, management, and treatment of these at-risk women need to be done, and the conclusions disseminated to health care providers caring for women,” Dr. Bohon said.
 

PrEP is an important, simple strategy for reducing HIV transmission

“Pre-exposure prophylaxis has been demonstrated to decrease HIV acquisition in those at risk by up to 90% when taken appropriately,” and yet prescribing rates are extremely low (2%-6%) in at-risk women and especially women of color. These disparities have only grown over time, with prophylactic prescriptions for women at 5% between 2012 and 2017, compared with 68% for men, Catherine S. Eppes, MD, MPH, and Jennifer McKinney, MD, MPH, said in a related editorial commenting on the Research Letter by Dr. Henny and colleagues in Obstetrics & Gynecology (2020 Dec;136[6]:1080-2).

Given the abundant research demonstrating the importance and ease of prescribing PrEP, the question remains: “why does preexposure prophylaxis uptake remain so low, especially for women and women of color? There are three important issues about preexposure prophylaxis raised by this study: the research gap, the implementation gap, and the effect of systemic racism and bias,” noted Dr. Eppes and Dr. McKinney.

Women constitute a significant portion of the population that would benefit from HIV-prevention strategies, yet they continue to be excluded from research, they noted. “Much focus on research into barriers and implementation interventions for preexposure prophylaxis have focused on men who have sex with men and transgender women,” the authors of the editorial wrote.

Most women eligible for treatment would be willing to consider it if they were aware of the option, but numerous studies have cited a lack of awareness, especially among high-risk women of color in the United States, Dr. Eppes and Dr. McKinney noted.

Clinicians also need to add it to their growing checklist of mandatory appointment discussion topics, the editorialists said. “We propose standardized inclusion of preexposure prophylaxis counseling during reproductive healthcare visits. This could be aided through an electronic medical record-based best practice advisory alert. … Standardized order sets with the medication and laboratory studies necessary for safe monitoring could facilitate ease of incorporating into routine visits,” they suggested.

“Preexposure prophylaxis is extremely effective in preventing HIV, is safe, and is the only prevention method that leaves control entirely in the hands of the female partner. As a specialty, we have a responsibility to make sure our patients know about this option,” the editorialists concluded.

The authors had no financial disclosures to report. Dr. Bohon had no conflicts of interest to report.
 

SOURCE: Henny KD et al. Obstet Gynecol. 2020 Dec;136(6):1083-5.

Clinical encounters with female patients presenting with a STI offer a key opportunity for health care professionals to identify and prevent HIV through testing and prophylactic treatment, reported Kirk D. Henny, PhD, and colleagues of the Centers for Disease Control and Prevention.

In an effort to quantify HIV testing rates as well as the rate of pre-exposure prophylaxis (PrEP) among women with gonorrhea or syphilis, Dr. Henny and his colleagues performed a multivariate logistic regression analysis of 13,074 female patients aged 15-64 diagnosed with a STI in the absence of HIV. Data was pulled in 2017 from the IBM MarketScan commercial and Medicaid insurance databases, and the research was published in Obstetrics & Gynecology.
 

Medicaid patients were more likely to be tested for HIV

A total of 3,709 patients with commercial insurance were diagnosed with gonorrhea and 1,696 with syphilis. Among those with Medicaid, 6,172 were diagnosed with gonorrhea and 1,497 with syphilis. Medicaid patients diagnosed with either STI were more likely to be tested for HIV than the commercially insured patients. With an adjusted prevalence ratio, patients commercially insured with had either STI were more likely to be tested for HIV than patients who had no STI. Prophylactic treatment rates were similar in both insurance groups: 0.15% in the commercial insurance group and 0.26% in the Medicaid group. No patient from either group who was diagnosed with gonorrhea or syphilis and subsequently tested for HIV received pre-exposure prophylactic (PrEP) treatment.

STI diagnosis is a significant indicator of future HIV

Female patients diagnosed with either STI are more likely to contract HIV, the researchers noted. They cautioned that their findings of low HIV testing rates and the absence of prophylactic treatment means that “these missed opportunities for health care professionals to intervene with female patients diagnosed with gonorrhea or syphilis might have contributed to HIV infections that could have been averted.”

The researchers also pointed out that, in a recent analysis of pharmacy data, prophylactic prescribing for female patients with clinical indications for PrEP was 6.6%, less than one-third the coverage provided to male patients.

Future research should target understanding “individual and contextual factors associated with low HIV testing” and PrEP treatment in female patients, especially those with STIs, Dr. Henny and his colleagues advised.

In a separate interview, Constance Bohon, MD FACOG, observed: “The authors present data to document the low incidence of pre-exposure prophylaxis in women who are at substantial risk of acquiring HIV and possible causes for the low utilization of this treatment.” It is important to identify barriers to diagnosis, counseling, and treatment, she advised.

“Multicenter studies to determine the best methodologies to improve the identification, management, and treatment of these at-risk women need to be done, and the conclusions disseminated to health care providers caring for women,” Dr. Bohon said.
 

PrEP is an important, simple strategy for reducing HIV transmission

“Pre-exposure prophylaxis has been demonstrated to decrease HIV acquisition in those at risk by up to 90% when taken appropriately,” and yet prescribing rates are extremely low (2%-6%) in at-risk women and especially women of color. These disparities have only grown over time, with prophylactic prescriptions for women at 5% between 2012 and 2017, compared with 68% for men, Catherine S. Eppes, MD, MPH, and Jennifer McKinney, MD, MPH, said in a related editorial commenting on the Research Letter by Dr. Henny and colleagues in Obstetrics & Gynecology (2020 Dec;136[6]:1080-2).

Given the abundant research demonstrating the importance and ease of prescribing PrEP, the question remains: “why does preexposure prophylaxis uptake remain so low, especially for women and women of color? There are three important issues about preexposure prophylaxis raised by this study: the research gap, the implementation gap, and the effect of systemic racism and bias,” noted Dr. Eppes and Dr. McKinney.

Women constitute a significant portion of the population that would benefit from HIV-prevention strategies, yet they continue to be excluded from research, they noted. “Much focus on research into barriers and implementation interventions for preexposure prophylaxis have focused on men who have sex with men and transgender women,” the authors of the editorial wrote.

Most women eligible for treatment would be willing to consider it if they were aware of the option, but numerous studies have cited a lack of awareness, especially among high-risk women of color in the United States, Dr. Eppes and Dr. McKinney noted.

Clinicians also need to add it to their growing checklist of mandatory appointment discussion topics, the editorialists said. “We propose standardized inclusion of preexposure prophylaxis counseling during reproductive healthcare visits. This could be aided through an electronic medical record-based best practice advisory alert. … Standardized order sets with the medication and laboratory studies necessary for safe monitoring could facilitate ease of incorporating into routine visits,” they suggested.

“Preexposure prophylaxis is extremely effective in preventing HIV, is safe, and is the only prevention method that leaves control entirely in the hands of the female partner. As a specialty, we have a responsibility to make sure our patients know about this option,” the editorialists concluded.

The authors had no financial disclosures to report. Dr. Bohon had no conflicts of interest to report.
 

SOURCE: Henny KD et al. Obstet Gynecol. 2020 Dec;136(6):1083-5.

Clinical encounters with female patients presenting with a STI offer a key opportunity for health care professionals to identify and prevent HIV through testing and prophylactic treatment, reported Kirk D. Henny, PhD, and colleagues of the Centers for Disease Control and Prevention.

In an effort to quantify HIV testing rates as well as the rate of pre-exposure prophylaxis (PrEP) among women with gonorrhea or syphilis, Dr. Henny and his colleagues performed a multivariate logistic regression analysis of 13,074 female patients aged 15-64 diagnosed with a STI in the absence of HIV. Data was pulled in 2017 from the IBM MarketScan commercial and Medicaid insurance databases, and the research was published in Obstetrics & Gynecology.
 

Medicaid patients were more likely to be tested for HIV

A total of 3,709 patients with commercial insurance were diagnosed with gonorrhea and 1,696 with syphilis. Among those with Medicaid, 6,172 were diagnosed with gonorrhea and 1,497 with syphilis. Medicaid patients diagnosed with either STI were more likely to be tested for HIV than the commercially insured patients. With an adjusted prevalence ratio, patients commercially insured with had either STI were more likely to be tested for HIV than patients who had no STI. Prophylactic treatment rates were similar in both insurance groups: 0.15% in the commercial insurance group and 0.26% in the Medicaid group. No patient from either group who was diagnosed with gonorrhea or syphilis and subsequently tested for HIV received pre-exposure prophylactic (PrEP) treatment.

STI diagnosis is a significant indicator of future HIV

Female patients diagnosed with either STI are more likely to contract HIV, the researchers noted. They cautioned that their findings of low HIV testing rates and the absence of prophylactic treatment means that “these missed opportunities for health care professionals to intervene with female patients diagnosed with gonorrhea or syphilis might have contributed to HIV infections that could have been averted.”

The researchers also pointed out that, in a recent analysis of pharmacy data, prophylactic prescribing for female patients with clinical indications for PrEP was 6.6%, less than one-third the coverage provided to male patients.

Future research should target understanding “individual and contextual factors associated with low HIV testing” and PrEP treatment in female patients, especially those with STIs, Dr. Henny and his colleagues advised.

In a separate interview, Constance Bohon, MD FACOG, observed: “The authors present data to document the low incidence of pre-exposure prophylaxis in women who are at substantial risk of acquiring HIV and possible causes for the low utilization of this treatment.” It is important to identify barriers to diagnosis, counseling, and treatment, she advised.

“Multicenter studies to determine the best methodologies to improve the identification, management, and treatment of these at-risk women need to be done, and the conclusions disseminated to health care providers caring for women,” Dr. Bohon said.
 

PrEP is an important, simple strategy for reducing HIV transmission

“Pre-exposure prophylaxis has been demonstrated to decrease HIV acquisition in those at risk by up to 90% when taken appropriately,” and yet prescribing rates are extremely low (2%-6%) in at-risk women and especially women of color. These disparities have only grown over time, with prophylactic prescriptions for women at 5% between 2012 and 2017, compared with 68% for men, Catherine S. Eppes, MD, MPH, and Jennifer McKinney, MD, MPH, said in a related editorial commenting on the Research Letter by Dr. Henny and colleagues in Obstetrics & Gynecology (2020 Dec;136[6]:1080-2).

Given the abundant research demonstrating the importance and ease of prescribing PrEP, the question remains: “why does preexposure prophylaxis uptake remain so low, especially for women and women of color? There are three important issues about preexposure prophylaxis raised by this study: the research gap, the implementation gap, and the effect of systemic racism and bias,” noted Dr. Eppes and Dr. McKinney.

Women constitute a significant portion of the population that would benefit from HIV-prevention strategies, yet they continue to be excluded from research, they noted. “Much focus on research into barriers and implementation interventions for preexposure prophylaxis have focused on men who have sex with men and transgender women,” the authors of the editorial wrote.

Most women eligible for treatment would be willing to consider it if they were aware of the option, but numerous studies have cited a lack of awareness, especially among high-risk women of color in the United States, Dr. Eppes and Dr. McKinney noted.

Clinicians also need to add it to their growing checklist of mandatory appointment discussion topics, the editorialists said. “We propose standardized inclusion of preexposure prophylaxis counseling during reproductive healthcare visits. This could be aided through an electronic medical record-based best practice advisory alert. … Standardized order sets with the medication and laboratory studies necessary for safe monitoring could facilitate ease of incorporating into routine visits,” they suggested.

“Preexposure prophylaxis is extremely effective in preventing HIV, is safe, and is the only prevention method that leaves control entirely in the hands of the female partner. As a specialty, we have a responsibility to make sure our patients know about this option,” the editorialists concluded.

The authors had no financial disclosures to report. Dr. Bohon had no conflicts of interest to report.
 

SOURCE: Henny KD et al. Obstet Gynecol. 2020 Dec;136(6):1083-5.

Individuals living with hepatitis C virus (HCV) infection face several challenges in accessing care, many of which are shared by patients in the HIV community.

Better linkage to care with providers who are familiar with both the HCV and HIV treatment cascade may not only improve access to HCV treatment, but it may also support patient retention, treatment adherence, and achievement of sustained virologic response (SVR) and viral suppression, said Stephanie LaMoy, CAN Community Health, North Point, Florida. She presented the results of a pilot study at the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.

In an effort to identify strategies most important for improving care access among their patients with HCV, LaMoy and her colleagues assessed 12-month patient data collected from three of their clinics. These data were evaluated for HCV treatment access, engagement, and outcomes.

The pilot study included 126 patients who were reactive and another 24 HCV-positive patients who were referred from other sources. Active HCV infections requiring treatment were reported in 144 patients.

A total of 59 patients were linked to care but did not initiate treatment for their active infection. LaMoy said there were multiple causes, including homelessness, substance abuse, and inability to maintain contact.

In contrast, 85 patients with HCV infection started treatment, but 35 of these patients did not complete their regimen. Out of the 50 patients who reported completing treatment, 30 did not return to the clinic to confirm sustained viral suppression.

According to LaMoy, this raised a red flag, causing the investigators to consider a different approach to care.
 

HIV care continuum model and its role in HCV

To improve the rate at which patients with HCV infection complete treatment within their clinics, the researchers formed a panel to determine necessary interventions that could reduce barriers to care.

The HIV care continuum came into play. They chose this model based on knowledge that HCV and HIV share the same care continuum with similar goals in diagnosis, linkage to care, retention, and suppression.

Based on the consensus of the panel and consideration of the HIV care continuum model, they identified a number of interventions needed to mitigate HCV treatment barriers. These included the incorporation of peer navigators or linkage-to-care (LCC) coordinators, use of the mobile medical unit, greater implementation of onsite lab visits, and medication-assisted treatment.

The LCC coordinators proved to be particularly important, as these team members helped assist patients with social and financial support to address challenges with access to treatment. These coordinators can also help  patients gain access to specialized providers, ultimately improving the chance of successful HCV management.

Additionally, LCC coordinators may help identify and reduce barriers associated with housing, transportation, and nutrition. Frequent patient contact by the LCC coordinators can encourage adherence and promote risk reduction education, such as providing referrals to needle exchange services.

“Linking individuals to care with providers who are familiar with the treatment cascade could help improve retention and should be a top priority for those involved in HCV screening and treatment,” said LaMoy. “An environment with knowledge, lack of judgment, and a tenacious need to heal the community that welcomes those with barriers to care is exactly what is needed for the patients in our program.”
 

National, community challenges fuel barriers to HCV treatment access

Substance use, trauma histories, and mental health problems can negatively affect care engagement and must be addressed before the benefits of HCV therapy can be realized.

Addressing these issues isn’t always easy, said Kathleen Bernock, FNP-BC, AACRN, AAHIVS, of the Bedford-Stuyvesant Family Health Center in New York City, in an email to Medscape Medical News. She pointed out that several states have harsh restrictions on who is able to access HCV treatment, and some states will not approve certain medications for people who actively use drugs.

“Even for states without these restrictions, many health systems are difficult to navigate and may not be welcoming to persons actively using,” said Bernock. Trauma-informed care can also be difficult to translate into clinics, she added.

“Decentralizing care to the communities most affected would greatly help mitigate these barriers,” suggested Bernock. Decentralization, she explained, might include co-locating services such as syringe exchanges, utilizing community health workers and patient navigators, and expanding capacity-to-treat to community-based providers.

“[And] with the expansion of telehealth services in the US,” said Bernock, “we now have even more avenues to reach people that we never had before.”

LaMoy and Bernock have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Individuals living with hepatitis C virus (HCV) infection face several challenges in accessing care, many of which are shared by patients in the HIV community.

Better linkage to care with providers who are familiar with both the HCV and HIV treatment cascade may not only improve access to HCV treatment, but it may also support patient retention, treatment adherence, and achievement of sustained virologic response (SVR) and viral suppression, said Stephanie LaMoy, CAN Community Health, North Point, Florida. She presented the results of a pilot study at the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.

In an effort to identify strategies most important for improving care access among their patients with HCV, LaMoy and her colleagues assessed 12-month patient data collected from three of their clinics. These data were evaluated for HCV treatment access, engagement, and outcomes.

The pilot study included 126 patients who were reactive and another 24 HCV-positive patients who were referred from other sources. Active HCV infections requiring treatment were reported in 144 patients.

A total of 59 patients were linked to care but did not initiate treatment for their active infection. LaMoy said there were multiple causes, including homelessness, substance abuse, and inability to maintain contact.

In contrast, 85 patients with HCV infection started treatment, but 35 of these patients did not complete their regimen. Out of the 50 patients who reported completing treatment, 30 did not return to the clinic to confirm sustained viral suppression.

According to LaMoy, this raised a red flag, causing the investigators to consider a different approach to care.
 

HIV care continuum model and its role in HCV

To improve the rate at which patients with HCV infection complete treatment within their clinics, the researchers formed a panel to determine necessary interventions that could reduce barriers to care.

The HIV care continuum came into play. They chose this model based on knowledge that HCV and HIV share the same care continuum with similar goals in diagnosis, linkage to care, retention, and suppression.

Based on the consensus of the panel and consideration of the HIV care continuum model, they identified a number of interventions needed to mitigate HCV treatment barriers. These included the incorporation of peer navigators or linkage-to-care (LCC) coordinators, use of the mobile medical unit, greater implementation of onsite lab visits, and medication-assisted treatment.

The LCC coordinators proved to be particularly important, as these team members helped assist patients with social and financial support to address challenges with access to treatment. These coordinators can also help  patients gain access to specialized providers, ultimately improving the chance of successful HCV management.

Additionally, LCC coordinators may help identify and reduce barriers associated with housing, transportation, and nutrition. Frequent patient contact by the LCC coordinators can encourage adherence and promote risk reduction education, such as providing referrals to needle exchange services.

“Linking individuals to care with providers who are familiar with the treatment cascade could help improve retention and should be a top priority for those involved in HCV screening and treatment,” said LaMoy. “An environment with knowledge, lack of judgment, and a tenacious need to heal the community that welcomes those with barriers to care is exactly what is needed for the patients in our program.”
 

National, community challenges fuel barriers to HCV treatment access

Substance use, trauma histories, and mental health problems can negatively affect care engagement and must be addressed before the benefits of HCV therapy can be realized.

Addressing these issues isn’t always easy, said Kathleen Bernock, FNP-BC, AACRN, AAHIVS, of the Bedford-Stuyvesant Family Health Center in New York City, in an email to Medscape Medical News. She pointed out that several states have harsh restrictions on who is able to access HCV treatment, and some states will not approve certain medications for people who actively use drugs.

“Even for states without these restrictions, many health systems are difficult to navigate and may not be welcoming to persons actively using,” said Bernock. Trauma-informed care can also be difficult to translate into clinics, she added.

“Decentralizing care to the communities most affected would greatly help mitigate these barriers,” suggested Bernock. Decentralization, she explained, might include co-locating services such as syringe exchanges, utilizing community health workers and patient navigators, and expanding capacity-to-treat to community-based providers.

“[And] with the expansion of telehealth services in the US,” said Bernock, “we now have even more avenues to reach people that we never had before.”

LaMoy and Bernock have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Individuals living with hepatitis C virus (HCV) infection face several challenges in accessing care, many of which are shared by patients in the HIV community.

Better linkage to care with providers who are familiar with both the HCV and HIV treatment cascade may not only improve access to HCV treatment, but it may also support patient retention, treatment adherence, and achievement of sustained virologic response (SVR) and viral suppression, said Stephanie LaMoy, CAN Community Health, North Point, Florida. She presented the results of a pilot study at the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.

In an effort to identify strategies most important for improving care access among their patients with HCV, LaMoy and her colleagues assessed 12-month patient data collected from three of their clinics. These data were evaluated for HCV treatment access, engagement, and outcomes.

The pilot study included 126 patients who were reactive and another 24 HCV-positive patients who were referred from other sources. Active HCV infections requiring treatment were reported in 144 patients.

A total of 59 patients were linked to care but did not initiate treatment for their active infection. LaMoy said there were multiple causes, including homelessness, substance abuse, and inability to maintain contact.

In contrast, 85 patients with HCV infection started treatment, but 35 of these patients did not complete their regimen. Out of the 50 patients who reported completing treatment, 30 did not return to the clinic to confirm sustained viral suppression.

According to LaMoy, this raised a red flag, causing the investigators to consider a different approach to care.
 

HIV care continuum model and its role in HCV

To improve the rate at which patients with HCV infection complete treatment within their clinics, the researchers formed a panel to determine necessary interventions that could reduce barriers to care.

The HIV care continuum came into play. They chose this model based on knowledge that HCV and HIV share the same care continuum with similar goals in diagnosis, linkage to care, retention, and suppression.

Based on the consensus of the panel and consideration of the HIV care continuum model, they identified a number of interventions needed to mitigate HCV treatment barriers. These included the incorporation of peer navigators or linkage-to-care (LCC) coordinators, use of the mobile medical unit, greater implementation of onsite lab visits, and medication-assisted treatment.

The LCC coordinators proved to be particularly important, as these team members helped assist patients with social and financial support to address challenges with access to treatment. These coordinators can also help  patients gain access to specialized providers, ultimately improving the chance of successful HCV management.

Additionally, LCC coordinators may help identify and reduce barriers associated with housing, transportation, and nutrition. Frequent patient contact by the LCC coordinators can encourage adherence and promote risk reduction education, such as providing referrals to needle exchange services.

“Linking individuals to care with providers who are familiar with the treatment cascade could help improve retention and should be a top priority for those involved in HCV screening and treatment,” said LaMoy. “An environment with knowledge, lack of judgment, and a tenacious need to heal the community that welcomes those with barriers to care is exactly what is needed for the patients in our program.”
 

National, community challenges fuel barriers to HCV treatment access

Substance use, trauma histories, and mental health problems can negatively affect care engagement and must be addressed before the benefits of HCV therapy can be realized.

Addressing these issues isn’t always easy, said Kathleen Bernock, FNP-BC, AACRN, AAHIVS, of the Bedford-Stuyvesant Family Health Center in New York City, in an email to Medscape Medical News. She pointed out that several states have harsh restrictions on who is able to access HCV treatment, and some states will not approve certain medications for people who actively use drugs.

“Even for states without these restrictions, many health systems are difficult to navigate and may not be welcoming to persons actively using,” said Bernock. Trauma-informed care can also be difficult to translate into clinics, she added.

“Decentralizing care to the communities most affected would greatly help mitigate these barriers,” suggested Bernock. Decentralization, she explained, might include co-locating services such as syringe exchanges, utilizing community health workers and patient navigators, and expanding capacity-to-treat to community-based providers.

“[And] with the expansion of telehealth services in the US,” said Bernock, “we now have even more avenues to reach people that we never had before.”

LaMoy and Bernock have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

It took an average of 380 days for people who had received an abnormal anal Pap test result after having been diagnosed with HIV to undergo high-resolution anoscopy (HRA), which is recommended as follow-up.

That delay “revealed missed opportunities for a better experience on the patient, clinic, and provider level,” Jessica Wells, PhD, research assistant professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said in an interview. After all, “a lot can happen in that 1 year,” including early development of human papillomavirus (HPV)–associated anal cancer.

Although it’s too soon to say how significant that delay is with respect to the natural history of anal cancer, Dr. Wells said the data are a potential signal of disparities.

“The findings from my study may foreshadow potential disparities if we don’t have the necessary resources in place to promote follow-up care after an abnormal Pap test, similar to the disparities that we see in cervical cancer,” she said during the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.
 

Single-center study

In the United States, people living with HIV are 19 times more likely to develop anal cancer than the general population, according to a 2018 article in the Journal of Clinical Oncology. Another single-center study from Yale University found that, in minority communities, anal cancer rates were 75% higher than in White communities. Anal cancer rates were 72% higher in communities with greater poverty. As a result, many clinics are beginning to administer Pap tests to determine early signs of HPV infection and associated changes.

In Dr. Wells’ study, which was conducted from 2012 to 2015, 150 adults with HIV who were aged 21 and older were recruited from Grady Ponce De Leon Center in Atlanta. According to a 2018 study from that center, a large minority of participants had late-stage HIV and suppressed immune systems.

All participants had been referred for HRA after a recent abnormal anal Pap test. Participants filled out questionnaires on sociodemographics, internalized HIV-related stigma, depression, risk behaviors, social support, and knowledge about HPV and anal cancer.

Participants were disproportionately older (mean age, 50.9 years); cisgender (86.7%), Black (78%); and gay, lesbian, or bisexual (84.3%). Slightly more than 1 in 10 participants (11.3%) were transgender women.

Although for 6% of participants, Pap test results indicated high-grade squamous intraepithelial lesions (HSIL), an additional 8% had atypical Pap findings that couldn’t exclude HSIL – the kinds of results that are one step away from a cancer diagnosis. More than 80% of participants had low-grade or inconclusive results. Nearly half (44%) of participants’ Pap tests revealed low-grade squamous cell intraepithelial cell lesions (LSIL); 42% indicated atypical squamous cells of undetermined significance.

When Dr. Wells looked at how long participants had waited to undergo HRA, she found something that surprised her: although some participants underwent follow-up assessment in 17 days, for many, it took much longer. The longest wait was 2,350 days – more than 6 years.

“There were quite a few patients who had follow-up beyond 1,000-plus days,” Dr. Wells said in an interview. “I didn›t think the delays were that long — at most, I would say that patients will get scheduled and come back within a few weeks or months.”

What’s more, she discovered through the HPV knowledge questionnaire that many participants did not understand why they were having a follow-up appointment. Anecdotally, some confused HPV with HIV.

“There’s education to be done to inform this target population that those living with HIV are more prone or at increased risk of this virus causing cancer later,” she said. “There are a lot of campaigns around women living with HIV, that they need to do cervical cancer screening. I think we need to really expand this campaign to include that HPV can also cause anal cancer.”

Dr. Wells had planned to primarily investigate the impact of psychosocial factors on wait time to follow-up, but none of those factors were associated with longer wait times.
 

Systems-level factors

That led Ann Gakumo, PhD, chair of nursing at the College of Nursing and Health Sciences of the University of Massachusetts, Boston, to ask what other factors could account for the delay.

There were several, Dr. Wells said. Precarious housing, for example, could have influenced this lag in follow-up. About one in four participants were in transient housing, and one participant reported having been incarcerated. She gathered street addresses and plans to analyze that data to see whether the cases occurred in clusters in specific neighborhoods, as the Yale data indicated.

In addition, the anoscopy clinic was only available to receive patients one day a week and was staffed with only one clinician who was trained to perform HRA. Wait times could stretch for hours. Sometimes, participants had to leave the clinic to attend to other business, and their appointments needed to be rescheduled, Wells said.

In addition to the sometimes poor understanding of the importance of the follow-up test, Dr. Wells said, “we start to see a layering of these barriers. That’s where we start seeing breakdowns. So I’m hoping in a larger study I can address some of these barriers on a multilevel approach.”

This resonated with Dr. Gakumo.

“Oftentimes, we put so much of the responsibility for this on the part of the client and not enough on the part of the provider or on the systems level,” she said.
 

Guiding guidelines

Guidelines on follow-up for abnormal anal Pap test results are scarce, mostly because, unlike cervical cancer, the natural history of HPV-related anal cancers hasn’t been established. The HIV Medical Association does recommend anal Pap tests, but only in cases in which “access to appropriate referral for follow-up, including high-resolution anoscopy, is available.”

In an interview, Cecile Lahiri, MD, assistant professor of infectious disease at Emory University, said that, at Ponce De Leon Center, they recommend an anal Pap for women with HIV who have a history of cervical dysplasia.

There is a reliable association between high-grade abnormal Pap tests and cervical cancer, although low-grade changes can resolve on their own. In the case of anal cancer, especially in patients with HIV, low-grade cell changes are predictive; moreover, for such patients, anal cancer is more likely to recur and is harder to treat, Dr. Lahiri said.

“The cervical environment and the anal environment are very different,” said Dr. Lahiri, who works at the Grady Ponce De Leon Center but was not involved in Dr. Wells’ study. Dr. Lahiri is also a coinvestigator of the multisite, randomized, controlled Anal Cancer HSIL Outcomes Research (ANCHOR) study, which seeks to establish whether early treatment of high-grade anal Pap changes is better than a watch-and-wait approach.

Dr. Lahiri said that when the results of that trial become available, they are more likely to know how important early anoscopy and treatment are. The findings should inform guidelines and insurance coverage of anal Pap tests and anoscopy.

In the meantime, she said, she suspected that, with the ANCHOR trial in 2015, many sites’ capacity for anoscopy may have increased, and the wait times may have gone down.

“One of the most important pieces of the study is actually the time period in which it was conducted,” said Dr. Lahiri, who in 2015 became the clinic’s second physician trained in anoscopy. Currently, more than 200 people at the Ponce De Leon Center are enrolled in the ANCHOR trial. In addition, the general capacity for performing anoscopies has gone up nationwide as a result of the trial, which required that more providers learn how to properly perform an HRA. Many clinicians are not routinely trained in performing HRA, including gastroenterologists and surgeons, Dr. Lahiri said.

“It would be interesting to look at the differences, with the start of ANCHOR being the time point for before and after,” she said.

This article first appeared on Medscape.com.

It took an average of 380 days for people who had received an abnormal anal Pap test result after having been diagnosed with HIV to undergo high-resolution anoscopy (HRA), which is recommended as follow-up.

That delay “revealed missed opportunities for a better experience on the patient, clinic, and provider level,” Jessica Wells, PhD, research assistant professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said in an interview. After all, “a lot can happen in that 1 year,” including early development of human papillomavirus (HPV)–associated anal cancer.

Although it’s too soon to say how significant that delay is with respect to the natural history of anal cancer, Dr. Wells said the data are a potential signal of disparities.

“The findings from my study may foreshadow potential disparities if we don’t have the necessary resources in place to promote follow-up care after an abnormal Pap test, similar to the disparities that we see in cervical cancer,” she said during the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.
 

Single-center study

In the United States, people living with HIV are 19 times more likely to develop anal cancer than the general population, according to a 2018 article in the Journal of Clinical Oncology. Another single-center study from Yale University found that, in minority communities, anal cancer rates were 75% higher than in White communities. Anal cancer rates were 72% higher in communities with greater poverty. As a result, many clinics are beginning to administer Pap tests to determine early signs of HPV infection and associated changes.

In Dr. Wells’ study, which was conducted from 2012 to 2015, 150 adults with HIV who were aged 21 and older were recruited from Grady Ponce De Leon Center in Atlanta. According to a 2018 study from that center, a large minority of participants had late-stage HIV and suppressed immune systems.

All participants had been referred for HRA after a recent abnormal anal Pap test. Participants filled out questionnaires on sociodemographics, internalized HIV-related stigma, depression, risk behaviors, social support, and knowledge about HPV and anal cancer.

Participants were disproportionately older (mean age, 50.9 years); cisgender (86.7%), Black (78%); and gay, lesbian, or bisexual (84.3%). Slightly more than 1 in 10 participants (11.3%) were transgender women.

Although for 6% of participants, Pap test results indicated high-grade squamous intraepithelial lesions (HSIL), an additional 8% had atypical Pap findings that couldn’t exclude HSIL – the kinds of results that are one step away from a cancer diagnosis. More than 80% of participants had low-grade or inconclusive results. Nearly half (44%) of participants’ Pap tests revealed low-grade squamous cell intraepithelial cell lesions (LSIL); 42% indicated atypical squamous cells of undetermined significance.

When Dr. Wells looked at how long participants had waited to undergo HRA, she found something that surprised her: although some participants underwent follow-up assessment in 17 days, for many, it took much longer. The longest wait was 2,350 days – more than 6 years.

“There were quite a few patients who had follow-up beyond 1,000-plus days,” Dr. Wells said in an interview. “I didn›t think the delays were that long — at most, I would say that patients will get scheduled and come back within a few weeks or months.”

What’s more, she discovered through the HPV knowledge questionnaire that many participants did not understand why they were having a follow-up appointment. Anecdotally, some confused HPV with HIV.

“There’s education to be done to inform this target population that those living with HIV are more prone or at increased risk of this virus causing cancer later,” she said. “There are a lot of campaigns around women living with HIV, that they need to do cervical cancer screening. I think we need to really expand this campaign to include that HPV can also cause anal cancer.”

Dr. Wells had planned to primarily investigate the impact of psychosocial factors on wait time to follow-up, but none of those factors were associated with longer wait times.
 

Systems-level factors

That led Ann Gakumo, PhD, chair of nursing at the College of Nursing and Health Sciences of the University of Massachusetts, Boston, to ask what other factors could account for the delay.

There were several, Dr. Wells said. Precarious housing, for example, could have influenced this lag in follow-up. About one in four participants were in transient housing, and one participant reported having been incarcerated. She gathered street addresses and plans to analyze that data to see whether the cases occurred in clusters in specific neighborhoods, as the Yale data indicated.

In addition, the anoscopy clinic was only available to receive patients one day a week and was staffed with only one clinician who was trained to perform HRA. Wait times could stretch for hours. Sometimes, participants had to leave the clinic to attend to other business, and their appointments needed to be rescheduled, Wells said.

In addition to the sometimes poor understanding of the importance of the follow-up test, Dr. Wells said, “we start to see a layering of these barriers. That’s where we start seeing breakdowns. So I’m hoping in a larger study I can address some of these barriers on a multilevel approach.”

This resonated with Dr. Gakumo.

“Oftentimes, we put so much of the responsibility for this on the part of the client and not enough on the part of the provider or on the systems level,” she said.
 

Guiding guidelines

Guidelines on follow-up for abnormal anal Pap test results are scarce, mostly because, unlike cervical cancer, the natural history of HPV-related anal cancers hasn’t been established. The HIV Medical Association does recommend anal Pap tests, but only in cases in which “access to appropriate referral for follow-up, including high-resolution anoscopy, is available.”

In an interview, Cecile Lahiri, MD, assistant professor of infectious disease at Emory University, said that, at Ponce De Leon Center, they recommend an anal Pap for women with HIV who have a history of cervical dysplasia.

There is a reliable association between high-grade abnormal Pap tests and cervical cancer, although low-grade changes can resolve on their own. In the case of anal cancer, especially in patients with HIV, low-grade cell changes are predictive; moreover, for such patients, anal cancer is more likely to recur and is harder to treat, Dr. Lahiri said.

“The cervical environment and the anal environment are very different,” said Dr. Lahiri, who works at the Grady Ponce De Leon Center but was not involved in Dr. Wells’ study. Dr. Lahiri is also a coinvestigator of the multisite, randomized, controlled Anal Cancer HSIL Outcomes Research (ANCHOR) study, which seeks to establish whether early treatment of high-grade anal Pap changes is better than a watch-and-wait approach.

Dr. Lahiri said that when the results of that trial become available, they are more likely to know how important early anoscopy and treatment are. The findings should inform guidelines and insurance coverage of anal Pap tests and anoscopy.

In the meantime, she said, she suspected that, with the ANCHOR trial in 2015, many sites’ capacity for anoscopy may have increased, and the wait times may have gone down.

“One of the most important pieces of the study is actually the time period in which it was conducted,” said Dr. Lahiri, who in 2015 became the clinic’s second physician trained in anoscopy. Currently, more than 200 people at the Ponce De Leon Center are enrolled in the ANCHOR trial. In addition, the general capacity for performing anoscopies has gone up nationwide as a result of the trial, which required that more providers learn how to properly perform an HRA. Many clinicians are not routinely trained in performing HRA, including gastroenterologists and surgeons, Dr. Lahiri said.

“It would be interesting to look at the differences, with the start of ANCHOR being the time point for before and after,” she said.

This article first appeared on Medscape.com.

It took an average of 380 days for people who had received an abnormal anal Pap test result after having been diagnosed with HIV to undergo high-resolution anoscopy (HRA), which is recommended as follow-up.

That delay “revealed missed opportunities for a better experience on the patient, clinic, and provider level,” Jessica Wells, PhD, research assistant professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said in an interview. After all, “a lot can happen in that 1 year,” including early development of human papillomavirus (HPV)–associated anal cancer.

Although it’s too soon to say how significant that delay is with respect to the natural history of anal cancer, Dr. Wells said the data are a potential signal of disparities.

“The findings from my study may foreshadow potential disparities if we don’t have the necessary resources in place to promote follow-up care after an abnormal Pap test, similar to the disparities that we see in cervical cancer,” she said during the virtual Association of Nurses in AIDS Care 2020 Annual Meeting.
 

Single-center study

In the United States, people living with HIV are 19 times more likely to develop anal cancer than the general population, according to a 2018 article in the Journal of Clinical Oncology. Another single-center study from Yale University found that, in minority communities, anal cancer rates were 75% higher than in White communities. Anal cancer rates were 72% higher in communities with greater poverty. As a result, many clinics are beginning to administer Pap tests to determine early signs of HPV infection and associated changes.

In Dr. Wells’ study, which was conducted from 2012 to 2015, 150 adults with HIV who were aged 21 and older were recruited from Grady Ponce De Leon Center in Atlanta. According to a 2018 study from that center, a large minority of participants had late-stage HIV and suppressed immune systems.

All participants had been referred for HRA after a recent abnormal anal Pap test. Participants filled out questionnaires on sociodemographics, internalized HIV-related stigma, depression, risk behaviors, social support, and knowledge about HPV and anal cancer.

Participants were disproportionately older (mean age, 50.9 years); cisgender (86.7%), Black (78%); and gay, lesbian, or bisexual (84.3%). Slightly more than 1 in 10 participants (11.3%) were transgender women.

Although for 6% of participants, Pap test results indicated high-grade squamous intraepithelial lesions (HSIL), an additional 8% had atypical Pap findings that couldn’t exclude HSIL – the kinds of results that are one step away from a cancer diagnosis. More than 80% of participants had low-grade or inconclusive results. Nearly half (44%) of participants’ Pap tests revealed low-grade squamous cell intraepithelial cell lesions (LSIL); 42% indicated atypical squamous cells of undetermined significance.

When Dr. Wells looked at how long participants had waited to undergo HRA, she found something that surprised her: although some participants underwent follow-up assessment in 17 days, for many, it took much longer. The longest wait was 2,350 days – more than 6 years.

“There were quite a few patients who had follow-up beyond 1,000-plus days,” Dr. Wells said in an interview. “I didn›t think the delays were that long — at most, I would say that patients will get scheduled and come back within a few weeks or months.”

What’s more, she discovered through the HPV knowledge questionnaire that many participants did not understand why they were having a follow-up appointment. Anecdotally, some confused HPV with HIV.

“There’s education to be done to inform this target population that those living with HIV are more prone or at increased risk of this virus causing cancer later,” she said. “There are a lot of campaigns around women living with HIV, that they need to do cervical cancer screening. I think we need to really expand this campaign to include that HPV can also cause anal cancer.”

Dr. Wells had planned to primarily investigate the impact of psychosocial factors on wait time to follow-up, but none of those factors were associated with longer wait times.
 

Systems-level factors

That led Ann Gakumo, PhD, chair of nursing at the College of Nursing and Health Sciences of the University of Massachusetts, Boston, to ask what other factors could account for the delay.

There were several, Dr. Wells said. Precarious housing, for example, could have influenced this lag in follow-up. About one in four participants were in transient housing, and one participant reported having been incarcerated. She gathered street addresses and plans to analyze that data to see whether the cases occurred in clusters in specific neighborhoods, as the Yale data indicated.

In addition, the anoscopy clinic was only available to receive patients one day a week and was staffed with only one clinician who was trained to perform HRA. Wait times could stretch for hours. Sometimes, participants had to leave the clinic to attend to other business, and their appointments needed to be rescheduled, Wells said.

In addition to the sometimes poor understanding of the importance of the follow-up test, Dr. Wells said, “we start to see a layering of these barriers. That’s where we start seeing breakdowns. So I’m hoping in a larger study I can address some of these barriers on a multilevel approach.”

This resonated with Dr. Gakumo.

“Oftentimes, we put so much of the responsibility for this on the part of the client and not enough on the part of the provider or on the systems level,” she said.
 

Guiding guidelines

Guidelines on follow-up for abnormal anal Pap test results are scarce, mostly because, unlike cervical cancer, the natural history of HPV-related anal cancers hasn’t been established. The HIV Medical Association does recommend anal Pap tests, but only in cases in which “access to appropriate referral for follow-up, including high-resolution anoscopy, is available.”

In an interview, Cecile Lahiri, MD, assistant professor of infectious disease at Emory University, said that, at Ponce De Leon Center, they recommend an anal Pap for women with HIV who have a history of cervical dysplasia.

There is a reliable association between high-grade abnormal Pap tests and cervical cancer, although low-grade changes can resolve on their own. In the case of anal cancer, especially in patients with HIV, low-grade cell changes are predictive; moreover, for such patients, anal cancer is more likely to recur and is harder to treat, Dr. Lahiri said.

“The cervical environment and the anal environment are very different,” said Dr. Lahiri, who works at the Grady Ponce De Leon Center but was not involved in Dr. Wells’ study. Dr. Lahiri is also a coinvestigator of the multisite, randomized, controlled Anal Cancer HSIL Outcomes Research (ANCHOR) study, which seeks to establish whether early treatment of high-grade anal Pap changes is better than a watch-and-wait approach.

Dr. Lahiri said that when the results of that trial become available, they are more likely to know how important early anoscopy and treatment are. The findings should inform guidelines and insurance coverage of anal Pap tests and anoscopy.

In the meantime, she said, she suspected that, with the ANCHOR trial in 2015, many sites’ capacity for anoscopy may have increased, and the wait times may have gone down.

“One of the most important pieces of the study is actually the time period in which it was conducted,” said Dr. Lahiri, who in 2015 became the clinic’s second physician trained in anoscopy. Currently, more than 200 people at the Ponce De Leon Center are enrolled in the ANCHOR trial. In addition, the general capacity for performing anoscopies has gone up nationwide as a result of the trial, which required that more providers learn how to properly perform an HRA. Many clinicians are not routinely trained in performing HRA, including gastroenterologists and surgeons, Dr. Lahiri said.

“It would be interesting to look at the differences, with the start of ANCHOR being the time point for before and after,” she said.

This article first appeared on Medscape.com.

Same-day HIV pre-exposure prophylaxis (PrEP) prescriptions and insurance navigation services led 70% of people at a Detroit sexually transmitted infection clinic to ask for a PrEP prescription. But only 40% of those same people came back for a follow-up appointment, and 5 acquired HIV during the review period.

To Amanda Allmacher, DNP, RN, nurse practitioner at the Detroit Public Health STD Clinic, that means that same-day PrEP prescribing works and is acceptable. But there’s more work to do on the clinic and pharmacy side to make HIV protection a reality for most of her patients. Allmacher presented her data at the Association of Nurses in AIDS Care 2020 virtual annual meeting.

Dawn K. Smith, MD, epidemiologist and medical officer in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said this adds to other data to show that we’re now entering the next phase of PrEP implementation.

“Our original focus was on uptake — informing folks what PrEP is, why they might benefit from its use, and then prescribing it if accepted,” Smith told Medscape Medical News via email. “Whether standard or same-day [PrEP prescribing], it is clear that uptake is only the first step.”
 

Nurses help navigate

Patients who attended the Detroit Public Health STD Clinic are more likely to be younger, have no insurance, and otherwise “have little to no contact with the healthcare system,” Allmacher said in her presentation. They also tend to come from communities that bear the greatest burden of HIV in the US — in other words, they are often the people most missed in PrEP rollouts thus far.

In response, the clinic implemented a same-day PrEP protocol, in which registered nurses trained in HIV risk assessment identify clients who might most benefit from PrEP. Criteria often include the presence of other STIs. Once the nurse explains what PrEP is and how it works, if the patient is interested, clients meet with a nurse practitioner right then to get the prescription for PrEP. The clinic also does labs to rule out current HIV infection, hepatitis B, metabolic issues, and other STI screening.

But it doesn’t stop there. The clinic used grant funding to offer PrEP navigation and financial counseling services, which help clients navigate the sometimes-thorny process of paying for PrEP. Payment comes either through Medicaid, which in Michigan charges $3 a month for a PrEP prescription, through patient assistance programs, or through private insurance. With clients under age 18 who are interested in PrEP, the clinic works to find a way to access PrEP without having to inform their parents. These same navigators schedule follow-up appointments, offer appointment reminders, and contact clients when they miss an appointment.

“Our navigators and financial counselors are a huge support for our same-day PrEP starts, helping with financial assistance, prior authorization, navigating different plans, and helping patients apply for Medicaid when appropriate,” she said.

The clinic also offers community outreach and incentives, which can include gift cards, bus passes, and pill containers, among other things.

This was a key lesson in setting up the program, Allmacher told Medscape Medical News.

“Starting PrEP at that initial visit allows for clinicians to meet patients where they are and administer care in a more equitable manner,” Allmacher said via email. “Use all available resources and funding sources. We have a versatile team working together to increase access for patients and promote HIV prevention and risk reduction.”
 

Script vs. follow-up

This approach is common, used in places like New York City and San Francisco. So once it was set up Allmacher sat back and waited to see how the program helped clients protect themselves from HIV.

Of the 451 clients eligible for PrEP in 2019, 336 were gay and bisexual men, 6 were transgender women, 61 were heterosexual, cisgender men, and 48 were cisgender women. One transgender man also screened as eligible. Allmacher did not break down data by race.

Uptake was high: 70% of all eligible clients did receive a prescription for PrEP, either generic tenofovir disoproxil fumarate/emtricitabine (Truvada) or tenofovir alafenamide/emtricitabine (Descovy). And uptake was high among people most at risk: 80% of gay and bisexual men who were eligible got a prescription, 60% of eligible cisgender women, 50% of the small number of transgender women, and 32.7% of heterosexual cisgender men did as well. The 1 transgender man also received a prescription.

This is a higher rate than found in a recent PrEP demonstration project, which found that despite gay and bisexual men, transgender adults, and Black people having the highest risk for HIV in the US, state health departments were more likely to refer heterosexual adults for PrEP.

That high uptake rate is encouraging, but follow-up? Not so much. After initial intake, clients are meant to return in a month to double-check their labs, ask about side effects, and start their 90-day supply of the medication. But just 40% showed up for their 30-day appointment, Allmacher said. And only one third of those showed up for the follow-up in 90 days.

By the end of 2019, just 73 of the original 451 clients screened were still taking PrEP.

“It was surprising to see just how significant the follow-up dropped off after that first visit, when the patient initially accepted the prescription,” Allmacher said.

And while it’s possible that some clients get their follow-up care from their primary care providers, “our clinic serves individuals regardless of insurance status and many do not identify having access to primary care for any type of service, PrEP or otherwise,” she said.
 

5 HIV acquisitions

In addition, the program review identified five clients who had been offered PrEP or had taken PrEP briefly who later acquired HIV. Those clients were offered same-day antiretroviral treatment, Allmacher said.

“So we’re finding people who are at high risk for HIV and we can prevent them, but we’re still not quite doing enough,” Allmacher said of those acquisitions. “Clearly we have a lot of work to do to focus on HIV prevention, and we are looking to create a more formal follow-up process” from the clinic’s side.

For instance, clinic staff call clients 1 week after their initial visit to share lab results. “This was identified as a missed opportunity for us to ask about their status, whether they filled their prescription, or if they need further assistance,” she said. “This is an area where our registered nurses are going to be taking on a greater role moving forward.”

Allmacher and team also discovered that, despite PrEP navigators arranging insurance coverage for clients on the day they receive their prescription, sometimes there were still barriers when the client showed up at the pharmacy to pick up their meds. The clinic does not have an in-house pharmacy and does not currently have the funding that would allow them to hand patients a bottle of the appropriate medication when they leave the clinic.

“Navigating the copays and the insurance coverage and using financial assistance through the drug manufacturer — even though we have the support in the clinic, it seems like there’s a disconnect between our clinic and getting to the pharmacy. Not every pharmacy is super familiar with navigating those,” she said. “So we have started to identify some area pharmacies near our clinic that are great at navigating these, and we really try to get our patients to go to places we know can give them assistance.”
 

A version of this story originally appeared on Medscape.com.

Same-day HIV pre-exposure prophylaxis (PrEP) prescriptions and insurance navigation services led 70% of people at a Detroit sexually transmitted infection clinic to ask for a PrEP prescription. But only 40% of those same people came back for a follow-up appointment, and 5 acquired HIV during the review period.

To Amanda Allmacher, DNP, RN, nurse practitioner at the Detroit Public Health STD Clinic, that means that same-day PrEP prescribing works and is acceptable. But there’s more work to do on the clinic and pharmacy side to make HIV protection a reality for most of her patients. Allmacher presented her data at the Association of Nurses in AIDS Care 2020 virtual annual meeting.

Dawn K. Smith, MD, epidemiologist and medical officer in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said this adds to other data to show that we’re now entering the next phase of PrEP implementation.

“Our original focus was on uptake — informing folks what PrEP is, why they might benefit from its use, and then prescribing it if accepted,” Smith told Medscape Medical News via email. “Whether standard or same-day [PrEP prescribing], it is clear that uptake is only the first step.”
 

Nurses help navigate

Patients who attended the Detroit Public Health STD Clinic are more likely to be younger, have no insurance, and otherwise “have little to no contact with the healthcare system,” Allmacher said in her presentation. They also tend to come from communities that bear the greatest burden of HIV in the US — in other words, they are often the people most missed in PrEP rollouts thus far.

In response, the clinic implemented a same-day PrEP protocol, in which registered nurses trained in HIV risk assessment identify clients who might most benefit from PrEP. Criteria often include the presence of other STIs. Once the nurse explains what PrEP is and how it works, if the patient is interested, clients meet with a nurse practitioner right then to get the prescription for PrEP. The clinic also does labs to rule out current HIV infection, hepatitis B, metabolic issues, and other STI screening.

But it doesn’t stop there. The clinic used grant funding to offer PrEP navigation and financial counseling services, which help clients navigate the sometimes-thorny process of paying for PrEP. Payment comes either through Medicaid, which in Michigan charges $3 a month for a PrEP prescription, through patient assistance programs, or through private insurance. With clients under age 18 who are interested in PrEP, the clinic works to find a way to access PrEP without having to inform their parents. These same navigators schedule follow-up appointments, offer appointment reminders, and contact clients when they miss an appointment.

“Our navigators and financial counselors are a huge support for our same-day PrEP starts, helping with financial assistance, prior authorization, navigating different plans, and helping patients apply for Medicaid when appropriate,” she said.

The clinic also offers community outreach and incentives, which can include gift cards, bus passes, and pill containers, among other things.

This was a key lesson in setting up the program, Allmacher told Medscape Medical News.

“Starting PrEP at that initial visit allows for clinicians to meet patients where they are and administer care in a more equitable manner,” Allmacher said via email. “Use all available resources and funding sources. We have a versatile team working together to increase access for patients and promote HIV prevention and risk reduction.”
 

Script vs. follow-up

This approach is common, used in places like New York City and San Francisco. So once it was set up Allmacher sat back and waited to see how the program helped clients protect themselves from HIV.

Of the 451 clients eligible for PrEP in 2019, 336 were gay and bisexual men, 6 were transgender women, 61 were heterosexual, cisgender men, and 48 were cisgender women. One transgender man also screened as eligible. Allmacher did not break down data by race.

Uptake was high: 70% of all eligible clients did receive a prescription for PrEP, either generic tenofovir disoproxil fumarate/emtricitabine (Truvada) or tenofovir alafenamide/emtricitabine (Descovy). And uptake was high among people most at risk: 80% of gay and bisexual men who were eligible got a prescription, 60% of eligible cisgender women, 50% of the small number of transgender women, and 32.7% of heterosexual cisgender men did as well. The 1 transgender man also received a prescription.

This is a higher rate than found in a recent PrEP demonstration project, which found that despite gay and bisexual men, transgender adults, and Black people having the highest risk for HIV in the US, state health departments were more likely to refer heterosexual adults for PrEP.

That high uptake rate is encouraging, but follow-up? Not so much. After initial intake, clients are meant to return in a month to double-check their labs, ask about side effects, and start their 90-day supply of the medication. But just 40% showed up for their 30-day appointment, Allmacher said. And only one third of those showed up for the follow-up in 90 days.

By the end of 2019, just 73 of the original 451 clients screened were still taking PrEP.

“It was surprising to see just how significant the follow-up dropped off after that first visit, when the patient initially accepted the prescription,” Allmacher said.

And while it’s possible that some clients get their follow-up care from their primary care providers, “our clinic serves individuals regardless of insurance status and many do not identify having access to primary care for any type of service, PrEP or otherwise,” she said.
 

5 HIV acquisitions

In addition, the program review identified five clients who had been offered PrEP or had taken PrEP briefly who later acquired HIV. Those clients were offered same-day antiretroviral treatment, Allmacher said.

“So we’re finding people who are at high risk for HIV and we can prevent them, but we’re still not quite doing enough,” Allmacher said of those acquisitions. “Clearly we have a lot of work to do to focus on HIV prevention, and we are looking to create a more formal follow-up process” from the clinic’s side.

For instance, clinic staff call clients 1 week after their initial visit to share lab results. “This was identified as a missed opportunity for us to ask about their status, whether they filled their prescription, or if they need further assistance,” she said. “This is an area where our registered nurses are going to be taking on a greater role moving forward.”

Allmacher and team also discovered that, despite PrEP navigators arranging insurance coverage for clients on the day they receive their prescription, sometimes there were still barriers when the client showed up at the pharmacy to pick up their meds. The clinic does not have an in-house pharmacy and does not currently have the funding that would allow them to hand patients a bottle of the appropriate medication when they leave the clinic.

“Navigating the copays and the insurance coverage and using financial assistance through the drug manufacturer — even though we have the support in the clinic, it seems like there’s a disconnect between our clinic and getting to the pharmacy. Not every pharmacy is super familiar with navigating those,” she said. “So we have started to identify some area pharmacies near our clinic that are great at navigating these, and we really try to get our patients to go to places we know can give them assistance.”
 

A version of this story originally appeared on Medscape.com.

Same-day HIV pre-exposure prophylaxis (PrEP) prescriptions and insurance navigation services led 70% of people at a Detroit sexually transmitted infection clinic to ask for a PrEP prescription. But only 40% of those same people came back for a follow-up appointment, and 5 acquired HIV during the review period.

To Amanda Allmacher, DNP, RN, nurse practitioner at the Detroit Public Health STD Clinic, that means that same-day PrEP prescribing works and is acceptable. But there’s more work to do on the clinic and pharmacy side to make HIV protection a reality for most of her patients. Allmacher presented her data at the Association of Nurses in AIDS Care 2020 virtual annual meeting.

Dawn K. Smith, MD, epidemiologist and medical officer in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said this adds to other data to show that we’re now entering the next phase of PrEP implementation.

“Our original focus was on uptake — informing folks what PrEP is, why they might benefit from its use, and then prescribing it if accepted,” Smith told Medscape Medical News via email. “Whether standard or same-day [PrEP prescribing], it is clear that uptake is only the first step.”
 

Nurses help navigate

Patients who attended the Detroit Public Health STD Clinic are more likely to be younger, have no insurance, and otherwise “have little to no contact with the healthcare system,” Allmacher said in her presentation. They also tend to come from communities that bear the greatest burden of HIV in the US — in other words, they are often the people most missed in PrEP rollouts thus far.

In response, the clinic implemented a same-day PrEP protocol, in which registered nurses trained in HIV risk assessment identify clients who might most benefit from PrEP. Criteria often include the presence of other STIs. Once the nurse explains what PrEP is and how it works, if the patient is interested, clients meet with a nurse practitioner right then to get the prescription for PrEP. The clinic also does labs to rule out current HIV infection, hepatitis B, metabolic issues, and other STI screening.

But it doesn’t stop there. The clinic used grant funding to offer PrEP navigation and financial counseling services, which help clients navigate the sometimes-thorny process of paying for PrEP. Payment comes either through Medicaid, which in Michigan charges $3 a month for a PrEP prescription, through patient assistance programs, or through private insurance. With clients under age 18 who are interested in PrEP, the clinic works to find a way to access PrEP without having to inform their parents. These same navigators schedule follow-up appointments, offer appointment reminders, and contact clients when they miss an appointment.

“Our navigators and financial counselors are a huge support for our same-day PrEP starts, helping with financial assistance, prior authorization, navigating different plans, and helping patients apply for Medicaid when appropriate,” she said.

The clinic also offers community outreach and incentives, which can include gift cards, bus passes, and pill containers, among other things.

This was a key lesson in setting up the program, Allmacher told Medscape Medical News.

“Starting PrEP at that initial visit allows for clinicians to meet patients where they are and administer care in a more equitable manner,” Allmacher said via email. “Use all available resources and funding sources. We have a versatile team working together to increase access for patients and promote HIV prevention and risk reduction.”
 

Script vs. follow-up

This approach is common, used in places like New York City and San Francisco. So once it was set up Allmacher sat back and waited to see how the program helped clients protect themselves from HIV.

Of the 451 clients eligible for PrEP in 2019, 336 were gay and bisexual men, 6 were transgender women, 61 were heterosexual, cisgender men, and 48 were cisgender women. One transgender man also screened as eligible. Allmacher did not break down data by race.

Uptake was high: 70% of all eligible clients did receive a prescription for PrEP, either generic tenofovir disoproxil fumarate/emtricitabine (Truvada) or tenofovir alafenamide/emtricitabine (Descovy). And uptake was high among people most at risk: 80% of gay and bisexual men who were eligible got a prescription, 60% of eligible cisgender women, 50% of the small number of transgender women, and 32.7% of heterosexual cisgender men did as well. The 1 transgender man also received a prescription.

This is a higher rate than found in a recent PrEP demonstration project, which found that despite gay and bisexual men, transgender adults, and Black people having the highest risk for HIV in the US, state health departments were more likely to refer heterosexual adults for PrEP.

That high uptake rate is encouraging, but follow-up? Not so much. After initial intake, clients are meant to return in a month to double-check their labs, ask about side effects, and start their 90-day supply of the medication. But just 40% showed up for their 30-day appointment, Allmacher said. And only one third of those showed up for the follow-up in 90 days.

By the end of 2019, just 73 of the original 451 clients screened were still taking PrEP.

“It was surprising to see just how significant the follow-up dropped off after that first visit, when the patient initially accepted the prescription,” Allmacher said.

And while it’s possible that some clients get their follow-up care from their primary care providers, “our clinic serves individuals regardless of insurance status and many do not identify having access to primary care for any type of service, PrEP or otherwise,” she said.
 

5 HIV acquisitions

In addition, the program review identified five clients who had been offered PrEP or had taken PrEP briefly who later acquired HIV. Those clients were offered same-day antiretroviral treatment, Allmacher said.

“So we’re finding people who are at high risk for HIV and we can prevent them, but we’re still not quite doing enough,” Allmacher said of those acquisitions. “Clearly we have a lot of work to do to focus on HIV prevention, and we are looking to create a more formal follow-up process” from the clinic’s side.

For instance, clinic staff call clients 1 week after their initial visit to share lab results. “This was identified as a missed opportunity for us to ask about their status, whether they filled their prescription, or if they need further assistance,” she said. “This is an area where our registered nurses are going to be taking on a greater role moving forward.”

Allmacher and team also discovered that, despite PrEP navigators arranging insurance coverage for clients on the day they receive their prescription, sometimes there were still barriers when the client showed up at the pharmacy to pick up their meds. The clinic does not have an in-house pharmacy and does not currently have the funding that would allow them to hand patients a bottle of the appropriate medication when they leave the clinic.

“Navigating the copays and the insurance coverage and using financial assistance through the drug manufacturer — even though we have the support in the clinic, it seems like there’s a disconnect between our clinic and getting to the pharmacy. Not every pharmacy is super familiar with navigating those,” she said. “So we have started to identify some area pharmacies near our clinic that are great at navigating these, and we really try to get our patients to go to places we know can give them assistance.”
 

A version of this story originally appeared on Medscape.com.

Bundled opt-out HIV/hepatitis C virus (HCV) testing increased the percentage of syringe service program (SSP) clients who received HIV and HCV rapid tests at enrollment into the program. Researchers conducted a retrospective comparative analysis of patient testing patterns before and after opt-out policy implementation in a single SSP program, according to a report published online in the International Journal of Drug Policy.

Because HCV is the most common infectious disease among people who inject drugs (PWID), engaging PWID in harm reduction services, such as SSPs, is critical to reduce HCV and HIV transmission, according to Tyler S. Bartholomew of the University of Miami, and colleagues. They added that testing for HIV and HCV among PWID is important for improvement of diagnosis and linkage to care.

Their study, conducted in the 37 months between December 2016 and January 2020 assessed 512 SSP participants 15 months prior to and 547 SSP participants 22 months after implementation of bundled HIV/HCV opt-out testing.

Opt-out optimal

There was a significant increase in uptake of HIV/HCV testing by 42.4% (95% confidence interval, 26.2%-58.5%; P < 0.001) immediately after the policy changed to opt-out testing, according to the researchers. In addition, they found that the significant predictors of accepting both HIV/HCV tests were cocaine injection (adjusted odds ratio, 2.36), self-reported HIV-positive status (aOR, 0.39), and self-reported HCV-positive status (aOR, 0.27).

The authors explained that participants who injected cocaine in the previous 30 days, compared with other drugs, might have had higher odds of accepting HIV/HCV testing because of their known added risk factors. Previous studies have shown that people who use stimulants describe higher rates of condomless sex, sex work, and sex in exchange for money or drugs, compared with people who use nonstimulant drugs.

“Our paper is the first of which we are aware to suggest that implementation of routine opt-out HIV/HCV testing among PWID at SSPs could enhance HIV/HCV testing among this high incidence population,” the researchers concluded.

The authors reported funding from the National Cancer Institute and the Frontlines of Communities in the United States, a program of Gilead Sciences. They provided no other disclosures.

[email protected]

SOURCE: Bartholomew TS et al. Int J Drug Policy. 2020; doi: 10.1016/j.drugpo.2020.102875.

Bundled opt-out HIV/hepatitis C virus (HCV) testing increased the percentage of syringe service program (SSP) clients who received HIV and HCV rapid tests at enrollment into the program. Researchers conducted a retrospective comparative analysis of patient testing patterns before and after opt-out policy implementation in a single SSP program, according to a report published online in the International Journal of Drug Policy.

Because HCV is the most common infectious disease among people who inject drugs (PWID), engaging PWID in harm reduction services, such as SSPs, is critical to reduce HCV and HIV transmission, according to Tyler S. Bartholomew of the University of Miami, and colleagues. They added that testing for HIV and HCV among PWID is important for improvement of diagnosis and linkage to care.

Their study, conducted in the 37 months between December 2016 and January 2020 assessed 512 SSP participants 15 months prior to and 547 SSP participants 22 months after implementation of bundled HIV/HCV opt-out testing.

Opt-out optimal

There was a significant increase in uptake of HIV/HCV testing by 42.4% (95% confidence interval, 26.2%-58.5%; P < 0.001) immediately after the policy changed to opt-out testing, according to the researchers. In addition, they found that the significant predictors of accepting both HIV/HCV tests were cocaine injection (adjusted odds ratio, 2.36), self-reported HIV-positive status (aOR, 0.39), and self-reported HCV-positive status (aOR, 0.27).

The authors explained that participants who injected cocaine in the previous 30 days, compared with other drugs, might have had higher odds of accepting HIV/HCV testing because of their known added risk factors. Previous studies have shown that people who use stimulants describe higher rates of condomless sex, sex work, and sex in exchange for money or drugs, compared with people who use nonstimulant drugs.

“Our paper is the first of which we are aware to suggest that implementation of routine opt-out HIV/HCV testing among PWID at SSPs could enhance HIV/HCV testing among this high incidence population,” the researchers concluded.

The authors reported funding from the National Cancer Institute and the Frontlines of Communities in the United States, a program of Gilead Sciences. They provided no other disclosures.

[email protected]

SOURCE: Bartholomew TS et al. Int J Drug Policy. 2020; doi: 10.1016/j.drugpo.2020.102875.

Bundled opt-out HIV/hepatitis C virus (HCV) testing increased the percentage of syringe service program (SSP) clients who received HIV and HCV rapid tests at enrollment into the program. Researchers conducted a retrospective comparative analysis of patient testing patterns before and after opt-out policy implementation in a single SSP program, according to a report published online in the International Journal of Drug Policy.

Because HCV is the most common infectious disease among people who inject drugs (PWID), engaging PWID in harm reduction services, such as SSPs, is critical to reduce HCV and HIV transmission, according to Tyler S. Bartholomew of the University of Miami, and colleagues. They added that testing for HIV and HCV among PWID is important for improvement of diagnosis and linkage to care.

Their study, conducted in the 37 months between December 2016 and January 2020 assessed 512 SSP participants 15 months prior to and 547 SSP participants 22 months after implementation of bundled HIV/HCV opt-out testing.

Opt-out optimal

There was a significant increase in uptake of HIV/HCV testing by 42.4% (95% confidence interval, 26.2%-58.5%; P < 0.001) immediately after the policy changed to opt-out testing, according to the researchers. In addition, they found that the significant predictors of accepting both HIV/HCV tests were cocaine injection (adjusted odds ratio, 2.36), self-reported HIV-positive status (aOR, 0.39), and self-reported HCV-positive status (aOR, 0.27).

The authors explained that participants who injected cocaine in the previous 30 days, compared with other drugs, might have had higher odds of accepting HIV/HCV testing because of their known added risk factors. Previous studies have shown that people who use stimulants describe higher rates of condomless sex, sex work, and sex in exchange for money or drugs, compared with people who use nonstimulant drugs.

“Our paper is the first of which we are aware to suggest that implementation of routine opt-out HIV/HCV testing among PWID at SSPs could enhance HIV/HCV testing among this high incidence population,” the researchers concluded.

The authors reported funding from the National Cancer Institute and the Frontlines of Communities in the United States, a program of Gilead Sciences. They provided no other disclosures.

[email protected]

SOURCE: Bartholomew TS et al. Int J Drug Policy. 2020; doi: 10.1016/j.drugpo.2020.102875.

The age of antiretroviral therapy (ART) for HIV is in its third decade, and many of the patients who live in areas of the world fortunate enough to have had early access to therapy have now lived for several decades with complications of HIV and viral suppressive therapy.

But while the life-expectancy of persons with HIV has approached that of noninfected persons over the last 20 years, the higher burden of comorbidities for aging patients with HIV has remained largely the same, according to an epidemiologist who specializes in HIV/AIDS research and aging.

“The pathways from HIV and its treatments to comorbidities are very long and winding, spanning a life course. Social determinants of health and individual risk factors also play an important role, and must be considered,” said Keri N. Althoff, PhD, MPH, of Johns Hopkins University, Baltimore.

Dr. Althoff discussed long-term complications of HIV and its treatment in a virtual symposium during an annual scientific meeting on infectious diseases.

“Many urban HIV providers have an increased proportion of patients who are older long-term survivors of the epidemic. Many, but not all of the comorbidities (including cardiovascular, neurocognitive, renal, and malignancies) have been associated with age, long-term HIV infection, especially uncontrolled HIV infection, and low CD4 nadirs,” commented Harry Lampiris, MD, professor of clinical medicine at the University of California, San Francisco.

“An increasing number of patients are experiencing geriatric syndromes (especially problems with mobility, cognitive decline, food insecurity, polypharmacy, and social isolation) at younger ages than HIV-negative populations,” he added.

Dr. Lampiris, who moderated the session where Dr. Althoff presented her findings, commented on it in an interview, but was not involved in her research.
 

Pathways to comorbidity

The three primary pathways to comorbidities in people with HIV infections are as follows, according to Dr. Athloff:

• The virus itself, with its associated inflammation, immunosuppression, immune activation, and AIDS.
• HIV therapies, beginning with the notoriously toxic dideoxynucleoside analogues or “d-drugs,” and following with subsequent generations of newer, less toxic agents.
• Individual risk factors, including smoking, stress, diet, exercise, and environment.

Cardiovascular and renal complications

Persons with HIV have an approximately twofold higher risk for major adverse cardiovascular events (myocardial infarction, stroke) compared with persons without HIV. Conditions contributing to cardiovascular disease including hypertension, diabetes, and hyperlipidemia are also significantly higher among persons with HIV, Dr. Althoff said.

Hypertension among persons with HIV from the ages 60-69 years is especially high for Black men and to a lesser degree non-Black men, compared with either White or Black women, she noted.

Pathways to renal disease in persons with HIV include diabetes and hypertension, as well as therapies to treat them, hepatitis B and C coinfection, HIV-associated nephropathy, and immune complex kidney disease, as well as chronic kidney disease resulting from acute kidney injury related to therapy.

“Cardiovascular disease and kidney disease are excellent examples of why the life-course perspective is essential when caring for people with HIV. For those diagnosed with HIV at younger ages, there are points of intervention along the decades-long path, and the timing and implementation of the most effective intervention may preserve comorbidity-free years,” Dr. Althoff said.

Prevention and screening interventions to lower risk for future heart- and kidney-related comorbidities include smoking cessation and lifestyle optimization (diet, exercise, mental health), as well as lipid-lowering medications to lower risk for cardiovascular events.
 

Liver comorbidities

“Primary drivers of liver disease are social determinants of health and individual lifestyle risk factors that share the same pathways as HIV, resulting in this increased burden of liver disease in people with HIV,” she said.

Risk factors include alcoholic liver disease, nonalcoholic fatty liver disease, hepatitis B and C coinfection, drug use, autoimmune disease, and aging. These risk factors contribute to oxidative stress, mitochondrial injury, lipotoxicity, cytotoxicity, and other mechanisms that can lead to fibrosis, cirrhosis, hepatocellular carcinoma, and end-stage liver disease.

“I want to be sure to acknowledge the importance of liver disease as a comorbidity among people with HIV. Liver disease accounts for nearly 20% of mortality in persons with HIV,” she said.
 

Neurocognitive problems

HIV has been linked to neurocognitive decline since the beginning of the epidemic, Dr. Althoff noted. The term HIV-associated neurocognitive disorders encompasses the broad spectrum of cognitive effects of HIV, from asymptomatic illness to AIDS-related dementia. Estimates of cognitive impairment in people with HIV range from 14% to 64% across various study populations, but diagnosing and treating it in the community can be challenging.

“Routine monitoring of cognition is often just out of reach in the clinical setting, due to the time it takes to use validated tools. We need a deeper toolbox of quick and validated tools calibrated to people with HIV in order to accurately monitor cognition,” she said.

She noted that the average age of onset of Alzheimer’s disease in the general population is 80 years, and that relatively few people with HIV infection have reached that age.

“But before the population age distribution shifts to the older ages, we can do more to monitor cognition in people with HIV,” she added.

In addition to HIV, factors that can contribute to worse neurocognitive outcomes include major depressive disorder, occurring in and estimated 20%-40% of adults with HIV versus 8% of the U.S. population, generalized anxiety disorder (10%-25% vs. 3%), bipolar disorder (3%-9% vs. 3%), schizophrenia (4%-15% vs. 1%), and posttraumatic stress disorder (10%-30% vs. 8%).

Substance use and polypharmacy, common among adults with HIV, can also contribute to cognitive decline, she said.
 

Decreased mobility

The Multicenter AIDS Cohort Study (MACS) showed that decreased mobility, defined as a gait speed less than 1 m/sec, occurred earlier in life among HIV-positive men than in HIV-negative men.

In the general aging population, slow gait speed is a predictor for lower extremity limitations, hospitalization, and death, and in more recent MACS studies was associated with increased hemoglobin A_1C levels, as well as neurocognitive impairment.

“Hemoglobin A_1C is an intervenable target, and perhaps it will help to slow the decline in gait speed,” Dr. Althoff said.
 

Reduce ‘healthspan’ disparities

The goal for treating aging adults with HIV “is to reduce the disparity in healthspan between people with HIV compared to people without HIV by delaying or eliminating the onset of comorbidities among people with HIV,” she said.

The gerontological concept of extending “healthspan” – the duration of life without significant comorbidities – is to target common mechanisms of aging, thereby delaying the onset of more than one age-related disease at the same time.

“Crude translation of this concept to the population of aging with HIV includes reducing that gap in comorbidity-free survival in people with versus without HIV,” she said.

Modification of care models from geriatrics may help infectious disease specialists manage adults with HIV who have increasingly complex needs.

For example, the geriatric “5 M” model emphasizes focusing on issues of mind (mentation, dementia, delirium, depression), mobility (impaired gait and balance, as well as fall prevention), medications (reducing polypharmacy, optimal prescribing), multicomplexity (multiple morbidities and complex bio-psycho-social situations), and “matters most” (each patient’s individual meaningful health outcome goals and care preferences).

Changing exposures that may influence the pattern of comorbidities for patients with HIV in the future include earlier start on ART, shorter duration of uncontrolled viremia, compared with older populations, newer and less toxic ARTs, long-term viral suppression, and risk factor interventions, Dr. Althoff concluded.

Dr. Lampiris noted that “patients who have initiated therapy in the last 5-10 years are more likely to initiate antiretroviral therapy at higher CD4 counts, and less likely to experience long-term toxicities of antiretroviral therapy. However, African Americans, Hispanics and HIV-positive women continue to lag behind others with regard to timely initiation of treatment.

“In addition there are toxicities associated with the newer agents, particularly weight gain, which disproportionately affect African Americans and women and which may be made worse by poverty, food insecurity, and other health-related behaviors.”

Dr. Athloff’s work is supported by grants from the National Institutes for Health. She disclosed serving as a consultant to the NIH-funded All of US study and to MediQ, and as an adviser to TrioHealth. Dr. Lampiris reported having no disclosures.

The age of antiretroviral therapy (ART) for HIV is in its third decade, and many of the patients who live in areas of the world fortunate enough to have had early access to therapy have now lived for several decades with complications of HIV and viral suppressive therapy.

But while the life-expectancy of persons with HIV has approached that of noninfected persons over the last 20 years, the higher burden of comorbidities for aging patients with HIV has remained largely the same, according to an epidemiologist who specializes in HIV/AIDS research and aging.

“The pathways from HIV and its treatments to comorbidities are very long and winding, spanning a life course. Social determinants of health and individual risk factors also play an important role, and must be considered,” said Keri N. Althoff, PhD, MPH, of Johns Hopkins University, Baltimore.

Dr. Althoff discussed long-term complications of HIV and its treatment in a virtual symposium during an annual scientific meeting on infectious diseases.

“Many urban HIV providers have an increased proportion of patients who are older long-term survivors of the epidemic. Many, but not all of the comorbidities (including cardiovascular, neurocognitive, renal, and malignancies) have been associated with age, long-term HIV infection, especially uncontrolled HIV infection, and low CD4 nadirs,” commented Harry Lampiris, MD, professor of clinical medicine at the University of California, San Francisco.

“An increasing number of patients are experiencing geriatric syndromes (especially problems with mobility, cognitive decline, food insecurity, polypharmacy, and social isolation) at younger ages than HIV-negative populations,” he added.

Dr. Lampiris, who moderated the session where Dr. Althoff presented her findings, commented on it in an interview, but was not involved in her research.
 

Pathways to comorbidity

The three primary pathways to comorbidities in people with HIV infections are as follows, according to Dr. Athloff:

• The virus itself, with its associated inflammation, immunosuppression, immune activation, and AIDS.
• HIV therapies, beginning with the notoriously toxic dideoxynucleoside analogues or “d-drugs,” and following with subsequent generations of newer, less toxic agents.
• Individual risk factors, including smoking, stress, diet, exercise, and environment.

Cardiovascular and renal complications

Persons with HIV have an approximately twofold higher risk for major adverse cardiovascular events (myocardial infarction, stroke) compared with persons without HIV. Conditions contributing to cardiovascular disease including hypertension, diabetes, and hyperlipidemia are also significantly higher among persons with HIV, Dr. Althoff said.

Hypertension among persons with HIV from the ages 60-69 years is especially high for Black men and to a lesser degree non-Black men, compared with either White or Black women, she noted.

Pathways to renal disease in persons with HIV include diabetes and hypertension, as well as therapies to treat them, hepatitis B and C coinfection, HIV-associated nephropathy, and immune complex kidney disease, as well as chronic kidney disease resulting from acute kidney injury related to therapy.

“Cardiovascular disease and kidney disease are excellent examples of why the life-course perspective is essential when caring for people with HIV. For those diagnosed with HIV at younger ages, there are points of intervention along the decades-long path, and the timing and implementation of the most effective intervention may preserve comorbidity-free years,” Dr. Althoff said.

Prevention and screening interventions to lower risk for future heart- and kidney-related comorbidities include smoking cessation and lifestyle optimization (diet, exercise, mental health), as well as lipid-lowering medications to lower risk for cardiovascular events.
 

Liver comorbidities

“Primary drivers of liver disease are social determinants of health and individual lifestyle risk factors that share the same pathways as HIV, resulting in this increased burden of liver disease in people with HIV,” she said.

Risk factors include alcoholic liver disease, nonalcoholic fatty liver disease, hepatitis B and C coinfection, drug use, autoimmune disease, and aging. These risk factors contribute to oxidative stress, mitochondrial injury, lipotoxicity, cytotoxicity, and other mechanisms that can lead to fibrosis, cirrhosis, hepatocellular carcinoma, and end-stage liver disease.

“I want to be sure to acknowledge the importance of liver disease as a comorbidity among people with HIV. Liver disease accounts for nearly 20% of mortality in persons with HIV,” she said.
 

Neurocognitive problems

HIV has been linked to neurocognitive decline since the beginning of the epidemic, Dr. Althoff noted. The term HIV-associated neurocognitive disorders encompasses the broad spectrum of cognitive effects of HIV, from asymptomatic illness to AIDS-related dementia. Estimates of cognitive impairment in people with HIV range from 14% to 64% across various study populations, but diagnosing and treating it in the community can be challenging.

“Routine monitoring of cognition is often just out of reach in the clinical setting, due to the time it takes to use validated tools. We need a deeper toolbox of quick and validated tools calibrated to people with HIV in order to accurately monitor cognition,” she said.

She noted that the average age of onset of Alzheimer’s disease in the general population is 80 years, and that relatively few people with HIV infection have reached that age.

“But before the population age distribution shifts to the older ages, we can do more to monitor cognition in people with HIV,” she added.

In addition to HIV, factors that can contribute to worse neurocognitive outcomes include major depressive disorder, occurring in and estimated 20%-40% of adults with HIV versus 8% of the U.S. population, generalized anxiety disorder (10%-25% vs. 3%), bipolar disorder (3%-9% vs. 3%), schizophrenia (4%-15% vs. 1%), and posttraumatic stress disorder (10%-30% vs. 8%).

Substance use and polypharmacy, common among adults with HIV, can also contribute to cognitive decline, she said.
 

Decreased mobility

The Multicenter AIDS Cohort Study (MACS) showed that decreased mobility, defined as a gait speed less than 1 m/sec, occurred earlier in life among HIV-positive men than in HIV-negative men.

In the general aging population, slow gait speed is a predictor for lower extremity limitations, hospitalization, and death, and in more recent MACS studies was associated with increased hemoglobin A_1C levels, as well as neurocognitive impairment.

“Hemoglobin A_1C is an intervenable target, and perhaps it will help to slow the decline in gait speed,” Dr. Althoff said.
 

Reduce ‘healthspan’ disparities

The goal for treating aging adults with HIV “is to reduce the disparity in healthspan between people with HIV compared to people without HIV by delaying or eliminating the onset of comorbidities among people with HIV,” she said.

The gerontological concept of extending “healthspan” – the duration of life without significant comorbidities – is to target common mechanisms of aging, thereby delaying the onset of more than one age-related disease at the same time.

“Crude translation of this concept to the population of aging with HIV includes reducing that gap in comorbidity-free survival in people with versus without HIV,” she said.

Modification of care models from geriatrics may help infectious disease specialists manage adults with HIV who have increasingly complex needs.

For example, the geriatric “5 M” model emphasizes focusing on issues of mind (mentation, dementia, delirium, depression), mobility (impaired gait and balance, as well as fall prevention), medications (reducing polypharmacy, optimal prescribing), multicomplexity (multiple morbidities and complex bio-psycho-social situations), and “matters most” (each patient’s individual meaningful health outcome goals and care preferences).

Changing exposures that may influence the pattern of comorbidities for patients with HIV in the future include earlier start on ART, shorter duration of uncontrolled viremia, compared with older populations, newer and less toxic ARTs, long-term viral suppression, and risk factor interventions, Dr. Althoff concluded.

Dr. Lampiris noted that “patients who have initiated therapy in the last 5-10 years are more likely to initiate antiretroviral therapy at higher CD4 counts, and less likely to experience long-term toxicities of antiretroviral therapy. However, African Americans, Hispanics and HIV-positive women continue to lag behind others with regard to timely initiation of treatment.

“In addition there are toxicities associated with the newer agents, particularly weight gain, which disproportionately affect African Americans and women and which may be made worse by poverty, food insecurity, and other health-related behaviors.”

Dr. Athloff’s work is supported by grants from the National Institutes for Health. She disclosed serving as a consultant to the NIH-funded All of US study and to MediQ, and as an adviser to TrioHealth. Dr. Lampiris reported having no disclosures.

The age of antiretroviral therapy (ART) for HIV is in its third decade, and many of the patients who live in areas of the world fortunate enough to have had early access to therapy have now lived for several decades with complications of HIV and viral suppressive therapy.

But while the life-expectancy of persons with HIV has approached that of noninfected persons over the last 20 years, the higher burden of comorbidities for aging patients with HIV has remained largely the same, according to an epidemiologist who specializes in HIV/AIDS research and aging.

“The pathways from HIV and its treatments to comorbidities are very long and winding, spanning a life course. Social determinants of health and individual risk factors also play an important role, and must be considered,” said Keri N. Althoff, PhD, MPH, of Johns Hopkins University, Baltimore.

Dr. Althoff discussed long-term complications of HIV and its treatment in a virtual symposium during an annual scientific meeting on infectious diseases.

“Many urban HIV providers have an increased proportion of patients who are older long-term survivors of the epidemic. Many, but not all of the comorbidities (including cardiovascular, neurocognitive, renal, and malignancies) have been associated with age, long-term HIV infection, especially uncontrolled HIV infection, and low CD4 nadirs,” commented Harry Lampiris, MD, professor of clinical medicine at the University of California, San Francisco.

“An increasing number of patients are experiencing geriatric syndromes (especially problems with mobility, cognitive decline, food insecurity, polypharmacy, and social isolation) at younger ages than HIV-negative populations,” he added.

Dr. Lampiris, who moderated the session where Dr. Althoff presented her findings, commented on it in an interview, but was not involved in her research.
 

Pathways to comorbidity

The three primary pathways to comorbidities in people with HIV infections are as follows, according to Dr. Athloff:

• The virus itself, with its associated inflammation, immunosuppression, immune activation, and AIDS.
• HIV therapies, beginning with the notoriously toxic dideoxynucleoside analogues or “d-drugs,” and following with subsequent generations of newer, less toxic agents.
• Individual risk factors, including smoking, stress, diet, exercise, and environment.

Cardiovascular and renal complications

Persons with HIV have an approximately twofold higher risk for major adverse cardiovascular events (myocardial infarction, stroke) compared with persons without HIV. Conditions contributing to cardiovascular disease including hypertension, diabetes, and hyperlipidemia are also significantly higher among persons with HIV, Dr. Althoff said.

Hypertension among persons with HIV from the ages 60-69 years is especially high for Black men and to a lesser degree non-Black men, compared with either White or Black women, she noted.

Pathways to renal disease in persons with HIV include diabetes and hypertension, as well as therapies to treat them, hepatitis B and C coinfection, HIV-associated nephropathy, and immune complex kidney disease, as well as chronic kidney disease resulting from acute kidney injury related to therapy.

“Cardiovascular disease and kidney disease are excellent examples of why the life-course perspective is essential when caring for people with HIV. For those diagnosed with HIV at younger ages, there are points of intervention along the decades-long path, and the timing and implementation of the most effective intervention may preserve comorbidity-free years,” Dr. Althoff said.

Prevention and screening interventions to lower risk for future heart- and kidney-related comorbidities include smoking cessation and lifestyle optimization (diet, exercise, mental health), as well as lipid-lowering medications to lower risk for cardiovascular events.
 

Liver comorbidities

“Primary drivers of liver disease are social determinants of health and individual lifestyle risk factors that share the same pathways as HIV, resulting in this increased burden of liver disease in people with HIV,” she said.

Risk factors include alcoholic liver disease, nonalcoholic fatty liver disease, hepatitis B and C coinfection, drug use, autoimmune disease, and aging. These risk factors contribute to oxidative stress, mitochondrial injury, lipotoxicity, cytotoxicity, and other mechanisms that can lead to fibrosis, cirrhosis, hepatocellular carcinoma, and end-stage liver disease.

“I want to be sure to acknowledge the importance of liver disease as a comorbidity among people with HIV. Liver disease accounts for nearly 20% of mortality in persons with HIV,” she said.
 

Neurocognitive problems

HIV has been linked to neurocognitive decline since the beginning of the epidemic, Dr. Althoff noted. The term HIV-associated neurocognitive disorders encompasses the broad spectrum of cognitive effects of HIV, from asymptomatic illness to AIDS-related dementia. Estimates of cognitive impairment in people with HIV range from 14% to 64% across various study populations, but diagnosing and treating it in the community can be challenging.

“Routine monitoring of cognition is often just out of reach in the clinical setting, due to the time it takes to use validated tools. We need a deeper toolbox of quick and validated tools calibrated to people with HIV in order to accurately monitor cognition,” she said.

She noted that the average age of onset of Alzheimer’s disease in the general population is 80 years, and that relatively few people with HIV infection have reached that age.

“But before the population age distribution shifts to the older ages, we can do more to monitor cognition in people with HIV,” she added.

In addition to HIV, factors that can contribute to worse neurocognitive outcomes include major depressive disorder, occurring in and estimated 20%-40% of adults with HIV versus 8% of the U.S. population, generalized anxiety disorder (10%-25% vs. 3%), bipolar disorder (3%-9% vs. 3%), schizophrenia (4%-15% vs. 1%), and posttraumatic stress disorder (10%-30% vs. 8%).

Substance use and polypharmacy, common among adults with HIV, can also contribute to cognitive decline, she said.
 

Decreased mobility

The Multicenter AIDS Cohort Study (MACS) showed that decreased mobility, defined as a gait speed less than 1 m/sec, occurred earlier in life among HIV-positive men than in HIV-negative men.

In the general aging population, slow gait speed is a predictor for lower extremity limitations, hospitalization, and death, and in more recent MACS studies was associated with increased hemoglobin A_1C levels, as well as neurocognitive impairment.

“Hemoglobin A_1C is an intervenable target, and perhaps it will help to slow the decline in gait speed,” Dr. Althoff said.
 

Reduce ‘healthspan’ disparities

The goal for treating aging adults with HIV “is to reduce the disparity in healthspan between people with HIV compared to people without HIV by delaying or eliminating the onset of comorbidities among people with HIV,” she said.

The gerontological concept of extending “healthspan” – the duration of life without significant comorbidities – is to target common mechanisms of aging, thereby delaying the onset of more than one age-related disease at the same time.

“Crude translation of this concept to the population of aging with HIV includes reducing that gap in comorbidity-free survival in people with versus without HIV,” she said.

Modification of care models from geriatrics may help infectious disease specialists manage adults with HIV who have increasingly complex needs.

For example, the geriatric “5 M” model emphasizes focusing on issues of mind (mentation, dementia, delirium, depression), mobility (impaired gait and balance, as well as fall prevention), medications (reducing polypharmacy, optimal prescribing), multicomplexity (multiple morbidities and complex bio-psycho-social situations), and “matters most” (each patient’s individual meaningful health outcome goals and care preferences).

Changing exposures that may influence the pattern of comorbidities for patients with HIV in the future include earlier start on ART, shorter duration of uncontrolled viremia, compared with older populations, newer and less toxic ARTs, long-term viral suppression, and risk factor interventions, Dr. Althoff concluded.

Dr. Lampiris noted that “patients who have initiated therapy in the last 5-10 years are more likely to initiate antiretroviral therapy at higher CD4 counts, and less likely to experience long-term toxicities of antiretroviral therapy. However, African Americans, Hispanics and HIV-positive women continue to lag behind others with regard to timely initiation of treatment.

“In addition there are toxicities associated with the newer agents, particularly weight gain, which disproportionately affect African Americans and women and which may be made worse by poverty, food insecurity, and other health-related behaviors.”

Dr. Athloff’s work is supported by grants from the National Institutes for Health. She disclosed serving as a consultant to the NIH-funded All of US study and to MediQ, and as an adviser to TrioHealth. Dr. Lampiris reported having no disclosures.