STIs

Persistent human papillomavirus (HPV) 16 and HPV 18 during a pregnancy may be associated with an increased risk of premature birth.

Findings published online in JAMA Network Open found that 15.9% of individuals who had a persistent HPV 16 or 18 infection during the first and third trimesters of their pregnancy gave birth prematurely, compared with 5.6% of those who did not have an HPV infection at all.

The findings prompted the question of “the pathophysiology of HPV in pregnancy and how the virus is affecting the placenta,” said Lisette Davidson Tanner, MD, MPH, FACOG, who was not involved in the study.

Researchers said the findings are the first to show the association between preterm birth and HPV, which is an incurable virus that most sexually active individuals will get at some point in their lives, according to the Centers for Disease Control and Prevention.

“The results of this study are very important in helping us understand the burden caused by HPV in pregnancy,” study author Helen Trottier, MSc, PhD, researcher at the Centre Hospitalier Universitaire Sainte-Justine, said in an interview. “We may have just pinpointed an important cause of preterm birth that has so far been unexplained.”

Dr. Trottier and colleagues examined data from 1,052 pregnant women from three university-affiliated health care centers in Montreal between Nov. 8, 2010, and Oct. 16, 2016.

Only 5.6% of those who did not have an HPV infection had a premature birth, compared with 6.9% of those who tested positive for any HPV infection in the first trimester.

When looking at the first trimester, researchers found 12% of those diagnosed with HPV 16 and 18 had a preterm birth, compared to 4.9% of those who had a high-risk HPV infection other than HPV 16/18. When looking at the third trimester, researchers found that 15.9% of those with HPV 16/18 had an increased risk of giving birth prematurely, compared to those who had other high-risk HPV infections.

When researchers looked at the persistence of these HPV infections, they found that most HPV infections detected in the first trimester persist to the third trimester. The findings also revealed that persistent vaginal HPV 16/18 detection was significantly associated with all preterm births and spontaneous preterm births. This association was also found among those who had HPV infections detected in their placentas.

Meanwhile, 5.8% of those who had an HPV infection only during the first trimester experienced a preterm birth.

The researchers also found that HPV infections were frequent in pregnancy even among populations “considered to be at low risk based on sociodemographic and sexual history characteristics,” they wrote. Dr. Trottier said she hopes the findings will strengthen support for HPV vaccination.

Dr. Trottier’s study adds to a growing body of research regarding the adverse effects of HPV, according to Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. “It is already well known that HPV is associated with a number of anogenital and oropharyngeal cancers,” Dr. Tanner said in an interview. “The potential association with preterm birth only adds weight to the recommendations to screen for and prevent HPV infection.”

HPV 16 and 18 are high-risk types that cause about 70% of cervical cancers and precancerous cervical lesions, according to the World Health Organization. However, there are three HPV vaccines – 9-valent HPV vaccine (Gardasil), quadrivalent HPV vaccine (Gardasil®, 4vHPV), and bivalent HPV vaccine (Cervarix) – that help protect against HPV 16/18.

The findings strengthen the benefits of HPV vaccination, Dr. Trottier explained. “There is no cure when the HPV infection is present,” Dr. Trottier said. “If the link [between preterm birth and HPV infections] is indeed causal, we can expect a greater risk of preterm delivery in these women. The effective tool we have is the HPV vaccination, but it should ideally be received before the start of sexual activity in order to prevent future infections that could occur in women.”

The American College of Obstetricians and Gynecologists recommends HPV vaccination for girls and women between the ages of 11 and 26 years old. However, Dr. Tanner said, women aged 27-45 who were previously unvaccinated may still receive benefit from the vaccine. 

“Despite the known efficacy of the vaccine, only 50% of patients are up to date with their HPV vaccination,” Dr. Tanner explained. “This study further highlights the need to educate and encourage patients to be vaccinated.”

The researchers said future studies should investigate the association of HPV vaccination and vaccination programs with the risk of preterm birth.

The experts disclosed no conflicts of interest.

Persistent human papillomavirus (HPV) 16 and HPV 18 during a pregnancy may be associated with an increased risk of premature birth.

Findings published online in JAMA Network Open found that 15.9% of individuals who had a persistent HPV 16 or 18 infection during the first and third trimesters of their pregnancy gave birth prematurely, compared with 5.6% of those who did not have an HPV infection at all.

The findings prompted the question of “the pathophysiology of HPV in pregnancy and how the virus is affecting the placenta,” said Lisette Davidson Tanner, MD, MPH, FACOG, who was not involved in the study.

Researchers said the findings are the first to show the association between preterm birth and HPV, which is an incurable virus that most sexually active individuals will get at some point in their lives, according to the Centers for Disease Control and Prevention.

“The results of this study are very important in helping us understand the burden caused by HPV in pregnancy,” study author Helen Trottier, MSc, PhD, researcher at the Centre Hospitalier Universitaire Sainte-Justine, said in an interview. “We may have just pinpointed an important cause of preterm birth that has so far been unexplained.”

Dr. Trottier and colleagues examined data from 1,052 pregnant women from three university-affiliated health care centers in Montreal between Nov. 8, 2010, and Oct. 16, 2016.

Only 5.6% of those who did not have an HPV infection had a premature birth, compared with 6.9% of those who tested positive for any HPV infection in the first trimester.

When looking at the first trimester, researchers found 12% of those diagnosed with HPV 16 and 18 had a preterm birth, compared to 4.9% of those who had a high-risk HPV infection other than HPV 16/18. When looking at the third trimester, researchers found that 15.9% of those with HPV 16/18 had an increased risk of giving birth prematurely, compared to those who had other high-risk HPV infections.

When researchers looked at the persistence of these HPV infections, they found that most HPV infections detected in the first trimester persist to the third trimester. The findings also revealed that persistent vaginal HPV 16/18 detection was significantly associated with all preterm births and spontaneous preterm births. This association was also found among those who had HPV infections detected in their placentas.

Meanwhile, 5.8% of those who had an HPV infection only during the first trimester experienced a preterm birth.

The researchers also found that HPV infections were frequent in pregnancy even among populations “considered to be at low risk based on sociodemographic and sexual history characteristics,” they wrote. Dr. Trottier said she hopes the findings will strengthen support for HPV vaccination.

Dr. Trottier’s study adds to a growing body of research regarding the adverse effects of HPV, according to Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. “It is already well known that HPV is associated with a number of anogenital and oropharyngeal cancers,” Dr. Tanner said in an interview. “The potential association with preterm birth only adds weight to the recommendations to screen for and prevent HPV infection.”

HPV 16 and 18 are high-risk types that cause about 70% of cervical cancers and precancerous cervical lesions, according to the World Health Organization. However, there are three HPV vaccines – 9-valent HPV vaccine (Gardasil), quadrivalent HPV vaccine (Gardasil®, 4vHPV), and bivalent HPV vaccine (Cervarix) – that help protect against HPV 16/18.

The findings strengthen the benefits of HPV vaccination, Dr. Trottier explained. “There is no cure when the HPV infection is present,” Dr. Trottier said. “If the link [between preterm birth and HPV infections] is indeed causal, we can expect a greater risk of preterm delivery in these women. The effective tool we have is the HPV vaccination, but it should ideally be received before the start of sexual activity in order to prevent future infections that could occur in women.”

The American College of Obstetricians and Gynecologists recommends HPV vaccination for girls and women between the ages of 11 and 26 years old. However, Dr. Tanner said, women aged 27-45 who were previously unvaccinated may still receive benefit from the vaccine. 

“Despite the known efficacy of the vaccine, only 50% of patients are up to date with their HPV vaccination,” Dr. Tanner explained. “This study further highlights the need to educate and encourage patients to be vaccinated.”

The researchers said future studies should investigate the association of HPV vaccination and vaccination programs with the risk of preterm birth.

The experts disclosed no conflicts of interest.

Persistent human papillomavirus (HPV) 16 and HPV 18 during a pregnancy may be associated with an increased risk of premature birth.

Findings published online in JAMA Network Open found that 15.9% of individuals who had a persistent HPV 16 or 18 infection during the first and third trimesters of their pregnancy gave birth prematurely, compared with 5.6% of those who did not have an HPV infection at all.

The findings prompted the question of “the pathophysiology of HPV in pregnancy and how the virus is affecting the placenta,” said Lisette Davidson Tanner, MD, MPH, FACOG, who was not involved in the study.

Researchers said the findings are the first to show the association between preterm birth and HPV, which is an incurable virus that most sexually active individuals will get at some point in their lives, according to the Centers for Disease Control and Prevention.

“The results of this study are very important in helping us understand the burden caused by HPV in pregnancy,” study author Helen Trottier, MSc, PhD, researcher at the Centre Hospitalier Universitaire Sainte-Justine, said in an interview. “We may have just pinpointed an important cause of preterm birth that has so far been unexplained.”

Dr. Trottier and colleagues examined data from 1,052 pregnant women from three university-affiliated health care centers in Montreal between Nov. 8, 2010, and Oct. 16, 2016.

Only 5.6% of those who did not have an HPV infection had a premature birth, compared with 6.9% of those who tested positive for any HPV infection in the first trimester.

When looking at the first trimester, researchers found 12% of those diagnosed with HPV 16 and 18 had a preterm birth, compared to 4.9% of those who had a high-risk HPV infection other than HPV 16/18. When looking at the third trimester, researchers found that 15.9% of those with HPV 16/18 had an increased risk of giving birth prematurely, compared to those who had other high-risk HPV infections.

When researchers looked at the persistence of these HPV infections, they found that most HPV infections detected in the first trimester persist to the third trimester. The findings also revealed that persistent vaginal HPV 16/18 detection was significantly associated with all preterm births and spontaneous preterm births. This association was also found among those who had HPV infections detected in their placentas.

Meanwhile, 5.8% of those who had an HPV infection only during the first trimester experienced a preterm birth.

The researchers also found that HPV infections were frequent in pregnancy even among populations “considered to be at low risk based on sociodemographic and sexual history characteristics,” they wrote. Dr. Trottier said she hopes the findings will strengthen support for HPV vaccination.

Dr. Trottier’s study adds to a growing body of research regarding the adverse effects of HPV, according to Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. “It is already well known that HPV is associated with a number of anogenital and oropharyngeal cancers,” Dr. Tanner said in an interview. “The potential association with preterm birth only adds weight to the recommendations to screen for and prevent HPV infection.”

HPV 16 and 18 are high-risk types that cause about 70% of cervical cancers and precancerous cervical lesions, according to the World Health Organization. However, there are three HPV vaccines – 9-valent HPV vaccine (Gardasil), quadrivalent HPV vaccine (Gardasil®, 4vHPV), and bivalent HPV vaccine (Cervarix) – that help protect against HPV 16/18.

The findings strengthen the benefits of HPV vaccination, Dr. Trottier explained. “There is no cure when the HPV infection is present,” Dr. Trottier said. “If the link [between preterm birth and HPV infections] is indeed causal, we can expect a greater risk of preterm delivery in these women. The effective tool we have is the HPV vaccination, but it should ideally be received before the start of sexual activity in order to prevent future infections that could occur in women.”

The American College of Obstetricians and Gynecologists recommends HPV vaccination for girls and women between the ages of 11 and 26 years old. However, Dr. Tanner said, women aged 27-45 who were previously unvaccinated may still receive benefit from the vaccine. 

“Despite the known efficacy of the vaccine, only 50% of patients are up to date with their HPV vaccination,” Dr. Tanner explained. “This study further highlights the need to educate and encourage patients to be vaccinated.”

The researchers said future studies should investigate the association of HPV vaccination and vaccination programs with the risk of preterm birth.

The experts disclosed no conflicts of interest.

The U.S. Preventive Services Task Force (USPSTF) announced on Tuesday that it is standing by its 2014 recommendations that sexually active girls and young women be screened for chlamydia and gonorrhea. But the panel is not ready to provide guidance about screening males even amid an outbreak of gonorrhea infections among men who have sex with men (MSM).

“For men in general, there’s not enough evidence to determine whether screening will reduce the risk of complications or spreading infections to others,” said Marti Kubik, PhD, RN, in an interview. Dr. Kubik is a professor at the George Mason University School of Nursing, Fairfax, Va., and is a member of the task force. “We need further research so we will know how to make those recommendations,” she said.

The screening recommendations for chlamydia and gonorrhea were published Sept. 14 in the Journal of the American Medical Association. The guidance is identical to the panel’s 2014 recommendations. The task force recommends screening for chlamydia and gonorrhea in all sexually active females aged 24 years or younger and in sexually active women aged 25 and older if they are at higher risk because of factors such as new or multiple sex partners.

“We continue to see rising rates of these infections in spite of consistent screening recommendations,” Dr. Kubik said. “In 2019, the CDC recorded nearly 2 million cases of chlamydia and a half million cases of gonorrhea. The big clincher is that chlamydia and gonorrhea can occur without symptoms. It’s critical to screen if we’re going to prevent serious health complications.”

The report notes that chlamydia and gonorrhea may lead to pelvic inflammatory disease in women and to multiple complications in infants born to infected mothers. Men can develop urethritis and epididymitis. Both diseases can boost the risk for HIV infection and transmission.

“We want clinicians to review the new recommendation and feel confident about the evidence base that supports a need for us to be screening young women and older women who are at increased risk,” Dr. Kubik said. She noted that almost two-thirds of chlamydia cases and more than half of gonorrhea cases occur in men and women aged 15-24.

Unlike the CDC, which recommends annual chlamydia and gonorrhea screening in appropriate female patients, the task force provides no guidance on screening frequency. “We didn’t have the evidence base to make a recommendation about how often to screen,” Dr. Kubik said. “But recognizing that these often occur without symptoms, it’s reasonable for clinicians to screen patients whose sexual history reveals new or consistent risk factors.”

Philip A. Chan, MD, an associate professor at Brown University, Providence, R.I., who directs a sexually transmitted disease clinic, told this news organization that he found it frustrating that the task force didn’t make recommendations about screening of MSM. According to a commentary accompanying the new recommendations, the rate of gonorrhea in MSM – 5,166 cases per 100,000, or more than 5% – is at a historic high.

In contrast to the task force, the CDC recommends annual or more frequent testing for gonorrhea and chlamydia plus HIV and syphilis in sexually active MSM.

Dr. Chan noted that the task force’s guidance “tends to be the most evidence-based recommendations that exist. If the evidence isn’t there, they usually don’t make a recommendation.” Still, he said, “I would argue that there’s good evidence that in MSM, the risk for HIV acquisition warrants routine screening.”

Jeanne Marrazzo, MD, MPH, director of the division of infectious diseases at the University of Alabama at Birmingham, also noted the limits of the task force’s insistence on certain kinds of evidence. Dr. Marrazzo, who coauthored a commentary that accompanies the recommendations, said in an interview that the panel’s “reliance on randomized-controlled-trial-level evidence tends to limit its ability to evolve their recommendations in a way that could account for evolving epidemiology or advances in our understanding of pathophysiology of these infections.”

Dr. Chan noted that obstacles exist for patients even when screening recommendations are in place. Although insurers typically cover costs of chlamydia and gonorrhea screening tests, he said, the uninsured may have to pay $100 or more each.

The USPSTF is supported by the U.S. Agency for Healthcare Research and Quality. Dr. Kubik, Dr. Chan, and Dr. Marrazzo report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The U.S. Preventive Services Task Force (USPSTF) announced on Tuesday that it is standing by its 2014 recommendations that sexually active girls and young women be screened for chlamydia and gonorrhea. But the panel is not ready to provide guidance about screening males even amid an outbreak of gonorrhea infections among men who have sex with men (MSM).

“For men in general, there’s not enough evidence to determine whether screening will reduce the risk of complications or spreading infections to others,” said Marti Kubik, PhD, RN, in an interview. Dr. Kubik is a professor at the George Mason University School of Nursing, Fairfax, Va., and is a member of the task force. “We need further research so we will know how to make those recommendations,” she said.

The screening recommendations for chlamydia and gonorrhea were published Sept. 14 in the Journal of the American Medical Association. The guidance is identical to the panel’s 2014 recommendations. The task force recommends screening for chlamydia and gonorrhea in all sexually active females aged 24 years or younger and in sexually active women aged 25 and older if they are at higher risk because of factors such as new or multiple sex partners.

“We continue to see rising rates of these infections in spite of consistent screening recommendations,” Dr. Kubik said. “In 2019, the CDC recorded nearly 2 million cases of chlamydia and a half million cases of gonorrhea. The big clincher is that chlamydia and gonorrhea can occur without symptoms. It’s critical to screen if we’re going to prevent serious health complications.”

The report notes that chlamydia and gonorrhea may lead to pelvic inflammatory disease in women and to multiple complications in infants born to infected mothers. Men can develop urethritis and epididymitis. Both diseases can boost the risk for HIV infection and transmission.

“We want clinicians to review the new recommendation and feel confident about the evidence base that supports a need for us to be screening young women and older women who are at increased risk,” Dr. Kubik said. She noted that almost two-thirds of chlamydia cases and more than half of gonorrhea cases occur in men and women aged 15-24.

Unlike the CDC, which recommends annual chlamydia and gonorrhea screening in appropriate female patients, the task force provides no guidance on screening frequency. “We didn’t have the evidence base to make a recommendation about how often to screen,” Dr. Kubik said. “But recognizing that these often occur without symptoms, it’s reasonable for clinicians to screen patients whose sexual history reveals new or consistent risk factors.”

Philip A. Chan, MD, an associate professor at Brown University, Providence, R.I., who directs a sexually transmitted disease clinic, told this news organization that he found it frustrating that the task force didn’t make recommendations about screening of MSM. According to a commentary accompanying the new recommendations, the rate of gonorrhea in MSM – 5,166 cases per 100,000, or more than 5% – is at a historic high.

In contrast to the task force, the CDC recommends annual or more frequent testing for gonorrhea and chlamydia plus HIV and syphilis in sexually active MSM.

Dr. Chan noted that the task force’s guidance “tends to be the most evidence-based recommendations that exist. If the evidence isn’t there, they usually don’t make a recommendation.” Still, he said, “I would argue that there’s good evidence that in MSM, the risk for HIV acquisition warrants routine screening.”

Jeanne Marrazzo, MD, MPH, director of the division of infectious diseases at the University of Alabama at Birmingham, also noted the limits of the task force’s insistence on certain kinds of evidence. Dr. Marrazzo, who coauthored a commentary that accompanies the recommendations, said in an interview that the panel’s “reliance on randomized-controlled-trial-level evidence tends to limit its ability to evolve their recommendations in a way that could account for evolving epidemiology or advances in our understanding of pathophysiology of these infections.”

Dr. Chan noted that obstacles exist for patients even when screening recommendations are in place. Although insurers typically cover costs of chlamydia and gonorrhea screening tests, he said, the uninsured may have to pay $100 or more each.

The USPSTF is supported by the U.S. Agency for Healthcare Research and Quality. Dr. Kubik, Dr. Chan, and Dr. Marrazzo report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The U.S. Preventive Services Task Force (USPSTF) announced on Tuesday that it is standing by its 2014 recommendations that sexually active girls and young women be screened for chlamydia and gonorrhea. But the panel is not ready to provide guidance about screening males even amid an outbreak of gonorrhea infections among men who have sex with men (MSM).

“For men in general, there’s not enough evidence to determine whether screening will reduce the risk of complications or spreading infections to others,” said Marti Kubik, PhD, RN, in an interview. Dr. Kubik is a professor at the George Mason University School of Nursing, Fairfax, Va., and is a member of the task force. “We need further research so we will know how to make those recommendations,” she said.

The screening recommendations for chlamydia and gonorrhea were published Sept. 14 in the Journal of the American Medical Association. The guidance is identical to the panel’s 2014 recommendations. The task force recommends screening for chlamydia and gonorrhea in all sexually active females aged 24 years or younger and in sexually active women aged 25 and older if they are at higher risk because of factors such as new or multiple sex partners.

“We continue to see rising rates of these infections in spite of consistent screening recommendations,” Dr. Kubik said. “In 2019, the CDC recorded nearly 2 million cases of chlamydia and a half million cases of gonorrhea. The big clincher is that chlamydia and gonorrhea can occur without symptoms. It’s critical to screen if we’re going to prevent serious health complications.”

The report notes that chlamydia and gonorrhea may lead to pelvic inflammatory disease in women and to multiple complications in infants born to infected mothers. Men can develop urethritis and epididymitis. Both diseases can boost the risk for HIV infection and transmission.

“We want clinicians to review the new recommendation and feel confident about the evidence base that supports a need for us to be screening young women and older women who are at increased risk,” Dr. Kubik said. She noted that almost two-thirds of chlamydia cases and more than half of gonorrhea cases occur in men and women aged 15-24.

Unlike the CDC, which recommends annual chlamydia and gonorrhea screening in appropriate female patients, the task force provides no guidance on screening frequency. “We didn’t have the evidence base to make a recommendation about how often to screen,” Dr. Kubik said. “But recognizing that these often occur without symptoms, it’s reasonable for clinicians to screen patients whose sexual history reveals new or consistent risk factors.”

Philip A. Chan, MD, an associate professor at Brown University, Providence, R.I., who directs a sexually transmitted disease clinic, told this news organization that he found it frustrating that the task force didn’t make recommendations about screening of MSM. According to a commentary accompanying the new recommendations, the rate of gonorrhea in MSM – 5,166 cases per 100,000, or more than 5% – is at a historic high.

In contrast to the task force, the CDC recommends annual or more frequent testing for gonorrhea and chlamydia plus HIV and syphilis in sexually active MSM.

Dr. Chan noted that the task force’s guidance “tends to be the most evidence-based recommendations that exist. If the evidence isn’t there, they usually don’t make a recommendation.” Still, he said, “I would argue that there’s good evidence that in MSM, the risk for HIV acquisition warrants routine screening.”

Jeanne Marrazzo, MD, MPH, director of the division of infectious diseases at the University of Alabama at Birmingham, also noted the limits of the task force’s insistence on certain kinds of evidence. Dr. Marrazzo, who coauthored a commentary that accompanies the recommendations, said in an interview that the panel’s “reliance on randomized-controlled-trial-level evidence tends to limit its ability to evolve their recommendations in a way that could account for evolving epidemiology or advances in our understanding of pathophysiology of these infections.”

Dr. Chan noted that obstacles exist for patients even when screening recommendations are in place. Although insurers typically cover costs of chlamydia and gonorrhea screening tests, he said, the uninsured may have to pay $100 or more each.

The USPSTF is supported by the U.S. Agency for Healthcare Research and Quality. Dr. Kubik, Dr. Chan, and Dr. Marrazzo report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The U.S. Preventive Services Task Force has updated its 2014 statement on screening asymptomatic individuals for chlamydia and gonorrhea infection.

Published online in JAMA, the 2021 version recommends that all sexually active women aged 24 years or younger and at-risk women 25 years or older should be screened for chlamydia and gonorrhea.

As in 2014, the task force made no screening recommendation for men owing to inconclusive evidence of benefit.

With cases of sexually transmitted infections reaching all-time highs, Amy G. Cantor, MD, MPH, of the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University, Portland, and colleagues noted that chlamydia and gonorrhea are among the most common STIs in this country. According to the Centers for Disease Control and Prevention, 2019 saw approximately 1.8 million reported cases of chlamydia and more than 600,000 of gonorrhea.

In the current analysis of 27 observational and randomized studies comprising 179,515 patients, the USPSTF panel found that, compared with no screening, chlamydia screening was significantly associated with a reduced risk of pelvic inflammatory disease (PID) in young women in 2 out of 4 trials.

The authors cautioned, however, that the magnitude of benefit was relatively small. No studies reported on screening effectiveness in men, except for one reporting rates of epididymitis, and no studies were done on pregnant women for any outcome.

The largest and newest study, the Australian Chlamydia Control Effectiveness Pilot trial of 2018, assessed chlamydia screening against usual care in 180,355 men and women aged 16-29 years in 130 rural Australian primary care clinics. Screening was associated with a reduced risk of hospital-diagnosed PID: the absolute risk was 0.24% for screening versus 0.38% for usual care (unadjusted risk ratio, 0.6; 95% confidence interval, 0.4-1.0). It was not, however, significantly associated with a reduced risk of clinic-diagnosed PID, with an absolute risk of 0.45% versus 0.39% (RR, 1.1; 95% CI, 0.7-18). Nor did it correlate with a risk reduction for clinic-diagnosed epididymitis: 0.26% vs. 0.27% (RR, 0.9; 95% CI, 0.6-1.4).

While risk prediction criteria apart from age were only minimally accurate, testing for asymptomatic chlamydial and gonococcal infections was highly accurate at most anatomical sites, including urine and self-collected specimens, the investigators observed. Age 22 years or younger alone versus multi-item risk criteria demonstrated similar discrimination in a study that included symptomatic and asymptomatic women.

Sensitivity of chlamydial testing was similar at endocervical (89%-100%) and self- and clinician-collected vaginal (90%-100%) sites for women and at meatal (100%), urethral (99%), and rectal (92%) sites for men. It was lower, however, at pharyngeal sites (69.2%) for men who have sex with men (MSM).

Sensitivity of gonococcal testing was 89% or greater for all anatomical samples. False-positive and false-negative testing rates were low across anatomical sites and collection methods.

“Effectiveness of screening in men and during pregnancy, optimal screening intervals, and adverse effects of screening require further evaluation, Dr. Cantor and associates concluded.

In an accompanying editorial, Jeanne Marrazzo, MD, MPH, and Jodie Dionne-Odom, MD, MSPH, of the division of infectious diseases at the University of Alabama at Birmingham, called the guidelines “timely” and “powerful agents of change” that “influence a wide spectrum of health-based metrics, from quality assurance measures to criteria for financial reimbursement.”

They pointed out that men who have sex with men are experiencing historically high rates of gonorrhea, with most infections occurring extragenitally at the pharynx or rectum. In 2019 CDC data, MSM had substantially higher rates of gonorrhea than men who had sex only with women. They recommended that guidelines for men consider STI risk because of sexual relations with men, women, or both.

“Comprehensive screening guidelines for common STIs like chlamydia and gonorrhea could incorporate the limited evidence base for MSM, whether it is regular practice or not,” they wrote, with the same approach for women who have sex with women but may be at risk for chlamydia, particularly if they also have sex with men.

In their view, these latest guidelines appropriately prioritize high-level clinically based data. They pointed, however, to recent progress in understanding the pathogenesis of upper reproductive tract infection in women and the sexual networks behind the current resurgence of STIs in the United States in the failure to manage exposed sex partners.

“Considering these critical advances in the evolution of clinic-based screening guidelines is a work in progress,” they wrote, “the dialogue among basic scientists, clinical trial investigators, and public health professionals to inform the next version of updated USPSTF chlamydia and gonorrhea screening guidelines should start now.”

In the opinion of Jennifer L. Reed, MD, MS, a professor of pediatrics and an emergency medicine physician at Cincinnati Children’s Hospital Medical Center and not involved in the updated statement, the recommendations are very reasonable. “The highest rates of infection occur in females 15-24 years of age, and therefore asymptomatic screening for chlamydia and gonorrhea is imperative at least annually or more often if they are high risk,” she said in an interview.

“I would hope that providers increase their asymptomatic screening as a result of these recommendations and highly consider it in the younger men,” Dr. Reed added. “I see a very high rate of gonorrhea and chlamydia infections.” Her center is studying the implementation of gonorrhea and chlamydia asymptomatic screening for adolescents in the pediatric emergency department, a high-risk patient population that will benefit from STI screening opportunities in nontraditional settings.

This research was funded by the Agency for Healthcare Research and Quality and the Department of Health & Human Services under a contract to support the USPSTF. One statement coauthor reported personal fees from Insmed, Paratek, RedHill, and Spero, as well as grants from Insmed. No other disclosures were reported. Dr. Dionne-Odom reported grants from the National Institutes of Health/National Institute of Child Health and Development. Dr. Reed reported a grant from NIH/NICHD for a pragmatic trial of improving STI detection in the pediatric ED.
 

The U.S. Preventive Services Task Force has updated its 2014 statement on screening asymptomatic individuals for chlamydia and gonorrhea infection.

Published online in JAMA, the 2021 version recommends that all sexually active women aged 24 years or younger and at-risk women 25 years or older should be screened for chlamydia and gonorrhea.

As in 2014, the task force made no screening recommendation for men owing to inconclusive evidence of benefit.

With cases of sexually transmitted infections reaching all-time highs, Amy G. Cantor, MD, MPH, of the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University, Portland, and colleagues noted that chlamydia and gonorrhea are among the most common STIs in this country. According to the Centers for Disease Control and Prevention, 2019 saw approximately 1.8 million reported cases of chlamydia and more than 600,000 of gonorrhea.

In the current analysis of 27 observational and randomized studies comprising 179,515 patients, the USPSTF panel found that, compared with no screening, chlamydia screening was significantly associated with a reduced risk of pelvic inflammatory disease (PID) in young women in 2 out of 4 trials.

The authors cautioned, however, that the magnitude of benefit was relatively small. No studies reported on screening effectiveness in men, except for one reporting rates of epididymitis, and no studies were done on pregnant women for any outcome.

The largest and newest study, the Australian Chlamydia Control Effectiveness Pilot trial of 2018, assessed chlamydia screening against usual care in 180,355 men and women aged 16-29 years in 130 rural Australian primary care clinics. Screening was associated with a reduced risk of hospital-diagnosed PID: the absolute risk was 0.24% for screening versus 0.38% for usual care (unadjusted risk ratio, 0.6; 95% confidence interval, 0.4-1.0). It was not, however, significantly associated with a reduced risk of clinic-diagnosed PID, with an absolute risk of 0.45% versus 0.39% (RR, 1.1; 95% CI, 0.7-18). Nor did it correlate with a risk reduction for clinic-diagnosed epididymitis: 0.26% vs. 0.27% (RR, 0.9; 95% CI, 0.6-1.4).

While risk prediction criteria apart from age were only minimally accurate, testing for asymptomatic chlamydial and gonococcal infections was highly accurate at most anatomical sites, including urine and self-collected specimens, the investigators observed. Age 22 years or younger alone versus multi-item risk criteria demonstrated similar discrimination in a study that included symptomatic and asymptomatic women.

Sensitivity of chlamydial testing was similar at endocervical (89%-100%) and self- and clinician-collected vaginal (90%-100%) sites for women and at meatal (100%), urethral (99%), and rectal (92%) sites for men. It was lower, however, at pharyngeal sites (69.2%) for men who have sex with men (MSM).

Sensitivity of gonococcal testing was 89% or greater for all anatomical samples. False-positive and false-negative testing rates were low across anatomical sites and collection methods.

“Effectiveness of screening in men and during pregnancy, optimal screening intervals, and adverse effects of screening require further evaluation, Dr. Cantor and associates concluded.

In an accompanying editorial, Jeanne Marrazzo, MD, MPH, and Jodie Dionne-Odom, MD, MSPH, of the division of infectious diseases at the University of Alabama at Birmingham, called the guidelines “timely” and “powerful agents of change” that “influence a wide spectrum of health-based metrics, from quality assurance measures to criteria for financial reimbursement.”

They pointed out that men who have sex with men are experiencing historically high rates of gonorrhea, with most infections occurring extragenitally at the pharynx or rectum. In 2019 CDC data, MSM had substantially higher rates of gonorrhea than men who had sex only with women. They recommended that guidelines for men consider STI risk because of sexual relations with men, women, or both.

“Comprehensive screening guidelines for common STIs like chlamydia and gonorrhea could incorporate the limited evidence base for MSM, whether it is regular practice or not,” they wrote, with the same approach for women who have sex with women but may be at risk for chlamydia, particularly if they also have sex with men.

In their view, these latest guidelines appropriately prioritize high-level clinically based data. They pointed, however, to recent progress in understanding the pathogenesis of upper reproductive tract infection in women and the sexual networks behind the current resurgence of STIs in the United States in the failure to manage exposed sex partners.

“Considering these critical advances in the evolution of clinic-based screening guidelines is a work in progress,” they wrote, “the dialogue among basic scientists, clinical trial investigators, and public health professionals to inform the next version of updated USPSTF chlamydia and gonorrhea screening guidelines should start now.”

In the opinion of Jennifer L. Reed, MD, MS, a professor of pediatrics and an emergency medicine physician at Cincinnati Children’s Hospital Medical Center and not involved in the updated statement, the recommendations are very reasonable. “The highest rates of infection occur in females 15-24 years of age, and therefore asymptomatic screening for chlamydia and gonorrhea is imperative at least annually or more often if they are high risk,” she said in an interview.

“I would hope that providers increase their asymptomatic screening as a result of these recommendations and highly consider it in the younger men,” Dr. Reed added. “I see a very high rate of gonorrhea and chlamydia infections.” Her center is studying the implementation of gonorrhea and chlamydia asymptomatic screening for adolescents in the pediatric emergency department, a high-risk patient population that will benefit from STI screening opportunities in nontraditional settings.

This research was funded by the Agency for Healthcare Research and Quality and the Department of Health & Human Services under a contract to support the USPSTF. One statement coauthor reported personal fees from Insmed, Paratek, RedHill, and Spero, as well as grants from Insmed. No other disclosures were reported. Dr. Dionne-Odom reported grants from the National Institutes of Health/National Institute of Child Health and Development. Dr. Reed reported a grant from NIH/NICHD for a pragmatic trial of improving STI detection in the pediatric ED.
 

The U.S. Preventive Services Task Force has updated its 2014 statement on screening asymptomatic individuals for chlamydia and gonorrhea infection.

Published online in JAMA, the 2021 version recommends that all sexually active women aged 24 years or younger and at-risk women 25 years or older should be screened for chlamydia and gonorrhea.

As in 2014, the task force made no screening recommendation for men owing to inconclusive evidence of benefit.

With cases of sexually transmitted infections reaching all-time highs, Amy G. Cantor, MD, MPH, of the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University, Portland, and colleagues noted that chlamydia and gonorrhea are among the most common STIs in this country. According to the Centers for Disease Control and Prevention, 2019 saw approximately 1.8 million reported cases of chlamydia and more than 600,000 of gonorrhea.

In the current analysis of 27 observational and randomized studies comprising 179,515 patients, the USPSTF panel found that, compared with no screening, chlamydia screening was significantly associated with a reduced risk of pelvic inflammatory disease (PID) in young women in 2 out of 4 trials.

The authors cautioned, however, that the magnitude of benefit was relatively small. No studies reported on screening effectiveness in men, except for one reporting rates of epididymitis, and no studies were done on pregnant women for any outcome.

The largest and newest study, the Australian Chlamydia Control Effectiveness Pilot trial of 2018, assessed chlamydia screening against usual care in 180,355 men and women aged 16-29 years in 130 rural Australian primary care clinics. Screening was associated with a reduced risk of hospital-diagnosed PID: the absolute risk was 0.24% for screening versus 0.38% for usual care (unadjusted risk ratio, 0.6; 95% confidence interval, 0.4-1.0). It was not, however, significantly associated with a reduced risk of clinic-diagnosed PID, with an absolute risk of 0.45% versus 0.39% (RR, 1.1; 95% CI, 0.7-18). Nor did it correlate with a risk reduction for clinic-diagnosed epididymitis: 0.26% vs. 0.27% (RR, 0.9; 95% CI, 0.6-1.4).

While risk prediction criteria apart from age were only minimally accurate, testing for asymptomatic chlamydial and gonococcal infections was highly accurate at most anatomical sites, including urine and self-collected specimens, the investigators observed. Age 22 years or younger alone versus multi-item risk criteria demonstrated similar discrimination in a study that included symptomatic and asymptomatic women.

Sensitivity of chlamydial testing was similar at endocervical (89%-100%) and self- and clinician-collected vaginal (90%-100%) sites for women and at meatal (100%), urethral (99%), and rectal (92%) sites for men. It was lower, however, at pharyngeal sites (69.2%) for men who have sex with men (MSM).

Sensitivity of gonococcal testing was 89% or greater for all anatomical samples. False-positive and false-negative testing rates were low across anatomical sites and collection methods.

“Effectiveness of screening in men and during pregnancy, optimal screening intervals, and adverse effects of screening require further evaluation, Dr. Cantor and associates concluded.

In an accompanying editorial, Jeanne Marrazzo, MD, MPH, and Jodie Dionne-Odom, MD, MSPH, of the division of infectious diseases at the University of Alabama at Birmingham, called the guidelines “timely” and “powerful agents of change” that “influence a wide spectrum of health-based metrics, from quality assurance measures to criteria for financial reimbursement.”

They pointed out that men who have sex with men are experiencing historically high rates of gonorrhea, with most infections occurring extragenitally at the pharynx or rectum. In 2019 CDC data, MSM had substantially higher rates of gonorrhea than men who had sex only with women. They recommended that guidelines for men consider STI risk because of sexual relations with men, women, or both.

“Comprehensive screening guidelines for common STIs like chlamydia and gonorrhea could incorporate the limited evidence base for MSM, whether it is regular practice or not,” they wrote, with the same approach for women who have sex with women but may be at risk for chlamydia, particularly if they also have sex with men.

In their view, these latest guidelines appropriately prioritize high-level clinically based data. They pointed, however, to recent progress in understanding the pathogenesis of upper reproductive tract infection in women and the sexual networks behind the current resurgence of STIs in the United States in the failure to manage exposed sex partners.

“Considering these critical advances in the evolution of clinic-based screening guidelines is a work in progress,” they wrote, “the dialogue among basic scientists, clinical trial investigators, and public health professionals to inform the next version of updated USPSTF chlamydia and gonorrhea screening guidelines should start now.”

In the opinion of Jennifer L. Reed, MD, MS, a professor of pediatrics and an emergency medicine physician at Cincinnati Children’s Hospital Medical Center and not involved in the updated statement, the recommendations are very reasonable. “The highest rates of infection occur in females 15-24 years of age, and therefore asymptomatic screening for chlamydia and gonorrhea is imperative at least annually or more often if they are high risk,” she said in an interview.

“I would hope that providers increase their asymptomatic screening as a result of these recommendations and highly consider it in the younger men,” Dr. Reed added. “I see a very high rate of gonorrhea and chlamydia infections.” Her center is studying the implementation of gonorrhea and chlamydia asymptomatic screening for adolescents in the pediatric emergency department, a high-risk patient population that will benefit from STI screening opportunities in nontraditional settings.

This research was funded by the Agency for Healthcare Research and Quality and the Department of Health & Human Services under a contract to support the USPSTF. One statement coauthor reported personal fees from Insmed, Paratek, RedHill, and Spero, as well as grants from Insmed. No other disclosures were reported. Dr. Dionne-Odom reported grants from the National Institutes of Health/National Institute of Child Health and Development. Dr. Reed reported a grant from NIH/NICHD for a pragmatic trial of improving STI detection in the pediatric ED.
 

Young women who received the quadrivalent human papillomavirus (HPV) vaccine had fewer and fewer infections with high-risk HPV strains covered by the vaccine year after year, but the incidence of high-risk strains that were not covered by the vaccine increased over the same 12-year period, researchers report in a study published August 23 in JAMA Open Network.

“One of the unique contributions that this study provides is the evaluation of a real-world example of the HPV infection rates following immunization in a population of adolescent girls and young adult women at a single health center in a large U.S. city, reflecting strong evidence of vaccine effectiveness,” write Nicolas F. Schlecht, PhD, a professor of oncology at Roswell Park Comprehensive Cancer Center, Buffalo, and his colleagues. “Previous surveillance studies from the U.S. have involved older women and populations with relatively low vaccine coverage.”

In addition to supporting the value of continuing to vaccinate teens against HPV, the findings underscore the importance of continuing to screen women for cervical cancer, Dr. Schlecht said in an interview.

“HPV has not and is not going away,” he said. “We need to keep on our toes with screening and other measures to continue to prevent the development of cervix cancer,” including monitoring different high-risk HPV types and keeping a close eye on cervical precancer rates, particularly CIN3 and cervix cancer, he said. “The vaccines are definitely a good thing. Just getting rid of HPV16 is an amazing accomplishment.”

Kevin Ault, MD, a professor of ob/gyn and academic specialist director of clinical and translational research at the University of Kansas, Kansas City, told this news organization that other studies have had similar findings, but this one is larger with longer follow-up.

“The take-home message is that vaccines work, and this is especially true for the HPV vaccine,” said Dr. Ault, who was not involved in the research. “The vaccine prevents HPV infections and the consequences of these infections, such as cervical cancer. The results are consistent with other studies in different settings, so they are likely generalizable.”

The researchers collected data from October 2007, shortly after the vaccine was approved, through September 2019 on sexually active adolescent and young women aged 13 to 21 years who had received the HPV vaccine and had agreed to follow-up assessments every 6 months until they turned 26. Each follow-up included the collecting of samples of cervical and anal cells for polymerase chain reaction testing for the presence of HPV types.

More than half of the 1,453 participants were Hispanic (58.8%), and half were Black (50.4%), including 15% Hispanic and Black patients. The average age of the participants was 18 years. They were tracked for a median 2.4 years. Nearly half the participants (48%) received the HPV vaccine prior to sexual debut.

For the longitudinal study, the researchers adjusted for participants’ age, the year they received the vaccine, and the years since they were vaccinated. They also tracked breakthrough infections for the four types of HPV covered by the vaccine in participants who received the vaccine before sexual debut.

“We evaluated whether infection rates for HPV have changed since the administration of the vaccine by assessing longitudinally the probability of HPV detection over time among vaccinated participants while adjusting for changes in cohort characteristics over time,” the researchers write. In their statistical analysis, they made adjustments for the number of vaccine doses participants received before their first study visit, age at sexual debut, age at first vaccine dose, number of sexual partners in the preceding 6 months, consistency of condom use during sex, history of a positive chlamydia test, and, for anal HPV analyses, whether the participants had had anal sex in the previous 6 months.

The average age at first intercourse remained steady at 15 years throughout the study, but the average age of vaccination dropped from 18 years in 2008 to 12 years in 2019 (P < .001). More than half the participants (64%) had had at least three lifetime sexual partners at baseline.

After adjustment for age, the researchers found that the incidence of the four HPV types covered by the vaccine – HPV-6, HPV-11, HPV-16, and HPV-18 – dropped more each year, shifting from 9.1% from 2008-2010 to 4.7% from 2017-2019. The effect was even greater among those vaccinated prior to sexual debut; for those patients, the incidence of the four vaccine types dropped from 8.8% to 1.7% over the course of the study. Declines over time also occurred for anal types HPV-31 (adjusted odds ratio [aOR] = 0.76) and HPV-45 (aOR = 0.77). Those vaccinated prior to any sexual intercourse had 19% lower odds of infection per year with a vaccine-covered HPV type.

“We were really excited to see that the types targeted by the vaccines were considerably lower over time in our population,” Dr. Schlecht told this news organization. “This is an important observation, since most of these types are the most worrisome for cervical cancer.”

They were surprised, however, to see overall HPV prevalence increase over time, particularly with the high-risk HPV types that were not covered by the quadrivalent vaccine.

Prevalence of cervical high-risk types not in the vaccine increased from 25.1% from 2008-2010 to 30.5% from 2017-2019. Odds of detection of high-risk HPV types not covered by the vaccine increased 8% each year, particularly for HPV-56 and HPV-68; anal HPV types increased 11% each year. Neither age nor recent number of sexual partners affected the findings.

“The underlying mechanisms for the observed increased detection of specific non-vaccine HPV types over time are not yet clear.”

“We hope this doesn’t translate into some increase in cervical neoplasia that is unanticipated,” Dr. Schlecht said. He noted that the attributable risks for cancer associated with nonvaccine high-risk HPV types remain low. “Theoretical concerns are one thing; actual data is what drives the show,” he said.

The research was funded by the National Institutes of Health and the Icahn School of Medicine at Mount Sinai, New York. Dr. Schlecht has served on advisory boards for Merck, GlaxoSmithKline (GSK), and PDS Biotechnology. One author previously served on a GSK advisory board, and another worked with Merck on an early vaccine trial. Dr. Ault has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Young women who received the quadrivalent human papillomavirus (HPV) vaccine had fewer and fewer infections with high-risk HPV strains covered by the vaccine year after year, but the incidence of high-risk strains that were not covered by the vaccine increased over the same 12-year period, researchers report in a study published August 23 in JAMA Open Network.

“One of the unique contributions that this study provides is the evaluation of a real-world example of the HPV infection rates following immunization in a population of adolescent girls and young adult women at a single health center in a large U.S. city, reflecting strong evidence of vaccine effectiveness,” write Nicolas F. Schlecht, PhD, a professor of oncology at Roswell Park Comprehensive Cancer Center, Buffalo, and his colleagues. “Previous surveillance studies from the U.S. have involved older women and populations with relatively low vaccine coverage.”

In addition to supporting the value of continuing to vaccinate teens against HPV, the findings underscore the importance of continuing to screen women for cervical cancer, Dr. Schlecht said in an interview.

“HPV has not and is not going away,” he said. “We need to keep on our toes with screening and other measures to continue to prevent the development of cervix cancer,” including monitoring different high-risk HPV types and keeping a close eye on cervical precancer rates, particularly CIN3 and cervix cancer, he said. “The vaccines are definitely a good thing. Just getting rid of HPV16 is an amazing accomplishment.”

Kevin Ault, MD, a professor of ob/gyn and academic specialist director of clinical and translational research at the University of Kansas, Kansas City, told this news organization that other studies have had similar findings, but this one is larger with longer follow-up.

“The take-home message is that vaccines work, and this is especially true for the HPV vaccine,” said Dr. Ault, who was not involved in the research. “The vaccine prevents HPV infections and the consequences of these infections, such as cervical cancer. The results are consistent with other studies in different settings, so they are likely generalizable.”

The researchers collected data from October 2007, shortly after the vaccine was approved, through September 2019 on sexually active adolescent and young women aged 13 to 21 years who had received the HPV vaccine and had agreed to follow-up assessments every 6 months until they turned 26. Each follow-up included the collecting of samples of cervical and anal cells for polymerase chain reaction testing for the presence of HPV types.

More than half of the 1,453 participants were Hispanic (58.8%), and half were Black (50.4%), including 15% Hispanic and Black patients. The average age of the participants was 18 years. They were tracked for a median 2.4 years. Nearly half the participants (48%) received the HPV vaccine prior to sexual debut.

For the longitudinal study, the researchers adjusted for participants’ age, the year they received the vaccine, and the years since they were vaccinated. They also tracked breakthrough infections for the four types of HPV covered by the vaccine in participants who received the vaccine before sexual debut.

“We evaluated whether infection rates for HPV have changed since the administration of the vaccine by assessing longitudinally the probability of HPV detection over time among vaccinated participants while adjusting for changes in cohort characteristics over time,” the researchers write. In their statistical analysis, they made adjustments for the number of vaccine doses participants received before their first study visit, age at sexual debut, age at first vaccine dose, number of sexual partners in the preceding 6 months, consistency of condom use during sex, history of a positive chlamydia test, and, for anal HPV analyses, whether the participants had had anal sex in the previous 6 months.

The average age at first intercourse remained steady at 15 years throughout the study, but the average age of vaccination dropped from 18 years in 2008 to 12 years in 2019 (P < .001). More than half the participants (64%) had had at least three lifetime sexual partners at baseline.

After adjustment for age, the researchers found that the incidence of the four HPV types covered by the vaccine – HPV-6, HPV-11, HPV-16, and HPV-18 – dropped more each year, shifting from 9.1% from 2008-2010 to 4.7% from 2017-2019. The effect was even greater among those vaccinated prior to sexual debut; for those patients, the incidence of the four vaccine types dropped from 8.8% to 1.7% over the course of the study. Declines over time also occurred for anal types HPV-31 (adjusted odds ratio [aOR] = 0.76) and HPV-45 (aOR = 0.77). Those vaccinated prior to any sexual intercourse had 19% lower odds of infection per year with a vaccine-covered HPV type.

“We were really excited to see that the types targeted by the vaccines were considerably lower over time in our population,” Dr. Schlecht told this news organization. “This is an important observation, since most of these types are the most worrisome for cervical cancer.”

They were surprised, however, to see overall HPV prevalence increase over time, particularly with the high-risk HPV types that were not covered by the quadrivalent vaccine.

Prevalence of cervical high-risk types not in the vaccine increased from 25.1% from 2008-2010 to 30.5% from 2017-2019. Odds of detection of high-risk HPV types not covered by the vaccine increased 8% each year, particularly for HPV-56 and HPV-68; anal HPV types increased 11% each year. Neither age nor recent number of sexual partners affected the findings.

“The underlying mechanisms for the observed increased detection of specific non-vaccine HPV types over time are not yet clear.”

“We hope this doesn’t translate into some increase in cervical neoplasia that is unanticipated,” Dr. Schlecht said. He noted that the attributable risks for cancer associated with nonvaccine high-risk HPV types remain low. “Theoretical concerns are one thing; actual data is what drives the show,” he said.

The research was funded by the National Institutes of Health and the Icahn School of Medicine at Mount Sinai, New York. Dr. Schlecht has served on advisory boards for Merck, GlaxoSmithKline (GSK), and PDS Biotechnology. One author previously served on a GSK advisory board, and another worked with Merck on an early vaccine trial. Dr. Ault has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Young women who received the quadrivalent human papillomavirus (HPV) vaccine had fewer and fewer infections with high-risk HPV strains covered by the vaccine year after year, but the incidence of high-risk strains that were not covered by the vaccine increased over the same 12-year period, researchers report in a study published August 23 in JAMA Open Network.

“One of the unique contributions that this study provides is the evaluation of a real-world example of the HPV infection rates following immunization in a population of adolescent girls and young adult women at a single health center in a large U.S. city, reflecting strong evidence of vaccine effectiveness,” write Nicolas F. Schlecht, PhD, a professor of oncology at Roswell Park Comprehensive Cancer Center, Buffalo, and his colleagues. “Previous surveillance studies from the U.S. have involved older women and populations with relatively low vaccine coverage.”

In addition to supporting the value of continuing to vaccinate teens against HPV, the findings underscore the importance of continuing to screen women for cervical cancer, Dr. Schlecht said in an interview.

“HPV has not and is not going away,” he said. “We need to keep on our toes with screening and other measures to continue to prevent the development of cervix cancer,” including monitoring different high-risk HPV types and keeping a close eye on cervical precancer rates, particularly CIN3 and cervix cancer, he said. “The vaccines are definitely a good thing. Just getting rid of HPV16 is an amazing accomplishment.”

Kevin Ault, MD, a professor of ob/gyn and academic specialist director of clinical and translational research at the University of Kansas, Kansas City, told this news organization that other studies have had similar findings, but this one is larger with longer follow-up.

“The take-home message is that vaccines work, and this is especially true for the HPV vaccine,” said Dr. Ault, who was not involved in the research. “The vaccine prevents HPV infections and the consequences of these infections, such as cervical cancer. The results are consistent with other studies in different settings, so they are likely generalizable.”

The researchers collected data from October 2007, shortly after the vaccine was approved, through September 2019 on sexually active adolescent and young women aged 13 to 21 years who had received the HPV vaccine and had agreed to follow-up assessments every 6 months until they turned 26. Each follow-up included the collecting of samples of cervical and anal cells for polymerase chain reaction testing for the presence of HPV types.

More than half of the 1,453 participants were Hispanic (58.8%), and half were Black (50.4%), including 15% Hispanic and Black patients. The average age of the participants was 18 years. They were tracked for a median 2.4 years. Nearly half the participants (48%) received the HPV vaccine prior to sexual debut.

For the longitudinal study, the researchers adjusted for participants’ age, the year they received the vaccine, and the years since they were vaccinated. They also tracked breakthrough infections for the four types of HPV covered by the vaccine in participants who received the vaccine before sexual debut.

“We evaluated whether infection rates for HPV have changed since the administration of the vaccine by assessing longitudinally the probability of HPV detection over time among vaccinated participants while adjusting for changes in cohort characteristics over time,” the researchers write. In their statistical analysis, they made adjustments for the number of vaccine doses participants received before their first study visit, age at sexual debut, age at first vaccine dose, number of sexual partners in the preceding 6 months, consistency of condom use during sex, history of a positive chlamydia test, and, for anal HPV analyses, whether the participants had had anal sex in the previous 6 months.

The average age at first intercourse remained steady at 15 years throughout the study, but the average age of vaccination dropped from 18 years in 2008 to 12 years in 2019 (P < .001). More than half the participants (64%) had had at least three lifetime sexual partners at baseline.

After adjustment for age, the researchers found that the incidence of the four HPV types covered by the vaccine – HPV-6, HPV-11, HPV-16, and HPV-18 – dropped more each year, shifting from 9.1% from 2008-2010 to 4.7% from 2017-2019. The effect was even greater among those vaccinated prior to sexual debut; for those patients, the incidence of the four vaccine types dropped from 8.8% to 1.7% over the course of the study. Declines over time also occurred for anal types HPV-31 (adjusted odds ratio [aOR] = 0.76) and HPV-45 (aOR = 0.77). Those vaccinated prior to any sexual intercourse had 19% lower odds of infection per year with a vaccine-covered HPV type.

“We were really excited to see that the types targeted by the vaccines were considerably lower over time in our population,” Dr. Schlecht told this news organization. “This is an important observation, since most of these types are the most worrisome for cervical cancer.”

They were surprised, however, to see overall HPV prevalence increase over time, particularly with the high-risk HPV types that were not covered by the quadrivalent vaccine.

Prevalence of cervical high-risk types not in the vaccine increased from 25.1% from 2008-2010 to 30.5% from 2017-2019. Odds of detection of high-risk HPV types not covered by the vaccine increased 8% each year, particularly for HPV-56 and HPV-68; anal HPV types increased 11% each year. Neither age nor recent number of sexual partners affected the findings.

“The underlying mechanisms for the observed increased detection of specific non-vaccine HPV types over time are not yet clear.”

“We hope this doesn’t translate into some increase in cervical neoplasia that is unanticipated,” Dr. Schlecht said. He noted that the attributable risks for cancer associated with nonvaccine high-risk HPV types remain low. “Theoretical concerns are one thing; actual data is what drives the show,” he said.

The research was funded by the National Institutes of Health and the Icahn School of Medicine at Mount Sinai, New York. Dr. Schlecht has served on advisory boards for Merck, GlaxoSmithKline (GSK), and PDS Biotechnology. One author previously served on a GSK advisory board, and another worked with Merck on an early vaccine trial. Dr. Ault has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A vital aspect of expanding access and care for sexually transmitted infections (STIs) in the United States is broadening responsibility for this care across the health care system and other community resources, according to an article published online July 6 in Clinical Infectious Diseases. This expansion and decentralization of care are central to adopting the “new sexual health paradigm” recommended by a National Academies report that was published in March.

“STIs represent a sizable, longstanding, and growing public health challenge,” write Vincent Guilamo-Ramos, PhD, MPH, dean and professor at the Duke University School of Nursing and director of the Center for Latino Adolescent and Family Health (CLAFH) at Duke University, both in Durham, N.C., and his colleagues. Yet the limitations on the current STI workforce and limited federal funding and support for STI prevention and care mean it will take clinicians of all types from across the health care spectrum to meet the challenge, they explain.

“For too long, STI prevention and treatment has been perceived as the sole responsibility of a narrow workforce of specialized STI and HIV service providers,” Dr. Guilamo-Ramos and his coauthor, Marco Thimm-Kaiser, MPH, associate in research at Duke University and epidemiologist at CLAFH, wrote in an email.

“However, the resources allocated to this STI specialty workforce have diminished over time, along with decreasing investments in the broader U.S. public health infrastructure,” they continued. “At the same time – and in part due to this underinvestment – STI rates have soared, reaching a record high for the sixth year in a row in 2019.”

Those factors led to the National Academies report, which recommends moving “away from the traditional, disease-focused perspective on STIs in favor of a holistic perspective of sexual health as an integral component of overall health and well-being,” Dr. Guilamo-Ramos and Mr. Thimm-Kaiser wrote to this news organization.

In their article, the authors review the limitations in the STI workforce, the implications of those limitations for the broader health care industry, and what it will take for STI and HIV specialists as well as regulators to ensure it’s possible to achieve the paradigm shift recommended by the National Academies.

Currently, the biggest limitation is access to care, said Laura Mercer, MD, MBA, of the department of obstetrics and gynecology and the ob.gyn. clerkship director at the University of Arizona, Phoenix. Dr. Mercer, who was not involved with the National Academies report or the analysis of it, said in an interview that it’s essential to emphasize “sexual health as a core element of routine primary and preventative care” to ensure it becomes more accessible to patients without the need to seek out specialty care.

Dr. Guilamo-Ramos and his colleagues drive home the importance of such a shift by noting that more than 200 million Americans live in counties with no practicing infectious disease physicians. The disparities are greatest in Southern states, which account for 40% of all reported STIs. The workforce shortage has continued to worsen alongside the deterioration of the clinical infrastructure supporting STI specialty services, the authors write.

Hence the need to expand accountability for care not only to primary-care physicians but also to nurses, pharmacists, physician assistants, nurse practitioners, and behavioral health practitioners. Doing so also requires normalizing sexual health services across health care professions.

“Prevention is a crucial first step” to this, Dr. Mercer said. “This is particularly important as we recall that almost half of new sexually transmitted infections occur in teenagers. Destigmatizing sexual health and sexual health education will also help encourage patients of all ages to request and accept testing.”

Further, with primary care practitioners managing most STI testing and treatment, subspecialists can focus primarily on complex or refractory cases, she added. Ways to help broaden care include developing point-of-care testing for STIs and improving the accuracy of existing testing, she said.

“The goal is to make routine sexual health services accessible in a wide range of settings, such as in primary care, at pharmacies, and in community-based settings, and to draw on a broader workforce for delivery of sexual health services,” Dr. Guilamo-Ramos and Mr. Thimm-Kaiser said in an interview.

Kevin Ault, MD, professor of obstetrics and gynecology and director of clinical and translational research at the University of Kansas Medical Center in Kansas City, said that many medical organizations, such as the American College of Obstetricians and Gynecologists, have long advocated incorporating sexual health into routine preventive care. He also noted that pharmacists have already become proactive in preventing STIs and could continue to do so.

“Vaccines for hepatitis and human papillomavirus are commonly available at pharmacies,” Dr. Ault said. He was not involved in the article by Dr. Guilamo-Ramos and colleagues or the original report. “Pharmacists could also fill a gap by administering injectable medications such as penicillin. States would have to approve changes in policy, but many states have already done this for expedited partner therapy.”

Dr. Guilamo-Ramos and Mr. Thimm-Kaiser noted similar barriers that must be removed to broaden delivery of STI services.

“Unfortunately, too many highly trained health care providers who are well-positioned for the delivery of sexual health services face regulatory or administrative barriers to practice to the full scope of their training,” they wrote. “These barriers can have a particularly negative impact in medically underserved communities, where physician shortages are common and where novel, decentralized health care service delivery models that draw on nonphysician providers may hold the greatest promise.”

As more diverse health care practitioners take on these roles, ID and HIV specialists can provide their expertise in developing training and technical assistance to support generalists, Dr. Guilamo-Ramos and Mr. Thimm-Kaiser wrote. They can also aid in aligning “clinical training curricula, licensing criteria, and practice guidelines with routine delivery of sexual health services.”

Dr. Guilamo-Ramos and his coauthors offer specific recommendations for professional training, licensing, and practice guidelines to help overcome the “insufficient knowledge, inadequate training, and absence of explicit protocols” that currently impede delivery of STI services in general practice settings.

Although the paradigm shift recommended by the National Academies is ambitious, it’s also necessary, and “none of the recommendations are out of reach,” Dr. Guilamo-Ramos and Mr. Thimm-Kaiser said in an interview. They pointed out how the COVID-19 pandemic has highlighted how underresourced the health care workforce and infrastructure are and how great health care disparities are.

“There is momentum toward rebuilding the nation’s health and public health system in a more effective and efficient way,” they said, and many of the STI report’s recommendations “overlap with priorities for the broader health and public health system moving forward.”

Dr. Mercer also believes the recommendations are realistic, “but only the beginning,” she told this news organization. “Comprehensive sexual education to expand knowledge about STI prevention and public health campaigns to help destigmatize sexual health care in general will remain crucial,” she said.

Sexual education, expanded access, and destigmatizing sexual care are particularly important for reaching the populations most in need of care, such as adolescents and young adults, as well as ethnic, racial, sexual, and gender-minority youth.

“It cannot be overstated how important of a priority population adolescents and young adults are,” Dr. Guilamo-Ramos and Mr. Thimm-Kaiser wrote. They noted that those aged 15-24 account for half of all STIs each year but represent only a quarter of the sexually active population. “Targeted efforts for STI prevention and treatment among adolescents and young adults are therefore essential for an overall successful strategy to address STIs and sexual health in the United States.”

The National Academies report was supported by the Centers for Disease Control and Prevention and the National Association of County and City Health Officials. Dr. Mercer, Dr. Ault, and Mr. Thimm-Kaiser have disclosed no relevant financial relationships. Dr. Guilamo-Ramos has received grants and personal fees from ViiV Health care.

A version of this article first appeared on Medscape.com.

A vital aspect of expanding access and care for sexually transmitted infections (STIs) in the United States is broadening responsibility for this care across the health care system and other community resources, according to an article published online July 6 in Clinical Infectious Diseases. This expansion and decentralization of care are central to adopting the “new sexual health paradigm” recommended by a National Academies report that was published in March.

“STIs represent a sizable, longstanding, and growing public health challenge,” write Vincent Guilamo-Ramos, PhD, MPH, dean and professor at the Duke University School of Nursing and director of the Center for Latino Adolescent and Family Health (CLAFH) at Duke University, both in Durham, N.C., and his colleagues. Yet the limitations on the current STI workforce and limited federal funding and support for STI prevention and care mean it will take clinicians of all types from across the health care spectrum to meet the challenge, they explain.

“For too long, STI prevention and treatment has been perceived as the sole responsibility of a narrow workforce of specialized STI and HIV service providers,” Dr. Guilamo-Ramos and his coauthor, Marco Thimm-Kaiser, MPH, associate in research at Duke University and epidemiologist at CLAFH, wrote in an email.

“However, the resources allocated to this STI specialty workforce have diminished over time, along with decreasing investments in the broader U.S. public health infrastructure,” they continued. “At the same time – and in part due to this underinvestment – STI rates have soared, reaching a record high for the sixth year in a row in 2019.”

Those factors led to the National Academies report, which recommends moving “away from the traditional, disease-focused perspective on STIs in favor of a holistic perspective of sexual health as an integral component of overall health and well-being,” Dr. Guilamo-Ramos and Mr. Thimm-Kaiser wrote to this news organization.

In their article, the authors review the limitations in the STI workforce, the implications of those limitations for the broader health care industry, and what it will take for STI and HIV specialists as well as regulators to ensure it’s possible to achieve the paradigm shift recommended by the National Academies.

Currently, the biggest limitation is access to care, said Laura Mercer, MD, MBA, of the department of obstetrics and gynecology and the ob.gyn. clerkship director at the University of Arizona, Phoenix. Dr. Mercer, who was not involved with the National Academies report or the analysis of it, said in an interview that it’s essential to emphasize “sexual health as a core element of routine primary and preventative care” to ensure it becomes more accessible to patients without the need to seek out specialty care.

Dr. Guilamo-Ramos and his colleagues drive home the importance of such a shift by noting that more than 200 million Americans live in counties with no practicing infectious disease physicians. The disparities are greatest in Southern states, which account for 40% of all reported STIs. The workforce shortage has continued to worsen alongside the deterioration of the clinical infrastructure supporting STI specialty services, the authors write.

Hence the need to expand accountability for care not only to primary-care physicians but also to nurses, pharmacists, physician assistants, nurse practitioners, and behavioral health practitioners. Doing so also requires normalizing sexual health services across health care professions.

“Prevention is a crucial first step” to this, Dr. Mercer said. “This is particularly important as we recall that almost half of new sexually transmitted infections occur in teenagers. Destigmatizing sexual health and sexual health education will also help encourage patients of all ages to request and accept testing.”

Further, with primary care practitioners managing most STI testing and treatment, subspecialists can focus primarily on complex or refractory cases, she added. Ways to help broaden care include developing point-of-care testing for STIs and improving the accuracy of existing testing, she said.

“The goal is to make routine sexual health services accessible in a wide range of settings, such as in primary care, at pharmacies, and in community-based settings, and to draw on a broader workforce for delivery of sexual health services,” Dr. Guilamo-Ramos and Mr. Thimm-Kaiser said in an interview.

Kevin Ault, MD, professor of obstetrics and gynecology and director of clinical and translational research at the University of Kansas Medical Center in Kansas City, said that many medical organizations, such as the American College of Obstetricians and Gynecologists, have long advocated incorporating sexual health into routine preventive care. He also noted that pharmacists have already become proactive in preventing STIs and could continue to do so.

“Vaccines for hepatitis and human papillomavirus are commonly available at pharmacies,” Dr. Ault said. He was not involved in the article by Dr. Guilamo-Ramos and colleagues or the original report. “Pharmacists could also fill a gap by administering injectable medications such as penicillin. States would have to approve changes in policy, but many states have already done this for expedited partner therapy.”

Dr. Guilamo-Ramos and Mr. Thimm-Kaiser noted similar barriers that must be removed to broaden delivery of STI services.

“Unfortunately, too many highly trained health care providers who are well-positioned for the delivery of sexual health services face regulatory or administrative barriers to practice to the full scope of their training,” they wrote. “These barriers can have a particularly negative impact in medically underserved communities, where physician shortages are common and where novel, decentralized health care service delivery models that draw on nonphysician providers may hold the greatest promise.”

As more diverse health care practitioners take on these roles, ID and HIV specialists can provide their expertise in developing training and technical assistance to support generalists, Dr. Guilamo-Ramos and Mr. Thimm-Kaiser wrote. They can also aid in aligning “clinical training curricula, licensing criteria, and practice guidelines with routine delivery of sexual health services.”

Dr. Guilamo-Ramos and his coauthors offer specific recommendations for professional training, licensing, and practice guidelines to help overcome the “insufficient knowledge, inadequate training, and absence of explicit protocols” that currently impede delivery of STI services in general practice settings.

Although the paradigm shift recommended by the National Academies is ambitious, it’s also necessary, and “none of the recommendations are out of reach,” Dr. Guilamo-Ramos and Mr. Thimm-Kaiser said in an interview. They pointed out how the COVID-19 pandemic has highlighted how underresourced the health care workforce and infrastructure are and how great health care disparities are.

“There is momentum toward rebuilding the nation’s health and public health system in a more effective and efficient way,” they said, and many of the STI report’s recommendations “overlap with priorities for the broader health and public health system moving forward.”

Dr. Mercer also believes the recommendations are realistic, “but only the beginning,” she told this news organization. “Comprehensive sexual education to expand knowledge about STI prevention and public health campaigns to help destigmatize sexual health care in general will remain crucial,” she said.

Sexual education, expanded access, and destigmatizing sexual care are particularly important for reaching the populations most in need of care, such as adolescents and young adults, as well as ethnic, racial, sexual, and gender-minority youth.

“It cannot be overstated how important of a priority population adolescents and young adults are,” Dr. Guilamo-Ramos and Mr. Thimm-Kaiser wrote. They noted that those aged 15-24 account for half of all STIs each year but represent only a quarter of the sexually active population. “Targeted efforts for STI prevention and treatment among adolescents and young adults are therefore essential for an overall successful strategy to address STIs and sexual health in the United States.”

The National Academies report was supported by the Centers for Disease Control and Prevention and the National Association of County and City Health Officials. Dr. Mercer, Dr. Ault, and Mr. Thimm-Kaiser have disclosed no relevant financial relationships. Dr. Guilamo-Ramos has received grants and personal fees from ViiV Health care.

A version of this article first appeared on Medscape.com.

A vital aspect of expanding access and care for sexually transmitted infections (STIs) in the United States is broadening responsibility for this care across the health care system and other community resources, according to an article published online July 6 in Clinical Infectious Diseases. This expansion and decentralization of care are central to adopting the “new sexual health paradigm” recommended by a National Academies report that was published in March.

“STIs represent a sizable, longstanding, and growing public health challenge,” write Vincent Guilamo-Ramos, PhD, MPH, dean and professor at the Duke University School of Nursing and director of the Center for Latino Adolescent and Family Health (CLAFH) at Duke University, both in Durham, N.C., and his colleagues. Yet the limitations on the current STI workforce and limited federal funding and support for STI prevention and care mean it will take clinicians of all types from across the health care spectrum to meet the challenge, they explain.

“For too long, STI prevention and treatment has been perceived as the sole responsibility of a narrow workforce of specialized STI and HIV service providers,” Dr. Guilamo-Ramos and his coauthor, Marco Thimm-Kaiser, MPH, associate in research at Duke University and epidemiologist at CLAFH, wrote in an email.

“However, the resources allocated to this STI specialty workforce have diminished over time, along with decreasing investments in the broader U.S. public health infrastructure,” they continued. “At the same time – and in part due to this underinvestment – STI rates have soared, reaching a record high for the sixth year in a row in 2019.”

Those factors led to the National Academies report, which recommends moving “away from the traditional, disease-focused perspective on STIs in favor of a holistic perspective of sexual health as an integral component of overall health and well-being,” Dr. Guilamo-Ramos and Mr. Thimm-Kaiser wrote to this news organization.

In their article, the authors review the limitations in the STI workforce, the implications of those limitations for the broader health care industry, and what it will take for STI and HIV specialists as well as regulators to ensure it’s possible to achieve the paradigm shift recommended by the National Academies.

Currently, the biggest limitation is access to care, said Laura Mercer, MD, MBA, of the department of obstetrics and gynecology and the ob.gyn. clerkship director at the University of Arizona, Phoenix. Dr. Mercer, who was not involved with the National Academies report or the analysis of it, said in an interview that it’s essential to emphasize “sexual health as a core element of routine primary and preventative care” to ensure it becomes more accessible to patients without the need to seek out specialty care.

Dr. Guilamo-Ramos and his colleagues drive home the importance of such a shift by noting that more than 200 million Americans live in counties with no practicing infectious disease physicians. The disparities are greatest in Southern states, which account for 40% of all reported STIs. The workforce shortage has continued to worsen alongside the deterioration of the clinical infrastructure supporting STI specialty services, the authors write.

Hence the need to expand accountability for care not only to primary-care physicians but also to nurses, pharmacists, physician assistants, nurse practitioners, and behavioral health practitioners. Doing so also requires normalizing sexual health services across health care professions.

“Prevention is a crucial first step” to this, Dr. Mercer said. “This is particularly important as we recall that almost half of new sexually transmitted infections occur in teenagers. Destigmatizing sexual health and sexual health education will also help encourage patients of all ages to request and accept testing.”

Further, with primary care practitioners managing most STI testing and treatment, subspecialists can focus primarily on complex or refractory cases, she added. Ways to help broaden care include developing point-of-care testing for STIs and improving the accuracy of existing testing, she said.

“The goal is to make routine sexual health services accessible in a wide range of settings, such as in primary care, at pharmacies, and in community-based settings, and to draw on a broader workforce for delivery of sexual health services,” Dr. Guilamo-Ramos and Mr. Thimm-Kaiser said in an interview.

Kevin Ault, MD, professor of obstetrics and gynecology and director of clinical and translational research at the University of Kansas Medical Center in Kansas City, said that many medical organizations, such as the American College of Obstetricians and Gynecologists, have long advocated incorporating sexual health into routine preventive care. He also noted that pharmacists have already become proactive in preventing STIs and could continue to do so.

“Vaccines for hepatitis and human papillomavirus are commonly available at pharmacies,” Dr. Ault said. He was not involved in the article by Dr. Guilamo-Ramos and colleagues or the original report. “Pharmacists could also fill a gap by administering injectable medications such as penicillin. States would have to approve changes in policy, but many states have already done this for expedited partner therapy.”

Dr. Guilamo-Ramos and Mr. Thimm-Kaiser noted similar barriers that must be removed to broaden delivery of STI services.

“Unfortunately, too many highly trained health care providers who are well-positioned for the delivery of sexual health services face regulatory or administrative barriers to practice to the full scope of their training,” they wrote. “These barriers can have a particularly negative impact in medically underserved communities, where physician shortages are common and where novel, decentralized health care service delivery models that draw on nonphysician providers may hold the greatest promise.”

As more diverse health care practitioners take on these roles, ID and HIV specialists can provide their expertise in developing training and technical assistance to support generalists, Dr. Guilamo-Ramos and Mr. Thimm-Kaiser wrote. They can also aid in aligning “clinical training curricula, licensing criteria, and practice guidelines with routine delivery of sexual health services.”

Dr. Guilamo-Ramos and his coauthors offer specific recommendations for professional training, licensing, and practice guidelines to help overcome the “insufficient knowledge, inadequate training, and absence of explicit protocols” that currently impede delivery of STI services in general practice settings.

Although the paradigm shift recommended by the National Academies is ambitious, it’s also necessary, and “none of the recommendations are out of reach,” Dr. Guilamo-Ramos and Mr. Thimm-Kaiser said in an interview. They pointed out how the COVID-19 pandemic has highlighted how underresourced the health care workforce and infrastructure are and how great health care disparities are.

“There is momentum toward rebuilding the nation’s health and public health system in a more effective and efficient way,” they said, and many of the STI report’s recommendations “overlap with priorities for the broader health and public health system moving forward.”

Dr. Mercer also believes the recommendations are realistic, “but only the beginning,” she told this news organization. “Comprehensive sexual education to expand knowledge about STI prevention and public health campaigns to help destigmatize sexual health care in general will remain crucial,” she said.

Sexual education, expanded access, and destigmatizing sexual care are particularly important for reaching the populations most in need of care, such as adolescents and young adults, as well as ethnic, racial, sexual, and gender-minority youth.

“It cannot be overstated how important of a priority population adolescents and young adults are,” Dr. Guilamo-Ramos and Mr. Thimm-Kaiser wrote. They noted that those aged 15-24 account for half of all STIs each year but represent only a quarter of the sexually active population. “Targeted efforts for STI prevention and treatment among adolescents and young adults are therefore essential for an overall successful strategy to address STIs and sexual health in the United States.”

The National Academies report was supported by the Centers for Disease Control and Prevention and the National Association of County and City Health Officials. Dr. Mercer, Dr. Ault, and Mr. Thimm-Kaiser have disclosed no relevant financial relationships. Dr. Guilamo-Ramos has received grants and personal fees from ViiV Health care.

A version of this article first appeared on Medscape.com.

For the first time, an HIV prevention trial that was limited to adolescent girls and young women found that, given sufficient support, girls will use either daily oral pre-exposure prophylaxis (PrEP) or the vaginal dapivirine ring to protect themselves from HIV.

The secret, said Gonasagrie Nair, MBChB, faculty of medicine and health sciences at Stellenbosch University, Zimbabwe, is offering intensive wraparound services to support teenagers – a lesson that may be useful as adolescent and family medicine professionals in the United States begin to roll out HIV prevention in their clinics.

This is important in the United States because cisgender Black women make up 60% of all new HIV cases in the United States while accounting for just 14% of the overall U.S. population. The Centers for Disease Control and Prevention has found that only about 1% of Black Americans who could benefit from PrEP have access to it.

“Younger women and adolescent girls in particular face a number of cultural and social challenges that impact their ability to make decisions related to their own health,” said Dr. Nair, who presented the data at the International AIDS Society (IAS) Conference 2021. “The adherence support provided by this study empowered them to make choices and stick to these choices,” she said.

In total, 247 women and girls aged 16 to 21 who were without HIV were enrolled in the Reversing the Epidemic in Africa with Choices in HIV Prevention (REACH) trial in two sites in South Africa and one each in Uganda and Zimbabwe beginning in February 2019. One-third of the participants were minors; the average age was 18.2 years.

The women were good candidates for PrEP. More than 1 in 3 of the women started the study with a sexually transmitted infection (STI), the most prevalent of which was chlamydia. This is often a good marker for condomless sex. Of the participants, 89% had a primary sex partner; a quarter of those thought their partner was having sex with other people. Only 7% of participants reported being very worried about acquiring HIV. More than 1 in 3 (39%) weren’t worried about HIV at all. This conforms to previous data suggesting that those who could most benefit from PrEP often don’t perceive their own vulnerability.

In the study, the women were randomly assigned two groups. In one group, the participants used the dapivirine ring for 6 months; in the other, participants used oral PrEP for 6 months. The participants then swapped prevention methods and used the alternative method for 6 more months. After a year of trying both methods, the women will be asked to choose one of the two prevention method or to stop PrEP altogether. At the IAS conference, the researchers reported interim data from the first year of the study, before the girls had the opportunity to choose for themselves.

During that first year, girls received intensive adherence support, including daily or weekly text check-ins, phone check-ins, peer buddy support, additional onsite counseling visits, access to adherence support groups, participation in online support groups via apps such as WhatsApp, and in-person social events designed to empower young women and to teach them skills. Support included discussion of adherence, contraceptives, and STIs. In addition, when girls came in for study visits, staff provided feedback on how adherent the girls had been, as determined on the basis of residual levels of dapivirine in the rings or, with regard to oral pills, drug levels as determined with blood spots.

Girls were considered to have had high adherence if they were found to have oral PrEP concentrations equivalent to four or more doses per week or if residual levels of dapivirine in their rings were 0.1071 mg/d. Moderate adherence was the equivalent of one to three doses of oral PrEP a week or dapivirine levels between 0.0321 mg/d and 0.1071 mg/d.

In total, 95.6% of ring users showed some adherence to the ring. Of those, adherence was high for 50.2%; 49.8% used the ring perfectly. For oral PrEP, 98.5% showed some level of PrEP use; for 58.6%, lab results suggested adherence high enough to provide protection from HIV, and 22% took their pills at least six times a week. Between the two arms, 54.3% of all participants used the medication sufficiently to be protected from HIV.

One person acquired HIV during the study. Dr. Nair did not say which study arm that participant was in or how adherent that person has been to their prevention method.

That level of adherence is on par with studies in the United States, which have found 56% adherence to PrEP among adolescent and young men who have sex with men. But the level of adherence is far higher than has been found in other studies that tested oral PrEP among women who did not have a partner with HIV. In particular, the VOICE and FEM-PrEP trials were both stopped early for lack of adherence. In those placebo-controlled oral-PrEP trials, fewer than 25% of participants used the oral prevention pills. Although adherence to the vaginal ring was estimated to be 61% for women older than 25 in the ASPIRE trial, it was effectively zero among women aged 18 to 21 years. Adherence has been the “bugaboo of efficacy for PrEP in young women,” said Judith Auerbach, PhD, independent science and policy consultant and professor of medicine at the University of California, San Francisco. But health care professionals have a long way to go to support young people in general in using PrEP.

“Yes, this shows improvement compared to previous studies,” Dr. Auerbach told this news organization. “But is it sufficient to have an epidemiological impact at the population level?”

Medical Advocacy and Outreach (MAO) is an HIV clinic and services program in Montgomery, Alabama, that offers a clinic specifically for some of their 144 clients to receive oral PrEP. In addition to in-person testing, MAO offers home HIV testing and lab work and televisits to support the college students they serve in taking PrEP whether they’re at school or at home on break. Currently, MAO provides a series of support groups and other social support programs for their clients living with HIV, but there are none for those receiving PrEP. The organization is in the process of hiring a social worker for the PrEP side of the clinic.

Until that person is on board, “I’m their support system in an unofficial capacity,” Shericka Williams, MPH, told this news organization. She runs education programs at MAO and handles all the phone calls from PrEP clients. “My title changes a lot, but the one I like to go with most often is the PrEP navigator,” she said.

She said she was intrigued by the dapivirine ring and oral PrEP data but said that currently, the women they serve are still learning that PrEP is for them, too. The women report that all the ads and all the information they receive is aimed at gay or bisexual men or transgender women. It takes a while for them to recognize that they could benefit, so a lot of the work that Ms. Williams does is focused on explaining the benefit of PrEP.

In MAO, the number of women receiving PrEP fluctuates more than for men. Mostly, women start PrEP because of they are in a relationship with someone who receives HIV care from MAO’s other wing – women who potentially would experience less vulnerability to HIV if their partners had undetectable viral loads. The other reason women take it is because they suspect that their partner is cheating or because they are in abusive relationships in which they want their partner to use a condom but the partner won’t. As in the PrEP trials, they often see women discontinue PrEP when they leave those relationships. In part, her job is to educate women regarding all the ways PrEP could serve them.

“Most of the time, they’re just no longer in that relationship, and they’re just taking some time for themselves,” she said in an interview. “We definitely try to bring up other reasons to stay on PrEP, but we don’t want to seem like we’re bullying someone to stay on it.”

Dr. Nair, Dr. Auerbach, and Ms. Williams report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

For the first time, an HIV prevention trial that was limited to adolescent girls and young women found that, given sufficient support, girls will use either daily oral pre-exposure prophylaxis (PrEP) or the vaginal dapivirine ring to protect themselves from HIV.

The secret, said Gonasagrie Nair, MBChB, faculty of medicine and health sciences at Stellenbosch University, Zimbabwe, is offering intensive wraparound services to support teenagers – a lesson that may be useful as adolescent and family medicine professionals in the United States begin to roll out HIV prevention in their clinics.

This is important in the United States because cisgender Black women make up 60% of all new HIV cases in the United States while accounting for just 14% of the overall U.S. population. The Centers for Disease Control and Prevention has found that only about 1% of Black Americans who could benefit from PrEP have access to it.

“Younger women and adolescent girls in particular face a number of cultural and social challenges that impact their ability to make decisions related to their own health,” said Dr. Nair, who presented the data at the International AIDS Society (IAS) Conference 2021. “The adherence support provided by this study empowered them to make choices and stick to these choices,” she said.

In total, 247 women and girls aged 16 to 21 who were without HIV were enrolled in the Reversing the Epidemic in Africa with Choices in HIV Prevention (REACH) trial in two sites in South Africa and one each in Uganda and Zimbabwe beginning in February 2019. One-third of the participants were minors; the average age was 18.2 years.

The women were good candidates for PrEP. More than 1 in 3 of the women started the study with a sexually transmitted infection (STI), the most prevalent of which was chlamydia. This is often a good marker for condomless sex. Of the participants, 89% had a primary sex partner; a quarter of those thought their partner was having sex with other people. Only 7% of participants reported being very worried about acquiring HIV. More than 1 in 3 (39%) weren’t worried about HIV at all. This conforms to previous data suggesting that those who could most benefit from PrEP often don’t perceive their own vulnerability.

In the study, the women were randomly assigned two groups. In one group, the participants used the dapivirine ring for 6 months; in the other, participants used oral PrEP for 6 months. The participants then swapped prevention methods and used the alternative method for 6 more months. After a year of trying both methods, the women will be asked to choose one of the two prevention method or to stop PrEP altogether. At the IAS conference, the researchers reported interim data from the first year of the study, before the girls had the opportunity to choose for themselves.

During that first year, girls received intensive adherence support, including daily or weekly text check-ins, phone check-ins, peer buddy support, additional onsite counseling visits, access to adherence support groups, participation in online support groups via apps such as WhatsApp, and in-person social events designed to empower young women and to teach them skills. Support included discussion of adherence, contraceptives, and STIs. In addition, when girls came in for study visits, staff provided feedback on how adherent the girls had been, as determined on the basis of residual levels of dapivirine in the rings or, with regard to oral pills, drug levels as determined with blood spots.

Girls were considered to have had high adherence if they were found to have oral PrEP concentrations equivalent to four or more doses per week or if residual levels of dapivirine in their rings were 0.1071 mg/d. Moderate adherence was the equivalent of one to three doses of oral PrEP a week or dapivirine levels between 0.0321 mg/d and 0.1071 mg/d.

In total, 95.6% of ring users showed some adherence to the ring. Of those, adherence was high for 50.2%; 49.8% used the ring perfectly. For oral PrEP, 98.5% showed some level of PrEP use; for 58.6%, lab results suggested adherence high enough to provide protection from HIV, and 22% took their pills at least six times a week. Between the two arms, 54.3% of all participants used the medication sufficiently to be protected from HIV.

One person acquired HIV during the study. Dr. Nair did not say which study arm that participant was in or how adherent that person has been to their prevention method.

That level of adherence is on par with studies in the United States, which have found 56% adherence to PrEP among adolescent and young men who have sex with men. But the level of adherence is far higher than has been found in other studies that tested oral PrEP among women who did not have a partner with HIV. In particular, the VOICE and FEM-PrEP trials were both stopped early for lack of adherence. In those placebo-controlled oral-PrEP trials, fewer than 25% of participants used the oral prevention pills. Although adherence to the vaginal ring was estimated to be 61% for women older than 25 in the ASPIRE trial, it was effectively zero among women aged 18 to 21 years. Adherence has been the “bugaboo of efficacy for PrEP in young women,” said Judith Auerbach, PhD, independent science and policy consultant and professor of medicine at the University of California, San Francisco. But health care professionals have a long way to go to support young people in general in using PrEP.

“Yes, this shows improvement compared to previous studies,” Dr. Auerbach told this news organization. “But is it sufficient to have an epidemiological impact at the population level?”

Medical Advocacy and Outreach (MAO) is an HIV clinic and services program in Montgomery, Alabama, that offers a clinic specifically for some of their 144 clients to receive oral PrEP. In addition to in-person testing, MAO offers home HIV testing and lab work and televisits to support the college students they serve in taking PrEP whether they’re at school or at home on break. Currently, MAO provides a series of support groups and other social support programs for their clients living with HIV, but there are none for those receiving PrEP. The organization is in the process of hiring a social worker for the PrEP side of the clinic.

Until that person is on board, “I’m their support system in an unofficial capacity,” Shericka Williams, MPH, told this news organization. She runs education programs at MAO and handles all the phone calls from PrEP clients. “My title changes a lot, but the one I like to go with most often is the PrEP navigator,” she said.

She said she was intrigued by the dapivirine ring and oral PrEP data but said that currently, the women they serve are still learning that PrEP is for them, too. The women report that all the ads and all the information they receive is aimed at gay or bisexual men or transgender women. It takes a while for them to recognize that they could benefit, so a lot of the work that Ms. Williams does is focused on explaining the benefit of PrEP.

In MAO, the number of women receiving PrEP fluctuates more than for men. Mostly, women start PrEP because of they are in a relationship with someone who receives HIV care from MAO’s other wing – women who potentially would experience less vulnerability to HIV if their partners had undetectable viral loads. The other reason women take it is because they suspect that their partner is cheating or because they are in abusive relationships in which they want their partner to use a condom but the partner won’t. As in the PrEP trials, they often see women discontinue PrEP when they leave those relationships. In part, her job is to educate women regarding all the ways PrEP could serve them.

“Most of the time, they’re just no longer in that relationship, and they’re just taking some time for themselves,” she said in an interview. “We definitely try to bring up other reasons to stay on PrEP, but we don’t want to seem like we’re bullying someone to stay on it.”

Dr. Nair, Dr. Auerbach, and Ms. Williams report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

For the first time, an HIV prevention trial that was limited to adolescent girls and young women found that, given sufficient support, girls will use either daily oral pre-exposure prophylaxis (PrEP) or the vaginal dapivirine ring to protect themselves from HIV.

The secret, said Gonasagrie Nair, MBChB, faculty of medicine and health sciences at Stellenbosch University, Zimbabwe, is offering intensive wraparound services to support teenagers – a lesson that may be useful as adolescent and family medicine professionals in the United States begin to roll out HIV prevention in their clinics.

This is important in the United States because cisgender Black women make up 60% of all new HIV cases in the United States while accounting for just 14% of the overall U.S. population. The Centers for Disease Control and Prevention has found that only about 1% of Black Americans who could benefit from PrEP have access to it.

“Younger women and adolescent girls in particular face a number of cultural and social challenges that impact their ability to make decisions related to their own health,” said Dr. Nair, who presented the data at the International AIDS Society (IAS) Conference 2021. “The adherence support provided by this study empowered them to make choices and stick to these choices,” she said.

In total, 247 women and girls aged 16 to 21 who were without HIV were enrolled in the Reversing the Epidemic in Africa with Choices in HIV Prevention (REACH) trial in two sites in South Africa and one each in Uganda and Zimbabwe beginning in February 2019. One-third of the participants were minors; the average age was 18.2 years.

The women were good candidates for PrEP. More than 1 in 3 of the women started the study with a sexually transmitted infection (STI), the most prevalent of which was chlamydia. This is often a good marker for condomless sex. Of the participants, 89% had a primary sex partner; a quarter of those thought their partner was having sex with other people. Only 7% of participants reported being very worried about acquiring HIV. More than 1 in 3 (39%) weren’t worried about HIV at all. This conforms to previous data suggesting that those who could most benefit from PrEP often don’t perceive their own vulnerability.

In the study, the women were randomly assigned two groups. In one group, the participants used the dapivirine ring for 6 months; in the other, participants used oral PrEP for 6 months. The participants then swapped prevention methods and used the alternative method for 6 more months. After a year of trying both methods, the women will be asked to choose one of the two prevention method or to stop PrEP altogether. At the IAS conference, the researchers reported interim data from the first year of the study, before the girls had the opportunity to choose for themselves.

During that first year, girls received intensive adherence support, including daily or weekly text check-ins, phone check-ins, peer buddy support, additional onsite counseling visits, access to adherence support groups, participation in online support groups via apps such as WhatsApp, and in-person social events designed to empower young women and to teach them skills. Support included discussion of adherence, contraceptives, and STIs. In addition, when girls came in for study visits, staff provided feedback on how adherent the girls had been, as determined on the basis of residual levels of dapivirine in the rings or, with regard to oral pills, drug levels as determined with blood spots.

Girls were considered to have had high adherence if they were found to have oral PrEP concentrations equivalent to four or more doses per week or if residual levels of dapivirine in their rings were 0.1071 mg/d. Moderate adherence was the equivalent of one to three doses of oral PrEP a week or dapivirine levels between 0.0321 mg/d and 0.1071 mg/d.

In total, 95.6% of ring users showed some adherence to the ring. Of those, adherence was high for 50.2%; 49.8% used the ring perfectly. For oral PrEP, 98.5% showed some level of PrEP use; for 58.6%, lab results suggested adherence high enough to provide protection from HIV, and 22% took their pills at least six times a week. Between the two arms, 54.3% of all participants used the medication sufficiently to be protected from HIV.

One person acquired HIV during the study. Dr. Nair did not say which study arm that participant was in or how adherent that person has been to their prevention method.

That level of adherence is on par with studies in the United States, which have found 56% adherence to PrEP among adolescent and young men who have sex with men. But the level of adherence is far higher than has been found in other studies that tested oral PrEP among women who did not have a partner with HIV. In particular, the VOICE and FEM-PrEP trials were both stopped early for lack of adherence. In those placebo-controlled oral-PrEP trials, fewer than 25% of participants used the oral prevention pills. Although adherence to the vaginal ring was estimated to be 61% for women older than 25 in the ASPIRE trial, it was effectively zero among women aged 18 to 21 years. Adherence has been the “bugaboo of efficacy for PrEP in young women,” said Judith Auerbach, PhD, independent science and policy consultant and professor of medicine at the University of California, San Francisco. But health care professionals have a long way to go to support young people in general in using PrEP.

“Yes, this shows improvement compared to previous studies,” Dr. Auerbach told this news organization. “But is it sufficient to have an epidemiological impact at the population level?”

Medical Advocacy and Outreach (MAO) is an HIV clinic and services program in Montgomery, Alabama, that offers a clinic specifically for some of their 144 clients to receive oral PrEP. In addition to in-person testing, MAO offers home HIV testing and lab work and televisits to support the college students they serve in taking PrEP whether they’re at school or at home on break. Currently, MAO provides a series of support groups and other social support programs for their clients living with HIV, but there are none for those receiving PrEP. The organization is in the process of hiring a social worker for the PrEP side of the clinic.

Until that person is on board, “I’m their support system in an unofficial capacity,” Shericka Williams, MPH, told this news organization. She runs education programs at MAO and handles all the phone calls from PrEP clients. “My title changes a lot, but the one I like to go with most often is the PrEP navigator,” she said.

She said she was intrigued by the dapivirine ring and oral PrEP data but said that currently, the women they serve are still learning that PrEP is for them, too. The women report that all the ads and all the information they receive is aimed at gay or bisexual men or transgender women. It takes a while for them to recognize that they could benefit, so a lot of the work that Ms. Williams does is focused on explaining the benefit of PrEP.

In MAO, the number of women receiving PrEP fluctuates more than for men. Mostly, women start PrEP because of they are in a relationship with someone who receives HIV care from MAO’s other wing – women who potentially would experience less vulnerability to HIV if their partners had undetectable viral loads. The other reason women take it is because they suspect that their partner is cheating or because they are in abusive relationships in which they want their partner to use a condom but the partner won’t. As in the PrEP trials, they often see women discontinue PrEP when they leave those relationships. In part, her job is to educate women regarding all the ways PrEP could serve them.

“Most of the time, they’re just no longer in that relationship, and they’re just taking some time for themselves,” she said in an interview. “We definitely try to bring up other reasons to stay on PrEP, but we don’t want to seem like we’re bullying someone to stay on it.”

Dr. Nair, Dr. Auerbach, and Ms. Williams report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

On July 22, the Centers for Disease Control and Prevention released updated sexually transmitted infection treatment guidelines to reflect current screening, testing, and treatment recommendations. The guidelines were last updated in 2015.

The new recommendations come at a pivotal moment in the field’s history, Kimberly Workowski, MD, a medical officer at the CDC’s Division of STD Prevention, told this news organization in an email. “The COVID-19 pandemic has caused decreased clinic capacity and drug and diagnostic test kit shortages,” she says. Many of these shortages have been resolved, she added, and it is important that health care professionals use the most current evidence-based recommendations for screening and management of STIs.

Updates to these guidelines were necessary to reflect “continued advances in research in the prevention of STIs, new interventions in terms of STI prevention, and thirdly, changing epidemiology,” Jeffrey Klausner, MD, MPH, an STI specialist with the Keck School of Medicine at the University of Southern California, Los Angeles, said in an interview. “There’s been increased concern about antimicrobial resistance, and that’s really driven some of the key changes in these new STI treatment guidelines.”

Notable updates to the guidelines include the following:

• Updated treatment recommendations for gonorrhea, chlamydia, , and 
• Two-step testing for diagnosing genital  virus
• Expanded risk factors for  testing in pregnant women
• Information on FDA-cleared rectal and oral tests to diagnose chlamydia and gonorrhea
• A recommendation that universal  screening be conducted at least once in a lifetime for adults aged 18 years and older

Dr. Workowski emphasized updates to gonorrhea treatment that built on the recommendation published in December 2020 in Morbidity and Mortality Weekly Report. The CDC now recommends that gonorrhea be treated with a single 500-mg injection of ceftriaxone, and if chlamydial infection is not ruled out, treating with a regimen of 100 mg of oral doxycycline taken twice daily for 7 days. Other gonorrhea treatment recommendations include retesting patients 3 months after treatment and that a test of cure be conducted for people with pharyngeal gonorrhea 1 to 2 weeks after treatment, using either culture or nucleic-acid amplification tests.

“Effectively treating gonorrhea remains a public health priority,” Dr. Workowski said. “Gonorrhea can rapidly develop antibiotic resistance and is the second most commonly reported bacterial STI in the U.S., increasing 56% from 2015 to 2019.”

The updates to syphilis screening for pregnant women are also important, added Dr. Klausner. “We’ve seen a dramatic and shameful rise in congenital syphilis,” he said. In addition to screening all pregnant women at the first prenatal visit, the CDC recommends retesting for syphilis at 28 weeks’ gestation and at delivery if the mother lives in an area where the prevalence of syphilis is high or if she is at risk of acquiring syphilis during pregnancy. An expectant mother is at higher risk if she has multiple sex partners, has an STI during pregnancy, has a partner with an STI, has a new sex partner, or misuses drugs, the recommendations state.

Dr. Klausner also noted that the updates provide more robust guidelines for treating transgender individuals and incarcerated people.

The treatment guidelines are available online along with a wall chart and a pocket guide that summarizes these updates. The mobile app with the 2015 guidelines will be retired at the end of July 2021, Dr. Workowski said. An app with these updated treatment recommendations is in development and will be available later this year.

A version of this article first appeared on Medscape.com.

On July 22, the Centers for Disease Control and Prevention released updated sexually transmitted infection treatment guidelines to reflect current screening, testing, and treatment recommendations. The guidelines were last updated in 2015.

The new recommendations come at a pivotal moment in the field’s history, Kimberly Workowski, MD, a medical officer at the CDC’s Division of STD Prevention, told this news organization in an email. “The COVID-19 pandemic has caused decreased clinic capacity and drug and diagnostic test kit shortages,” she says. Many of these shortages have been resolved, she added, and it is important that health care professionals use the most current evidence-based recommendations for screening and management of STIs.

Updates to these guidelines were necessary to reflect “continued advances in research in the prevention of STIs, new interventions in terms of STI prevention, and thirdly, changing epidemiology,” Jeffrey Klausner, MD, MPH, an STI specialist with the Keck School of Medicine at the University of Southern California, Los Angeles, said in an interview. “There’s been increased concern about antimicrobial resistance, and that’s really driven some of the key changes in these new STI treatment guidelines.”

Notable updates to the guidelines include the following:

• Updated treatment recommendations for gonorrhea, chlamydia, , and 
• Two-step testing for diagnosing genital  virus
• Expanded risk factors for  testing in pregnant women
• Information on FDA-cleared rectal and oral tests to diagnose chlamydia and gonorrhea
• A recommendation that universal  screening be conducted at least once in a lifetime for adults aged 18 years and older

Dr. Workowski emphasized updates to gonorrhea treatment that built on the recommendation published in December 2020 in Morbidity and Mortality Weekly Report. The CDC now recommends that gonorrhea be treated with a single 500-mg injection of ceftriaxone, and if chlamydial infection is not ruled out, treating with a regimen of 100 mg of oral doxycycline taken twice daily for 7 days. Other gonorrhea treatment recommendations include retesting patients 3 months after treatment and that a test of cure be conducted for people with pharyngeal gonorrhea 1 to 2 weeks after treatment, using either culture or nucleic-acid amplification tests.

“Effectively treating gonorrhea remains a public health priority,” Dr. Workowski said. “Gonorrhea can rapidly develop antibiotic resistance and is the second most commonly reported bacterial STI in the U.S., increasing 56% from 2015 to 2019.”

The updates to syphilis screening for pregnant women are also important, added Dr. Klausner. “We’ve seen a dramatic and shameful rise in congenital syphilis,” he said. In addition to screening all pregnant women at the first prenatal visit, the CDC recommends retesting for syphilis at 28 weeks’ gestation and at delivery if the mother lives in an area where the prevalence of syphilis is high or if she is at risk of acquiring syphilis during pregnancy. An expectant mother is at higher risk if she has multiple sex partners, has an STI during pregnancy, has a partner with an STI, has a new sex partner, or misuses drugs, the recommendations state.

Dr. Klausner also noted that the updates provide more robust guidelines for treating transgender individuals and incarcerated people.

The treatment guidelines are available online along with a wall chart and a pocket guide that summarizes these updates. The mobile app with the 2015 guidelines will be retired at the end of July 2021, Dr. Workowski said. An app with these updated treatment recommendations is in development and will be available later this year.

A version of this article first appeared on Medscape.com.

On July 22, the Centers for Disease Control and Prevention released updated sexually transmitted infection treatment guidelines to reflect current screening, testing, and treatment recommendations. The guidelines were last updated in 2015.

The new recommendations come at a pivotal moment in the field’s history, Kimberly Workowski, MD, a medical officer at the CDC’s Division of STD Prevention, told this news organization in an email. “The COVID-19 pandemic has caused decreased clinic capacity and drug and diagnostic test kit shortages,” she says. Many of these shortages have been resolved, she added, and it is important that health care professionals use the most current evidence-based recommendations for screening and management of STIs.

Updates to these guidelines were necessary to reflect “continued advances in research in the prevention of STIs, new interventions in terms of STI prevention, and thirdly, changing epidemiology,” Jeffrey Klausner, MD, MPH, an STI specialist with the Keck School of Medicine at the University of Southern California, Los Angeles, said in an interview. “There’s been increased concern about antimicrobial resistance, and that’s really driven some of the key changes in these new STI treatment guidelines.”

Notable updates to the guidelines include the following:

• Updated treatment recommendations for gonorrhea, chlamydia, , and 
• Two-step testing for diagnosing genital  virus
• Expanded risk factors for  testing in pregnant women
• Information on FDA-cleared rectal and oral tests to diagnose chlamydia and gonorrhea
• A recommendation that universal  screening be conducted at least once in a lifetime for adults aged 18 years and older

Dr. Workowski emphasized updates to gonorrhea treatment that built on the recommendation published in December 2020 in Morbidity and Mortality Weekly Report. The CDC now recommends that gonorrhea be treated with a single 500-mg injection of ceftriaxone, and if chlamydial infection is not ruled out, treating with a regimen of 100 mg of oral doxycycline taken twice daily for 7 days. Other gonorrhea treatment recommendations include retesting patients 3 months after treatment and that a test of cure be conducted for people with pharyngeal gonorrhea 1 to 2 weeks after treatment, using either culture or nucleic-acid amplification tests.

“Effectively treating gonorrhea remains a public health priority,” Dr. Workowski said. “Gonorrhea can rapidly develop antibiotic resistance and is the second most commonly reported bacterial STI in the U.S., increasing 56% from 2015 to 2019.”

The updates to syphilis screening for pregnant women are also important, added Dr. Klausner. “We’ve seen a dramatic and shameful rise in congenital syphilis,” he said. In addition to screening all pregnant women at the first prenatal visit, the CDC recommends retesting for syphilis at 28 weeks’ gestation and at delivery if the mother lives in an area where the prevalence of syphilis is high or if she is at risk of acquiring syphilis during pregnancy. An expectant mother is at higher risk if she has multiple sex partners, has an STI during pregnancy, has a partner with an STI, has a new sex partner, or misuses drugs, the recommendations state.

Dr. Klausner also noted that the updates provide more robust guidelines for treating transgender individuals and incarcerated people.

The treatment guidelines are available online along with a wall chart and a pocket guide that summarizes these updates. The mobile app with the 2015 guidelines will be retired at the end of July 2021, Dr. Workowski said. An app with these updated treatment recommendations is in development and will be available later this year.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has expanded the approval of secnidazole to include treatment of trichomoniasis in adults, according to a statement from manufacturer Lupin Pharmaceuticals.

Trichomoniasis vaginalis is a common, nonviral, curable sexually transmitted disease that affects approximately 3 million to 5 million adults in the United States each year; the infection can linger for months or years if left untreated, and may have a negative impact on reproductive health. The drug was approved for the treatment of bacterial vaginosis in 2017.

The availability of a single-dose oral treatment for both trichomoniasis and bacterial vaginosis may help improve adherence and reduce risk factors associated with these conditions, including pelvic inflammatory disease and other sexually transmitted infections, according to the statement.

The approval for the new indication was based primarily on data from a phase 3 clinical trial in which women with a confirmed trichomoniasis diagnosis were randomized to a single dose of 2 g oral secnidazole or a placebo. Secnidazole showed a 92.2% cure rate for patients with trichomoniasis, compared with placebo, based on cultures collected 6-12 days after dosing. Cure rates in subsets of patients with HIV and bacterial vaginosis were 100% and 95%, respectively.

The most common treatment-related adverse events were vulvovaginal candidiasis and nausea, each reported in 2.7% of study participants. The study findings were published in March 2021 in Clinical Infections Diseases.

Secnidazole also is approved for treatment of trichomoniasis in men, based on data from four open-label studies, one with men only and three including both men and women, according to the statement.

Full prescribing information for secnidazole is available here.

The Food and Drug Administration has expanded the approval of secnidazole to include treatment of trichomoniasis in adults, according to a statement from manufacturer Lupin Pharmaceuticals.

Trichomoniasis vaginalis is a common, nonviral, curable sexually transmitted disease that affects approximately 3 million to 5 million adults in the United States each year; the infection can linger for months or years if left untreated, and may have a negative impact on reproductive health. The drug was approved for the treatment of bacterial vaginosis in 2017.

The availability of a single-dose oral treatment for both trichomoniasis and bacterial vaginosis may help improve adherence and reduce risk factors associated with these conditions, including pelvic inflammatory disease and other sexually transmitted infections, according to the statement.

The approval for the new indication was based primarily on data from a phase 3 clinical trial in which women with a confirmed trichomoniasis diagnosis were randomized to a single dose of 2 g oral secnidazole or a placebo. Secnidazole showed a 92.2% cure rate for patients with trichomoniasis, compared with placebo, based on cultures collected 6-12 days after dosing. Cure rates in subsets of patients with HIV and bacterial vaginosis were 100% and 95%, respectively.

The most common treatment-related adverse events were vulvovaginal candidiasis and nausea, each reported in 2.7% of study participants. The study findings were published in March 2021 in Clinical Infections Diseases.

Secnidazole also is approved for treatment of trichomoniasis in men, based on data from four open-label studies, one with men only and three including both men and women, according to the statement.

Full prescribing information for secnidazole is available here.

The Food and Drug Administration has expanded the approval of secnidazole to include treatment of trichomoniasis in adults, according to a statement from manufacturer Lupin Pharmaceuticals.

Trichomoniasis vaginalis is a common, nonviral, curable sexually transmitted disease that affects approximately 3 million to 5 million adults in the United States each year; the infection can linger for months or years if left untreated, and may have a negative impact on reproductive health. The drug was approved for the treatment of bacterial vaginosis in 2017.

The availability of a single-dose oral treatment for both trichomoniasis and bacterial vaginosis may help improve adherence and reduce risk factors associated with these conditions, including pelvic inflammatory disease and other sexually transmitted infections, according to the statement.

The approval for the new indication was based primarily on data from a phase 3 clinical trial in which women with a confirmed trichomoniasis diagnosis were randomized to a single dose of 2 g oral secnidazole or a placebo. Secnidazole showed a 92.2% cure rate for patients with trichomoniasis, compared with placebo, based on cultures collected 6-12 days after dosing. Cure rates in subsets of patients with HIV and bacterial vaginosis were 100% and 95%, respectively.

The most common treatment-related adverse events were vulvovaginal candidiasis and nausea, each reported in 2.7% of study participants. The study findings were published in March 2021 in Clinical Infections Diseases.

Secnidazole also is approved for treatment of trichomoniasis in men, based on data from four open-label studies, one with men only and three including both men and women, according to the statement.

Full prescribing information for secnidazole is available here.

A 1-week course of doxycycline is more effective than single-dose azithromycin to treat rectal chlamydia in men who have sex with men (MSM), according to newly published results in the New England Journal of Medicine.

Chlamydia is the most commonly reported bacterial STI in the United States, with 4 million cases reported in 2018, and 127 million globally. Most infections are asymptomatic.

Rates of rectal chlamydia among MSM screened for infection range from 3% to 10.5%.

The most recent Centers for Disease Control and Prevention chlamydia guidelines recommend either a single dose of azithromycin (1 g) or doxycycline 100 mg twice daily for 7 days. These 2015 guidelines were based on a meta-analysis of urogenital chlamydia infections, which showed comparable efficacy of 97% or 98%, respectively.

Study coauthor Jane S. Hocking, PhD, head of the sexual health unit at the University of Melbourne, told this news organization that “observational studies had suggested that azithromycin was about 20% less effective than doxycycline,” prompting this clinical trial.

The study, conducted at five sexual health clinics in Australia, was a double-blind, randomized, controlled trial of doxycycline (100 mg twice daily for 7 days) or azithromycin (1-g single dose).

Because 85% of infected men are asymptomatic, the study’s primary outcome was a negative nucleic acid amplification test at 4 weeks, confirming a microbiologic cure.

Using a modified intention-to-treat population, the study showed a microbiologic cure in 281 of 290 men (96.9%) in the doxycycline group and 227 of 297 (76.4%) in the azithromycin group (P < .001).

Adverse events were more common in the azithromycin group. Nausea, diarrhea, and vomiting occurred in 134 (45.1%) men in that group versus 98 men (33.8%) in those receiving doxycycline (P = .006).

A similar study was reported in Clinical Infectious Diseases in February 2021 by Dombrowski and colleagues. It was also randomized, double blinded, and placebo controlled but was smaller and conducted in Seattle and Boston. A 20% difference was found, with 80/88 (91%) in the doxycycline group and 63/89 (71%) in the azithromycin group having a microbiologic cure at 4 weeks of follow-up.

Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that the researchers focused solely on asymptomatic proctitis because “other symptoms might indicate need for broader presumptive antibiotics” for coinfections. Similarly, symptomatic proctitis “could indicate LGV [lymphogranuloma venereum] chlamydia, which ... automatically mandates that 3-weeks of doxycycline be used.” Dr. Marrazzo concluded: “The fact that this was a blinded study obviously strengthens the conclusions/findings, which is great. It’s very reassuring that results overall are so consistent with the CID paper.” Dr. Marrazzo was not involved in either the New England Journal of Medicine investigation or CID study.

Ina Park, MD, associate professor in the department of family and community medicine at the University of California, San Francisco, and author of “Strange Bedfellows: Adventures in the Science, History, and Surprising Secrets of STDs,” (New York: Flatiron Books, 2021) was not involved in either study but has a long history of working with adolescents in clinics for STDs. Based on that experience, she told this news organization that, while doxycycline now clearly appears to be the drug of choice, “if compliance is an issue and rectal chlamydia is not likely, then I think azithromycin is still something we need to consider, particularly for younger patients, and folks for whom compliance is going to be an issue.” She added: “with adolescent patients, there are issues of parents possibly discovering the antibiotic and asking lots of questions. So, it’s very nice for folks to be able to get therapy, sort of a one and done approach in the clinic.”

The 2020 CDC Guidelines for Gonococcal Infections says: “CDC recommends a single 500 mg intramuscular dose of ceftriaxone for uncomplicated gonorrhea. Treatment for coinfection with Chlamydia trachomatis with oral doxycycline (100 mg twice daily for 7 days) should be administered when chlamydial infection has not been excluded.”

Hocking concluded – and Dr. Marrazzo and Dr. Park concur – that this study “provides conclusive evidence that doxycycline should be the first-line treatment for rectal chlamydia, but probably for just any chlamydia infection,” with specific exceptions.

The University of Melbourne researchers also noted that the doxycycline course requires more compliant patients, as adherence isn’t assured. The issue of compliance and need for directly observed therapy, allergy to doxycycline, and pregnancy (where doxycycline is contraindicated) will remain the primary indications for continued use of azithromycin.

A version of this article first appeared on Medscape.com.

A 1-week course of doxycycline is more effective than single-dose azithromycin to treat rectal chlamydia in men who have sex with men (MSM), according to newly published results in the New England Journal of Medicine.

Chlamydia is the most commonly reported bacterial STI in the United States, with 4 million cases reported in 2018, and 127 million globally. Most infections are asymptomatic.

Rates of rectal chlamydia among MSM screened for infection range from 3% to 10.5%.

The most recent Centers for Disease Control and Prevention chlamydia guidelines recommend either a single dose of azithromycin (1 g) or doxycycline 100 mg twice daily for 7 days. These 2015 guidelines were based on a meta-analysis of urogenital chlamydia infections, which showed comparable efficacy of 97% or 98%, respectively.

Study coauthor Jane S. Hocking, PhD, head of the sexual health unit at the University of Melbourne, told this news organization that “observational studies had suggested that azithromycin was about 20% less effective than doxycycline,” prompting this clinical trial.

The study, conducted at five sexual health clinics in Australia, was a double-blind, randomized, controlled trial of doxycycline (100 mg twice daily for 7 days) or azithromycin (1-g single dose).

Because 85% of infected men are asymptomatic, the study’s primary outcome was a negative nucleic acid amplification test at 4 weeks, confirming a microbiologic cure.

Using a modified intention-to-treat population, the study showed a microbiologic cure in 281 of 290 men (96.9%) in the doxycycline group and 227 of 297 (76.4%) in the azithromycin group (P < .001).

Adverse events were more common in the azithromycin group. Nausea, diarrhea, and vomiting occurred in 134 (45.1%) men in that group versus 98 men (33.8%) in those receiving doxycycline (P = .006).

A similar study was reported in Clinical Infectious Diseases in February 2021 by Dombrowski and colleagues. It was also randomized, double blinded, and placebo controlled but was smaller and conducted in Seattle and Boston. A 20% difference was found, with 80/88 (91%) in the doxycycline group and 63/89 (71%) in the azithromycin group having a microbiologic cure at 4 weeks of follow-up.

Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that the researchers focused solely on asymptomatic proctitis because “other symptoms might indicate need for broader presumptive antibiotics” for coinfections. Similarly, symptomatic proctitis “could indicate LGV [lymphogranuloma venereum] chlamydia, which ... automatically mandates that 3-weeks of doxycycline be used.” Dr. Marrazzo concluded: “The fact that this was a blinded study obviously strengthens the conclusions/findings, which is great. It’s very reassuring that results overall are so consistent with the CID paper.” Dr. Marrazzo was not involved in either the New England Journal of Medicine investigation or CID study.

Ina Park, MD, associate professor in the department of family and community medicine at the University of California, San Francisco, and author of “Strange Bedfellows: Adventures in the Science, History, and Surprising Secrets of STDs,” (New York: Flatiron Books, 2021) was not involved in either study but has a long history of working with adolescents in clinics for STDs. Based on that experience, she told this news organization that, while doxycycline now clearly appears to be the drug of choice, “if compliance is an issue and rectal chlamydia is not likely, then I think azithromycin is still something we need to consider, particularly for younger patients, and folks for whom compliance is going to be an issue.” She added: “with adolescent patients, there are issues of parents possibly discovering the antibiotic and asking lots of questions. So, it’s very nice for folks to be able to get therapy, sort of a one and done approach in the clinic.”

The 2020 CDC Guidelines for Gonococcal Infections says: “CDC recommends a single 500 mg intramuscular dose of ceftriaxone for uncomplicated gonorrhea. Treatment for coinfection with Chlamydia trachomatis with oral doxycycline (100 mg twice daily for 7 days) should be administered when chlamydial infection has not been excluded.”

Hocking concluded – and Dr. Marrazzo and Dr. Park concur – that this study “provides conclusive evidence that doxycycline should be the first-line treatment for rectal chlamydia, but probably for just any chlamydia infection,” with specific exceptions.

The University of Melbourne researchers also noted that the doxycycline course requires more compliant patients, as adherence isn’t assured. The issue of compliance and need for directly observed therapy, allergy to doxycycline, and pregnancy (where doxycycline is contraindicated) will remain the primary indications for continued use of azithromycin.

A version of this article first appeared on Medscape.com.

A 1-week course of doxycycline is more effective than single-dose azithromycin to treat rectal chlamydia in men who have sex with men (MSM), according to newly published results in the New England Journal of Medicine.

Chlamydia is the most commonly reported bacterial STI in the United States, with 4 million cases reported in 2018, and 127 million globally. Most infections are asymptomatic.

Rates of rectal chlamydia among MSM screened for infection range from 3% to 10.5%.

The most recent Centers for Disease Control and Prevention chlamydia guidelines recommend either a single dose of azithromycin (1 g) or doxycycline 100 mg twice daily for 7 days. These 2015 guidelines were based on a meta-analysis of urogenital chlamydia infections, which showed comparable efficacy of 97% or 98%, respectively.

Study coauthor Jane S. Hocking, PhD, head of the sexual health unit at the University of Melbourne, told this news organization that “observational studies had suggested that azithromycin was about 20% less effective than doxycycline,” prompting this clinical trial.

The study, conducted at five sexual health clinics in Australia, was a double-blind, randomized, controlled trial of doxycycline (100 mg twice daily for 7 days) or azithromycin (1-g single dose).

Because 85% of infected men are asymptomatic, the study’s primary outcome was a negative nucleic acid amplification test at 4 weeks, confirming a microbiologic cure.

Using a modified intention-to-treat population, the study showed a microbiologic cure in 281 of 290 men (96.9%) in the doxycycline group and 227 of 297 (76.4%) in the azithromycin group (P < .001).

Adverse events were more common in the azithromycin group. Nausea, diarrhea, and vomiting occurred in 134 (45.1%) men in that group versus 98 men (33.8%) in those receiving doxycycline (P = .006).

A similar study was reported in Clinical Infectious Diseases in February 2021 by Dombrowski and colleagues. It was also randomized, double blinded, and placebo controlled but was smaller and conducted in Seattle and Boston. A 20% difference was found, with 80/88 (91%) in the doxycycline group and 63/89 (71%) in the azithromycin group having a microbiologic cure at 4 weeks of follow-up.

Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that the researchers focused solely on asymptomatic proctitis because “other symptoms might indicate need for broader presumptive antibiotics” for coinfections. Similarly, symptomatic proctitis “could indicate LGV [lymphogranuloma venereum] chlamydia, which ... automatically mandates that 3-weeks of doxycycline be used.” Dr. Marrazzo concluded: “The fact that this was a blinded study obviously strengthens the conclusions/findings, which is great. It’s very reassuring that results overall are so consistent with the CID paper.” Dr. Marrazzo was not involved in either the New England Journal of Medicine investigation or CID study.

Ina Park, MD, associate professor in the department of family and community medicine at the University of California, San Francisco, and author of “Strange Bedfellows: Adventures in the Science, History, and Surprising Secrets of STDs,” (New York: Flatiron Books, 2021) was not involved in either study but has a long history of working with adolescents in clinics for STDs. Based on that experience, she told this news organization that, while doxycycline now clearly appears to be the drug of choice, “if compliance is an issue and rectal chlamydia is not likely, then I think azithromycin is still something we need to consider, particularly for younger patients, and folks for whom compliance is going to be an issue.” She added: “with adolescent patients, there are issues of parents possibly discovering the antibiotic and asking lots of questions. So, it’s very nice for folks to be able to get therapy, sort of a one and done approach in the clinic.”

The 2020 CDC Guidelines for Gonococcal Infections says: “CDC recommends a single 500 mg intramuscular dose of ceftriaxone for uncomplicated gonorrhea. Treatment for coinfection with Chlamydia trachomatis with oral doxycycline (100 mg twice daily for 7 days) should be administered when chlamydial infection has not been excluded.”

Hocking concluded – and Dr. Marrazzo and Dr. Park concur – that this study “provides conclusive evidence that doxycycline should be the first-line treatment for rectal chlamydia, but probably for just any chlamydia infection,” with specific exceptions.

The University of Melbourne researchers also noted that the doxycycline course requires more compliant patients, as adherence isn’t assured. The issue of compliance and need for directly observed therapy, allergy to doxycycline, and pregnancy (where doxycycline is contraindicated) will remain the primary indications for continued use of azithromycin.

A version of this article first appeared on Medscape.com.

Primary care for LGBTQ+ patients should focus on early identification and management of unique health risks, according to a leading expert.

Patients who are transgender, for instance, are nine times more likely to commit suicide than the general population (2015 U.S. Transgender Survey (USTS). Inter-university Consortium for Political and Social Research. 2019 May 22. doi: 10.3886/ICPSR37229.v1), and those who are also Black have an estimated HIV prevalence of 62%, demonstrating the cumulative, negative health effects of intersectionality (www.cdc.gov/hiv/group/gender/transgender/hiv-prevalence.html).

“Experiences with marginalization and stigma directly relate to some of the poor physical and mental health outcomes that these patients experience,” Megan McNamara, MD, said during a presentation at the American College of Physicians annual Internal Medicine meeting.

Dr. McNamara, who is director of the Gender Identity Veteran’s Experience (GIVE) Clinic, Veterans Affairs Northeast Ohio Healthcare System, Cleveland, offered a brief guide to managing LGBTQ+ patients. She emphasized increased rates of psychological distress and substance abuse, and encouraged familiarity with specific risks associated with three subgroups: men who have sex with men (MSM), women who have sex with women (WSW), and those who are transgender.

Men who have sex with men

According to Dr. McNamara, preexposure prophylaxis (PrEP) should be offered based on Centers for Disease Control and Prevention eligibility criteria, which require that the patient is HIV negative, has had a male sex partner in the past 6 months, is not in a monogamous relationship, and has had anal sex or a bacterial sexually transmitted infection in the past 6 months. The two PrEP options, emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide, are equally effective and have similar safety profiles, Dr. McNamara said, but patients with impaired renal function should receive the alafenamide formulation.

Dr. McNamara also advised screening gay men for extragenital STIs, noting a 13.3% increased risk. When asked about anal Pap testing for HPV, Dr. McNamara called the subject “very controversial,” and ultimately recommended against it, citing a lack of data linking anal HPV infection and dysplasia with later development of rectal carcinoma, as well as the nonactionable impact of a positive result.

“For me, the issue is ... if [a positive anal Pap test] is not going to change my management, if I don’t know that the anal HPV that I diagnose will result in cancer, should I continue to monitor it?” Dr. McNamara said.

Women who have sex with women

Beyond higher rates of psychological distress and substance abuse among lesbian and bisexual women, Dr. McNamara described increased risks of overweight and obesity, higher rates of smoking, and lower rates of Pap testing, all of which should prompt clinicians to advise accordingly, with cervical cancer screening in alignment with guidelines. Clinicians should also discuss HPV vaccination with patients, taking care to weigh benefits and risks, as “catch-up” HPV vaccination is not unilaterally recommended for adults older than 26 years.

Transgender patients

Discussing transgender patients, Dr. McNamara focused on cross-sex hormone therapy (CSHT), first noting the significant psychological benefits, including improvements in depression, somatization, interpersonal sensitivity, hostility, anxiety, phobic anxiety/agoraphobia, and quality of life.

According to Dr. McNamara, CSHT is relatively simple and may be safely administered by primary care providers. For transmasculine patients, testosterone supplementation is all that is needed, whereas transfeminine patients will require spironolactone or GnRH agonists to reduce testosterone and estradiol to increase feminizing hormones to pubertal levels.

CSHT is not without risks, Dr. McNamara said, including “very high” risks of erythrocytosis among transmasculine patients and venous thromboembolic disease among transfeminine patients; but these risks need to be considered in the context of an approximate 40% suicide rate among transgender individuals.

“I can tell you in my own practice that these [suicide] data ring true,” Dr. McNamara said. “Many, many of my patients have attempted suicide, so [CSHT] is something that you really want to think about right away.”

Even when additional risk factors are present, such as preexisting cardiovascular disease, Dr. McNamara suggested that “there are very few absolute contraindications to CSHT,” and described it as a “life-sustaining treatment” that should be viewed analogously with any other long-term management strategy, such as therapy for diabetes or hypertension.

Fostering a transgender-friendly practice

In an interview, Nicole Nisly, MD, codirector of the LGBTQ+ Clinic at the University of Iowa Hospitals and Clinics, Iowa City, reflected upon Dr. McNamara’s presentation, noting that primary care providers – with a little education – are the best candidates to care for transgender patients.

“I think [primary care providers] do a better job [caring for transgender patients] than endocrinologists, honestly, because they can provide care for the whole person,” Dr. Nisly said. “They can do a Pap, they can do STI screening, they can assess mood, they can [evaluate] safety, and the whole person, as opposed to endocrinologists, who do hormone therapy, but somebody else does everything else.”

Dr. Nisly emphasized the importance of personalizing care for transgender individuals, which depends upon a welcoming practice environment, with careful attention to language.

Foremost, Dr. Nisly recommended asking patients for their preferred name, sexual orientation, and gender identity.

“One of the most difficult things [for transgender patients] is to see notes with the wrong name – the name that makes them feel uncomfortable – or the wrong pronoun,” Dr. Nisly said. “That’s very important to the community.”

Dr. Nisly also recommended an alternative term for cross-sex hormone therapy.

“I hate cross-sex hormone therapy terminology, honestly,” Dr. Nisly said. “I just think it’s so unwelcoming, and I think most of our patients don’t like the terminology, so we use ‘gender-affirming hormone therapy.’”

Dr. Nisly explained that the term “cross-sex” assumes a conventional definition of sex, which is inherently flawed.

When discussing certain medical risk factors, such as pregnancy or HIV, it is helpful to know “sex assigned at birth” for both patients and their sexual partners, Dr. Nisly said. It’s best to ask in this way, instead of using terms like “boyfriend” or “girlfriend,” as “sex assigned at birth” is “terminology the community recognizes, affirms, and feels comfortable with.”

Concerning management of medical risk factors, Dr. Nisly offered some additional perspectives.

For one, she recommended giving PrEP to any patient who has a desire to be on PrEP, noting that this desire can indicate a change in future sexual practices, which the CDC criteria do not anticipate. She also advised in-hospital self-swabbing for extragenital STIs, as this can increase patient comfort and adherence. And, in contrast with Dr. McNamara, Dr. Nisly recommended anal Pap screening for any man that has sex with men and anyone with HIV of any gender. She noted that rates of anal dysplasia are “pretty high” among men who have sex with men, and that detection may reduce cancer risk.

For clinicians who would like to learn more about caring for transgender patients, Dr. Nisly recommended that they start by reading the World Professional Association for Transgender Health guidelines.

“It’s about 300 pages,” Dr. Nisly said, “but it is great.”

Dr. McNamara and Dr. Nisly reported no conflicts of interest.

Primary care for LGBTQ+ patients should focus on early identification and management of unique health risks, according to a leading expert.

Patients who are transgender, for instance, are nine times more likely to commit suicide than the general population (2015 U.S. Transgender Survey (USTS). Inter-university Consortium for Political and Social Research. 2019 May 22. doi: 10.3886/ICPSR37229.v1), and those who are also Black have an estimated HIV prevalence of 62%, demonstrating the cumulative, negative health effects of intersectionality (www.cdc.gov/hiv/group/gender/transgender/hiv-prevalence.html).

“Experiences with marginalization and stigma directly relate to some of the poor physical and mental health outcomes that these patients experience,” Megan McNamara, MD, said during a presentation at the American College of Physicians annual Internal Medicine meeting.

Dr. McNamara, who is director of the Gender Identity Veteran’s Experience (GIVE) Clinic, Veterans Affairs Northeast Ohio Healthcare System, Cleveland, offered a brief guide to managing LGBTQ+ patients. She emphasized increased rates of psychological distress and substance abuse, and encouraged familiarity with specific risks associated with three subgroups: men who have sex with men (MSM), women who have sex with women (WSW), and those who are transgender.

Men who have sex with men

According to Dr. McNamara, preexposure prophylaxis (PrEP) should be offered based on Centers for Disease Control and Prevention eligibility criteria, which require that the patient is HIV negative, has had a male sex partner in the past 6 months, is not in a monogamous relationship, and has had anal sex or a bacterial sexually transmitted infection in the past 6 months. The two PrEP options, emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide, are equally effective and have similar safety profiles, Dr. McNamara said, but patients with impaired renal function should receive the alafenamide formulation.

Dr. McNamara also advised screening gay men for extragenital STIs, noting a 13.3% increased risk. When asked about anal Pap testing for HPV, Dr. McNamara called the subject “very controversial,” and ultimately recommended against it, citing a lack of data linking anal HPV infection and dysplasia with later development of rectal carcinoma, as well as the nonactionable impact of a positive result.

“For me, the issue is ... if [a positive anal Pap test] is not going to change my management, if I don’t know that the anal HPV that I diagnose will result in cancer, should I continue to monitor it?” Dr. McNamara said.

Women who have sex with women

Beyond higher rates of psychological distress and substance abuse among lesbian and bisexual women, Dr. McNamara described increased risks of overweight and obesity, higher rates of smoking, and lower rates of Pap testing, all of which should prompt clinicians to advise accordingly, with cervical cancer screening in alignment with guidelines. Clinicians should also discuss HPV vaccination with patients, taking care to weigh benefits and risks, as “catch-up” HPV vaccination is not unilaterally recommended for adults older than 26 years.

Transgender patients

Discussing transgender patients, Dr. McNamara focused on cross-sex hormone therapy (CSHT), first noting the significant psychological benefits, including improvements in depression, somatization, interpersonal sensitivity, hostility, anxiety, phobic anxiety/agoraphobia, and quality of life.

According to Dr. McNamara, CSHT is relatively simple and may be safely administered by primary care providers. For transmasculine patients, testosterone supplementation is all that is needed, whereas transfeminine patients will require spironolactone or GnRH agonists to reduce testosterone and estradiol to increase feminizing hormones to pubertal levels.

CSHT is not without risks, Dr. McNamara said, including “very high” risks of erythrocytosis among transmasculine patients and venous thromboembolic disease among transfeminine patients; but these risks need to be considered in the context of an approximate 40% suicide rate among transgender individuals.

“I can tell you in my own practice that these [suicide] data ring true,” Dr. McNamara said. “Many, many of my patients have attempted suicide, so [CSHT] is something that you really want to think about right away.”

Even when additional risk factors are present, such as preexisting cardiovascular disease, Dr. McNamara suggested that “there are very few absolute contraindications to CSHT,” and described it as a “life-sustaining treatment” that should be viewed analogously with any other long-term management strategy, such as therapy for diabetes or hypertension.

Fostering a transgender-friendly practice

In an interview, Nicole Nisly, MD, codirector of the LGBTQ+ Clinic at the University of Iowa Hospitals and Clinics, Iowa City, reflected upon Dr. McNamara’s presentation, noting that primary care providers – with a little education – are the best candidates to care for transgender patients.

“I think [primary care providers] do a better job [caring for transgender patients] than endocrinologists, honestly, because they can provide care for the whole person,” Dr. Nisly said. “They can do a Pap, they can do STI screening, they can assess mood, they can [evaluate] safety, and the whole person, as opposed to endocrinologists, who do hormone therapy, but somebody else does everything else.”

Dr. Nisly emphasized the importance of personalizing care for transgender individuals, which depends upon a welcoming practice environment, with careful attention to language.

Foremost, Dr. Nisly recommended asking patients for their preferred name, sexual orientation, and gender identity.

“One of the most difficult things [for transgender patients] is to see notes with the wrong name – the name that makes them feel uncomfortable – or the wrong pronoun,” Dr. Nisly said. “That’s very important to the community.”

Dr. Nisly also recommended an alternative term for cross-sex hormone therapy.

“I hate cross-sex hormone therapy terminology, honestly,” Dr. Nisly said. “I just think it’s so unwelcoming, and I think most of our patients don’t like the terminology, so we use ‘gender-affirming hormone therapy.’”

Dr. Nisly explained that the term “cross-sex” assumes a conventional definition of sex, which is inherently flawed.

When discussing certain medical risk factors, such as pregnancy or HIV, it is helpful to know “sex assigned at birth” for both patients and their sexual partners, Dr. Nisly said. It’s best to ask in this way, instead of using terms like “boyfriend” or “girlfriend,” as “sex assigned at birth” is “terminology the community recognizes, affirms, and feels comfortable with.”

Concerning management of medical risk factors, Dr. Nisly offered some additional perspectives.

For one, she recommended giving PrEP to any patient who has a desire to be on PrEP, noting that this desire can indicate a change in future sexual practices, which the CDC criteria do not anticipate. She also advised in-hospital self-swabbing for extragenital STIs, as this can increase patient comfort and adherence. And, in contrast with Dr. McNamara, Dr. Nisly recommended anal Pap screening for any man that has sex with men and anyone with HIV of any gender. She noted that rates of anal dysplasia are “pretty high” among men who have sex with men, and that detection may reduce cancer risk.

For clinicians who would like to learn more about caring for transgender patients, Dr. Nisly recommended that they start by reading the World Professional Association for Transgender Health guidelines.

“It’s about 300 pages,” Dr. Nisly said, “but it is great.”

Dr. McNamara and Dr. Nisly reported no conflicts of interest.

Primary care for LGBTQ+ patients should focus on early identification and management of unique health risks, according to a leading expert.

Patients who are transgender, for instance, are nine times more likely to commit suicide than the general population (2015 U.S. Transgender Survey (USTS). Inter-university Consortium for Political and Social Research. 2019 May 22. doi: 10.3886/ICPSR37229.v1), and those who are also Black have an estimated HIV prevalence of 62%, demonstrating the cumulative, negative health effects of intersectionality (www.cdc.gov/hiv/group/gender/transgender/hiv-prevalence.html).

“Experiences with marginalization and stigma directly relate to some of the poor physical and mental health outcomes that these patients experience,” Megan McNamara, MD, said during a presentation at the American College of Physicians annual Internal Medicine meeting.

Dr. McNamara, who is director of the Gender Identity Veteran’s Experience (GIVE) Clinic, Veterans Affairs Northeast Ohio Healthcare System, Cleveland, offered a brief guide to managing LGBTQ+ patients. She emphasized increased rates of psychological distress and substance abuse, and encouraged familiarity with specific risks associated with three subgroups: men who have sex with men (MSM), women who have sex with women (WSW), and those who are transgender.

Men who have sex with men

According to Dr. McNamara, preexposure prophylaxis (PrEP) should be offered based on Centers for Disease Control and Prevention eligibility criteria, which require that the patient is HIV negative, has had a male sex partner in the past 6 months, is not in a monogamous relationship, and has had anal sex or a bacterial sexually transmitted infection in the past 6 months. The two PrEP options, emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide, are equally effective and have similar safety profiles, Dr. McNamara said, but patients with impaired renal function should receive the alafenamide formulation.

Dr. McNamara also advised screening gay men for extragenital STIs, noting a 13.3% increased risk. When asked about anal Pap testing for HPV, Dr. McNamara called the subject “very controversial,” and ultimately recommended against it, citing a lack of data linking anal HPV infection and dysplasia with later development of rectal carcinoma, as well as the nonactionable impact of a positive result.

“For me, the issue is ... if [a positive anal Pap test] is not going to change my management, if I don’t know that the anal HPV that I diagnose will result in cancer, should I continue to monitor it?” Dr. McNamara said.

Women who have sex with women

Beyond higher rates of psychological distress and substance abuse among lesbian and bisexual women, Dr. McNamara described increased risks of overweight and obesity, higher rates of smoking, and lower rates of Pap testing, all of which should prompt clinicians to advise accordingly, with cervical cancer screening in alignment with guidelines. Clinicians should also discuss HPV vaccination with patients, taking care to weigh benefits and risks, as “catch-up” HPV vaccination is not unilaterally recommended for adults older than 26 years.

Transgender patients

Discussing transgender patients, Dr. McNamara focused on cross-sex hormone therapy (CSHT), first noting the significant psychological benefits, including improvements in depression, somatization, interpersonal sensitivity, hostility, anxiety, phobic anxiety/agoraphobia, and quality of life.

According to Dr. McNamara, CSHT is relatively simple and may be safely administered by primary care providers. For transmasculine patients, testosterone supplementation is all that is needed, whereas transfeminine patients will require spironolactone or GnRH agonists to reduce testosterone and estradiol to increase feminizing hormones to pubertal levels.

CSHT is not without risks, Dr. McNamara said, including “very high” risks of erythrocytosis among transmasculine patients and venous thromboembolic disease among transfeminine patients; but these risks need to be considered in the context of an approximate 40% suicide rate among transgender individuals.

“I can tell you in my own practice that these [suicide] data ring true,” Dr. McNamara said. “Many, many of my patients have attempted suicide, so [CSHT] is something that you really want to think about right away.”

Even when additional risk factors are present, such as preexisting cardiovascular disease, Dr. McNamara suggested that “there are very few absolute contraindications to CSHT,” and described it as a “life-sustaining treatment” that should be viewed analogously with any other long-term management strategy, such as therapy for diabetes or hypertension.

Fostering a transgender-friendly practice

In an interview, Nicole Nisly, MD, codirector of the LGBTQ+ Clinic at the University of Iowa Hospitals and Clinics, Iowa City, reflected upon Dr. McNamara’s presentation, noting that primary care providers – with a little education – are the best candidates to care for transgender patients.

“I think [primary care providers] do a better job [caring for transgender patients] than endocrinologists, honestly, because they can provide care for the whole person,” Dr. Nisly said. “They can do a Pap, they can do STI screening, they can assess mood, they can [evaluate] safety, and the whole person, as opposed to endocrinologists, who do hormone therapy, but somebody else does everything else.”

Dr. Nisly emphasized the importance of personalizing care for transgender individuals, which depends upon a welcoming practice environment, with careful attention to language.

Foremost, Dr. Nisly recommended asking patients for their preferred name, sexual orientation, and gender identity.

“One of the most difficult things [for transgender patients] is to see notes with the wrong name – the name that makes them feel uncomfortable – or the wrong pronoun,” Dr. Nisly said. “That’s very important to the community.”

Dr. Nisly also recommended an alternative term for cross-sex hormone therapy.

“I hate cross-sex hormone therapy terminology, honestly,” Dr. Nisly said. “I just think it’s so unwelcoming, and I think most of our patients don’t like the terminology, so we use ‘gender-affirming hormone therapy.’”

Dr. Nisly explained that the term “cross-sex” assumes a conventional definition of sex, which is inherently flawed.

When discussing certain medical risk factors, such as pregnancy or HIV, it is helpful to know “sex assigned at birth” for both patients and their sexual partners, Dr. Nisly said. It’s best to ask in this way, instead of using terms like “boyfriend” or “girlfriend,” as “sex assigned at birth” is “terminology the community recognizes, affirms, and feels comfortable with.”

Concerning management of medical risk factors, Dr. Nisly offered some additional perspectives.

For one, she recommended giving PrEP to any patient who has a desire to be on PrEP, noting that this desire can indicate a change in future sexual practices, which the CDC criteria do not anticipate. She also advised in-hospital self-swabbing for extragenital STIs, as this can increase patient comfort and adherence. And, in contrast with Dr. McNamara, Dr. Nisly recommended anal Pap screening for any man that has sex with men and anyone with HIV of any gender. She noted that rates of anal dysplasia are “pretty high” among men who have sex with men, and that detection may reduce cancer risk.

For clinicians who would like to learn more about caring for transgender patients, Dr. Nisly recommended that they start by reading the World Professional Association for Transgender Health guidelines.

“It’s about 300 pages,” Dr. Nisly said, “but it is great.”

Dr. McNamara and Dr. Nisly reported no conflicts of interest.