User login
Opt-out HIV testing in EDs can help identify undiagnosed cases
in populations with an HIV positivity rate greater than 0.2%.
On implementation of opt-out testing of patients aged 18-59 years admitted to the ED at St. George’s University Hospital in London, the proportion of tests performed increased from 57.9% to 69%. Upon increasing the age range to those 16 and older and implementing notional consent, overall testing coverage improved to 74.2%.
“An opt-out HIV testing program in the emergency department provides an excellent opportunity to diagnose patients who do not perceive themselves to be at risk or who have never tested before,” lead author Rebecca Marchant, MBBS, of St. George’s Hospital, said in an interview.
The study was published online in HIV Medicine.
She continued, “I think this take-away message would be applicable to other countries with prevalence of HIV greater than 2 per 1,000 people, as routine HIV testing in areas of high prevalence removes the need to target testing of specific populations, potentially preventing stigmatization.”
Despite excellent uptake of HIV testing in antenatal and sexual health services, 6% of people living in the United Kingdom are unaware of their status, and up to 42% of people living with HIV are diagnosed at a late stage of infection. Because blood is routinely drawn in EDs, it’s an excellent opportunity for increased testing. Late-stage diagnosis carries an increased risk of developing an AIDS-related illness, a sevenfold increase in risk for death in the first year after diagnosis, and increased rates of HIV transmission and health care costs.
The study was conducted in a region of London that has an HIV prevalence of 5.4 cases per 1,000 residents aged 15-59 years. Opt-out HIV testing was implemented in February 2019 for people aged 18-59, and in March 2021, this was changed to include those aged 16-plus years along with a move to notional consent.
Out of 78,333 HIV tests, there were 1054 reactive results. Of these, 728 (69%) were known people living with HIV, 8 (0.8%) were not contactable, 2 (0.2%) retested elsewhere and 3 (0.3%) declined a retest. A total of 259 false positives were determined by follow-up testing.
Of those who received a confirmed HIV diagnosis, 50 (4.8%) were newly diagnosed. HIV was suspected in only 22% of these people, and 48% had never previously tested for the virus. New diagnoses were 80% male with a median age of 42 years. CD4 counts varied widely (3 cells/mcL to 1,344 cells/mcL), with 60% diagnosed at a late stage (CD4 < 350 cells/mcL) and 40% with advanced immunosuppression (CD4 < 200 cells/mcL).
“It did not surprise me that heterosexuals made up 62% of all new diagnoses,” Dr. Marchant noted. “This is because routine opt-out testing in the ED offers the opportunity to test people who don’t perceive themselves to be at risk or who have never tested before, and I believe heterosexual people are more likely to fit into those categories. In London, new HIV diagnoses amongst men who have sex with men have fallen year on year likely due to pre-exposure prophylaxis being more readily available and a generally good awareness of HIV and testing amongst MSM.”
Michael D. Levine, MD, associate professor of emergency medicine at the University of California, Los Angeles, agreed with its main findings.
“Doing widespread screening of patients in the emergency department is a feasible option,” Dr. Levine, who was not involved with this study, said in an interview. “But it only makes sense to do this in a population with some prevalence of HIV. With some forms of testing, like rapid HIV tests, you only get a presumptive positive and you then have a confirmatory test. The presumptive positives do have false positives associated with them. So if you’re in a population with very few cases of HIV, and you have a significant number of false positives, that’s going to be problematic. It’s going to add a tremendous amount of stress to the patient.”
A version of this article first appeared on Medscape.com.
in populations with an HIV positivity rate greater than 0.2%.
On implementation of opt-out testing of patients aged 18-59 years admitted to the ED at St. George’s University Hospital in London, the proportion of tests performed increased from 57.9% to 69%. Upon increasing the age range to those 16 and older and implementing notional consent, overall testing coverage improved to 74.2%.
“An opt-out HIV testing program in the emergency department provides an excellent opportunity to diagnose patients who do not perceive themselves to be at risk or who have never tested before,” lead author Rebecca Marchant, MBBS, of St. George’s Hospital, said in an interview.
The study was published online in HIV Medicine.
She continued, “I think this take-away message would be applicable to other countries with prevalence of HIV greater than 2 per 1,000 people, as routine HIV testing in areas of high prevalence removes the need to target testing of specific populations, potentially preventing stigmatization.”
Despite excellent uptake of HIV testing in antenatal and sexual health services, 6% of people living in the United Kingdom are unaware of their status, and up to 42% of people living with HIV are diagnosed at a late stage of infection. Because blood is routinely drawn in EDs, it’s an excellent opportunity for increased testing. Late-stage diagnosis carries an increased risk of developing an AIDS-related illness, a sevenfold increase in risk for death in the first year after diagnosis, and increased rates of HIV transmission and health care costs.
The study was conducted in a region of London that has an HIV prevalence of 5.4 cases per 1,000 residents aged 15-59 years. Opt-out HIV testing was implemented in February 2019 for people aged 18-59, and in March 2021, this was changed to include those aged 16-plus years along with a move to notional consent.
Out of 78,333 HIV tests, there were 1054 reactive results. Of these, 728 (69%) were known people living with HIV, 8 (0.8%) were not contactable, 2 (0.2%) retested elsewhere and 3 (0.3%) declined a retest. A total of 259 false positives were determined by follow-up testing.
Of those who received a confirmed HIV diagnosis, 50 (4.8%) were newly diagnosed. HIV was suspected in only 22% of these people, and 48% had never previously tested for the virus. New diagnoses were 80% male with a median age of 42 years. CD4 counts varied widely (3 cells/mcL to 1,344 cells/mcL), with 60% diagnosed at a late stage (CD4 < 350 cells/mcL) and 40% with advanced immunosuppression (CD4 < 200 cells/mcL).
“It did not surprise me that heterosexuals made up 62% of all new diagnoses,” Dr. Marchant noted. “This is because routine opt-out testing in the ED offers the opportunity to test people who don’t perceive themselves to be at risk or who have never tested before, and I believe heterosexual people are more likely to fit into those categories. In London, new HIV diagnoses amongst men who have sex with men have fallen year on year likely due to pre-exposure prophylaxis being more readily available and a generally good awareness of HIV and testing amongst MSM.”
Michael D. Levine, MD, associate professor of emergency medicine at the University of California, Los Angeles, agreed with its main findings.
“Doing widespread screening of patients in the emergency department is a feasible option,” Dr. Levine, who was not involved with this study, said in an interview. “But it only makes sense to do this in a population with some prevalence of HIV. With some forms of testing, like rapid HIV tests, you only get a presumptive positive and you then have a confirmatory test. The presumptive positives do have false positives associated with them. So if you’re in a population with very few cases of HIV, and you have a significant number of false positives, that’s going to be problematic. It’s going to add a tremendous amount of stress to the patient.”
A version of this article first appeared on Medscape.com.
in populations with an HIV positivity rate greater than 0.2%.
On implementation of opt-out testing of patients aged 18-59 years admitted to the ED at St. George’s University Hospital in London, the proportion of tests performed increased from 57.9% to 69%. Upon increasing the age range to those 16 and older and implementing notional consent, overall testing coverage improved to 74.2%.
“An opt-out HIV testing program in the emergency department provides an excellent opportunity to diagnose patients who do not perceive themselves to be at risk or who have never tested before,” lead author Rebecca Marchant, MBBS, of St. George’s Hospital, said in an interview.
The study was published online in HIV Medicine.
She continued, “I think this take-away message would be applicable to other countries with prevalence of HIV greater than 2 per 1,000 people, as routine HIV testing in areas of high prevalence removes the need to target testing of specific populations, potentially preventing stigmatization.”
Despite excellent uptake of HIV testing in antenatal and sexual health services, 6% of people living in the United Kingdom are unaware of their status, and up to 42% of people living with HIV are diagnosed at a late stage of infection. Because blood is routinely drawn in EDs, it’s an excellent opportunity for increased testing. Late-stage diagnosis carries an increased risk of developing an AIDS-related illness, a sevenfold increase in risk for death in the first year after diagnosis, and increased rates of HIV transmission and health care costs.
The study was conducted in a region of London that has an HIV prevalence of 5.4 cases per 1,000 residents aged 15-59 years. Opt-out HIV testing was implemented in February 2019 for people aged 18-59, and in March 2021, this was changed to include those aged 16-plus years along with a move to notional consent.
Out of 78,333 HIV tests, there were 1054 reactive results. Of these, 728 (69%) were known people living with HIV, 8 (0.8%) were not contactable, 2 (0.2%) retested elsewhere and 3 (0.3%) declined a retest. A total of 259 false positives were determined by follow-up testing.
Of those who received a confirmed HIV diagnosis, 50 (4.8%) were newly diagnosed. HIV was suspected in only 22% of these people, and 48% had never previously tested for the virus. New diagnoses were 80% male with a median age of 42 years. CD4 counts varied widely (3 cells/mcL to 1,344 cells/mcL), with 60% diagnosed at a late stage (CD4 < 350 cells/mcL) and 40% with advanced immunosuppression (CD4 < 200 cells/mcL).
“It did not surprise me that heterosexuals made up 62% of all new diagnoses,” Dr. Marchant noted. “This is because routine opt-out testing in the ED offers the opportunity to test people who don’t perceive themselves to be at risk or who have never tested before, and I believe heterosexual people are more likely to fit into those categories. In London, new HIV diagnoses amongst men who have sex with men have fallen year on year likely due to pre-exposure prophylaxis being more readily available and a generally good awareness of HIV and testing amongst MSM.”
Michael D. Levine, MD, associate professor of emergency medicine at the University of California, Los Angeles, agreed with its main findings.
“Doing widespread screening of patients in the emergency department is a feasible option,” Dr. Levine, who was not involved with this study, said in an interview. “But it only makes sense to do this in a population with some prevalence of HIV. With some forms of testing, like rapid HIV tests, you only get a presumptive positive and you then have a confirmatory test. The presumptive positives do have false positives associated with them. So if you’re in a population with very few cases of HIV, and you have a significant number of false positives, that’s going to be problematic. It’s going to add a tremendous amount of stress to the patient.”
A version of this article first appeared on Medscape.com.
FROM HIV MEDICINE
HIV prevention: Clinician attitudes may be curtailing PrEP use
Taking an antiretroviral tablet daily for preexposure prophylaxis (PrEP) has been shown to be a safe and effective method of HIV prevention. However, low and variable uptake of PrEP among men who have sex with men (MSM) remains concerning.
Lead author Samuel R. Bunting, MD, and colleagues explored whether the attitudes of prescribing clinicians are impeding access to PrEP among MSM in the United States. They sought to understand whether clinician biases and expectations about race, HIV risk, adherence, and condom use might be affecting willingness to prescribe PrEP to a patient who specifically requests it.
They reached out to 16 U.S. medical schools (allopathic and osteopathic) with a combined total of 12,660 students. A total of 1,592 students indicated interest in participating in the study, and 600 completed it accurately.
Researchers simulated an electronic medical record for a fictional patient: a sexually active cisgender MSM presenting to a primary care physician and directly requesting access to PrEP for the first time. The simulated record included an uncomplicated medical history and lab results indicating that the patient was negative for HIV and other STIs.
Researchers systematically varied key aspects of the fictional patient, including his race (White or Black) and his intentions for future condom use if prescribed PrEP (continue using, unlikely to begin using, or will stop using). They asked the medical students a series of questions about their hypothetical patient interaction, including assessing patient HIV risk and provider willingness to prescribe PrEP.
The simulated medical records randomly included Black and White patients.
Dr. Bunting and coauthors found that the medical students were significantly less likely to indicate that they would prescribe PrEP to a patient described as “intending to discontinue” condom use were he to be prescribed PrEP, compared with patients “intending to continue” former practices of condom use or nonuse. On a scale from 1 (least likely to prescribe) to 7 (most likely to prescribe), willingness to prescribe was highest for the continued-nonuse group (mean score 6.35; 95% confidence interval, 6.18-6.52) and was lower for the planned-discontinuation group (mean score 5.91; 95% CI, 5.75-6.08; P = .001).
This finding reflects a prevailing fear of “risk compensation” – the concern that an individual on PrEP may start to take additional compensatory risks in his HIV exposures, including discontinuing condom use or increasing number of sexual partners.
In an interview with this news organization, Julia Marcus, PhD, MPH, an associate professor in the department of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, said: “These provider concerns [about risk compensation] are missing the mark. Just like oral contraception, the whole point of a prevention tool like PrEP is to allow people to engage in certain behaviors more safely. Rather than an unwanted consequence, behavior change may be the intended goal.” Dr. Marcus was not involved in the study.
Prior research has shown that uptake of PrEP among Black MSM is significantly lower than among White MSM in the United States. But this study showed no associations with patient race. However, Dr. Bunting and his coauthors found a troubling association with the personal attitudes of the medical students toward sexual activity: The more likely the medical students were to disapprove of nonmonogamy, the more likely they were to assume the possibility of future nonadherence to PrEP and to hesitate before prescribing PrEP.
Were the medical students making assumptions about patients’ ability to be faithful and consistent, whether to a partner or to a drug regimen? Either way, provider hesitancy to prescribe PrEP to a patient on the basis of their stated intention to discontinue condom use or because of the clinician’s own internalized biases about nonmonogamous relationships both represent troubling barriers to accessing clinical care, reinforcing the clinician’s role as gatekeeper to PrEP.
“It’s frustrating that these biases are still in play and potentially contributing to slow and inequitable PrEP uptake” Dr. Marcus commented. “Every sexually active primary care patient should be informed about PrEP, in accordance with CDC guidance, but providers often feel constrained by time ... We need tools that can normalize PrEP in primary care and help limit the potential effect of biases on PrEP prescribing decisions.”
In an interview, Dr. Bunting, resident physician in the department of psychiatry and behavioral neuroscience at University of Chicago Medicine, said in an interview, “Condom use has long been a stalwart prevention mechanism, but PrEP offers superior protection and patients who are seeking PrEP are exhibiting agency and informed risk mitigation ... When a patient is seeking additional protection, it is less about what is the right way to experience a sexual relationship, and more about what is the right way to be safe from HIV.”
Although this study has a number of limitations, including the fact that it is based on a controlled and hypothetical scenario and study participants are still medical students not yet licensed to prescribe, its results have important implications: It underscores the need to train clinicians to recognize and set aside their own social biases during clinical interactions.
Bunting suggested that provider training should support clinicians to evaluate patient requests in a nonjudgmental, pragmatic, and realistic manner appropriately reflecting patient informed agency and knowledge of their own risk factors.
And Dr. Marcus concurred, noting that standardizing the delivery of PrEP through a screening algorithm presents an alternative pathway for eliminating the role of stigmatizing clinician biases and working toward equitable access to PrEP.
This study was supported by unrestricted research funding from Gilead Sciences. The funder had no input into research design, implementation, analysis, interpretation, or publication decisions. Coauthor Brian A. Feinstein’s time was supported by a grant from the National Institute on Drug Abuse. No additional funding was received to support this research.
A version of this article first appeared on Medscape.com.
Taking an antiretroviral tablet daily for preexposure prophylaxis (PrEP) has been shown to be a safe and effective method of HIV prevention. However, low and variable uptake of PrEP among men who have sex with men (MSM) remains concerning.
Lead author Samuel R. Bunting, MD, and colleagues explored whether the attitudes of prescribing clinicians are impeding access to PrEP among MSM in the United States. They sought to understand whether clinician biases and expectations about race, HIV risk, adherence, and condom use might be affecting willingness to prescribe PrEP to a patient who specifically requests it.
They reached out to 16 U.S. medical schools (allopathic and osteopathic) with a combined total of 12,660 students. A total of 1,592 students indicated interest in participating in the study, and 600 completed it accurately.
Researchers simulated an electronic medical record for a fictional patient: a sexually active cisgender MSM presenting to a primary care physician and directly requesting access to PrEP for the first time. The simulated record included an uncomplicated medical history and lab results indicating that the patient was negative for HIV and other STIs.
Researchers systematically varied key aspects of the fictional patient, including his race (White or Black) and his intentions for future condom use if prescribed PrEP (continue using, unlikely to begin using, or will stop using). They asked the medical students a series of questions about their hypothetical patient interaction, including assessing patient HIV risk and provider willingness to prescribe PrEP.
The simulated medical records randomly included Black and White patients.
Dr. Bunting and coauthors found that the medical students were significantly less likely to indicate that they would prescribe PrEP to a patient described as “intending to discontinue” condom use were he to be prescribed PrEP, compared with patients “intending to continue” former practices of condom use or nonuse. On a scale from 1 (least likely to prescribe) to 7 (most likely to prescribe), willingness to prescribe was highest for the continued-nonuse group (mean score 6.35; 95% confidence interval, 6.18-6.52) and was lower for the planned-discontinuation group (mean score 5.91; 95% CI, 5.75-6.08; P = .001).
This finding reflects a prevailing fear of “risk compensation” – the concern that an individual on PrEP may start to take additional compensatory risks in his HIV exposures, including discontinuing condom use or increasing number of sexual partners.
In an interview with this news organization, Julia Marcus, PhD, MPH, an associate professor in the department of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, said: “These provider concerns [about risk compensation] are missing the mark. Just like oral contraception, the whole point of a prevention tool like PrEP is to allow people to engage in certain behaviors more safely. Rather than an unwanted consequence, behavior change may be the intended goal.” Dr. Marcus was not involved in the study.
Prior research has shown that uptake of PrEP among Black MSM is significantly lower than among White MSM in the United States. But this study showed no associations with patient race. However, Dr. Bunting and his coauthors found a troubling association with the personal attitudes of the medical students toward sexual activity: The more likely the medical students were to disapprove of nonmonogamy, the more likely they were to assume the possibility of future nonadherence to PrEP and to hesitate before prescribing PrEP.
Were the medical students making assumptions about patients’ ability to be faithful and consistent, whether to a partner or to a drug regimen? Either way, provider hesitancy to prescribe PrEP to a patient on the basis of their stated intention to discontinue condom use or because of the clinician’s own internalized biases about nonmonogamous relationships both represent troubling barriers to accessing clinical care, reinforcing the clinician’s role as gatekeeper to PrEP.
“It’s frustrating that these biases are still in play and potentially contributing to slow and inequitable PrEP uptake” Dr. Marcus commented. “Every sexually active primary care patient should be informed about PrEP, in accordance with CDC guidance, but providers often feel constrained by time ... We need tools that can normalize PrEP in primary care and help limit the potential effect of biases on PrEP prescribing decisions.”
In an interview, Dr. Bunting, resident physician in the department of psychiatry and behavioral neuroscience at University of Chicago Medicine, said in an interview, “Condom use has long been a stalwart prevention mechanism, but PrEP offers superior protection and patients who are seeking PrEP are exhibiting agency and informed risk mitigation ... When a patient is seeking additional protection, it is less about what is the right way to experience a sexual relationship, and more about what is the right way to be safe from HIV.”
Although this study has a number of limitations, including the fact that it is based on a controlled and hypothetical scenario and study participants are still medical students not yet licensed to prescribe, its results have important implications: It underscores the need to train clinicians to recognize and set aside their own social biases during clinical interactions.
Bunting suggested that provider training should support clinicians to evaluate patient requests in a nonjudgmental, pragmatic, and realistic manner appropriately reflecting patient informed agency and knowledge of their own risk factors.
And Dr. Marcus concurred, noting that standardizing the delivery of PrEP through a screening algorithm presents an alternative pathway for eliminating the role of stigmatizing clinician biases and working toward equitable access to PrEP.
This study was supported by unrestricted research funding from Gilead Sciences. The funder had no input into research design, implementation, analysis, interpretation, or publication decisions. Coauthor Brian A. Feinstein’s time was supported by a grant from the National Institute on Drug Abuse. No additional funding was received to support this research.
A version of this article first appeared on Medscape.com.
Taking an antiretroviral tablet daily for preexposure prophylaxis (PrEP) has been shown to be a safe and effective method of HIV prevention. However, low and variable uptake of PrEP among men who have sex with men (MSM) remains concerning.
Lead author Samuel R. Bunting, MD, and colleagues explored whether the attitudes of prescribing clinicians are impeding access to PrEP among MSM in the United States. They sought to understand whether clinician biases and expectations about race, HIV risk, adherence, and condom use might be affecting willingness to prescribe PrEP to a patient who specifically requests it.
They reached out to 16 U.S. medical schools (allopathic and osteopathic) with a combined total of 12,660 students. A total of 1,592 students indicated interest in participating in the study, and 600 completed it accurately.
Researchers simulated an electronic medical record for a fictional patient: a sexually active cisgender MSM presenting to a primary care physician and directly requesting access to PrEP for the first time. The simulated record included an uncomplicated medical history and lab results indicating that the patient was negative for HIV and other STIs.
Researchers systematically varied key aspects of the fictional patient, including his race (White or Black) and his intentions for future condom use if prescribed PrEP (continue using, unlikely to begin using, or will stop using). They asked the medical students a series of questions about their hypothetical patient interaction, including assessing patient HIV risk and provider willingness to prescribe PrEP.
The simulated medical records randomly included Black and White patients.
Dr. Bunting and coauthors found that the medical students were significantly less likely to indicate that they would prescribe PrEP to a patient described as “intending to discontinue” condom use were he to be prescribed PrEP, compared with patients “intending to continue” former practices of condom use or nonuse. On a scale from 1 (least likely to prescribe) to 7 (most likely to prescribe), willingness to prescribe was highest for the continued-nonuse group (mean score 6.35; 95% confidence interval, 6.18-6.52) and was lower for the planned-discontinuation group (mean score 5.91; 95% CI, 5.75-6.08; P = .001).
This finding reflects a prevailing fear of “risk compensation” – the concern that an individual on PrEP may start to take additional compensatory risks in his HIV exposures, including discontinuing condom use or increasing number of sexual partners.
In an interview with this news organization, Julia Marcus, PhD, MPH, an associate professor in the department of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, said: “These provider concerns [about risk compensation] are missing the mark. Just like oral contraception, the whole point of a prevention tool like PrEP is to allow people to engage in certain behaviors more safely. Rather than an unwanted consequence, behavior change may be the intended goal.” Dr. Marcus was not involved in the study.
Prior research has shown that uptake of PrEP among Black MSM is significantly lower than among White MSM in the United States. But this study showed no associations with patient race. However, Dr. Bunting and his coauthors found a troubling association with the personal attitudes of the medical students toward sexual activity: The more likely the medical students were to disapprove of nonmonogamy, the more likely they were to assume the possibility of future nonadherence to PrEP and to hesitate before prescribing PrEP.
Were the medical students making assumptions about patients’ ability to be faithful and consistent, whether to a partner or to a drug regimen? Either way, provider hesitancy to prescribe PrEP to a patient on the basis of their stated intention to discontinue condom use or because of the clinician’s own internalized biases about nonmonogamous relationships both represent troubling barriers to accessing clinical care, reinforcing the clinician’s role as gatekeeper to PrEP.
“It’s frustrating that these biases are still in play and potentially contributing to slow and inequitable PrEP uptake” Dr. Marcus commented. “Every sexually active primary care patient should be informed about PrEP, in accordance with CDC guidance, but providers often feel constrained by time ... We need tools that can normalize PrEP in primary care and help limit the potential effect of biases on PrEP prescribing decisions.”
In an interview, Dr. Bunting, resident physician in the department of psychiatry and behavioral neuroscience at University of Chicago Medicine, said in an interview, “Condom use has long been a stalwart prevention mechanism, but PrEP offers superior protection and patients who are seeking PrEP are exhibiting agency and informed risk mitigation ... When a patient is seeking additional protection, it is less about what is the right way to experience a sexual relationship, and more about what is the right way to be safe from HIV.”
Although this study has a number of limitations, including the fact that it is based on a controlled and hypothetical scenario and study participants are still medical students not yet licensed to prescribe, its results have important implications: It underscores the need to train clinicians to recognize and set aside their own social biases during clinical interactions.
Bunting suggested that provider training should support clinicians to evaluate patient requests in a nonjudgmental, pragmatic, and realistic manner appropriately reflecting patient informed agency and knowledge of their own risk factors.
And Dr. Marcus concurred, noting that standardizing the delivery of PrEP through a screening algorithm presents an alternative pathway for eliminating the role of stigmatizing clinician biases and working toward equitable access to PrEP.
This study was supported by unrestricted research funding from Gilead Sciences. The funder had no input into research design, implementation, analysis, interpretation, or publication decisions. Coauthor Brian A. Feinstein’s time was supported by a grant from the National Institute on Drug Abuse. No additional funding was received to support this research.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROME
HIV: Treating ‘symptom clusters’ could help improve QOL
TAMPA – People living with HIV experience many symptoms that can be grouped into “clusters” to help guide therapy and ideally treat more than one symptom at a time in an effort to improve quality of life, according to a study presented at the annual meeting of the Association of Nurses in AIDS Care.
Interestingly, these symptoms were more common among people living with HIV who are older than 45 years versus those who are younger, with one exception.
“In HIV, with exception of anxiety, we saw older people had more symptoms than younger ones,” said Natalie Wilson, PhD, assistant professor of community health systems at the University of California, San Francisco.
Dr. Wilson and colleagues performed a study that also suggests the older group experienced more distress from their symptoms than the younger cohort, again with the exception of anxiety.
Symptom clusters are two or more related symptoms that occur together with or without the same etiology. “Imagine you can’t sleep and the next day you’re tired and have no energy, you have trouble remembering someone’s name ... and then the next night you get so anxious about not getting sleep that it keeps you from sleeping.” That’s an example of a symptom cluster, Dr. Wilson said.
A high burden
“Why should we even evaluate symptom clusters?” Dr. Wilson asked. “The symptom burden is still high in people living with HIV. The medications got better but the symptoms remain.”
A high symptom burden also is linked to lower adherence to antiretrovirals. Also, considering groups of symptoms together could lead to targeted interventions that treat multiple symptoms, she said, “instead of treating one symptom at a time and increasing the pill burden for people living with HIV.”
Accelerated aging concerns
In addition, people living with HIV can experience accelerated aging, which is one reason Dr. Wilson and colleagues chose the 45-year-old cutoff in the study. Living with inflammation from HIV and the toxicity of earlier treatments likely contribute.
“Those over age 45 have higher rates of age-associated noncommunicable comorbidities developing at an earlier age than uninfected people with comparable lifestyles and demographics,” Dr. Wilson said.
In the full study, published in the Journal of Pain and Symptom Management, a total 2,000 people living with HIV completed the 20-item HIV Symptom Index. The participants reported their symptoms on their first visit to one of six national HIV Centers of Excellence. People were asked to report presence or absence of a particular symptom, and if they had it, how distressing it was on a scale of 1 “doesn’t bother me” to 4 “bothers me a lot.”
Younger people not only reported more anxiety but were also more distressed by it, Dr. Wilson said. The older group was more likely to be distressed by muscle aches and joint pain, trouble remembering things, and more.
The mean age in the younger group was 35 years, and it was 55 years in the older group. A total of 86% in the younger group and 87% in the older were men, and there were some differences by race, Dr. Wilson said.
More research needed
“These findings warrant further confirmation,” Dr. Wilson added. Future work could evaluate whether symptom clusters share etiology and how symptom clusters change over time. “We need to look at outcomes over time. Can we predict poorer outcomes, such as cardiac events, over time based on symptom clusters?”
Also, as part of HIV treatment success in recent years, “Our guidelines are moving people out further – if you’re undetectable sometimes you can come back at 6 months or 1 year.” The question, she said, is then: “Do we need to watch people with certain symptom clusters more closely?”
Limitations of the study include a lack of information on symptom causes and severity and its cross-sectional design.
‘Absolutely useful’
The study is “absolutely useful,” said session moderator Cheryl Netherly, an HIV nurse and clinical educator for CAN Community Health headquartered in Sarasota, Fla.
“One of the things that she mentioned was people with HIV, especially long-term HIV, they’re aging faster than the population without HIV. So, that is really important to look at.”
People living with HIV and dying from age-related comorbidities is something “we never thought would happen,” Ms. Netherly said. “Unfortunately, we’re now losing them to the different things like kidney issues, heart disease, and diabetes.”
The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Wilson and Ms. Netherly disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TAMPA – People living with HIV experience many symptoms that can be grouped into “clusters” to help guide therapy and ideally treat more than one symptom at a time in an effort to improve quality of life, according to a study presented at the annual meeting of the Association of Nurses in AIDS Care.
Interestingly, these symptoms were more common among people living with HIV who are older than 45 years versus those who are younger, with one exception.
“In HIV, with exception of anxiety, we saw older people had more symptoms than younger ones,” said Natalie Wilson, PhD, assistant professor of community health systems at the University of California, San Francisco.
Dr. Wilson and colleagues performed a study that also suggests the older group experienced more distress from their symptoms than the younger cohort, again with the exception of anxiety.
Symptom clusters are two or more related symptoms that occur together with or without the same etiology. “Imagine you can’t sleep and the next day you’re tired and have no energy, you have trouble remembering someone’s name ... and then the next night you get so anxious about not getting sleep that it keeps you from sleeping.” That’s an example of a symptom cluster, Dr. Wilson said.
A high burden
“Why should we even evaluate symptom clusters?” Dr. Wilson asked. “The symptom burden is still high in people living with HIV. The medications got better but the symptoms remain.”
A high symptom burden also is linked to lower adherence to antiretrovirals. Also, considering groups of symptoms together could lead to targeted interventions that treat multiple symptoms, she said, “instead of treating one symptom at a time and increasing the pill burden for people living with HIV.”
Accelerated aging concerns
In addition, people living with HIV can experience accelerated aging, which is one reason Dr. Wilson and colleagues chose the 45-year-old cutoff in the study. Living with inflammation from HIV and the toxicity of earlier treatments likely contribute.
“Those over age 45 have higher rates of age-associated noncommunicable comorbidities developing at an earlier age than uninfected people with comparable lifestyles and demographics,” Dr. Wilson said.
In the full study, published in the Journal of Pain and Symptom Management, a total 2,000 people living with HIV completed the 20-item HIV Symptom Index. The participants reported their symptoms on their first visit to one of six national HIV Centers of Excellence. People were asked to report presence or absence of a particular symptom, and if they had it, how distressing it was on a scale of 1 “doesn’t bother me” to 4 “bothers me a lot.”
Younger people not only reported more anxiety but were also more distressed by it, Dr. Wilson said. The older group was more likely to be distressed by muscle aches and joint pain, trouble remembering things, and more.
The mean age in the younger group was 35 years, and it was 55 years in the older group. A total of 86% in the younger group and 87% in the older were men, and there were some differences by race, Dr. Wilson said.
More research needed
“These findings warrant further confirmation,” Dr. Wilson added. Future work could evaluate whether symptom clusters share etiology and how symptom clusters change over time. “We need to look at outcomes over time. Can we predict poorer outcomes, such as cardiac events, over time based on symptom clusters?”
Also, as part of HIV treatment success in recent years, “Our guidelines are moving people out further – if you’re undetectable sometimes you can come back at 6 months or 1 year.” The question, she said, is then: “Do we need to watch people with certain symptom clusters more closely?”
Limitations of the study include a lack of information on symptom causes and severity and its cross-sectional design.
‘Absolutely useful’
The study is “absolutely useful,” said session moderator Cheryl Netherly, an HIV nurse and clinical educator for CAN Community Health headquartered in Sarasota, Fla.
“One of the things that she mentioned was people with HIV, especially long-term HIV, they’re aging faster than the population without HIV. So, that is really important to look at.”
People living with HIV and dying from age-related comorbidities is something “we never thought would happen,” Ms. Netherly said. “Unfortunately, we’re now losing them to the different things like kidney issues, heart disease, and diabetes.”
The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Wilson and Ms. Netherly disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TAMPA – People living with HIV experience many symptoms that can be grouped into “clusters” to help guide therapy and ideally treat more than one symptom at a time in an effort to improve quality of life, according to a study presented at the annual meeting of the Association of Nurses in AIDS Care.
Interestingly, these symptoms were more common among people living with HIV who are older than 45 years versus those who are younger, with one exception.
“In HIV, with exception of anxiety, we saw older people had more symptoms than younger ones,” said Natalie Wilson, PhD, assistant professor of community health systems at the University of California, San Francisco.
Dr. Wilson and colleagues performed a study that also suggests the older group experienced more distress from their symptoms than the younger cohort, again with the exception of anxiety.
Symptom clusters are two or more related symptoms that occur together with or without the same etiology. “Imagine you can’t sleep and the next day you’re tired and have no energy, you have trouble remembering someone’s name ... and then the next night you get so anxious about not getting sleep that it keeps you from sleeping.” That’s an example of a symptom cluster, Dr. Wilson said.
A high burden
“Why should we even evaluate symptom clusters?” Dr. Wilson asked. “The symptom burden is still high in people living with HIV. The medications got better but the symptoms remain.”
A high symptom burden also is linked to lower adherence to antiretrovirals. Also, considering groups of symptoms together could lead to targeted interventions that treat multiple symptoms, she said, “instead of treating one symptom at a time and increasing the pill burden for people living with HIV.”
Accelerated aging concerns
In addition, people living with HIV can experience accelerated aging, which is one reason Dr. Wilson and colleagues chose the 45-year-old cutoff in the study. Living with inflammation from HIV and the toxicity of earlier treatments likely contribute.
“Those over age 45 have higher rates of age-associated noncommunicable comorbidities developing at an earlier age than uninfected people with comparable lifestyles and demographics,” Dr. Wilson said.
In the full study, published in the Journal of Pain and Symptom Management, a total 2,000 people living with HIV completed the 20-item HIV Symptom Index. The participants reported their symptoms on their first visit to one of six national HIV Centers of Excellence. People were asked to report presence or absence of a particular symptom, and if they had it, how distressing it was on a scale of 1 “doesn’t bother me” to 4 “bothers me a lot.”
Younger people not only reported more anxiety but were also more distressed by it, Dr. Wilson said. The older group was more likely to be distressed by muscle aches and joint pain, trouble remembering things, and more.
The mean age in the younger group was 35 years, and it was 55 years in the older group. A total of 86% in the younger group and 87% in the older were men, and there were some differences by race, Dr. Wilson said.
More research needed
“These findings warrant further confirmation,” Dr. Wilson added. Future work could evaluate whether symptom clusters share etiology and how symptom clusters change over time. “We need to look at outcomes over time. Can we predict poorer outcomes, such as cardiac events, over time based on symptom clusters?”
Also, as part of HIV treatment success in recent years, “Our guidelines are moving people out further – if you’re undetectable sometimes you can come back at 6 months or 1 year.” The question, she said, is then: “Do we need to watch people with certain symptom clusters more closely?”
Limitations of the study include a lack of information on symptom causes and severity and its cross-sectional design.
‘Absolutely useful’
The study is “absolutely useful,” said session moderator Cheryl Netherly, an HIV nurse and clinical educator for CAN Community Health headquartered in Sarasota, Fla.
“One of the things that she mentioned was people with HIV, especially long-term HIV, they’re aging faster than the population without HIV. So, that is really important to look at.”
People living with HIV and dying from age-related comorbidities is something “we never thought would happen,” Ms. Netherly said. “Unfortunately, we’re now losing them to the different things like kidney issues, heart disease, and diabetes.”
The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Wilson and Ms. Netherly disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
As STDs proliferate, companies rush to market at-home test kits. But are they reliable?
Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.
But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.
Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.
But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.
The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”
Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.
The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.
The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.
The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.
In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.
And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.
CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.
Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.
Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.
“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.
“CVS should not be selling that test,” he added.
In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.
CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.
Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.
“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”
Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.
Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.
“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”
Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.
He noted that doctors have years of experience using home collection kits.
The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.
Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.
“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.
But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.
Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”
Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.
Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.
“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.
But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.
Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.
But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.
The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”
Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.
The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.
The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.
The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.
In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.
And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.
CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.
Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.
Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.
“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.
“CVS should not be selling that test,” he added.
In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.
CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.
Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.
“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”
Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.
Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.
“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”
Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.
He noted that doctors have years of experience using home collection kits.
The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.
Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.
“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.
But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.
Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”
Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.
Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.
“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.
But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.
Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.
But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.
The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”
Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.
The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.
The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.
The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.
In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.
And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.
CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.
Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.
Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.
“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.
“CVS should not be selling that test,” he added.
In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.
CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.
Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.
“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”
Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.
Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.
“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”
Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.
He noted that doctors have years of experience using home collection kits.
The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.
Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.
“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.
But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.
Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”
Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.
Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.
“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
HIV: Greater parental involvement needed with young men who have sex with men
“Take it from me, parents just don’t understand.”
Fresh Prince and D.J. Jazzy Jeff penned this lyric roughly 35 years ago, and coincidentally the HIV/AIDS epidemic has also been with us just as long. But the connection between the two may be highly relevant – that is, if you consider how infrequently parents appear (or have the proper tools) to engage with their gay or bisexual sons to prevent and curb HIV infections.
Currently, YMSM between the ages of 13 and 24 are among the most affected by the ongoing HIV epidemic, with CDC estimates suggesting that, in 2020, this group alone represented about 35% of new diagnoses. At the same time, about half of these HIV infections go undiagnosed. Recent data also suggest that care linkage in this group is similar to adults, but only a third of YMSM start antiretroviral therapy and are retained in care, leading to viral suppression rates as low as 12%.
With a goal to change these discouraging numbers, researchers from George Washington University, Washington, and other institutions conducted a randomized controlled pilot study targeting parents of YMSM to improve both the frequency and quality of communication around sexual health and HIV risk, prevention, and testing.
The findings, which were published online in the journal AIDS and Behavior, highlight the observation that parents could be an essential resource for combating the HIV epidemic, but they’re a resource that’s often underutilized. In fact, after participating in an online offering – PATHS (Parents and Adolescents Talking about Healthy Sexuality) – parents reported significantly greater engagement with their sons, especially around discussions focusing on HIV information and condom use.
“From what we know from the research, parents are uncomfortable talking about sex; they’re not great at talking about it. But when they do and do it effectively, those kids seem to have better health outcomes,” lead author David Huebner, PhD, MPH, associate professor of prevention and community health at George Washington University, said in an interview.
“The goal was to get parents to deliver more messages and engage in more behaviors with their sons that we think are likely to help their sons stay healthy,” he said.
For the pilot study, Huebner and his team recruited 61 parents (95% of whom were mothers) with predominantly high school-aged cisgender sons (median, 16.7-17 years) who had come out as gay or bisexual at least a month prior, whose HIV status was negative or unknown, and who were living at home.
The interventions were strictly parent focused, Dr. Huebner said, noting that the only interaction with the kids involved independent surveys at the start and end of the study that explored parental behavior and engagement.
For the study, parental participants were stratified by son’s age (13-17 or 18-22 years) and then randomly assigned to participate in a web-accessible PATHS intervention (intervention group) or view a 35-minute, documentary-style film that encouraged acceptance of lesbian, gay, or bisexual children (control group),
Parents assigned to the intervention group were asked to engage in their own time with six modules that explored the importance of communication, HIV information, using and acquiring condoms, HIV testing, and as follow-up, a “to-do” list encouraging selection of how they would follow up with their sons about the content. They were also offered the option to participate in supplemental modules on pre-exposure prophylaxis (PrEP), anal intercourse, and what to do if a child tested positive for HIV.
“The intervention ... showed strong evidence of being effective at changing the parent behaviors that we hoped to change,” Dr. Huebner explained.
“We got independent reports from parents and kids that showed the same thing: parents were more likely to communicate with their sons about HIV in the 3 months after the intervention and were more likely to help their sons get access to condoms,” he said.
Both of these findings were significant, with parents in the experimental group being almost 10 times more likely to share HIV information with their sons (odds ratio, 9.50; 95% confidence interval, 1.02-39.99; P < .05) and five times more likely to teach proper condom use (OR, 5.04; 95% CI 1.56-12.46; P < .05), compared with parents receiving the placebo.
“It’s very promising that the initial signals from their intervention do show that parents facilitating the acquisition of information for young men who have sex with men really works,” said Dalmacio Dennis Flores, PhD, ACRN, an assistant professor of nursing in family and community health at the University of Pennsylvania, Philadelphia. He was not directly involved in the study.
“On the outcomes that matter for us, such as HIV prevention or getting tested, they were able to document that parents receiving guidance on how to have these conversations does result in youth outcomes – something that has been lacking in the literature specifically for this population up until today,” Dr. Flores told this news organization.
Overall, parents engaging in the PATHS intervention showed improvements in skills, attitudes, and behavioral intention toward engagement with their sons, including assisting with HIV testing. However, what about parental involvement in these types of dialogues with children who have not yet come out to their parents?
Dr. Flores said that, although Dr. Huebner’s work is pivotal for families where the child’s sexual orientation is known to parents, there is value in inclusive sex communication for all youth, regardless of how they identify (that is, out of the closet, closeted, straight, or those who are questioning their identity), especially since younger generations of LGBTQ youth are coming out at earlier ages, compared with previous generations.
It’s not just parents. Clinicians also have critical roles to play in helping bridge the sex-talk communication gaps between parents and adolescents and young adult children.
“In my work, I’ve found that more clinicians are willing to broach this within the discussion with dyads, with parents and adolescents in the room,” said Dr. Flores.
And he added: “If clinicians signal that there’s no such thing as too early to have these conversations or that issues such as consent, safety, and sexting are all okay to talk about because these are the current realities of young people, then parents can feel that they’re empowered to broach or sustain these conversations.”
Importantly, Dr. Huebner and associates are currently recruiting larger numbers of families for a new, yearlong trial that will not only examine parental behavior changes but also whether these changes translate into improvements in their child’s sexual health and/or competency. Interested families can learn more about the study and sign up to receive updates at www.parentwithlove.org.
Dr. Huebner and Dr. Flores reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“Take it from me, parents just don’t understand.”
Fresh Prince and D.J. Jazzy Jeff penned this lyric roughly 35 years ago, and coincidentally the HIV/AIDS epidemic has also been with us just as long. But the connection between the two may be highly relevant – that is, if you consider how infrequently parents appear (or have the proper tools) to engage with their gay or bisexual sons to prevent and curb HIV infections.
Currently, YMSM between the ages of 13 and 24 are among the most affected by the ongoing HIV epidemic, with CDC estimates suggesting that, in 2020, this group alone represented about 35% of new diagnoses. At the same time, about half of these HIV infections go undiagnosed. Recent data also suggest that care linkage in this group is similar to adults, but only a third of YMSM start antiretroviral therapy and are retained in care, leading to viral suppression rates as low as 12%.
With a goal to change these discouraging numbers, researchers from George Washington University, Washington, and other institutions conducted a randomized controlled pilot study targeting parents of YMSM to improve both the frequency and quality of communication around sexual health and HIV risk, prevention, and testing.
The findings, which were published online in the journal AIDS and Behavior, highlight the observation that parents could be an essential resource for combating the HIV epidemic, but they’re a resource that’s often underutilized. In fact, after participating in an online offering – PATHS (Parents and Adolescents Talking about Healthy Sexuality) – parents reported significantly greater engagement with their sons, especially around discussions focusing on HIV information and condom use.
“From what we know from the research, parents are uncomfortable talking about sex; they’re not great at talking about it. But when they do and do it effectively, those kids seem to have better health outcomes,” lead author David Huebner, PhD, MPH, associate professor of prevention and community health at George Washington University, said in an interview.
“The goal was to get parents to deliver more messages and engage in more behaviors with their sons that we think are likely to help their sons stay healthy,” he said.
For the pilot study, Huebner and his team recruited 61 parents (95% of whom were mothers) with predominantly high school-aged cisgender sons (median, 16.7-17 years) who had come out as gay or bisexual at least a month prior, whose HIV status was negative or unknown, and who were living at home.
The interventions were strictly parent focused, Dr. Huebner said, noting that the only interaction with the kids involved independent surveys at the start and end of the study that explored parental behavior and engagement.
For the study, parental participants were stratified by son’s age (13-17 or 18-22 years) and then randomly assigned to participate in a web-accessible PATHS intervention (intervention group) or view a 35-minute, documentary-style film that encouraged acceptance of lesbian, gay, or bisexual children (control group),
Parents assigned to the intervention group were asked to engage in their own time with six modules that explored the importance of communication, HIV information, using and acquiring condoms, HIV testing, and as follow-up, a “to-do” list encouraging selection of how they would follow up with their sons about the content. They were also offered the option to participate in supplemental modules on pre-exposure prophylaxis (PrEP), anal intercourse, and what to do if a child tested positive for HIV.
“The intervention ... showed strong evidence of being effective at changing the parent behaviors that we hoped to change,” Dr. Huebner explained.
“We got independent reports from parents and kids that showed the same thing: parents were more likely to communicate with their sons about HIV in the 3 months after the intervention and were more likely to help their sons get access to condoms,” he said.
Both of these findings were significant, with parents in the experimental group being almost 10 times more likely to share HIV information with their sons (odds ratio, 9.50; 95% confidence interval, 1.02-39.99; P < .05) and five times more likely to teach proper condom use (OR, 5.04; 95% CI 1.56-12.46; P < .05), compared with parents receiving the placebo.
“It’s very promising that the initial signals from their intervention do show that parents facilitating the acquisition of information for young men who have sex with men really works,” said Dalmacio Dennis Flores, PhD, ACRN, an assistant professor of nursing in family and community health at the University of Pennsylvania, Philadelphia. He was not directly involved in the study.
“On the outcomes that matter for us, such as HIV prevention or getting tested, they were able to document that parents receiving guidance on how to have these conversations does result in youth outcomes – something that has been lacking in the literature specifically for this population up until today,” Dr. Flores told this news organization.
Overall, parents engaging in the PATHS intervention showed improvements in skills, attitudes, and behavioral intention toward engagement with their sons, including assisting with HIV testing. However, what about parental involvement in these types of dialogues with children who have not yet come out to their parents?
Dr. Flores said that, although Dr. Huebner’s work is pivotal for families where the child’s sexual orientation is known to parents, there is value in inclusive sex communication for all youth, regardless of how they identify (that is, out of the closet, closeted, straight, or those who are questioning their identity), especially since younger generations of LGBTQ youth are coming out at earlier ages, compared with previous generations.
It’s not just parents. Clinicians also have critical roles to play in helping bridge the sex-talk communication gaps between parents and adolescents and young adult children.
“In my work, I’ve found that more clinicians are willing to broach this within the discussion with dyads, with parents and adolescents in the room,” said Dr. Flores.
And he added: “If clinicians signal that there’s no such thing as too early to have these conversations or that issues such as consent, safety, and sexting are all okay to talk about because these are the current realities of young people, then parents can feel that they’re empowered to broach or sustain these conversations.”
Importantly, Dr. Huebner and associates are currently recruiting larger numbers of families for a new, yearlong trial that will not only examine parental behavior changes but also whether these changes translate into improvements in their child’s sexual health and/or competency. Interested families can learn more about the study and sign up to receive updates at www.parentwithlove.org.
Dr. Huebner and Dr. Flores reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“Take it from me, parents just don’t understand.”
Fresh Prince and D.J. Jazzy Jeff penned this lyric roughly 35 years ago, and coincidentally the HIV/AIDS epidemic has also been with us just as long. But the connection between the two may be highly relevant – that is, if you consider how infrequently parents appear (or have the proper tools) to engage with their gay or bisexual sons to prevent and curb HIV infections.
Currently, YMSM between the ages of 13 and 24 are among the most affected by the ongoing HIV epidemic, with CDC estimates suggesting that, in 2020, this group alone represented about 35% of new diagnoses. At the same time, about half of these HIV infections go undiagnosed. Recent data also suggest that care linkage in this group is similar to adults, but only a third of YMSM start antiretroviral therapy and are retained in care, leading to viral suppression rates as low as 12%.
With a goal to change these discouraging numbers, researchers from George Washington University, Washington, and other institutions conducted a randomized controlled pilot study targeting parents of YMSM to improve both the frequency and quality of communication around sexual health and HIV risk, prevention, and testing.
The findings, which were published online in the journal AIDS and Behavior, highlight the observation that parents could be an essential resource for combating the HIV epidemic, but they’re a resource that’s often underutilized. In fact, after participating in an online offering – PATHS (Parents and Adolescents Talking about Healthy Sexuality) – parents reported significantly greater engagement with their sons, especially around discussions focusing on HIV information and condom use.
“From what we know from the research, parents are uncomfortable talking about sex; they’re not great at talking about it. But when they do and do it effectively, those kids seem to have better health outcomes,” lead author David Huebner, PhD, MPH, associate professor of prevention and community health at George Washington University, said in an interview.
“The goal was to get parents to deliver more messages and engage in more behaviors with their sons that we think are likely to help their sons stay healthy,” he said.
For the pilot study, Huebner and his team recruited 61 parents (95% of whom were mothers) with predominantly high school-aged cisgender sons (median, 16.7-17 years) who had come out as gay or bisexual at least a month prior, whose HIV status was negative or unknown, and who were living at home.
The interventions were strictly parent focused, Dr. Huebner said, noting that the only interaction with the kids involved independent surveys at the start and end of the study that explored parental behavior and engagement.
For the study, parental participants were stratified by son’s age (13-17 or 18-22 years) and then randomly assigned to participate in a web-accessible PATHS intervention (intervention group) or view a 35-minute, documentary-style film that encouraged acceptance of lesbian, gay, or bisexual children (control group),
Parents assigned to the intervention group were asked to engage in their own time with six modules that explored the importance of communication, HIV information, using and acquiring condoms, HIV testing, and as follow-up, a “to-do” list encouraging selection of how they would follow up with their sons about the content. They were also offered the option to participate in supplemental modules on pre-exposure prophylaxis (PrEP), anal intercourse, and what to do if a child tested positive for HIV.
“The intervention ... showed strong evidence of being effective at changing the parent behaviors that we hoped to change,” Dr. Huebner explained.
“We got independent reports from parents and kids that showed the same thing: parents were more likely to communicate with their sons about HIV in the 3 months after the intervention and were more likely to help their sons get access to condoms,” he said.
Both of these findings were significant, with parents in the experimental group being almost 10 times more likely to share HIV information with their sons (odds ratio, 9.50; 95% confidence interval, 1.02-39.99; P < .05) and five times more likely to teach proper condom use (OR, 5.04; 95% CI 1.56-12.46; P < .05), compared with parents receiving the placebo.
“It’s very promising that the initial signals from their intervention do show that parents facilitating the acquisition of information for young men who have sex with men really works,” said Dalmacio Dennis Flores, PhD, ACRN, an assistant professor of nursing in family and community health at the University of Pennsylvania, Philadelphia. He was not directly involved in the study.
“On the outcomes that matter for us, such as HIV prevention or getting tested, they were able to document that parents receiving guidance on how to have these conversations does result in youth outcomes – something that has been lacking in the literature specifically for this population up until today,” Dr. Flores told this news organization.
Overall, parents engaging in the PATHS intervention showed improvements in skills, attitudes, and behavioral intention toward engagement with their sons, including assisting with HIV testing. However, what about parental involvement in these types of dialogues with children who have not yet come out to their parents?
Dr. Flores said that, although Dr. Huebner’s work is pivotal for families where the child’s sexual orientation is known to parents, there is value in inclusive sex communication for all youth, regardless of how they identify (that is, out of the closet, closeted, straight, or those who are questioning their identity), especially since younger generations of LGBTQ youth are coming out at earlier ages, compared with previous generations.
It’s not just parents. Clinicians also have critical roles to play in helping bridge the sex-talk communication gaps between parents and adolescents and young adult children.
“In my work, I’ve found that more clinicians are willing to broach this within the discussion with dyads, with parents and adolescents in the room,” said Dr. Flores.
And he added: “If clinicians signal that there’s no such thing as too early to have these conversations or that issues such as consent, safety, and sexting are all okay to talk about because these are the current realities of young people, then parents can feel that they’re empowered to broach or sustain these conversations.”
Importantly, Dr. Huebner and associates are currently recruiting larger numbers of families for a new, yearlong trial that will not only examine parental behavior changes but also whether these changes translate into improvements in their child’s sexual health and/or competency. Interested families can learn more about the study and sign up to receive updates at www.parentwithlove.org.
Dr. Huebner and Dr. Flores reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AIDS AND BEHAVIOR
In patients with untreated AIDS, monkeypox can be life-threatening
Monkeypox, though often mild, may be severe and even fatal in immunocompromised individuals, particularly those with untreated AIDS, according to a Centers for Disease Control and Prevention study in Morbidity and Mortality Weekly Report.
The study described a group of patients recently treated for severe monkeypox. The majority were Black, HIV positive, and not receiving treatment. Many were also facing homelessness.
The authors urged HIV testing for all sexually active individuals with suspected monkeypox. Early or prolonged monkeypox treatment may be necessary, they concluded.
Coauthor John T. Brooks, MD, called the study “a real call to action.”
“If we want to reduce cases of severe monkeypox, we need to reduce the number of persons with HIV who are undiagnosed and not treated,” said Dr. Brooks, a medical epidemiologist who is chief medical officer of CDC›s multinational monkeypox response. Dr. Brooks also leads the epidemiology research team in CDC’s division of HIV/AIDS prevention.
noted Richard Silvera, MD, MPH, CPH, who is associate program director of the infectious diseases fellowship and assistant professor of medicine (infectious diseases) at the Icahn School of Medicine at Mount Sinai, New York. He was not involved with the study.
“These patients really have not been served by the health care system,” Dr. Silvera said. “Monkeypox is just really taking advantage of that.”
How severe monkeypox can manifest
The authors reported on 57 adults hospitalized with severe monkeypox between Aug. 10 and Sept. 10, 2022, for whose care the providers sought CDC consultation.
The vast majority (95%) were men, their median age was 34 years, and 68% were Black. Nearly one in four were homeless (23%).
Overall, 47 (82%) were HIV positive, of whom just 4 had been receiving antiretroviral therapy (ART). Of 43 for whom CD4 counts were known, 71% had fewer than 50 CD4 cells/mm3.
Clinical signs included severe skin lesions in all patients and severe mucosal lesions in 68%. Other affected organ systems included lungs (21%), eyes (21%), and central nervous system (7%).
Treatments included oral or intravenous tecovirimat (93% and 65%, respectively), vaccinia immune globulin intravenous (VIGIV, 51%), and cidofovir (23%).
Nearly 1 in 3 patients (30%) received care in an ICU; 12 died (21%). Monkeypox was considered the cause or a contributing factor in five of the deaths and not a factor in one death; the remaining six deaths are under investigation.
Case studies
The report included details of three representative cases of the CDC consultations.
One was a Hispanic man in his 20s with a fever of 102.8° F, a rash including eschars, oral lesions, neck mass, and cervical lymphadenopathy. He had tested positive for monkeypox as an outpatient and upon admission was found to be HIV positive, with a CD4 count of 79 cells/mm3. He experienced a severe and ultimately fatal clinical course that included intubation, refractory hypotension, seizures, renal failure, and cardiac arrest. An autopsy revealed diffuse organ necrosis plus orthopoxvirus and cytomegalovirus.
The second was a Black man in his 30s with untreated AIDS and diffuse rash. He was tested and treated for gonorrhea, chlamydia, and syphilis before phimosis and urinary retention led to admission and a monkeypox diagnosis 4 weeks after his rash began. He was discharged with oral tecovirimat, but his skin lesions developed necrosis and he was readmitted twice, each time with new lesions. His clinical course included methicillin-resistant Staphylococcus aureus bacteremia, atrial fibrillation, eye and ear involvement, a suprapubic catheter, and progressive necrosis of his lesions. As of the CDC report, he was receiving ART and intravenous tecovirimat.
The third patient, a White man in his 40s with untreated AIDS, presented with diffuse rash. He was promptly diagnosed with monkeypox and admitted for pain control. He was discharged with oral tecovirimat and ART, but homelessness and food insecurity jeopardized the absorption of his tecovirimat (which depends on a full fatty meal), and the lesions worsened. Despite readmission and aggressive medical treatment, the patient required finger debridement and a toe amputation. After discharge, he was again readmitted for lesions and pain and, at report publication, remained hospitalized, taking oral tecovirimat and ART.
The patients in the study may not be typical of severe monkeypox cases, wrote the authors reported. Deaths after the study period were not counted.
Fewer cases, some severe
As of Nov. 7, the CDC has confirmed 28,709 monkeypox cases. These have trended downward since August. Most people with recent diagnoses are men who are gay, bisexual, same gender loving, or who have sex with men, and most are Black, according to Brooks.
Dr. Brooks urges clinicians to report suspected monkeypox cases – especially severe ones – to their health departments.
“We don’t have a good bead on exactly how many severe cases there are in the States because of complexities in our surveillance systems,” Dr. Brooks said.
For patients with suspected or confirmed monkeypox, Brooks recommends testing for sexually transmitted infections, including HIV if status is unknown. Patients with HIV should receive prompt ART. For those at risk for severe disease, the authors recommend early treatment for suspected monkeypox, even before results are back. Some patients may benefit from tecovirimat courses lasting beyond 14 days, plus additional antivirals (cidofovir or brincidofovir) and/or VIGIV.
“With severe cases, clinicians may want to consider the value of more than one drug to attack the virus at different stages of its replication cycle,” Dr. Brooks said.
Inequities matter
The authors called on providers to engage communities burdened by HIV and to ensure access to not only monkeypox vaccination, diagnosis, and treatment but also sustained HIV care.
Dr. Silvera added that providers need to tailor care plans to patients’ social determinants of health. For example, he explained, inpatient care for monkeypox could be appropriate for some patients facing homelessness and food insecurity – even if they are able to take tecovirimat orally.
He recommends tapping others’ expertise: “Our social work colleagues are well versed in this.”
“I don’t think these clinicians failed these patients. ... I think everyone made all the right choices medically,” Dr. Silvera added. “I think that the system failed these patients – and we as clinicians are part of those systems. So we also have the power to change those systems. And I think we just need to start opening our eyes to that and [start] to work together towards that goal to take better care of our patients.”
Dr. Brooks reported no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Monkeypox, though often mild, may be severe and even fatal in immunocompromised individuals, particularly those with untreated AIDS, according to a Centers for Disease Control and Prevention study in Morbidity and Mortality Weekly Report.
The study described a group of patients recently treated for severe monkeypox. The majority were Black, HIV positive, and not receiving treatment. Many were also facing homelessness.
The authors urged HIV testing for all sexually active individuals with suspected monkeypox. Early or prolonged monkeypox treatment may be necessary, they concluded.
Coauthor John T. Brooks, MD, called the study “a real call to action.”
“If we want to reduce cases of severe monkeypox, we need to reduce the number of persons with HIV who are undiagnosed and not treated,” said Dr. Brooks, a medical epidemiologist who is chief medical officer of CDC›s multinational monkeypox response. Dr. Brooks also leads the epidemiology research team in CDC’s division of HIV/AIDS prevention.
noted Richard Silvera, MD, MPH, CPH, who is associate program director of the infectious diseases fellowship and assistant professor of medicine (infectious diseases) at the Icahn School of Medicine at Mount Sinai, New York. He was not involved with the study.
“These patients really have not been served by the health care system,” Dr. Silvera said. “Monkeypox is just really taking advantage of that.”
How severe monkeypox can manifest
The authors reported on 57 adults hospitalized with severe monkeypox between Aug. 10 and Sept. 10, 2022, for whose care the providers sought CDC consultation.
The vast majority (95%) were men, their median age was 34 years, and 68% were Black. Nearly one in four were homeless (23%).
Overall, 47 (82%) were HIV positive, of whom just 4 had been receiving antiretroviral therapy (ART). Of 43 for whom CD4 counts were known, 71% had fewer than 50 CD4 cells/mm3.
Clinical signs included severe skin lesions in all patients and severe mucosal lesions in 68%. Other affected organ systems included lungs (21%), eyes (21%), and central nervous system (7%).
Treatments included oral or intravenous tecovirimat (93% and 65%, respectively), vaccinia immune globulin intravenous (VIGIV, 51%), and cidofovir (23%).
Nearly 1 in 3 patients (30%) received care in an ICU; 12 died (21%). Monkeypox was considered the cause or a contributing factor in five of the deaths and not a factor in one death; the remaining six deaths are under investigation.
Case studies
The report included details of three representative cases of the CDC consultations.
One was a Hispanic man in his 20s with a fever of 102.8° F, a rash including eschars, oral lesions, neck mass, and cervical lymphadenopathy. He had tested positive for monkeypox as an outpatient and upon admission was found to be HIV positive, with a CD4 count of 79 cells/mm3. He experienced a severe and ultimately fatal clinical course that included intubation, refractory hypotension, seizures, renal failure, and cardiac arrest. An autopsy revealed diffuse organ necrosis plus orthopoxvirus and cytomegalovirus.
The second was a Black man in his 30s with untreated AIDS and diffuse rash. He was tested and treated for gonorrhea, chlamydia, and syphilis before phimosis and urinary retention led to admission and a monkeypox diagnosis 4 weeks after his rash began. He was discharged with oral tecovirimat, but his skin lesions developed necrosis and he was readmitted twice, each time with new lesions. His clinical course included methicillin-resistant Staphylococcus aureus bacteremia, atrial fibrillation, eye and ear involvement, a suprapubic catheter, and progressive necrosis of his lesions. As of the CDC report, he was receiving ART and intravenous tecovirimat.
The third patient, a White man in his 40s with untreated AIDS, presented with diffuse rash. He was promptly diagnosed with monkeypox and admitted for pain control. He was discharged with oral tecovirimat and ART, but homelessness and food insecurity jeopardized the absorption of his tecovirimat (which depends on a full fatty meal), and the lesions worsened. Despite readmission and aggressive medical treatment, the patient required finger debridement and a toe amputation. After discharge, he was again readmitted for lesions and pain and, at report publication, remained hospitalized, taking oral tecovirimat and ART.
The patients in the study may not be typical of severe monkeypox cases, wrote the authors reported. Deaths after the study period were not counted.
Fewer cases, some severe
As of Nov. 7, the CDC has confirmed 28,709 monkeypox cases. These have trended downward since August. Most people with recent diagnoses are men who are gay, bisexual, same gender loving, or who have sex with men, and most are Black, according to Brooks.
Dr. Brooks urges clinicians to report suspected monkeypox cases – especially severe ones – to their health departments.
“We don’t have a good bead on exactly how many severe cases there are in the States because of complexities in our surveillance systems,” Dr. Brooks said.
For patients with suspected or confirmed monkeypox, Brooks recommends testing for sexually transmitted infections, including HIV if status is unknown. Patients with HIV should receive prompt ART. For those at risk for severe disease, the authors recommend early treatment for suspected monkeypox, even before results are back. Some patients may benefit from tecovirimat courses lasting beyond 14 days, plus additional antivirals (cidofovir or brincidofovir) and/or VIGIV.
“With severe cases, clinicians may want to consider the value of more than one drug to attack the virus at different stages of its replication cycle,” Dr. Brooks said.
Inequities matter
The authors called on providers to engage communities burdened by HIV and to ensure access to not only monkeypox vaccination, diagnosis, and treatment but also sustained HIV care.
Dr. Silvera added that providers need to tailor care plans to patients’ social determinants of health. For example, he explained, inpatient care for monkeypox could be appropriate for some patients facing homelessness and food insecurity – even if they are able to take tecovirimat orally.
He recommends tapping others’ expertise: “Our social work colleagues are well versed in this.”
“I don’t think these clinicians failed these patients. ... I think everyone made all the right choices medically,” Dr. Silvera added. “I think that the system failed these patients – and we as clinicians are part of those systems. So we also have the power to change those systems. And I think we just need to start opening our eyes to that and [start] to work together towards that goal to take better care of our patients.”
Dr. Brooks reported no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Monkeypox, though often mild, may be severe and even fatal in immunocompromised individuals, particularly those with untreated AIDS, according to a Centers for Disease Control and Prevention study in Morbidity and Mortality Weekly Report.
The study described a group of patients recently treated for severe monkeypox. The majority were Black, HIV positive, and not receiving treatment. Many were also facing homelessness.
The authors urged HIV testing for all sexually active individuals with suspected monkeypox. Early or prolonged monkeypox treatment may be necessary, they concluded.
Coauthor John T. Brooks, MD, called the study “a real call to action.”
“If we want to reduce cases of severe monkeypox, we need to reduce the number of persons with HIV who are undiagnosed and not treated,” said Dr. Brooks, a medical epidemiologist who is chief medical officer of CDC›s multinational monkeypox response. Dr. Brooks also leads the epidemiology research team in CDC’s division of HIV/AIDS prevention.
noted Richard Silvera, MD, MPH, CPH, who is associate program director of the infectious diseases fellowship and assistant professor of medicine (infectious diseases) at the Icahn School of Medicine at Mount Sinai, New York. He was not involved with the study.
“These patients really have not been served by the health care system,” Dr. Silvera said. “Monkeypox is just really taking advantage of that.”
How severe monkeypox can manifest
The authors reported on 57 adults hospitalized with severe monkeypox between Aug. 10 and Sept. 10, 2022, for whose care the providers sought CDC consultation.
The vast majority (95%) were men, their median age was 34 years, and 68% were Black. Nearly one in four were homeless (23%).
Overall, 47 (82%) were HIV positive, of whom just 4 had been receiving antiretroviral therapy (ART). Of 43 for whom CD4 counts were known, 71% had fewer than 50 CD4 cells/mm3.
Clinical signs included severe skin lesions in all patients and severe mucosal lesions in 68%. Other affected organ systems included lungs (21%), eyes (21%), and central nervous system (7%).
Treatments included oral or intravenous tecovirimat (93% and 65%, respectively), vaccinia immune globulin intravenous (VIGIV, 51%), and cidofovir (23%).
Nearly 1 in 3 patients (30%) received care in an ICU; 12 died (21%). Monkeypox was considered the cause or a contributing factor in five of the deaths and not a factor in one death; the remaining six deaths are under investigation.
Case studies
The report included details of three representative cases of the CDC consultations.
One was a Hispanic man in his 20s with a fever of 102.8° F, a rash including eschars, oral lesions, neck mass, and cervical lymphadenopathy. He had tested positive for monkeypox as an outpatient and upon admission was found to be HIV positive, with a CD4 count of 79 cells/mm3. He experienced a severe and ultimately fatal clinical course that included intubation, refractory hypotension, seizures, renal failure, and cardiac arrest. An autopsy revealed diffuse organ necrosis plus orthopoxvirus and cytomegalovirus.
The second was a Black man in his 30s with untreated AIDS and diffuse rash. He was tested and treated for gonorrhea, chlamydia, and syphilis before phimosis and urinary retention led to admission and a monkeypox diagnosis 4 weeks after his rash began. He was discharged with oral tecovirimat, but his skin lesions developed necrosis and he was readmitted twice, each time with new lesions. His clinical course included methicillin-resistant Staphylococcus aureus bacteremia, atrial fibrillation, eye and ear involvement, a suprapubic catheter, and progressive necrosis of his lesions. As of the CDC report, he was receiving ART and intravenous tecovirimat.
The third patient, a White man in his 40s with untreated AIDS, presented with diffuse rash. He was promptly diagnosed with monkeypox and admitted for pain control. He was discharged with oral tecovirimat and ART, but homelessness and food insecurity jeopardized the absorption of his tecovirimat (which depends on a full fatty meal), and the lesions worsened. Despite readmission and aggressive medical treatment, the patient required finger debridement and a toe amputation. After discharge, he was again readmitted for lesions and pain and, at report publication, remained hospitalized, taking oral tecovirimat and ART.
The patients in the study may not be typical of severe monkeypox cases, wrote the authors reported. Deaths after the study period were not counted.
Fewer cases, some severe
As of Nov. 7, the CDC has confirmed 28,709 monkeypox cases. These have trended downward since August. Most people with recent diagnoses are men who are gay, bisexual, same gender loving, or who have sex with men, and most are Black, according to Brooks.
Dr. Brooks urges clinicians to report suspected monkeypox cases – especially severe ones – to their health departments.
“We don’t have a good bead on exactly how many severe cases there are in the States because of complexities in our surveillance systems,” Dr. Brooks said.
For patients with suspected or confirmed monkeypox, Brooks recommends testing for sexually transmitted infections, including HIV if status is unknown. Patients with HIV should receive prompt ART. For those at risk for severe disease, the authors recommend early treatment for suspected monkeypox, even before results are back. Some patients may benefit from tecovirimat courses lasting beyond 14 days, plus additional antivirals (cidofovir or brincidofovir) and/or VIGIV.
“With severe cases, clinicians may want to consider the value of more than one drug to attack the virus at different stages of its replication cycle,” Dr. Brooks said.
Inequities matter
The authors called on providers to engage communities burdened by HIV and to ensure access to not only monkeypox vaccination, diagnosis, and treatment but also sustained HIV care.
Dr. Silvera added that providers need to tailor care plans to patients’ social determinants of health. For example, he explained, inpatient care for monkeypox could be appropriate for some patients facing homelessness and food insecurity – even if they are able to take tecovirimat orally.
He recommends tapping others’ expertise: “Our social work colleagues are well versed in this.”
“I don’t think these clinicians failed these patients. ... I think everyone made all the right choices medically,” Dr. Silvera added. “I think that the system failed these patients – and we as clinicians are part of those systems. So we also have the power to change those systems. And I think we just need to start opening our eyes to that and [start] to work together towards that goal to take better care of our patients.”
Dr. Brooks reported no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
FROM THE MMWR
Life expectancy 6.3 years shorter for Black MSM with HIV
WASHINGTON –
Lead author Katherine Rich, MPH, a student at Harvard Medical School, Boston, presented the data during an annual scientific meeting on infectious diseases.
“Substantial disparities in care exist between Black and White MSM here in the United States,” she said. “The 2030 goals of the EHE [Ending the HIV Epidemic in the U.S. initiative] won’t be met until HIV-related disparities are reduced.”
Using modeling, the team was able to measure both the gaps and the potential of interventions to address those gaps.
- The team found that improving engagement in care had the largest benefit in narrowing the gap. Improving engagement and retention in care, they write, would result in a gain of 1.4 life-years for Black MSM and 1 year for White MSM.
- Annual testing would add 0.6 life-years for Black MSM and 0.3 life-years for White MSM, compared with standard care.
- In simulating viral suppression, the model-predicted gain would be 1.1 years for Black MSM and 0.3 for White.
Furthermore, a combination of annual testing, 95% engagement in care, and 95% virologic suppression would add 3.4 years for Black MSM (more than double the increase in life-years for any one intervention) and 1.6 years for their White counterparts, the research suggests.
The researchers projected life expectancy from age 15 to be 52.2 years for Black MSM (or 67.2 years old) and 58.5 years from age 15 for White MSM (or 73.5 years old), a difference of 6.3 years.
Kathleen McManus, MD, assistant professor of medicine in infectious diseases and international health at the University of Virginia, Charlottesville, said in an interview that the projected gap in years of life should be a call to action. Dr. McManus was not involved with the study.
Life expectancy gap ‘alarming’
“It is alarming that with current usual HIV care Black MSM with HIV have 6.3 fewer years of life expectancy than White MSM,” she said. “Black MSM having lower retention in care and a lower rate of viral suppression than White MSM demonstrates that there is a problem with our current health care delivery to Black MSM.”
With qualitative, community-engaged research, she said, “we need to ask the Black MSM community what care innovations they need – and then we need clinics and organizations to make the identified changes.”
Researchers used the validated CEPAC (Cost-Effectiveness of Preventing AIDS Complications) microsimulation HIV model to project life expectancy. Using data from the United States Centers for Disease Control and Prevention, they estimated the average age at HIV infection to be 26.8 years for Black MSM and 35 years for White MSM.
They estimated the proportion of time that MSM with diagnosed HIV are retained in care to be 75.2% for Black MSM and 80.6% for White MSM. They calculated the proportion who achieve virologic suppression to be 82% for Black MSM and 91.2% for White MSM.
Senior author Emily P. Hyle, MD, associate professor of medicine at Harvard and infectious diseases physician at Massachusetts General Hospital, both in Boston, said in a press conference before the presentation that strategies to narrow the gap will look different by region.
“Our study highlights that if you can find effective interventions, the effect can be incredibly large. These are very large differences in life-years and life expectancies,” she said.
Ms. Rich gave an example of promising interventions by pointing to work by study coauthor Aima Ahonkhai, MD, MPH, assistant professor of medicine at Vanderbilt University, Nashville, Tenn., who has received federal funding to pursue research on whether preventive care outreach in barbershops can improve prevention for Black men with HIV.
Ms. Rich noted that the modeling has limitations in that it focused on health outcomes and did not simulate transmissions. Results also reflect national data and not local HIV care continuums, which, she acknowledged, differ substantially.
Dr. McManus and the study authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON –
Lead author Katherine Rich, MPH, a student at Harvard Medical School, Boston, presented the data during an annual scientific meeting on infectious diseases.
“Substantial disparities in care exist between Black and White MSM here in the United States,” she said. “The 2030 goals of the EHE [Ending the HIV Epidemic in the U.S. initiative] won’t be met until HIV-related disparities are reduced.”
Using modeling, the team was able to measure both the gaps and the potential of interventions to address those gaps.
- The team found that improving engagement in care had the largest benefit in narrowing the gap. Improving engagement and retention in care, they write, would result in a gain of 1.4 life-years for Black MSM and 1 year for White MSM.
- Annual testing would add 0.6 life-years for Black MSM and 0.3 life-years for White MSM, compared with standard care.
- In simulating viral suppression, the model-predicted gain would be 1.1 years for Black MSM and 0.3 for White.
Furthermore, a combination of annual testing, 95% engagement in care, and 95% virologic suppression would add 3.4 years for Black MSM (more than double the increase in life-years for any one intervention) and 1.6 years for their White counterparts, the research suggests.
The researchers projected life expectancy from age 15 to be 52.2 years for Black MSM (or 67.2 years old) and 58.5 years from age 15 for White MSM (or 73.5 years old), a difference of 6.3 years.
Kathleen McManus, MD, assistant professor of medicine in infectious diseases and international health at the University of Virginia, Charlottesville, said in an interview that the projected gap in years of life should be a call to action. Dr. McManus was not involved with the study.
Life expectancy gap ‘alarming’
“It is alarming that with current usual HIV care Black MSM with HIV have 6.3 fewer years of life expectancy than White MSM,” she said. “Black MSM having lower retention in care and a lower rate of viral suppression than White MSM demonstrates that there is a problem with our current health care delivery to Black MSM.”
With qualitative, community-engaged research, she said, “we need to ask the Black MSM community what care innovations they need – and then we need clinics and organizations to make the identified changes.”
Researchers used the validated CEPAC (Cost-Effectiveness of Preventing AIDS Complications) microsimulation HIV model to project life expectancy. Using data from the United States Centers for Disease Control and Prevention, they estimated the average age at HIV infection to be 26.8 years for Black MSM and 35 years for White MSM.
They estimated the proportion of time that MSM with diagnosed HIV are retained in care to be 75.2% for Black MSM and 80.6% for White MSM. They calculated the proportion who achieve virologic suppression to be 82% for Black MSM and 91.2% for White MSM.
Senior author Emily P. Hyle, MD, associate professor of medicine at Harvard and infectious diseases physician at Massachusetts General Hospital, both in Boston, said in a press conference before the presentation that strategies to narrow the gap will look different by region.
“Our study highlights that if you can find effective interventions, the effect can be incredibly large. These are very large differences in life-years and life expectancies,” she said.
Ms. Rich gave an example of promising interventions by pointing to work by study coauthor Aima Ahonkhai, MD, MPH, assistant professor of medicine at Vanderbilt University, Nashville, Tenn., who has received federal funding to pursue research on whether preventive care outreach in barbershops can improve prevention for Black men with HIV.
Ms. Rich noted that the modeling has limitations in that it focused on health outcomes and did not simulate transmissions. Results also reflect national data and not local HIV care continuums, which, she acknowledged, differ substantially.
Dr. McManus and the study authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON –
Lead author Katherine Rich, MPH, a student at Harvard Medical School, Boston, presented the data during an annual scientific meeting on infectious diseases.
“Substantial disparities in care exist between Black and White MSM here in the United States,” she said. “The 2030 goals of the EHE [Ending the HIV Epidemic in the U.S. initiative] won’t be met until HIV-related disparities are reduced.”
Using modeling, the team was able to measure both the gaps and the potential of interventions to address those gaps.
- The team found that improving engagement in care had the largest benefit in narrowing the gap. Improving engagement and retention in care, they write, would result in a gain of 1.4 life-years for Black MSM and 1 year for White MSM.
- Annual testing would add 0.6 life-years for Black MSM and 0.3 life-years for White MSM, compared with standard care.
- In simulating viral suppression, the model-predicted gain would be 1.1 years for Black MSM and 0.3 for White.
Furthermore, a combination of annual testing, 95% engagement in care, and 95% virologic suppression would add 3.4 years for Black MSM (more than double the increase in life-years for any one intervention) and 1.6 years for their White counterparts, the research suggests.
The researchers projected life expectancy from age 15 to be 52.2 years for Black MSM (or 67.2 years old) and 58.5 years from age 15 for White MSM (or 73.5 years old), a difference of 6.3 years.
Kathleen McManus, MD, assistant professor of medicine in infectious diseases and international health at the University of Virginia, Charlottesville, said in an interview that the projected gap in years of life should be a call to action. Dr. McManus was not involved with the study.
Life expectancy gap ‘alarming’
“It is alarming that with current usual HIV care Black MSM with HIV have 6.3 fewer years of life expectancy than White MSM,” she said. “Black MSM having lower retention in care and a lower rate of viral suppression than White MSM demonstrates that there is a problem with our current health care delivery to Black MSM.”
With qualitative, community-engaged research, she said, “we need to ask the Black MSM community what care innovations they need – and then we need clinics and organizations to make the identified changes.”
Researchers used the validated CEPAC (Cost-Effectiveness of Preventing AIDS Complications) microsimulation HIV model to project life expectancy. Using data from the United States Centers for Disease Control and Prevention, they estimated the average age at HIV infection to be 26.8 years for Black MSM and 35 years for White MSM.
They estimated the proportion of time that MSM with diagnosed HIV are retained in care to be 75.2% for Black MSM and 80.6% for White MSM. They calculated the proportion who achieve virologic suppression to be 82% for Black MSM and 91.2% for White MSM.
Senior author Emily P. Hyle, MD, associate professor of medicine at Harvard and infectious diseases physician at Massachusetts General Hospital, both in Boston, said in a press conference before the presentation that strategies to narrow the gap will look different by region.
“Our study highlights that if you can find effective interventions, the effect can be incredibly large. These are very large differences in life-years and life expectancies,” she said.
Ms. Rich gave an example of promising interventions by pointing to work by study coauthor Aima Ahonkhai, MD, MPH, assistant professor of medicine at Vanderbilt University, Nashville, Tenn., who has received federal funding to pursue research on whether preventive care outreach in barbershops can improve prevention for Black men with HIV.
Ms. Rich noted that the modeling has limitations in that it focused on health outcomes and did not simulate transmissions. Results also reflect national data and not local HIV care continuums, which, she acknowledged, differ substantially.
Dr. McManus and the study authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT IDWEEK 2022
Monkeypox presentations, prevention strategies shifting
New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.
Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.
Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.
Shift away from White men
Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.
“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.
In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.
“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.
No sustained spread outside MSM
Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.
However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.
“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”
She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.
“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.
Severe cases among immunocompromised
Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.
Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”
Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.
She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.
Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”
Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.
Differences from past epidemics
Dr. Titanji said the current outbreak has some differences from historic outbreaks.
The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.
There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.
The scope of suspected cases has also broadened, with changing clinical features.
“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.
Expanding the case definition will help identify who should be tested.
“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”
Vaccine strategy has evolved
Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.
Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”
It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.
Early data from the CDC indicate that the Jynneos vaccine is effective.
In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.
“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.
Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”
Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.
Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.
Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.
Shift away from White men
Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.
“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.
In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.
“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.
No sustained spread outside MSM
Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.
However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.
“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”
She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.
“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.
Severe cases among immunocompromised
Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.
Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”
Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.
She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.
Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”
Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.
Differences from past epidemics
Dr. Titanji said the current outbreak has some differences from historic outbreaks.
The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.
There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.
The scope of suspected cases has also broadened, with changing clinical features.
“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.
Expanding the case definition will help identify who should be tested.
“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”
Vaccine strategy has evolved
Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.
Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”
It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.
Early data from the CDC indicate that the Jynneos vaccine is effective.
In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.
“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.
Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”
Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.
Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.
Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.
Shift away from White men
Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.
“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.
In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.
“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.
No sustained spread outside MSM
Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.
However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.
“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”
She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.
“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.
Severe cases among immunocompromised
Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.
Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”
Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.
She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.
Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”
Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.
Differences from past epidemics
Dr. Titanji said the current outbreak has some differences from historic outbreaks.
The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.
There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.
The scope of suspected cases has also broadened, with changing clinical features.
“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.
Expanding the case definition will help identify who should be tested.
“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”
Vaccine strategy has evolved
Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.
Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”
It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.
Early data from the CDC indicate that the Jynneos vaccine is effective.
In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.
“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.
Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”
Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM IDWEEK 2022
Increased HIV infection linked to pandemic-related access to PrEP
Changes to HIV pre-exposure prophylaxis (PrEP) access during the COVID-19 pandemic were linked to higher rates of HIV infection among young sexual minority men and gender-diverse individuals who identified as Black and/or Hispanic/Latino, according to a national survey.
“The public health crisis surrounding COVID-19 had clear impact on PrEP access and risk of HIV acquisition overall,” said lead investigator Ethan Morgan, PhD, College of Nursing and the Infectious Disease Institute at Ohio State University, Columbus.
he said in an interview.
The online survey was administered in four waves during the first year and a half of the pandemic, starting in March 2020. Participants were recruited through mailing lists, national networks, community partners, and social media.
Among 796 baseline respondents, 300 agreed to three follow-up surveys administered between February and March 2021, between July and August 2021, and between October and November 2021.
Inclusion required participants to identify as Black and/or Hispanic/Latino, be between ages 18-29 years, be assigned male at birth, reside in the United States, and have reported anal intercourse with a man in the past 12 months. The researchers noted that given the limited uptake of and adherence to PrEP in the targeted population, they prioritized baseline respondents who reported either current PrEP use or use at least once in their lifetime.
The researchers used separate multivariable logistic regression models to assess the association between odds of testing positive for HIV and other STIs across the four online study visits and pandemic-related changes to PrEP access, and pandemic-related changes to sexual activity.
Changes in PrEP access were reported by a total of 109 (13.8%) of baseline respondents, and HIV seroconversion was reported in 25 of 292 respondents (8.6%) who reported their HIV and other STI status at follow-up. STI positivity was reported 25.6% of the baseline cohort (n = 204).
Compared with respondents who reported no changes to PrEP access, those who did report change to access were significantly more likely to report HIV seroconversion (adjusted odds ratio, 2.80; 95% confidence interval, 1.02-7.68). However, Dr. Morgan emphasized that the study question did not ask how PrEP had changed, only if it had.
“While we presume this survey question corresponds to a diminished access to PrEP medication during the COVID-19 pandemic, the question was: ‘Has your access to PrEP been impacted by the COVID-19 pandemic?’ So, it is unfortunately unclear whether access was diminished or improved,” he explained. STI positivity was not associated with PrEP access.
The survey also asked respondents how much the pandemic had impacted their sexual activity (measured on a Likert scale of not at all, a little, moderately, quite a bit, and extremely). Respondents reporting greater impact on their sexual activity were more likely to report an STI (aOR, 1.24; 95% CI, 1.10-1.40) during the study period.
In addition, though participants reported a mean of 2.8 sexual partners in the past 3 months, those reporting a greater number were more likely to report an STI (aOR, 1.29; 95% CI, 1.21-1.38).
The researchers suggested that expansion of telehealth and mail-order prescriptions as well as structural-level interventions addressing pandemic-related unemployment and loss of health insurance could have helped preserve access to PrEP.
Commenting on the study, Monica Gandhi, MD, MPH, who was not involved in the research, noted that self-reported data can be subject to bias. “However, reduction in services for other medical care has been reported frequently throughout COVID and so this finding of reduced PrEP access, and subsequent HIV infection, is completely in line with the other studies,” she said in an interview.
Dr. Gandhi, who is director of the University of California, San Francisco Center for AIDS Research and medical director of the HIV/AIDS Clinic (“Ward 86”) at San Francisco General Hospital, added: “We knew early on in the COVID-19 pandemic that access to and uptake of PrEP was decreased based on data from Boston’s Fenway Institute.”
The Boston data, reported July 2020 at the virtual International AIDS Conference, prompted “a real attempt” by clinicians to increase PrEP access and uptake – raising community awareness, dispensing PrEP through mobile units, and changing prescribing patterns, Dr. Gandhi said. “We usually see patients every 3 months for PrEP but with HIV self-testing, we can extend that interval to every 6 months, and we did so in many centers during COVID.”
The study was funded by National Institute on Drug Abuse, part of the National Institutes of Health.
Dr. Morgan and Dr. Gandhi reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Changes to HIV pre-exposure prophylaxis (PrEP) access during the COVID-19 pandemic were linked to higher rates of HIV infection among young sexual minority men and gender-diverse individuals who identified as Black and/or Hispanic/Latino, according to a national survey.
“The public health crisis surrounding COVID-19 had clear impact on PrEP access and risk of HIV acquisition overall,” said lead investigator Ethan Morgan, PhD, College of Nursing and the Infectious Disease Institute at Ohio State University, Columbus.
he said in an interview.
The online survey was administered in four waves during the first year and a half of the pandemic, starting in March 2020. Participants were recruited through mailing lists, national networks, community partners, and social media.
Among 796 baseline respondents, 300 agreed to three follow-up surveys administered between February and March 2021, between July and August 2021, and between October and November 2021.
Inclusion required participants to identify as Black and/or Hispanic/Latino, be between ages 18-29 years, be assigned male at birth, reside in the United States, and have reported anal intercourse with a man in the past 12 months. The researchers noted that given the limited uptake of and adherence to PrEP in the targeted population, they prioritized baseline respondents who reported either current PrEP use or use at least once in their lifetime.
The researchers used separate multivariable logistic regression models to assess the association between odds of testing positive for HIV and other STIs across the four online study visits and pandemic-related changes to PrEP access, and pandemic-related changes to sexual activity.
Changes in PrEP access were reported by a total of 109 (13.8%) of baseline respondents, and HIV seroconversion was reported in 25 of 292 respondents (8.6%) who reported their HIV and other STI status at follow-up. STI positivity was reported 25.6% of the baseline cohort (n = 204).
Compared with respondents who reported no changes to PrEP access, those who did report change to access were significantly more likely to report HIV seroconversion (adjusted odds ratio, 2.80; 95% confidence interval, 1.02-7.68). However, Dr. Morgan emphasized that the study question did not ask how PrEP had changed, only if it had.
“While we presume this survey question corresponds to a diminished access to PrEP medication during the COVID-19 pandemic, the question was: ‘Has your access to PrEP been impacted by the COVID-19 pandemic?’ So, it is unfortunately unclear whether access was diminished or improved,” he explained. STI positivity was not associated with PrEP access.
The survey also asked respondents how much the pandemic had impacted their sexual activity (measured on a Likert scale of not at all, a little, moderately, quite a bit, and extremely). Respondents reporting greater impact on their sexual activity were more likely to report an STI (aOR, 1.24; 95% CI, 1.10-1.40) during the study period.
In addition, though participants reported a mean of 2.8 sexual partners in the past 3 months, those reporting a greater number were more likely to report an STI (aOR, 1.29; 95% CI, 1.21-1.38).
The researchers suggested that expansion of telehealth and mail-order prescriptions as well as structural-level interventions addressing pandemic-related unemployment and loss of health insurance could have helped preserve access to PrEP.
Commenting on the study, Monica Gandhi, MD, MPH, who was not involved in the research, noted that self-reported data can be subject to bias. “However, reduction in services for other medical care has been reported frequently throughout COVID and so this finding of reduced PrEP access, and subsequent HIV infection, is completely in line with the other studies,” she said in an interview.
Dr. Gandhi, who is director of the University of California, San Francisco Center for AIDS Research and medical director of the HIV/AIDS Clinic (“Ward 86”) at San Francisco General Hospital, added: “We knew early on in the COVID-19 pandemic that access to and uptake of PrEP was decreased based on data from Boston’s Fenway Institute.”
The Boston data, reported July 2020 at the virtual International AIDS Conference, prompted “a real attempt” by clinicians to increase PrEP access and uptake – raising community awareness, dispensing PrEP through mobile units, and changing prescribing patterns, Dr. Gandhi said. “We usually see patients every 3 months for PrEP but with HIV self-testing, we can extend that interval to every 6 months, and we did so in many centers during COVID.”
The study was funded by National Institute on Drug Abuse, part of the National Institutes of Health.
Dr. Morgan and Dr. Gandhi reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Changes to HIV pre-exposure prophylaxis (PrEP) access during the COVID-19 pandemic were linked to higher rates of HIV infection among young sexual minority men and gender-diverse individuals who identified as Black and/or Hispanic/Latino, according to a national survey.
“The public health crisis surrounding COVID-19 had clear impact on PrEP access and risk of HIV acquisition overall,” said lead investigator Ethan Morgan, PhD, College of Nursing and the Infectious Disease Institute at Ohio State University, Columbus.
he said in an interview.
The online survey was administered in four waves during the first year and a half of the pandemic, starting in March 2020. Participants were recruited through mailing lists, national networks, community partners, and social media.
Among 796 baseline respondents, 300 agreed to three follow-up surveys administered between February and March 2021, between July and August 2021, and between October and November 2021.
Inclusion required participants to identify as Black and/or Hispanic/Latino, be between ages 18-29 years, be assigned male at birth, reside in the United States, and have reported anal intercourse with a man in the past 12 months. The researchers noted that given the limited uptake of and adherence to PrEP in the targeted population, they prioritized baseline respondents who reported either current PrEP use or use at least once in their lifetime.
The researchers used separate multivariable logistic regression models to assess the association between odds of testing positive for HIV and other STIs across the four online study visits and pandemic-related changes to PrEP access, and pandemic-related changes to sexual activity.
Changes in PrEP access were reported by a total of 109 (13.8%) of baseline respondents, and HIV seroconversion was reported in 25 of 292 respondents (8.6%) who reported their HIV and other STI status at follow-up. STI positivity was reported 25.6% of the baseline cohort (n = 204).
Compared with respondents who reported no changes to PrEP access, those who did report change to access were significantly more likely to report HIV seroconversion (adjusted odds ratio, 2.80; 95% confidence interval, 1.02-7.68). However, Dr. Morgan emphasized that the study question did not ask how PrEP had changed, only if it had.
“While we presume this survey question corresponds to a diminished access to PrEP medication during the COVID-19 pandemic, the question was: ‘Has your access to PrEP been impacted by the COVID-19 pandemic?’ So, it is unfortunately unclear whether access was diminished or improved,” he explained. STI positivity was not associated with PrEP access.
The survey also asked respondents how much the pandemic had impacted their sexual activity (measured on a Likert scale of not at all, a little, moderately, quite a bit, and extremely). Respondents reporting greater impact on their sexual activity were more likely to report an STI (aOR, 1.24; 95% CI, 1.10-1.40) during the study period.
In addition, though participants reported a mean of 2.8 sexual partners in the past 3 months, those reporting a greater number were more likely to report an STI (aOR, 1.29; 95% CI, 1.21-1.38).
The researchers suggested that expansion of telehealth and mail-order prescriptions as well as structural-level interventions addressing pandemic-related unemployment and loss of health insurance could have helped preserve access to PrEP.
Commenting on the study, Monica Gandhi, MD, MPH, who was not involved in the research, noted that self-reported data can be subject to bias. “However, reduction in services for other medical care has been reported frequently throughout COVID and so this finding of reduced PrEP access, and subsequent HIV infection, is completely in line with the other studies,” she said in an interview.
Dr. Gandhi, who is director of the University of California, San Francisco Center for AIDS Research and medical director of the HIV/AIDS Clinic (“Ward 86”) at San Francisco General Hospital, added: “We knew early on in the COVID-19 pandemic that access to and uptake of PrEP was decreased based on data from Boston’s Fenway Institute.”
The Boston data, reported July 2020 at the virtual International AIDS Conference, prompted “a real attempt” by clinicians to increase PrEP access and uptake – raising community awareness, dispensing PrEP through mobile units, and changing prescribing patterns, Dr. Gandhi said. “We usually see patients every 3 months for PrEP but with HIV self-testing, we can extend that interval to every 6 months, and we did so in many centers during COVID.”
The study was funded by National Institute on Drug Abuse, part of the National Institutes of Health.
Dr. Morgan and Dr. Gandhi reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROME
HPV infection in pregnancy higher among women living with HIV
Pregnant women living with HIV were more likely to be infected with human papillomavirus (HPV) than were pregnant women without HIV, a recent systematic review and meta-analysis reports.
“High prevalence of HPV was documented in pregnant WLWH [women living with HIV], exceeding the prevalence among pregnant women without HIV,” Elisabeth McClymont, PhD, of the University of British Columbia, Vancouver, and colleagues wrote in the Journal of Acquired Immune Deficiency Syndrome.
Their results contribute to two major global public health goals: eliminating cervical cancer and improving the health outcomes of newborn babies.
“Our findings of a high prevalence of HPV infection during pregnancy in WLWH, particularly of highly oncogenic HPV types, emphasize the need for HPV screening and vaccination in WLWH,” they added. “WLWH are a key population for both HPV and adverse pregnancy outcome prevention.”
Emerging evidence suggests that being infected with HPV during pregnancy may be linked with adverse pregnancy outcomes. Although women living with HIV have higher rates of HPV infection and adverse pregnancy outcomes, no prior reviews have reported on HPV infection during pregnancy in women living with HIV, the authors explained.
A study of studies
Dr. McClymont and colleagues searched the standard medical research databases through Jan. 18, 2022, for pooled and type-specific HPV prevalence and associated pregnancy outcomes among pregnant women living with HIV, including available within-study comparators of women without HIV.
They performed subgroup analyses according to polymerase chain reaction primers used to detect HPV type and according to region (Africa, Asia and Europe, the Americas).
Their analysis of 10 studies describing HPV prevalence in 1,594 pregnant women living with HIV found:
- The pooled HPV prevalence in pregnant women living with HIV was 75.5% (95% confidence interval, 50.2%-90.4%) but ranged from 23% to 98% between individual studies.
- Among the five studies that also analyzed HPV prevalence in pregnant women without HIV, the pooled prevalence was 48.1% (95% CI, 27.1%-69.8%).
- Pregnant women living with HIV had 54% higher odds of being HPV positive than did pregnant women without HIV.
- HPV-16 was the most common HPV type detected in pregnant women living with HIV, followed by HPV-52; other common types included HPV-18 and HPV-58.
- One study provided data on pregnancy outcomes in women living with HIV but did not correlate pregnancy outcomes with HPV status.
Experts urge HPV, cervical cancer screening for women living with HIV
“HPV is a common virus that can lead to cervical dysplasia and cervical cancer,” cautioned Clara Paik, MD, professor and clinic medical director of obstetrics and gynecology at UC Davis Health, Sacramento.
“HPV can also be associated with adverse pregnancy outcomes, including preterm birth and premature membrane rupture,” she said in an interview. “It is important to know the prevalence of HPV infection in pregnant women living with HIV in order to assess if this specific population is at higher risk for adverse pregnancy outcomes.”
Dr. Paik, who was not involved in the study, would like these results to lead to better HPV screening in pregnant women living with HIV.
“The study’s strengths include the large number of women studied when all the research studies were pooled,” she said. “A weakness is that, if individual studies had limitations, a systematic review based on weaker studies may not necessarily yield results that are conclusive.”
Linda Eckert, MD, professor of obstetrics and gynecology at the University of Washington, Seattle, said that the study highlights the importance of including cervical cancer screening in antepartum care, especially in areas of high HIV prevalence.
“Women living with HIV have a sixfold increased rate of developing cervical cancer compared to women without HIV,” she added, citing a 2020 analysis in The Lancet Global Health that estimated global cervical cancer risk among women living with HIV.
“This [new] study allows us to definitively say that pregnant women living with HIV have higher rates of HPV than do pregnant women without HIV,” noted Dr. Eckert, who was not involved in either study. “And HPV type 16 – the HPV type most associated with developing cervical cancer – was the most common high-risk HPV type found in these patients.”
HPV vaccination recommended
The World Health Organization’s call to eliminate cervical cancer has generated interest and funding for cervical cancer screening of women with HIV, Dr. Eckert said. “WHO recommends that women living with HIV who are 25 years of age and above be screened for cervical cancer annually.”
The authors urged that women living with HIV not only be screened for HPV but that they also be vaccinated against HPV.
“We know that HPV vaccination is unprecedented in its ability to prevent HPV infections when it is received prior to acquiring HPV infection,” Dr. Eckert said, “but currently data showing that HPV vaccination would treat HPV16 in pregnant women already infected with HPV16 are lacking.
“This study points to the need for a trial to investigate HPV vaccination in pregnant women living with HIV who have the high-risk HPV types,” she suggested.
Dr. Eckert contributed to the American College of Obstetricians and Gynecologists’ 2020 Human Papillomavirus Vaccination Committee Opinion. One study coauthor reported financial relationships with Merck. Dr. McClymont, the other coauthors, as well as Dr. Paik and Dr. Eckert reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pregnant women living with HIV were more likely to be infected with human papillomavirus (HPV) than were pregnant women without HIV, a recent systematic review and meta-analysis reports.
“High prevalence of HPV was documented in pregnant WLWH [women living with HIV], exceeding the prevalence among pregnant women without HIV,” Elisabeth McClymont, PhD, of the University of British Columbia, Vancouver, and colleagues wrote in the Journal of Acquired Immune Deficiency Syndrome.
Their results contribute to two major global public health goals: eliminating cervical cancer and improving the health outcomes of newborn babies.
“Our findings of a high prevalence of HPV infection during pregnancy in WLWH, particularly of highly oncogenic HPV types, emphasize the need for HPV screening and vaccination in WLWH,” they added. “WLWH are a key population for both HPV and adverse pregnancy outcome prevention.”
Emerging evidence suggests that being infected with HPV during pregnancy may be linked with adverse pregnancy outcomes. Although women living with HIV have higher rates of HPV infection and adverse pregnancy outcomes, no prior reviews have reported on HPV infection during pregnancy in women living with HIV, the authors explained.
A study of studies
Dr. McClymont and colleagues searched the standard medical research databases through Jan. 18, 2022, for pooled and type-specific HPV prevalence and associated pregnancy outcomes among pregnant women living with HIV, including available within-study comparators of women without HIV.
They performed subgroup analyses according to polymerase chain reaction primers used to detect HPV type and according to region (Africa, Asia and Europe, the Americas).
Their analysis of 10 studies describing HPV prevalence in 1,594 pregnant women living with HIV found:
- The pooled HPV prevalence in pregnant women living with HIV was 75.5% (95% confidence interval, 50.2%-90.4%) but ranged from 23% to 98% between individual studies.
- Among the five studies that also analyzed HPV prevalence in pregnant women without HIV, the pooled prevalence was 48.1% (95% CI, 27.1%-69.8%).
- Pregnant women living with HIV had 54% higher odds of being HPV positive than did pregnant women without HIV.
- HPV-16 was the most common HPV type detected in pregnant women living with HIV, followed by HPV-52; other common types included HPV-18 and HPV-58.
- One study provided data on pregnancy outcomes in women living with HIV but did not correlate pregnancy outcomes with HPV status.
Experts urge HPV, cervical cancer screening for women living with HIV
“HPV is a common virus that can lead to cervical dysplasia and cervical cancer,” cautioned Clara Paik, MD, professor and clinic medical director of obstetrics and gynecology at UC Davis Health, Sacramento.
“HPV can also be associated with adverse pregnancy outcomes, including preterm birth and premature membrane rupture,” she said in an interview. “It is important to know the prevalence of HPV infection in pregnant women living with HIV in order to assess if this specific population is at higher risk for adverse pregnancy outcomes.”
Dr. Paik, who was not involved in the study, would like these results to lead to better HPV screening in pregnant women living with HIV.
“The study’s strengths include the large number of women studied when all the research studies were pooled,” she said. “A weakness is that, if individual studies had limitations, a systematic review based on weaker studies may not necessarily yield results that are conclusive.”
Linda Eckert, MD, professor of obstetrics and gynecology at the University of Washington, Seattle, said that the study highlights the importance of including cervical cancer screening in antepartum care, especially in areas of high HIV prevalence.
“Women living with HIV have a sixfold increased rate of developing cervical cancer compared to women without HIV,” she added, citing a 2020 analysis in The Lancet Global Health that estimated global cervical cancer risk among women living with HIV.
“This [new] study allows us to definitively say that pregnant women living with HIV have higher rates of HPV than do pregnant women without HIV,” noted Dr. Eckert, who was not involved in either study. “And HPV type 16 – the HPV type most associated with developing cervical cancer – was the most common high-risk HPV type found in these patients.”
HPV vaccination recommended
The World Health Organization’s call to eliminate cervical cancer has generated interest and funding for cervical cancer screening of women with HIV, Dr. Eckert said. “WHO recommends that women living with HIV who are 25 years of age and above be screened for cervical cancer annually.”
The authors urged that women living with HIV not only be screened for HPV but that they also be vaccinated against HPV.
“We know that HPV vaccination is unprecedented in its ability to prevent HPV infections when it is received prior to acquiring HPV infection,” Dr. Eckert said, “but currently data showing that HPV vaccination would treat HPV16 in pregnant women already infected with HPV16 are lacking.
“This study points to the need for a trial to investigate HPV vaccination in pregnant women living with HIV who have the high-risk HPV types,” she suggested.
Dr. Eckert contributed to the American College of Obstetricians and Gynecologists’ 2020 Human Papillomavirus Vaccination Committee Opinion. One study coauthor reported financial relationships with Merck. Dr. McClymont, the other coauthors, as well as Dr. Paik and Dr. Eckert reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pregnant women living with HIV were more likely to be infected with human papillomavirus (HPV) than were pregnant women without HIV, a recent systematic review and meta-analysis reports.
“High prevalence of HPV was documented in pregnant WLWH [women living with HIV], exceeding the prevalence among pregnant women without HIV,” Elisabeth McClymont, PhD, of the University of British Columbia, Vancouver, and colleagues wrote in the Journal of Acquired Immune Deficiency Syndrome.
Their results contribute to two major global public health goals: eliminating cervical cancer and improving the health outcomes of newborn babies.
“Our findings of a high prevalence of HPV infection during pregnancy in WLWH, particularly of highly oncogenic HPV types, emphasize the need for HPV screening and vaccination in WLWH,” they added. “WLWH are a key population for both HPV and adverse pregnancy outcome prevention.”
Emerging evidence suggests that being infected with HPV during pregnancy may be linked with adverse pregnancy outcomes. Although women living with HIV have higher rates of HPV infection and adverse pregnancy outcomes, no prior reviews have reported on HPV infection during pregnancy in women living with HIV, the authors explained.
A study of studies
Dr. McClymont and colleagues searched the standard medical research databases through Jan. 18, 2022, for pooled and type-specific HPV prevalence and associated pregnancy outcomes among pregnant women living with HIV, including available within-study comparators of women without HIV.
They performed subgroup analyses according to polymerase chain reaction primers used to detect HPV type and according to region (Africa, Asia and Europe, the Americas).
Their analysis of 10 studies describing HPV prevalence in 1,594 pregnant women living with HIV found:
- The pooled HPV prevalence in pregnant women living with HIV was 75.5% (95% confidence interval, 50.2%-90.4%) but ranged from 23% to 98% between individual studies.
- Among the five studies that also analyzed HPV prevalence in pregnant women without HIV, the pooled prevalence was 48.1% (95% CI, 27.1%-69.8%).
- Pregnant women living with HIV had 54% higher odds of being HPV positive than did pregnant women without HIV.
- HPV-16 was the most common HPV type detected in pregnant women living with HIV, followed by HPV-52; other common types included HPV-18 and HPV-58.
- One study provided data on pregnancy outcomes in women living with HIV but did not correlate pregnancy outcomes with HPV status.
Experts urge HPV, cervical cancer screening for women living with HIV
“HPV is a common virus that can lead to cervical dysplasia and cervical cancer,” cautioned Clara Paik, MD, professor and clinic medical director of obstetrics and gynecology at UC Davis Health, Sacramento.
“HPV can also be associated with adverse pregnancy outcomes, including preterm birth and premature membrane rupture,” she said in an interview. “It is important to know the prevalence of HPV infection in pregnant women living with HIV in order to assess if this specific population is at higher risk for adverse pregnancy outcomes.”
Dr. Paik, who was not involved in the study, would like these results to lead to better HPV screening in pregnant women living with HIV.
“The study’s strengths include the large number of women studied when all the research studies were pooled,” she said. “A weakness is that, if individual studies had limitations, a systematic review based on weaker studies may not necessarily yield results that are conclusive.”
Linda Eckert, MD, professor of obstetrics and gynecology at the University of Washington, Seattle, said that the study highlights the importance of including cervical cancer screening in antepartum care, especially in areas of high HIV prevalence.
“Women living with HIV have a sixfold increased rate of developing cervical cancer compared to women without HIV,” she added, citing a 2020 analysis in The Lancet Global Health that estimated global cervical cancer risk among women living with HIV.
“This [new] study allows us to definitively say that pregnant women living with HIV have higher rates of HPV than do pregnant women without HIV,” noted Dr. Eckert, who was not involved in either study. “And HPV type 16 – the HPV type most associated with developing cervical cancer – was the most common high-risk HPV type found in these patients.”
HPV vaccination recommended
The World Health Organization’s call to eliminate cervical cancer has generated interest and funding for cervical cancer screening of women with HIV, Dr. Eckert said. “WHO recommends that women living with HIV who are 25 years of age and above be screened for cervical cancer annually.”
The authors urged that women living with HIV not only be screened for HPV but that they also be vaccinated against HPV.
“We know that HPV vaccination is unprecedented in its ability to prevent HPV infections when it is received prior to acquiring HPV infection,” Dr. Eckert said, “but currently data showing that HPV vaccination would treat HPV16 in pregnant women already infected with HPV16 are lacking.
“This study points to the need for a trial to investigate HPV vaccination in pregnant women living with HIV who have the high-risk HPV types,” she suggested.
Dr. Eckert contributed to the American College of Obstetricians and Gynecologists’ 2020 Human Papillomavirus Vaccination Committee Opinion. One study coauthor reported financial relationships with Merck. Dr. McClymont, the other coauthors, as well as Dr. Paik and Dr. Eckert reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROME.