STIs

Vaginal swabs are more effective than urine analysis in detecting certain types of sexually transmitted infections, researchers have found.

In the study, which was published online in the Annals of Family Medicine, investigators found that the diagnostic sensitivity of commercially available vaginal swabs was significantly greater than that of urine tests in detecting certain infections, including those caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Researchers studied chlamydia and gonorrhea, which are two of the most frequently reported STIs in the United States. Trichomoniasis is the most curable nonviral STI globally, with 156 million cases worldwide in 2016.

The Centers for Disease Control and Prevention has long recommended that vaginal swabs be used to produce optimal samples.

But despite the CDC’s recommendation, urine analysis for these STIs is more commonly used than vaginal swabs among U.S. health care providers.

“We’re using a poor sample type, and we can do better,” said Barbara Van Der Pol, PhD, a professor of medicine and public health at the University of Alabama at Birmingham and an author of the new study, a meta-analysis of 97 studies published between 1995 and 2021.

Vaginal swabs for chlamydia trachomatis had a diagnostic sensitivity of 94.1% (95% confidence interval, 93.2%-94.9%; P < .001), higher than urine testing (86.9%; 95% CI, 85.6%-88.0%; P < .001). The pooled sensitivity estimates for Neisseria gonorrhoeae were 96.5% (95% CI, 94.8%-97.7%; P < .001) for vaginal swabs and 90.7% (95% CI, 88.4%-92.5%; P < .001) for urine specimens.

The difference in pooled sensitivity estimates between vaginal swabs and urine analyses for Trichomonas vaginalis was 98% (95% CI, 97.0%-98.7%; P < .001) for vaginal swabs and 95.1% (95% CI, 93.6%-96.3%) for urine specimens.

STIs included in the study are not typically found in the urethra and appear in urine analyses only if cervical or vaginal cells have dripped into a urine sample. Dr. Van Der Pol and her colleagues estimated that the use of urine samples rather than vaginal swabs may result in more than 400,000 undiagnosed infections annually.

Undiagnosed and untreated STIs can lead to transmissions of the infection as well as infertility and can have negative effects on romantic relationships, according to Dr. Van Der Pol.

Sarah Wood, MD, an attending physician at Children’s Hospital of Philadelphia, said some health care providers may use urine analysis because patients may be more comfortable with this method. The approach also can be more convenient for medical offices: All they must do is hand a specimen container to the patient.

Conversations between clinicians and patients about vaginal swabbing may be considered “sensitive” and the swabbing more invasive, Dr. Wood, an author of an editorial accompanying the journal article, said. Clinicians may also lack awareness that the swab is a more sensitive method of detecting these STIs.

“We all want to do what’s right for our patient, but we often don’t know what’s right for the patient,” Dr. Wood said. “I don’t think people are really aware of a potential real difference in outcomes with one method over the other.”

Dr. Wood advised making STI screening using vaginal swabs more common by “offering universal opt-out screening, so not waiting until you find out if someone’s having sex but just sort of saying, ‘Hey, across our practice, we screen everybody for chlamydia. Is that something that you want to do today?’ That approach sort of takes out the piece of talking about sex, talking about sexual activity.”

Dr. Van Der Pol, who said she has worked in STI diagnostics for 40 years, said she was not surprised by the results and hopes the study changes how samples are collected and used.

“I really hope that it influences practice so that we really start using vaginal swabs, because it gives us better diagnostics for chlamydia and gonorrhea,” Dr. Van Der Pol said.

“Also, then starting to think about comprehensive women’s care in such a way that they actually order other tests on that same sample if a woman is presenting with complaints.”

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

Vaginal swabs are more effective than urine analysis in detecting certain types of sexually transmitted infections, researchers have found.

In the study, which was published online in the Annals of Family Medicine, investigators found that the diagnostic sensitivity of commercially available vaginal swabs was significantly greater than that of urine tests in detecting certain infections, including those caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Researchers studied chlamydia and gonorrhea, which are two of the most frequently reported STIs in the United States. Trichomoniasis is the most curable nonviral STI globally, with 156 million cases worldwide in 2016.

The Centers for Disease Control and Prevention has long recommended that vaginal swabs be used to produce optimal samples.

But despite the CDC’s recommendation, urine analysis for these STIs is more commonly used than vaginal swabs among U.S. health care providers.

“We’re using a poor sample type, and we can do better,” said Barbara Van Der Pol, PhD, a professor of medicine and public health at the University of Alabama at Birmingham and an author of the new study, a meta-analysis of 97 studies published between 1995 and 2021.

Vaginal swabs for chlamydia trachomatis had a diagnostic sensitivity of 94.1% (95% confidence interval, 93.2%-94.9%; P < .001), higher than urine testing (86.9%; 95% CI, 85.6%-88.0%; P < .001). The pooled sensitivity estimates for Neisseria gonorrhoeae were 96.5% (95% CI, 94.8%-97.7%; P < .001) for vaginal swabs and 90.7% (95% CI, 88.4%-92.5%; P < .001) for urine specimens.

The difference in pooled sensitivity estimates between vaginal swabs and urine analyses for Trichomonas vaginalis was 98% (95% CI, 97.0%-98.7%; P < .001) for vaginal swabs and 95.1% (95% CI, 93.6%-96.3%) for urine specimens.

STIs included in the study are not typically found in the urethra and appear in urine analyses only if cervical or vaginal cells have dripped into a urine sample. Dr. Van Der Pol and her colleagues estimated that the use of urine samples rather than vaginal swabs may result in more than 400,000 undiagnosed infections annually.

Undiagnosed and untreated STIs can lead to transmissions of the infection as well as infertility and can have negative effects on romantic relationships, according to Dr. Van Der Pol.

Sarah Wood, MD, an attending physician at Children’s Hospital of Philadelphia, said some health care providers may use urine analysis because patients may be more comfortable with this method. The approach also can be more convenient for medical offices: All they must do is hand a specimen container to the patient.

Conversations between clinicians and patients about vaginal swabbing may be considered “sensitive” and the swabbing more invasive, Dr. Wood, an author of an editorial accompanying the journal article, said. Clinicians may also lack awareness that the swab is a more sensitive method of detecting these STIs.

“We all want to do what’s right for our patient, but we often don’t know what’s right for the patient,” Dr. Wood said. “I don’t think people are really aware of a potential real difference in outcomes with one method over the other.”

Dr. Wood advised making STI screening using vaginal swabs more common by “offering universal opt-out screening, so not waiting until you find out if someone’s having sex but just sort of saying, ‘Hey, across our practice, we screen everybody for chlamydia. Is that something that you want to do today?’ That approach sort of takes out the piece of talking about sex, talking about sexual activity.”

Dr. Van Der Pol, who said she has worked in STI diagnostics for 40 years, said she was not surprised by the results and hopes the study changes how samples are collected and used.

“I really hope that it influences practice so that we really start using vaginal swabs, because it gives us better diagnostics for chlamydia and gonorrhea,” Dr. Van Der Pol said.

“Also, then starting to think about comprehensive women’s care in such a way that they actually order other tests on that same sample if a woman is presenting with complaints.”

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

Vaginal swabs are more effective than urine analysis in detecting certain types of sexually transmitted infections, researchers have found.

In the study, which was published online in the Annals of Family Medicine, investigators found that the diagnostic sensitivity of commercially available vaginal swabs was significantly greater than that of urine tests in detecting certain infections, including those caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Researchers studied chlamydia and gonorrhea, which are two of the most frequently reported STIs in the United States. Trichomoniasis is the most curable nonviral STI globally, with 156 million cases worldwide in 2016.

The Centers for Disease Control and Prevention has long recommended that vaginal swabs be used to produce optimal samples.

But despite the CDC’s recommendation, urine analysis for these STIs is more commonly used than vaginal swabs among U.S. health care providers.

“We’re using a poor sample type, and we can do better,” said Barbara Van Der Pol, PhD, a professor of medicine and public health at the University of Alabama at Birmingham and an author of the new study, a meta-analysis of 97 studies published between 1995 and 2021.

Vaginal swabs for chlamydia trachomatis had a diagnostic sensitivity of 94.1% (95% confidence interval, 93.2%-94.9%; P < .001), higher than urine testing (86.9%; 95% CI, 85.6%-88.0%; P < .001). The pooled sensitivity estimates for Neisseria gonorrhoeae were 96.5% (95% CI, 94.8%-97.7%; P < .001) for vaginal swabs and 90.7% (95% CI, 88.4%-92.5%; P < .001) for urine specimens.

The difference in pooled sensitivity estimates between vaginal swabs and urine analyses for Trichomonas vaginalis was 98% (95% CI, 97.0%-98.7%; P < .001) for vaginal swabs and 95.1% (95% CI, 93.6%-96.3%) for urine specimens.

STIs included in the study are not typically found in the urethra and appear in urine analyses only if cervical or vaginal cells have dripped into a urine sample. Dr. Van Der Pol and her colleagues estimated that the use of urine samples rather than vaginal swabs may result in more than 400,000 undiagnosed infections annually.

Undiagnosed and untreated STIs can lead to transmissions of the infection as well as infertility and can have negative effects on romantic relationships, according to Dr. Van Der Pol.

Sarah Wood, MD, an attending physician at Children’s Hospital of Philadelphia, said some health care providers may use urine analysis because patients may be more comfortable with this method. The approach also can be more convenient for medical offices: All they must do is hand a specimen container to the patient.

Conversations between clinicians and patients about vaginal swabbing may be considered “sensitive” and the swabbing more invasive, Dr. Wood, an author of an editorial accompanying the journal article, said. Clinicians may also lack awareness that the swab is a more sensitive method of detecting these STIs.

“We all want to do what’s right for our patient, but we often don’t know what’s right for the patient,” Dr. Wood said. “I don’t think people are really aware of a potential real difference in outcomes with one method over the other.”

Dr. Wood advised making STI screening using vaginal swabs more common by “offering universal opt-out screening, so not waiting until you find out if someone’s having sex but just sort of saying, ‘Hey, across our practice, we screen everybody for chlamydia. Is that something that you want to do today?’ That approach sort of takes out the piece of talking about sex, talking about sexual activity.”

Dr. Van Der Pol, who said she has worked in STI diagnostics for 40 years, said she was not surprised by the results and hopes the study changes how samples are collected and used.

“I really hope that it influences practice so that we really start using vaginal swabs, because it gives us better diagnostics for chlamydia and gonorrhea,” Dr. Van Der Pol said.

“Also, then starting to think about comprehensive women’s care in such a way that they actually order other tests on that same sample if a woman is presenting with complaints.”

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

The benefits of doxycycline postexposure prophylaxis (Doxy PEP) in preventing the transmission of sexually transmitted infections (STIs) in men and transgender women do not appear to extend to cisgender women, who have disproportionately high rates of infection in many regions.

“This was the first trial to evaluate doxycycline PEP for cisgender women,” said first author Jenell Stewart, DO, of the University of Minnesota, Minneapolis, in discussing the findings at a press conference at the Conference on Retroviruses & Opportunistic Infections.

“Unfortunately, our primary outcome was not statistically significant – we did not see a reduction in STIs among cisgender women, which is in stark contrast to [reported effects] among cisgender men and transgender women,” she said.

The findings are from a study of 449 nonpregnant cisgender women (mean age, 24 years) in Kenya who had been taking daily oral HIV preexposure prophylaxis (PrEP) for a median of about 7 months.

The women were randomly assigned to receive either Doxy PEP 200 mg, to be taken within 72 hours of sex (n = 224), or standard care, which included quarterly screening and treatment of STIs (n = 225).

Of the women, 36.7% reported transactional sex at enrollment; their baseline prevalence of STIs was 17.9%, including 14.1% with chlamydia, 3.8% gonorrhea, and 0.4% syphilis. There were no differences between the study groups.

In surveys, 78% of the women reported adherence to the use of Doxy PEP; they took the prophylaxis at least as many days as they had sex.

Nevertheless, there was no significant difference in the incidence of STIs, reported over 1 year, at quarterly visits that included genital STI testing, between groups, with 50 patients in the Doxy PEP group and 59 in the standard screening group developing STIs (relative risk, 0.88; P = .51).

Of the infections, 85 were chlamydia, including 35 in the Doxy PEP group and 50 with standard of care, while 31 were gonorrhea, including 19 in the Doxy PEP group and 12 with standard of care; 8 had both infections, and there was 1 syphilis infection.

The results were consistent across subanalyses of patients grouped according to STI, who became pregnant (n = 80), or sorted by other factors including age, contraceptive use, transactional sex, and STI at baseline.

None of the women developed HIV, and there were no serious events associated with the Doxy PEP treatment.
 

Cisgender women bear ‘highest burden’ of STIs

The findings are disappointing in light of the higher rates of STIs among cisgender women, with the Centers for Disease Control and Prevention reporting that women also disproportionately bear the long-term consequences of STIs.

“For example, each year, untreated sexually transmitted diseases cause infertility in at least 20,000 women in the United States, and a pregnant woman is highly likely to pass syphilis unto her unborn baby if left untested or untreated,” the CDC reports.

The STI rates are particularly high for women taking HIV PrEP in regions like East Africa, where rates of STIs among cisgender women in many cases are higher than rates for men taking PrEP in high income countries, Dr. Stewart said.

Previous studies of Doxy PEP in men and transgender women taking HIV PrEP, including new research presented at CROI, have shown highly encouraging reductions in STIs, at rates of up to approximately 80% for chlamydia and syphilis.
 

Adherence, anatomy, resistance

The key theories for the lack of a prevention of infections in cisgender women surround the issues of resistances, as well as anatomy and adherence, said Dr. Stewart.

In terms of bacterial resistances, while initial testing in a limited number of samples the study found no evidence of markers of resistance for chlamydia, all of the gonorrhea samples did show tetracycline-resistant N gonorrhea at baseline and follow-up in both groups.

Regarding anatomic differences, doxycycline may not prevent STIs in endocervical tissue among cisgender women, Dr. Stewart noted. Women are known to be at higher risk of infection because the lining of the vagina is thinner than the skin of the penis, allowing for easier penetration of bacteria and viruses.

The study was designed to optimize adherence to Doxy PEP. Measures included monitoring with weekly text message surveys, in which the women reported a high rate of adherence.

The overall retention rate in the study was high; as many as 97% of the quarterly follow-up visits were completed, including 95% in the Doxy PEP group and 98% of the standard care group. The response rate for the weekly surveys was 81%.

Of note, women reported the use of the treatment to be “imperfect,” suggesting social problems, such as biases toward the use of the prophylaxis.

The results underscore the need for ongoing efforts to make sure no groups of patients are left behind as interventions advance, Dr. Stewart said.

“The burden of STIs on cisgender women is large and growing,” she concluded. “STI prevention interventions are needed.”

Commenting on the study, Renee A. Heffron, PhD, MPH, said the findings “are somewhat surprising because results from trials in other populations have been positive.

“But cisgender women are exposed through the cervix, and this tissue is different from rectal or urethral tissue,” Dr. Heffron, a professor at the department of medicine and director of the Center for AIDS Research at the University of Alabama, Birmingham, told this news organization.

Further findings from the research should help shed light on key issues of adherence and drug concentration levels in cervical tissue, she added.

“For cisgender women, these data are the first and the beginning of understanding whether this is a viable strategy,” Dr. Heffron said.

“We have more to learn to better understand the results from the trial main outcomes, and if there are tweaks to this strategy that would improve efficacy.”

The authors and Dr. Heffron have disclosed no relevant financial relationships.

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

The benefits of doxycycline postexposure prophylaxis (Doxy PEP) in preventing the transmission of sexually transmitted infections (STIs) in men and transgender women do not appear to extend to cisgender women, who have disproportionately high rates of infection in many regions.

“This was the first trial to evaluate doxycycline PEP for cisgender women,” said first author Jenell Stewart, DO, of the University of Minnesota, Minneapolis, in discussing the findings at a press conference at the Conference on Retroviruses & Opportunistic Infections.

“Unfortunately, our primary outcome was not statistically significant – we did not see a reduction in STIs among cisgender women, which is in stark contrast to [reported effects] among cisgender men and transgender women,” she said.

The findings are from a study of 449 nonpregnant cisgender women (mean age, 24 years) in Kenya who had been taking daily oral HIV preexposure prophylaxis (PrEP) for a median of about 7 months.

The women were randomly assigned to receive either Doxy PEP 200 mg, to be taken within 72 hours of sex (n = 224), or standard care, which included quarterly screening and treatment of STIs (n = 225).

Of the women, 36.7% reported transactional sex at enrollment; their baseline prevalence of STIs was 17.9%, including 14.1% with chlamydia, 3.8% gonorrhea, and 0.4% syphilis. There were no differences between the study groups.

In surveys, 78% of the women reported adherence to the use of Doxy PEP; they took the prophylaxis at least as many days as they had sex.

Nevertheless, there was no significant difference in the incidence of STIs, reported over 1 year, at quarterly visits that included genital STI testing, between groups, with 50 patients in the Doxy PEP group and 59 in the standard screening group developing STIs (relative risk, 0.88; P = .51).

Of the infections, 85 were chlamydia, including 35 in the Doxy PEP group and 50 with standard of care, while 31 were gonorrhea, including 19 in the Doxy PEP group and 12 with standard of care; 8 had both infections, and there was 1 syphilis infection.

The results were consistent across subanalyses of patients grouped according to STI, who became pregnant (n = 80), or sorted by other factors including age, contraceptive use, transactional sex, and STI at baseline.

None of the women developed HIV, and there were no serious events associated with the Doxy PEP treatment.
 

Cisgender women bear ‘highest burden’ of STIs

The findings are disappointing in light of the higher rates of STIs among cisgender women, with the Centers for Disease Control and Prevention reporting that women also disproportionately bear the long-term consequences of STIs.

“For example, each year, untreated sexually transmitted diseases cause infertility in at least 20,000 women in the United States, and a pregnant woman is highly likely to pass syphilis unto her unborn baby if left untested or untreated,” the CDC reports.

The STI rates are particularly high for women taking HIV PrEP in regions like East Africa, where rates of STIs among cisgender women in many cases are higher than rates for men taking PrEP in high income countries, Dr. Stewart said.

Previous studies of Doxy PEP in men and transgender women taking HIV PrEP, including new research presented at CROI, have shown highly encouraging reductions in STIs, at rates of up to approximately 80% for chlamydia and syphilis.
 

Adherence, anatomy, resistance

The key theories for the lack of a prevention of infections in cisgender women surround the issues of resistances, as well as anatomy and adherence, said Dr. Stewart.

In terms of bacterial resistances, while initial testing in a limited number of samples the study found no evidence of markers of resistance for chlamydia, all of the gonorrhea samples did show tetracycline-resistant N gonorrhea at baseline and follow-up in both groups.

Regarding anatomic differences, doxycycline may not prevent STIs in endocervical tissue among cisgender women, Dr. Stewart noted. Women are known to be at higher risk of infection because the lining of the vagina is thinner than the skin of the penis, allowing for easier penetration of bacteria and viruses.

The study was designed to optimize adherence to Doxy PEP. Measures included monitoring with weekly text message surveys, in which the women reported a high rate of adherence.

The overall retention rate in the study was high; as many as 97% of the quarterly follow-up visits were completed, including 95% in the Doxy PEP group and 98% of the standard care group. The response rate for the weekly surveys was 81%.

Of note, women reported the use of the treatment to be “imperfect,” suggesting social problems, such as biases toward the use of the prophylaxis.

The results underscore the need for ongoing efforts to make sure no groups of patients are left behind as interventions advance, Dr. Stewart said.

“The burden of STIs on cisgender women is large and growing,” she concluded. “STI prevention interventions are needed.”

Commenting on the study, Renee A. Heffron, PhD, MPH, said the findings “are somewhat surprising because results from trials in other populations have been positive.

“But cisgender women are exposed through the cervix, and this tissue is different from rectal or urethral tissue,” Dr. Heffron, a professor at the department of medicine and director of the Center for AIDS Research at the University of Alabama, Birmingham, told this news organization.

Further findings from the research should help shed light on key issues of adherence and drug concentration levels in cervical tissue, she added.

“For cisgender women, these data are the first and the beginning of understanding whether this is a viable strategy,” Dr. Heffron said.

“We have more to learn to better understand the results from the trial main outcomes, and if there are tweaks to this strategy that would improve efficacy.”

The authors and Dr. Heffron have disclosed no relevant financial relationships.

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

The benefits of doxycycline postexposure prophylaxis (Doxy PEP) in preventing the transmission of sexually transmitted infections (STIs) in men and transgender women do not appear to extend to cisgender women, who have disproportionately high rates of infection in many regions.

“This was the first trial to evaluate doxycycline PEP for cisgender women,” said first author Jenell Stewart, DO, of the University of Minnesota, Minneapolis, in discussing the findings at a press conference at the Conference on Retroviruses & Opportunistic Infections.

“Unfortunately, our primary outcome was not statistically significant – we did not see a reduction in STIs among cisgender women, which is in stark contrast to [reported effects] among cisgender men and transgender women,” she said.

The findings are from a study of 449 nonpregnant cisgender women (mean age, 24 years) in Kenya who had been taking daily oral HIV preexposure prophylaxis (PrEP) for a median of about 7 months.

The women were randomly assigned to receive either Doxy PEP 200 mg, to be taken within 72 hours of sex (n = 224), or standard care, which included quarterly screening and treatment of STIs (n = 225).

Of the women, 36.7% reported transactional sex at enrollment; their baseline prevalence of STIs was 17.9%, including 14.1% with chlamydia, 3.8% gonorrhea, and 0.4% syphilis. There were no differences between the study groups.

In surveys, 78% of the women reported adherence to the use of Doxy PEP; they took the prophylaxis at least as many days as they had sex.

Nevertheless, there was no significant difference in the incidence of STIs, reported over 1 year, at quarterly visits that included genital STI testing, between groups, with 50 patients in the Doxy PEP group and 59 in the standard screening group developing STIs (relative risk, 0.88; P = .51).

Of the infections, 85 were chlamydia, including 35 in the Doxy PEP group and 50 with standard of care, while 31 were gonorrhea, including 19 in the Doxy PEP group and 12 with standard of care; 8 had both infections, and there was 1 syphilis infection.

The results were consistent across subanalyses of patients grouped according to STI, who became pregnant (n = 80), or sorted by other factors including age, contraceptive use, transactional sex, and STI at baseline.

None of the women developed HIV, and there were no serious events associated with the Doxy PEP treatment.
 

Cisgender women bear ‘highest burden’ of STIs

The findings are disappointing in light of the higher rates of STIs among cisgender women, with the Centers for Disease Control and Prevention reporting that women also disproportionately bear the long-term consequences of STIs.

“For example, each year, untreated sexually transmitted diseases cause infertility in at least 20,000 women in the United States, and a pregnant woman is highly likely to pass syphilis unto her unborn baby if left untested or untreated,” the CDC reports.

The STI rates are particularly high for women taking HIV PrEP in regions like East Africa, where rates of STIs among cisgender women in many cases are higher than rates for men taking PrEP in high income countries, Dr. Stewart said.

Previous studies of Doxy PEP in men and transgender women taking HIV PrEP, including new research presented at CROI, have shown highly encouraging reductions in STIs, at rates of up to approximately 80% for chlamydia and syphilis.
 

Adherence, anatomy, resistance

The key theories for the lack of a prevention of infections in cisgender women surround the issues of resistances, as well as anatomy and adherence, said Dr. Stewart.

In terms of bacterial resistances, while initial testing in a limited number of samples the study found no evidence of markers of resistance for chlamydia, all of the gonorrhea samples did show tetracycline-resistant N gonorrhea at baseline and follow-up in both groups.

Regarding anatomic differences, doxycycline may not prevent STIs in endocervical tissue among cisgender women, Dr. Stewart noted. Women are known to be at higher risk of infection because the lining of the vagina is thinner than the skin of the penis, allowing for easier penetration of bacteria and viruses.

The study was designed to optimize adherence to Doxy PEP. Measures included monitoring with weekly text message surveys, in which the women reported a high rate of adherence.

The overall retention rate in the study was high; as many as 97% of the quarterly follow-up visits were completed, including 95% in the Doxy PEP group and 98% of the standard care group. The response rate for the weekly surveys was 81%.

Of note, women reported the use of the treatment to be “imperfect,” suggesting social problems, such as biases toward the use of the prophylaxis.

The results underscore the need for ongoing efforts to make sure no groups of patients are left behind as interventions advance, Dr. Stewart said.

“The burden of STIs on cisgender women is large and growing,” she concluded. “STI prevention interventions are needed.”

Commenting on the study, Renee A. Heffron, PhD, MPH, said the findings “are somewhat surprising because results from trials in other populations have been positive.

“But cisgender women are exposed through the cervix, and this tissue is different from rectal or urethral tissue,” Dr. Heffron, a professor at the department of medicine and director of the Center for AIDS Research at the University of Alabama, Birmingham, told this news organization.

Further findings from the research should help shed light on key issues of adherence and drug concentration levels in cervical tissue, she added.

“For cisgender women, these data are the first and the beginning of understanding whether this is a viable strategy,” Dr. Heffron said.

“We have more to learn to better understand the results from the trial main outcomes, and if there are tweaks to this strategy that would improve efficacy.”

The authors and Dr. Heffron have disclosed no relevant financial relationships.

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

The latest study to show high efficacy of doxycycline post-exposure prophylaxis (Doxy PEP) in preventing sexually transmitted infections among men who have sex with men (MSM) adds a new twist, showing – for the first time – reductions in gonorrhea among those receiving the meningococcal B vaccine.

“Among men who have sex with men on HIV PrEP, doxycycline PEP significantly reduced the incidence of chlamydia and syphilis and also had a significant impact on the incidence of gonorrhea,” said first author Jean-Michel Molina, MD, PhD, in presenting the findings at the Conference on Retroviruses and Opportunistic Infections.

In addition, “two doses of the meningococcal B vaccine reduced the incidence of a first episode of gonorrhea by roughly 50% among men who have sex with men,” said Dr. Molina, a professor of infectious diseases at the University of Paris, and head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals, Paris.

Whereas the advent of PrEP has been associated with significant reductions in HIV transmission, rates of STIs have conversely been on the rise among MSM, specifically among those receiving PrEP.

Post-exposure prophylaxis with Doxy PEP has been shown to reduce the incidence of chlamydia and syphilis by approximately 70%; however, effects on prevention of gonorrhea have been less clear.

Meningococcal B vaccination has, meanwhile, shown intriguing reductions of gonorrhea incidence of as much as 26%-46% in some observational studies.

Therefore, Dr. Molina and colleagues decided to further investigate Doxy PEP as well as the meningococcal B vaccine in prevention of STIs.

For the ANRS 174 DOXYVAC trial, they enrolled 546 MSM in the open-label, multicenter study between January 2021 and July 2022.

The men were randomly assigned to one of 4 groups: doxycycline postexposure prophylaxis (Doxy PEP: 200 mg; n = 332), no Doxy PEP (n = 170), two shots of meningococcal B vaccine (4CMenB vaccine; n = 257), or no 4CMenB vaccine (n = 245).

All participants were assigned to their groups within 72 hours of condomless sex.

The men, who had a median age of 39, had a median time of PrEP use of 42 months, a history of an STI in the past year, and their median number of sexual partners in the past 3 months was 10.

Their characteristics were well-balanced across the treatment groups. After discontinuations of 54 patients across the groups, the final analysis included 502 participants.

With a median follow-up of 9 months, the intent-to-treat analysis showed 13 subjects had a first episode of chlamydia or syphilis in the Doxy PEP group, versus 49 subjects infected in the no Doxy PEP arm, for an incidence of 5.6 versus 35.4 per 100 person-years, respectively (adjusted hazard ratio, 0.16; P < .0001).

Infection specifically with chlamydia occurred among 21 men with no Doxy PEP versus 5 receiving Dox PEP (19.3 vs. 2.1 per 100 person-years, respectively; HR, 0.11; P < .0001).

And infection with syphilis occurred in 18 men receiving no Doxy PEP versus 8 receiving the treatment (16.3 vs. 3.4 per 100 person-years, respectively; HR, 0.21; P < .001).

The corresponding rates for gonorrhea infection were an incidence 41.3 versus 20.5 per 100 person-years, in the no Doxy PEP versus Doxy PEP arms, respectively (adjusted HR, 0.49; P = .001), and 29.4 versus 16.8 per 100 person-years for Mycoplasma genitalium infection (aHR, 0.55; P = .015).

Throughout the study, about 80% of patients in the Doxy PEP group reported using the prophylaxis treatment after their most recent sexual intercourse, with subjects reporting taking a median of seven pills per month.

In the vaccine/no vaccine comparisons, 32 subjects in the no meningococcal vaccine group were infected with a first gonorrhea infection, compared with 17 in the vaccine group, representing an incidence of 19.7 versus 9.8 per 100 person-years, respectively (adjusted HR, 0.49; P = .016), which Dr. Molina called “highly significant.”

An analysis of the cumulative incidence of gonorrhea infection with the meningococcal vaccine showed rates in the no vaccine versus vaccine groups of 30.4 versus 20.1 per 100 person-years, respectively; however, statistical significance was not reached (aHR, 0.66; P = .052).

Importantly, there were no significant interactions in the results between those receiving Doxy PEP or the 4CMenB vaccine group, and there were no significant differences in drug-related serious adverse events between the groups.

Dr. Molina noted that the meningococcal B vaccine is known to contain key antigens that are shared between meningitis and gonorrhea, which could explain the benefits.

Although chlamydia and syphilis thus far appear to remain susceptible to Doxy PEP, resistances with gonorrhea remain a concern, hence the ability of the vaccine to provide some protection could be an added bonus.

“We know that [gonorrhea] is able to very quickly develop resistances to any antibiotics, so that was why we wanted to look beyond the antibiotic prophylaxis,” said Dr. Molina.

Among questions to explore looking ahead is the potential longevity of protection with the vaccine.

“We don’t know at this point how long the protection with the vaccine could last, or if [people] may need booster injections, for instance, but the literature suggests benefits for at least a year,” Dr. Molina said. “We are still monitoring the patients in the study to see what happens.”

He added that combination of the interventions may be of benefit.

“In the future, we think we may need to combine these approaches if we want to meet the WHO/UNAIDS targets to reduce the incidence of HIV and STIs by 90% by 2030.”

Commenting on the study, CROI vice-chair Landon Myer, MD, PhD, noted that “gonorrhea develops resistance quickly and can be hard to treat or prophylaxis, so the vaccine finding, which was hinted at by previous observational data, is really important.”

He agrees that “the duration of protective efficacy – a big thing in vaccines – is unknown.”

“Still, this is really significant,” Dr. Myer stressed. “An efficacious vaccine against a stubborn sexually transmitted infection.”

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

The latest study to show high efficacy of doxycycline post-exposure prophylaxis (Doxy PEP) in preventing sexually transmitted infections among men who have sex with men (MSM) adds a new twist, showing – for the first time – reductions in gonorrhea among those receiving the meningococcal B vaccine.

“Among men who have sex with men on HIV PrEP, doxycycline PEP significantly reduced the incidence of chlamydia and syphilis and also had a significant impact on the incidence of gonorrhea,” said first author Jean-Michel Molina, MD, PhD, in presenting the findings at the Conference on Retroviruses and Opportunistic Infections.

In addition, “two doses of the meningococcal B vaccine reduced the incidence of a first episode of gonorrhea by roughly 50% among men who have sex with men,” said Dr. Molina, a professor of infectious diseases at the University of Paris, and head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals, Paris.

Whereas the advent of PrEP has been associated with significant reductions in HIV transmission, rates of STIs have conversely been on the rise among MSM, specifically among those receiving PrEP.

Post-exposure prophylaxis with Doxy PEP has been shown to reduce the incidence of chlamydia and syphilis by approximately 70%; however, effects on prevention of gonorrhea have been less clear.

Meningococcal B vaccination has, meanwhile, shown intriguing reductions of gonorrhea incidence of as much as 26%-46% in some observational studies.

Therefore, Dr. Molina and colleagues decided to further investigate Doxy PEP as well as the meningococcal B vaccine in prevention of STIs.

For the ANRS 174 DOXYVAC trial, they enrolled 546 MSM in the open-label, multicenter study between January 2021 and July 2022.

The men were randomly assigned to one of 4 groups: doxycycline postexposure prophylaxis (Doxy PEP: 200 mg; n = 332), no Doxy PEP (n = 170), two shots of meningococcal B vaccine (4CMenB vaccine; n = 257), or no 4CMenB vaccine (n = 245).

All participants were assigned to their groups within 72 hours of condomless sex.

The men, who had a median age of 39, had a median time of PrEP use of 42 months, a history of an STI in the past year, and their median number of sexual partners in the past 3 months was 10.

Their characteristics were well-balanced across the treatment groups. After discontinuations of 54 patients across the groups, the final analysis included 502 participants.

With a median follow-up of 9 months, the intent-to-treat analysis showed 13 subjects had a first episode of chlamydia or syphilis in the Doxy PEP group, versus 49 subjects infected in the no Doxy PEP arm, for an incidence of 5.6 versus 35.4 per 100 person-years, respectively (adjusted hazard ratio, 0.16; P < .0001).

Infection specifically with chlamydia occurred among 21 men with no Doxy PEP versus 5 receiving Dox PEP (19.3 vs. 2.1 per 100 person-years, respectively; HR, 0.11; P < .0001).

And infection with syphilis occurred in 18 men receiving no Doxy PEP versus 8 receiving the treatment (16.3 vs. 3.4 per 100 person-years, respectively; HR, 0.21; P < .001).

The corresponding rates for gonorrhea infection were an incidence 41.3 versus 20.5 per 100 person-years, in the no Doxy PEP versus Doxy PEP arms, respectively (adjusted HR, 0.49; P = .001), and 29.4 versus 16.8 per 100 person-years for Mycoplasma genitalium infection (aHR, 0.55; P = .015).

Throughout the study, about 80% of patients in the Doxy PEP group reported using the prophylaxis treatment after their most recent sexual intercourse, with subjects reporting taking a median of seven pills per month.

In the vaccine/no vaccine comparisons, 32 subjects in the no meningococcal vaccine group were infected with a first gonorrhea infection, compared with 17 in the vaccine group, representing an incidence of 19.7 versus 9.8 per 100 person-years, respectively (adjusted HR, 0.49; P = .016), which Dr. Molina called “highly significant.”

An analysis of the cumulative incidence of gonorrhea infection with the meningococcal vaccine showed rates in the no vaccine versus vaccine groups of 30.4 versus 20.1 per 100 person-years, respectively; however, statistical significance was not reached (aHR, 0.66; P = .052).

Importantly, there were no significant interactions in the results between those receiving Doxy PEP or the 4CMenB vaccine group, and there were no significant differences in drug-related serious adverse events between the groups.

Dr. Molina noted that the meningococcal B vaccine is known to contain key antigens that are shared between meningitis and gonorrhea, which could explain the benefits.

Although chlamydia and syphilis thus far appear to remain susceptible to Doxy PEP, resistances with gonorrhea remain a concern, hence the ability of the vaccine to provide some protection could be an added bonus.

“We know that [gonorrhea] is able to very quickly develop resistances to any antibiotics, so that was why we wanted to look beyond the antibiotic prophylaxis,” said Dr. Molina.

Among questions to explore looking ahead is the potential longevity of protection with the vaccine.

“We don’t know at this point how long the protection with the vaccine could last, or if [people] may need booster injections, for instance, but the literature suggests benefits for at least a year,” Dr. Molina said. “We are still monitoring the patients in the study to see what happens.”

He added that combination of the interventions may be of benefit.

“In the future, we think we may need to combine these approaches if we want to meet the WHO/UNAIDS targets to reduce the incidence of HIV and STIs by 90% by 2030.”

Commenting on the study, CROI vice-chair Landon Myer, MD, PhD, noted that “gonorrhea develops resistance quickly and can be hard to treat or prophylaxis, so the vaccine finding, which was hinted at by previous observational data, is really important.”

He agrees that “the duration of protective efficacy – a big thing in vaccines – is unknown.”

“Still, this is really significant,” Dr. Myer stressed. “An efficacious vaccine against a stubborn sexually transmitted infection.”

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

The latest study to show high efficacy of doxycycline post-exposure prophylaxis (Doxy PEP) in preventing sexually transmitted infections among men who have sex with men (MSM) adds a new twist, showing – for the first time – reductions in gonorrhea among those receiving the meningococcal B vaccine.

“Among men who have sex with men on HIV PrEP, doxycycline PEP significantly reduced the incidence of chlamydia and syphilis and also had a significant impact on the incidence of gonorrhea,” said first author Jean-Michel Molina, MD, PhD, in presenting the findings at the Conference on Retroviruses and Opportunistic Infections.

In addition, “two doses of the meningococcal B vaccine reduced the incidence of a first episode of gonorrhea by roughly 50% among men who have sex with men,” said Dr. Molina, a professor of infectious diseases at the University of Paris, and head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals, Paris.

Whereas the advent of PrEP has been associated with significant reductions in HIV transmission, rates of STIs have conversely been on the rise among MSM, specifically among those receiving PrEP.

Post-exposure prophylaxis with Doxy PEP has been shown to reduce the incidence of chlamydia and syphilis by approximately 70%; however, effects on prevention of gonorrhea have been less clear.

Meningococcal B vaccination has, meanwhile, shown intriguing reductions of gonorrhea incidence of as much as 26%-46% in some observational studies.

Therefore, Dr. Molina and colleagues decided to further investigate Doxy PEP as well as the meningococcal B vaccine in prevention of STIs.

For the ANRS 174 DOXYVAC trial, they enrolled 546 MSM in the open-label, multicenter study between January 2021 and July 2022.

The men were randomly assigned to one of 4 groups: doxycycline postexposure prophylaxis (Doxy PEP: 200 mg; n = 332), no Doxy PEP (n = 170), two shots of meningococcal B vaccine (4CMenB vaccine; n = 257), or no 4CMenB vaccine (n = 245).

All participants were assigned to their groups within 72 hours of condomless sex.

The men, who had a median age of 39, had a median time of PrEP use of 42 months, a history of an STI in the past year, and their median number of sexual partners in the past 3 months was 10.

Their characteristics were well-balanced across the treatment groups. After discontinuations of 54 patients across the groups, the final analysis included 502 participants.

With a median follow-up of 9 months, the intent-to-treat analysis showed 13 subjects had a first episode of chlamydia or syphilis in the Doxy PEP group, versus 49 subjects infected in the no Doxy PEP arm, for an incidence of 5.6 versus 35.4 per 100 person-years, respectively (adjusted hazard ratio, 0.16; P < .0001).

Infection specifically with chlamydia occurred among 21 men with no Doxy PEP versus 5 receiving Dox PEP (19.3 vs. 2.1 per 100 person-years, respectively; HR, 0.11; P < .0001).

And infection with syphilis occurred in 18 men receiving no Doxy PEP versus 8 receiving the treatment (16.3 vs. 3.4 per 100 person-years, respectively; HR, 0.21; P < .001).

The corresponding rates for gonorrhea infection were an incidence 41.3 versus 20.5 per 100 person-years, in the no Doxy PEP versus Doxy PEP arms, respectively (adjusted HR, 0.49; P = .001), and 29.4 versus 16.8 per 100 person-years for Mycoplasma genitalium infection (aHR, 0.55; P = .015).

Throughout the study, about 80% of patients in the Doxy PEP group reported using the prophylaxis treatment after their most recent sexual intercourse, with subjects reporting taking a median of seven pills per month.

In the vaccine/no vaccine comparisons, 32 subjects in the no meningococcal vaccine group were infected with a first gonorrhea infection, compared with 17 in the vaccine group, representing an incidence of 19.7 versus 9.8 per 100 person-years, respectively (adjusted HR, 0.49; P = .016), which Dr. Molina called “highly significant.”

An analysis of the cumulative incidence of gonorrhea infection with the meningococcal vaccine showed rates in the no vaccine versus vaccine groups of 30.4 versus 20.1 per 100 person-years, respectively; however, statistical significance was not reached (aHR, 0.66; P = .052).

Importantly, there were no significant interactions in the results between those receiving Doxy PEP or the 4CMenB vaccine group, and there were no significant differences in drug-related serious adverse events between the groups.

Dr. Molina noted that the meningococcal B vaccine is known to contain key antigens that are shared between meningitis and gonorrhea, which could explain the benefits.

Although chlamydia and syphilis thus far appear to remain susceptible to Doxy PEP, resistances with gonorrhea remain a concern, hence the ability of the vaccine to provide some protection could be an added bonus.

“We know that [gonorrhea] is able to very quickly develop resistances to any antibiotics, so that was why we wanted to look beyond the antibiotic prophylaxis,” said Dr. Molina.

Among questions to explore looking ahead is the potential longevity of protection with the vaccine.

“We don’t know at this point how long the protection with the vaccine could last, or if [people] may need booster injections, for instance, but the literature suggests benefits for at least a year,” Dr. Molina said. “We are still monitoring the patients in the study to see what happens.”

He added that combination of the interventions may be of benefit.

“In the future, we think we may need to combine these approaches if we want to meet the WHO/UNAIDS targets to reduce the incidence of HIV and STIs by 90% by 2030.”

Commenting on the study, CROI vice-chair Landon Myer, MD, PhD, noted that “gonorrhea develops resistance quickly and can be hard to treat or prophylaxis, so the vaccine finding, which was hinted at by previous observational data, is really important.”

He agrees that “the duration of protective efficacy – a big thing in vaccines – is unknown.”

“Still, this is really significant,” Dr. Myer stressed. “An efficacious vaccine against a stubborn sexually transmitted infection.”

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

It was Friday, and oncologist Coral Olazagasti, MD, faced a ticking clock.

Her patient had taken his last prescription antinausea pill. Without a refill of ondansetron, he faced a long, painful weekend.

The patient – a man with HPV-related oropharyngeal cancer – was experiencing severe side effects from standard chemoradiation with weekly cisplatin. Intense nausea and grade 3 mucositis, in particular, left him struggling to swallow or take in any food or fluids.

He was on 8 mg of ondansetron (Zofran) every 8 hours, as needed, to keep the nausea at bay. The pills along with a feeding tube helped, but his symptoms were so intense, neither was quite enough.

“He still needed to be hospitalized twice for dehydration,” said Dr. Olazagasti, who specializes in head and neck medical cancer at Sylvester Comprehensive Cancer Center in Miami.

But when it came time to renew his ondansetron prescription, his insurance company denied it.

The reasoning: “The company had only approved 30 tablets a month and, for them, it was unjustifiable to approve anything above that amount,” Dr. Olazagasti explained.

After Dr. Olazagasti called the insurance company to resolve the issue, a company representative told her to fill out a prior authorization form.

But it was already after 7:30 p.m. ET on Friday.

At that point, finding the prior authorization documents, filling them out, and submitting them would take more time – and the paperwork couldn’t be filed until Monday.

“My patient was at home with zero tablets left and horrible symptoms. He couldn’t keep anything down,” Dr. Olazagasti said.

On Monday, the oncology team sent the prior authorization request, and her patient received his medication a few days later.

“My patient had to wait about 5 days to get the nausea meds he needed,” she said. In the meantime, he was in pain. “Having a refill of this simple supportive care medication rejected was infuriating.”

When Dr. Olazagasti vented her frustrations on Twitter, several people chimed in, suggesting purchasing the drug at a discount through GoodRx or Cost Plus instead of going through the insurance company.

At Cost Plus, for instance, 30 8-mg pills would cost $6.30, but ordering from the online pharmacy would mean waiting several days for delivery.

Discounts through GoodRx may provide a potentially faster solution in a pinch, but the pharmacy matters. In Miami, 30 8-mg pills would cost $19.99 at Costco with a GoodRx coupon, but $233.56 at CVS and $253.60 at Walgreens.

Although potentially useful, these options may not be the obvious choice for oncologists and patients, especially when a drug has already been approved and covered by the insurer. In this case, the denial was also a surprise, which left Dr. Olazagasti and her patient scrambling right before the weekend.

In addition, companies providing discounted generic drugs may only have a limited number of oncology-related medications. Cost Plus, for instance, now sells more than 1,000 generic prescription drugs at a fraction of what insurance companies charge, but only about 7 are cancer drugs.

On a broader level, Dr. Olazagasti noted, “insurance companies have a responsibility to cover these drugs. If we all get so fed up that we start relying on alternate routes to get patients their treatments, then insurance companies are let off the hook.”

However, using an alternative option like GoodRx or CostPlus could mean bypassing insurance company obstacles in certain cases.

“The hurdles someone may have to go through to get a generic drug approved are very frustrating,” said Stacie B. Dusetzina, PhD, professor of health policy and a professor of cancer research at Vanderbilt University in Nashville, Tenn.

In a weekend emergency situation, if the drug is discounted through GoodRx, “it can be a good backup strategy to send the prescription to the pharmacy” and more generally “worth it for patients to check if they can get a better deal on generic drugs through these companies.”

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

It was Friday, and oncologist Coral Olazagasti, MD, faced a ticking clock.

Her patient had taken his last prescription antinausea pill. Without a refill of ondansetron, he faced a long, painful weekend.

The patient – a man with HPV-related oropharyngeal cancer – was experiencing severe side effects from standard chemoradiation with weekly cisplatin. Intense nausea and grade 3 mucositis, in particular, left him struggling to swallow or take in any food or fluids.

He was on 8 mg of ondansetron (Zofran) every 8 hours, as needed, to keep the nausea at bay. The pills along with a feeding tube helped, but his symptoms were so intense, neither was quite enough.

“He still needed to be hospitalized twice for dehydration,” said Dr. Olazagasti, who specializes in head and neck medical cancer at Sylvester Comprehensive Cancer Center in Miami.

But when it came time to renew his ondansetron prescription, his insurance company denied it.

The reasoning: “The company had only approved 30 tablets a month and, for them, it was unjustifiable to approve anything above that amount,” Dr. Olazagasti explained.

After Dr. Olazagasti called the insurance company to resolve the issue, a company representative told her to fill out a prior authorization form.

But it was already after 7:30 p.m. ET on Friday.

At that point, finding the prior authorization documents, filling them out, and submitting them would take more time – and the paperwork couldn’t be filed until Monday.

“My patient was at home with zero tablets left and horrible symptoms. He couldn’t keep anything down,” Dr. Olazagasti said.

On Monday, the oncology team sent the prior authorization request, and her patient received his medication a few days later.

“My patient had to wait about 5 days to get the nausea meds he needed,” she said. In the meantime, he was in pain. “Having a refill of this simple supportive care medication rejected was infuriating.”

When Dr. Olazagasti vented her frustrations on Twitter, several people chimed in, suggesting purchasing the drug at a discount through GoodRx or Cost Plus instead of going through the insurance company.

At Cost Plus, for instance, 30 8-mg pills would cost $6.30, but ordering from the online pharmacy would mean waiting several days for delivery.

Discounts through GoodRx may provide a potentially faster solution in a pinch, but the pharmacy matters. In Miami, 30 8-mg pills would cost $19.99 at Costco with a GoodRx coupon, but $233.56 at CVS and $253.60 at Walgreens.

Although potentially useful, these options may not be the obvious choice for oncologists and patients, especially when a drug has already been approved and covered by the insurer. In this case, the denial was also a surprise, which left Dr. Olazagasti and her patient scrambling right before the weekend.

In addition, companies providing discounted generic drugs may only have a limited number of oncology-related medications. Cost Plus, for instance, now sells more than 1,000 generic prescription drugs at a fraction of what insurance companies charge, but only about 7 are cancer drugs.

On a broader level, Dr. Olazagasti noted, “insurance companies have a responsibility to cover these drugs. If we all get so fed up that we start relying on alternate routes to get patients their treatments, then insurance companies are let off the hook.”

However, using an alternative option like GoodRx or CostPlus could mean bypassing insurance company obstacles in certain cases.

“The hurdles someone may have to go through to get a generic drug approved are very frustrating,” said Stacie B. Dusetzina, PhD, professor of health policy and a professor of cancer research at Vanderbilt University in Nashville, Tenn.

In a weekend emergency situation, if the drug is discounted through GoodRx, “it can be a good backup strategy to send the prescription to the pharmacy” and more generally “worth it for patients to check if they can get a better deal on generic drugs through these companies.”

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

It was Friday, and oncologist Coral Olazagasti, MD, faced a ticking clock.

Her patient had taken his last prescription antinausea pill. Without a refill of ondansetron, he faced a long, painful weekend.

The patient – a man with HPV-related oropharyngeal cancer – was experiencing severe side effects from standard chemoradiation with weekly cisplatin. Intense nausea and grade 3 mucositis, in particular, left him struggling to swallow or take in any food or fluids.

He was on 8 mg of ondansetron (Zofran) every 8 hours, as needed, to keep the nausea at bay. The pills along with a feeding tube helped, but his symptoms were so intense, neither was quite enough.

“He still needed to be hospitalized twice for dehydration,” said Dr. Olazagasti, who specializes in head and neck medical cancer at Sylvester Comprehensive Cancer Center in Miami.

But when it came time to renew his ondansetron prescription, his insurance company denied it.

The reasoning: “The company had only approved 30 tablets a month and, for them, it was unjustifiable to approve anything above that amount,” Dr. Olazagasti explained.

After Dr. Olazagasti called the insurance company to resolve the issue, a company representative told her to fill out a prior authorization form.

But it was already after 7:30 p.m. ET on Friday.

At that point, finding the prior authorization documents, filling them out, and submitting them would take more time – and the paperwork couldn’t be filed until Monday.

“My patient was at home with zero tablets left and horrible symptoms. He couldn’t keep anything down,” Dr. Olazagasti said.

On Monday, the oncology team sent the prior authorization request, and her patient received his medication a few days later.

“My patient had to wait about 5 days to get the nausea meds he needed,” she said. In the meantime, he was in pain. “Having a refill of this simple supportive care medication rejected was infuriating.”

When Dr. Olazagasti vented her frustrations on Twitter, several people chimed in, suggesting purchasing the drug at a discount through GoodRx or Cost Plus instead of going through the insurance company.

At Cost Plus, for instance, 30 8-mg pills would cost $6.30, but ordering from the online pharmacy would mean waiting several days for delivery.

Discounts through GoodRx may provide a potentially faster solution in a pinch, but the pharmacy matters. In Miami, 30 8-mg pills would cost $19.99 at Costco with a GoodRx coupon, but $233.56 at CVS and $253.60 at Walgreens.

Although potentially useful, these options may not be the obvious choice for oncologists and patients, especially when a drug has already been approved and covered by the insurer. In this case, the denial was also a surprise, which left Dr. Olazagasti and her patient scrambling right before the weekend.

In addition, companies providing discounted generic drugs may only have a limited number of oncology-related medications. Cost Plus, for instance, now sells more than 1,000 generic prescription drugs at a fraction of what insurance companies charge, but only about 7 are cancer drugs.

On a broader level, Dr. Olazagasti noted, “insurance companies have a responsibility to cover these drugs. If we all get so fed up that we start relying on alternate routes to get patients their treatments, then insurance companies are let off the hook.”

However, using an alternative option like GoodRx or CostPlus could mean bypassing insurance company obstacles in certain cases.

“The hurdles someone may have to go through to get a generic drug approved are very frustrating,” said Stacie B. Dusetzina, PhD, professor of health policy and a professor of cancer research at Vanderbilt University in Nashville, Tenn.

In a weekend emergency situation, if the drug is discounted through GoodRx, “it can be a good backup strategy to send the prescription to the pharmacy” and more generally “worth it for patients to check if they can get a better deal on generic drugs through these companies.”

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

Asymptomatic adults, teens, and pregnant women with no known history or symptoms of herpes infection need not undergo routine screening, according to the latest recommendation from the U.S. Preventive Services Task Force.

The 2023 recommendation reaffirms the conclusion from 2016, wrote Carol M. Mangione, MD, of the University of California, Los Angeles, and members of the task force.

“Currently, routine serologic screening for genital herpes is limited by the low predictive value of the widely available serologic screening tests and the expected high rate of false-positive results likely to occur with routine screening of asymptomatic persons in the U.S.,” the authors said.

In the recommendation, published in JAMA, the authors affirmed with moderate certainty and a grade D recommendation that the risks of routine screening for herpes simplex virus (HSV) in asymptomatic individuals outweigh the benefits.

The task force found no new evidence on the accuracy of serologic screening tests, the benefits of early detection and treatment, or on the harms of screening and treatment since the 2016 review of 17 studies in 19 publications, with data from more than 9,000 individuals.

Studies of the accuracy of serologic screening for herpes simplex virus-2 in the 2016 report mainly reflect populations with higher HSV-2 prevalence and are of limited applicability to the U.S. primary care population, the authors wrote. Evidence from the 2016 review also showed limited and inconsistent support for the early identification and treatment of HSV-2 in asymptomatic individuals, including those who were pregnant.

No new evidence has emerged since 2016 regarding harms of screening or treating genital herpes in asymptomatic individuals, the authors noted. “Based on previous evidence, the USPSTF estimated that using the widely available serologic tests for HSV-2, nearly 1 of every 2 diagnoses in the general U.S. primary care population could be false,” they said. The task force also concluded that the low accuracy of the current tests could prompt unnecessary treatment for individuals with false-positive diagnoses, as well as social and emotional harm for these individuals.

During a period of public comment from Aug. 16, 2022, to Sept. 12, 2022, individuals expressed concerns that the recommendation against routine screening showed a disinclination to take herpes seriously, and concerns that asymptomatic individuals could transmit the infection to sexual partners, the authors said. However, the estimated seroprevalence of HSV-1 and HSV-2 has declined in recent decades, and other comments supported the USPSTF’s analysis of the evidence and noted their consistency with current clinical practice.

The task force noted that research gaps remain and recognized the need to improve screening and treatment of genital herpes to prevent symptomatic episodes and transmission. Specifically, the USPSTF recommendation calls for more research to assess the accuracy of screening tests, to enroll more study participants from populations disproportionately affected by HSV, to examine the effect of behavioral counseling, and to clarify associations between HSV and pregnancy outcomes. In addition, the task force called for research to create an effective vaccine to prevent genital HSV infection and to develop a cure.
 

Targeted screening makes sense for now

“Given the frequency and severity of the range of diseases seen with HSV and the large proportion of persons who are asymptomatic, identifying carriers through type-specific serologic screening has long been considered a plausible strategy,” Mark D. Pearlman, MD, of the University of Michigan, Ann Arbor, wrote in an accompanying editorial.

However, accuracy of the currently available serology screening tests is low, and the adverse social and psychological effects and the impact on relationships for many asymptomatic individuals who test positive and may be incorrectly identified as infected remains a concern, said Dr. Pearlman.

Although some may be disagree about the value of routine serotesting for HSV-2 in asymptomatic individuals, other strategies can reduce the spread of infection and help those infected, he said.

Many experts continue to recommend targeted serotesting to high-risk populations, such as pregnant women whose nonpregnant partner is known to have genital or oral herpes and whose own infection status or serostatus is uncertain, said Dr. Pearlman. Other targeted strategies include screening individuals with recurrent or atypical genital symptoms and negative polymerase chain reaction assay or culture results, a clinical herpes diagnosis without laboratory confirmation, or those at increased risk because of a high number of sexual partners or a history of HIV infection, he said.

“Of note, the current CDC STI guidelines and ACOG both concur with the USPSTF that routine screening in the general population or routine screening during pregnancy are not recommended,” Dr. Pearlman said. Meanwhile, research efforts continue to help reduce the impact of HSV disease and development of a more effective testing methodology “might tip the balance in favor of routine screening” in the future, he emphasized.

The recommendations were supported by the Agency for Healthcare Research and Quality. The members of the task force received reimbursement for travel and an honorarium but had no other relevant financial conflicts to disclose. Dr. Pearlman had no financial conflicts to disclose.

Asymptomatic adults, teens, and pregnant women with no known history or symptoms of herpes infection need not undergo routine screening, according to the latest recommendation from the U.S. Preventive Services Task Force.

The 2023 recommendation reaffirms the conclusion from 2016, wrote Carol M. Mangione, MD, of the University of California, Los Angeles, and members of the task force.

“Currently, routine serologic screening for genital herpes is limited by the low predictive value of the widely available serologic screening tests and the expected high rate of false-positive results likely to occur with routine screening of asymptomatic persons in the U.S.,” the authors said.

In the recommendation, published in JAMA, the authors affirmed with moderate certainty and a grade D recommendation that the risks of routine screening for herpes simplex virus (HSV) in asymptomatic individuals outweigh the benefits.

The task force found no new evidence on the accuracy of serologic screening tests, the benefits of early detection and treatment, or on the harms of screening and treatment since the 2016 review of 17 studies in 19 publications, with data from more than 9,000 individuals.

Studies of the accuracy of serologic screening for herpes simplex virus-2 in the 2016 report mainly reflect populations with higher HSV-2 prevalence and are of limited applicability to the U.S. primary care population, the authors wrote. Evidence from the 2016 review also showed limited and inconsistent support for the early identification and treatment of HSV-2 in asymptomatic individuals, including those who were pregnant.

No new evidence has emerged since 2016 regarding harms of screening or treating genital herpes in asymptomatic individuals, the authors noted. “Based on previous evidence, the USPSTF estimated that using the widely available serologic tests for HSV-2, nearly 1 of every 2 diagnoses in the general U.S. primary care population could be false,” they said. The task force also concluded that the low accuracy of the current tests could prompt unnecessary treatment for individuals with false-positive diagnoses, as well as social and emotional harm for these individuals.

During a period of public comment from Aug. 16, 2022, to Sept. 12, 2022, individuals expressed concerns that the recommendation against routine screening showed a disinclination to take herpes seriously, and concerns that asymptomatic individuals could transmit the infection to sexual partners, the authors said. However, the estimated seroprevalence of HSV-1 and HSV-2 has declined in recent decades, and other comments supported the USPSTF’s analysis of the evidence and noted their consistency with current clinical practice.

The task force noted that research gaps remain and recognized the need to improve screening and treatment of genital herpes to prevent symptomatic episodes and transmission. Specifically, the USPSTF recommendation calls for more research to assess the accuracy of screening tests, to enroll more study participants from populations disproportionately affected by HSV, to examine the effect of behavioral counseling, and to clarify associations between HSV and pregnancy outcomes. In addition, the task force called for research to create an effective vaccine to prevent genital HSV infection and to develop a cure.
 

Targeted screening makes sense for now

“Given the frequency and severity of the range of diseases seen with HSV and the large proportion of persons who are asymptomatic, identifying carriers through type-specific serologic screening has long been considered a plausible strategy,” Mark D. Pearlman, MD, of the University of Michigan, Ann Arbor, wrote in an accompanying editorial.

However, accuracy of the currently available serology screening tests is low, and the adverse social and psychological effects and the impact on relationships for many asymptomatic individuals who test positive and may be incorrectly identified as infected remains a concern, said Dr. Pearlman.

Although some may be disagree about the value of routine serotesting for HSV-2 in asymptomatic individuals, other strategies can reduce the spread of infection and help those infected, he said.

Many experts continue to recommend targeted serotesting to high-risk populations, such as pregnant women whose nonpregnant partner is known to have genital or oral herpes and whose own infection status or serostatus is uncertain, said Dr. Pearlman. Other targeted strategies include screening individuals with recurrent or atypical genital symptoms and negative polymerase chain reaction assay or culture results, a clinical herpes diagnosis without laboratory confirmation, or those at increased risk because of a high number of sexual partners or a history of HIV infection, he said.

“Of note, the current CDC STI guidelines and ACOG both concur with the USPSTF that routine screening in the general population or routine screening during pregnancy are not recommended,” Dr. Pearlman said. Meanwhile, research efforts continue to help reduce the impact of HSV disease and development of a more effective testing methodology “might tip the balance in favor of routine screening” in the future, he emphasized.

The recommendations were supported by the Agency for Healthcare Research and Quality. The members of the task force received reimbursement for travel and an honorarium but had no other relevant financial conflicts to disclose. Dr. Pearlman had no financial conflicts to disclose.

Asymptomatic adults, teens, and pregnant women with no known history or symptoms of herpes infection need not undergo routine screening, according to the latest recommendation from the U.S. Preventive Services Task Force.

The 2023 recommendation reaffirms the conclusion from 2016, wrote Carol M. Mangione, MD, of the University of California, Los Angeles, and members of the task force.

“Currently, routine serologic screening for genital herpes is limited by the low predictive value of the widely available serologic screening tests and the expected high rate of false-positive results likely to occur with routine screening of asymptomatic persons in the U.S.,” the authors said.

In the recommendation, published in JAMA, the authors affirmed with moderate certainty and a grade D recommendation that the risks of routine screening for herpes simplex virus (HSV) in asymptomatic individuals outweigh the benefits.

The task force found no new evidence on the accuracy of serologic screening tests, the benefits of early detection and treatment, or on the harms of screening and treatment since the 2016 review of 17 studies in 19 publications, with data from more than 9,000 individuals.

Studies of the accuracy of serologic screening for herpes simplex virus-2 in the 2016 report mainly reflect populations with higher HSV-2 prevalence and are of limited applicability to the U.S. primary care population, the authors wrote. Evidence from the 2016 review also showed limited and inconsistent support for the early identification and treatment of HSV-2 in asymptomatic individuals, including those who were pregnant.

No new evidence has emerged since 2016 regarding harms of screening or treating genital herpes in asymptomatic individuals, the authors noted. “Based on previous evidence, the USPSTF estimated that using the widely available serologic tests for HSV-2, nearly 1 of every 2 diagnoses in the general U.S. primary care population could be false,” they said. The task force also concluded that the low accuracy of the current tests could prompt unnecessary treatment for individuals with false-positive diagnoses, as well as social and emotional harm for these individuals.

During a period of public comment from Aug. 16, 2022, to Sept. 12, 2022, individuals expressed concerns that the recommendation against routine screening showed a disinclination to take herpes seriously, and concerns that asymptomatic individuals could transmit the infection to sexual partners, the authors said. However, the estimated seroprevalence of HSV-1 and HSV-2 has declined in recent decades, and other comments supported the USPSTF’s analysis of the evidence and noted their consistency with current clinical practice.

The task force noted that research gaps remain and recognized the need to improve screening and treatment of genital herpes to prevent symptomatic episodes and transmission. Specifically, the USPSTF recommendation calls for more research to assess the accuracy of screening tests, to enroll more study participants from populations disproportionately affected by HSV, to examine the effect of behavioral counseling, and to clarify associations between HSV and pregnancy outcomes. In addition, the task force called for research to create an effective vaccine to prevent genital HSV infection and to develop a cure.
 

Targeted screening makes sense for now

“Given the frequency and severity of the range of diseases seen with HSV and the large proportion of persons who are asymptomatic, identifying carriers through type-specific serologic screening has long been considered a plausible strategy,” Mark D. Pearlman, MD, of the University of Michigan, Ann Arbor, wrote in an accompanying editorial.

However, accuracy of the currently available serology screening tests is low, and the adverse social and psychological effects and the impact on relationships for many asymptomatic individuals who test positive and may be incorrectly identified as infected remains a concern, said Dr. Pearlman.

Although some may be disagree about the value of routine serotesting for HSV-2 in asymptomatic individuals, other strategies can reduce the spread of infection and help those infected, he said.

Many experts continue to recommend targeted serotesting to high-risk populations, such as pregnant women whose nonpregnant partner is known to have genital or oral herpes and whose own infection status or serostatus is uncertain, said Dr. Pearlman. Other targeted strategies include screening individuals with recurrent or atypical genital symptoms and negative polymerase chain reaction assay or culture results, a clinical herpes diagnosis without laboratory confirmation, or those at increased risk because of a high number of sexual partners or a history of HIV infection, he said.

“Of note, the current CDC STI guidelines and ACOG both concur with the USPSTF that routine screening in the general population or routine screening during pregnancy are not recommended,” Dr. Pearlman said. Meanwhile, research efforts continue to help reduce the impact of HSV disease and development of a more effective testing methodology “might tip the balance in favor of routine screening” in the future, he emphasized.

The recommendations were supported by the Agency for Healthcare Research and Quality. The members of the task force received reimbursement for travel and an honorarium but had no other relevant financial conflicts to disclose. Dr. Pearlman had no financial conflicts to disclose.

For years, women’s health advocates have argued that far more research is needed on women’s bodies and health. The world’s first-ever “vagina on a chip,” recently developed at Harvard’s Wyss Institute for Biologically Inspired Engineering in Boston, could go a long way to making that happen. 

“Women’s health has not received the attention it deserves,” says Don Ingber, MD, PhD, who led the team that created the vagina chip. The advance quickly drew media attention after it was reported in the journal Microbiome. But researchers hope for more than headlines. They see the chip as a way to facilitate vaginal health research and open the door to vital new treatments. 

By now, you may have heard of “organs on chips”: tiny devices about the size of a flash drive that are designed to mimic the biological activity of human organs. These glass chips contain living human cells within grooves that allow the passage of fluid, to either maintain or disrupt the cells’ function. So far, Dr. Ingber and his team at the Wyss Institute have developed more than 15 organ chip models, including chips that mimic the lung, intestine, kidney, and bone marrow. 

The idea to develop a vagina chip grew out of research, funded by the Gates Foundation, on a childhood disease called environmental enteric dysfunction, an intestinal disease most commonly found in low-resource nations that is the second leading cause of death in children under 5. That’s when Dr. Ingber discovered just how much the child’s microbiome influences this disease. 

Stemming from that work, the Gates Foundation turned its attention to newborn health – in particular, the impact of bacterial vaginosis, an imbalance in the vagina’s bacterial makeup. Bacterial vaginosis occurs in one out of four women worldwide and has been linked to premature birth as well as HIV, HPV persistence, and cervical cancer. 

Upon establishing the Vaginal Microbiome Research Consortium,  the foundation asked Dr. Ingber to engineer an organ chip that mimicked the vagina’s microbiome. The goal was to test “live biotherapeutic products,” or living microbes like probiotics, that might restore the vagina’s microbiome to health.  

No other preclinical model exists to perform tests like that, says Dr. Ingber. 

“The vagina chip is a way to help make some advances,” he says. 

The Gates Foundation recognized that women’s reproductive health is a major issue, not only in low-income nations, but everywhere around the world. As the project evolved, Dr. Ingber began to hear from female colleagues about how neglected women’s reproductive health is in medical science. 

“It is something I became sensitive to and realized this is just the starting point,” Dr. Ingber says.

Take bacterial vaginosis, for example. Since 1982, treatment has revolved around the same two antibiotics. That’s partly because there is no animal model to study. No other species has the same vaginal bacterial community as humans do.

That makes developing any new therapy “incredibly challenging,” explains Caroline Mitchell, MD, MPH, an ob.gyn. at Massachusetts General Hospital, Boston, and a member of the consortium. 

It turns out, replicating the vagina in a lab dish is, to use the technical term, very hard. 

“That’s where a vagina chip offers an opportunity,” Dr. Mitchell says. “It’s not super-high throughput, but it’s way more high throughput than a [human] clinical trial.” 

As such, the vagina chip could help scientists find new treatments much faster. 

Like Dr. Ingber, Dr. Mitchell also sees the chip as a way to bring more attention to the largely unmet needs in female reproductive medicine.

“Women’s reproductive health has been under-resourced, under-prioritized, and largely disregarded for decades,” she says. And the time may be ripe for change: Dr. Mitchell says she was encouraged by the National Institutes of Health’s Advancing NIH Research on the Health of Women conference, held in 2021 in response to a congressional request to address women’s health research efforts.  

Beyond bacterial vaginosis, Dr. Mitchell imagines the chip could help scientists find new treatments for vaginal yeast infection (candidiasis), chlamydia, and endometriosis. As with bacterial vaginosis, medicines for vaginal yeast infections have not advanced in decades, Dr. Mitchell says.  Efforts to develop a vaccine for chlamydia – which can cause permanent damage to a woman’s reproductive system – have dragged on for many years. And endometriosis, an often painful condition in which the tissue that makes up the uterine lining grows outside the uterus, remains under-researched despite affecting 10% of childbearing-age women.

While some mouse models are used in chlamydia research, it’s hard to say if they’ll translate to humans, given the vaginal and cervical bacterial differences. 

“Our understanding of the basic physiology of the environment of the vagina and cervix is another area where we’re woefully ignorant,” Dr. Mitchell says.

To that end, Dr. Ingber’s team is developing more complex chips mimicking the vagina and the cervix. One of his team members wants to use the chips to study infertility. The researchers have already used the chips to see how bacterial vaginosis and mucous changes impact the way sperm migrates up the reproductive tract. 

The lab is now linking vagina and cervix chips together to study viral infections of the cervix, like HPV, and all types of bacterial diseases of the vaginal tract. By applying cervical mucus to the vagina chip, they hope to learn more about how female reproductive tissues respond to infection and inflammation.

“I always say that organ chips are like synthetic biology at the cell tissue and organ level,” says Dr. Ingber. “You start simple and see if you [can] mimic a clinical situation.” 

As they make the chips more complex – perhaps by adding blood vessel cells and female hormones – Dr. Ingber foresees being able to study the response to hormonal changes during the menstrual cycle.

“We can begin to explore the effects of cycling over time as well as other types of hormonal effects,” he says.

Dr. Ingber also envisions linking the vagina chip to other organ chips – he’s already succeeded in linking eight different organ types together. But for now, the team hopes the vagina chip will enhance our understanding of basic female reproductive biology and speed up the process of developing new treatments for women’s health. 

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

For years, women’s health advocates have argued that far more research is needed on women’s bodies and health. The world’s first-ever “vagina on a chip,” recently developed at Harvard’s Wyss Institute for Biologically Inspired Engineering in Boston, could go a long way to making that happen. 

“Women’s health has not received the attention it deserves,” says Don Ingber, MD, PhD, who led the team that created the vagina chip. The advance quickly drew media attention after it was reported in the journal Microbiome. But researchers hope for more than headlines. They see the chip as a way to facilitate vaginal health research and open the door to vital new treatments. 

By now, you may have heard of “organs on chips”: tiny devices about the size of a flash drive that are designed to mimic the biological activity of human organs. These glass chips contain living human cells within grooves that allow the passage of fluid, to either maintain or disrupt the cells’ function. So far, Dr. Ingber and his team at the Wyss Institute have developed more than 15 organ chip models, including chips that mimic the lung, intestine, kidney, and bone marrow. 

The idea to develop a vagina chip grew out of research, funded by the Gates Foundation, on a childhood disease called environmental enteric dysfunction, an intestinal disease most commonly found in low-resource nations that is the second leading cause of death in children under 5. That’s when Dr. Ingber discovered just how much the child’s microbiome influences this disease. 

Stemming from that work, the Gates Foundation turned its attention to newborn health – in particular, the impact of bacterial vaginosis, an imbalance in the vagina’s bacterial makeup. Bacterial vaginosis occurs in one out of four women worldwide and has been linked to premature birth as well as HIV, HPV persistence, and cervical cancer. 

Upon establishing the Vaginal Microbiome Research Consortium,  the foundation asked Dr. Ingber to engineer an organ chip that mimicked the vagina’s microbiome. The goal was to test “live biotherapeutic products,” or living microbes like probiotics, that might restore the vagina’s microbiome to health.  

No other preclinical model exists to perform tests like that, says Dr. Ingber. 

“The vagina chip is a way to help make some advances,” he says. 

The Gates Foundation recognized that women’s reproductive health is a major issue, not only in low-income nations, but everywhere around the world. As the project evolved, Dr. Ingber began to hear from female colleagues about how neglected women’s reproductive health is in medical science. 

“It is something I became sensitive to and realized this is just the starting point,” Dr. Ingber says.

Take bacterial vaginosis, for example. Since 1982, treatment has revolved around the same two antibiotics. That’s partly because there is no animal model to study. No other species has the same vaginal bacterial community as humans do.

That makes developing any new therapy “incredibly challenging,” explains Caroline Mitchell, MD, MPH, an ob.gyn. at Massachusetts General Hospital, Boston, and a member of the consortium. 

It turns out, replicating the vagina in a lab dish is, to use the technical term, very hard. 

“That’s where a vagina chip offers an opportunity,” Dr. Mitchell says. “It’s not super-high throughput, but it’s way more high throughput than a [human] clinical trial.” 

As such, the vagina chip could help scientists find new treatments much faster. 

Like Dr. Ingber, Dr. Mitchell also sees the chip as a way to bring more attention to the largely unmet needs in female reproductive medicine.

“Women’s reproductive health has been under-resourced, under-prioritized, and largely disregarded for decades,” she says. And the time may be ripe for change: Dr. Mitchell says she was encouraged by the National Institutes of Health’s Advancing NIH Research on the Health of Women conference, held in 2021 in response to a congressional request to address women’s health research efforts.  

Beyond bacterial vaginosis, Dr. Mitchell imagines the chip could help scientists find new treatments for vaginal yeast infection (candidiasis), chlamydia, and endometriosis. As with bacterial vaginosis, medicines for vaginal yeast infections have not advanced in decades, Dr. Mitchell says.  Efforts to develop a vaccine for chlamydia – which can cause permanent damage to a woman’s reproductive system – have dragged on for many years. And endometriosis, an often painful condition in which the tissue that makes up the uterine lining grows outside the uterus, remains under-researched despite affecting 10% of childbearing-age women.

While some mouse models are used in chlamydia research, it’s hard to say if they’ll translate to humans, given the vaginal and cervical bacterial differences. 

“Our understanding of the basic physiology of the environment of the vagina and cervix is another area where we’re woefully ignorant,” Dr. Mitchell says.

To that end, Dr. Ingber’s team is developing more complex chips mimicking the vagina and the cervix. One of his team members wants to use the chips to study infertility. The researchers have already used the chips to see how bacterial vaginosis and mucous changes impact the way sperm migrates up the reproductive tract. 

The lab is now linking vagina and cervix chips together to study viral infections of the cervix, like HPV, and all types of bacterial diseases of the vaginal tract. By applying cervical mucus to the vagina chip, they hope to learn more about how female reproductive tissues respond to infection and inflammation.

“I always say that organ chips are like synthetic biology at the cell tissue and organ level,” says Dr. Ingber. “You start simple and see if you [can] mimic a clinical situation.” 

As they make the chips more complex – perhaps by adding blood vessel cells and female hormones – Dr. Ingber foresees being able to study the response to hormonal changes during the menstrual cycle.

“We can begin to explore the effects of cycling over time as well as other types of hormonal effects,” he says.

Dr. Ingber also envisions linking the vagina chip to other organ chips – he’s already succeeded in linking eight different organ types together. But for now, the team hopes the vagina chip will enhance our understanding of basic female reproductive biology and speed up the process of developing new treatments for women’s health. 

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

For years, women’s health advocates have argued that far more research is needed on women’s bodies and health. The world’s first-ever “vagina on a chip,” recently developed at Harvard’s Wyss Institute for Biologically Inspired Engineering in Boston, could go a long way to making that happen. 

“Women’s health has not received the attention it deserves,” says Don Ingber, MD, PhD, who led the team that created the vagina chip. The advance quickly drew media attention after it was reported in the journal Microbiome. But researchers hope for more than headlines. They see the chip as a way to facilitate vaginal health research and open the door to vital new treatments. 

By now, you may have heard of “organs on chips”: tiny devices about the size of a flash drive that are designed to mimic the biological activity of human organs. These glass chips contain living human cells within grooves that allow the passage of fluid, to either maintain or disrupt the cells’ function. So far, Dr. Ingber and his team at the Wyss Institute have developed more than 15 organ chip models, including chips that mimic the lung, intestine, kidney, and bone marrow. 

The idea to develop a vagina chip grew out of research, funded by the Gates Foundation, on a childhood disease called environmental enteric dysfunction, an intestinal disease most commonly found in low-resource nations that is the second leading cause of death in children under 5. That’s when Dr. Ingber discovered just how much the child’s microbiome influences this disease. 

Stemming from that work, the Gates Foundation turned its attention to newborn health – in particular, the impact of bacterial vaginosis, an imbalance in the vagina’s bacterial makeup. Bacterial vaginosis occurs in one out of four women worldwide and has been linked to premature birth as well as HIV, HPV persistence, and cervical cancer. 

Upon establishing the Vaginal Microbiome Research Consortium,  the foundation asked Dr. Ingber to engineer an organ chip that mimicked the vagina’s microbiome. The goal was to test “live biotherapeutic products,” or living microbes like probiotics, that might restore the vagina’s microbiome to health.  

No other preclinical model exists to perform tests like that, says Dr. Ingber. 

“The vagina chip is a way to help make some advances,” he says. 

The Gates Foundation recognized that women’s reproductive health is a major issue, not only in low-income nations, but everywhere around the world. As the project evolved, Dr. Ingber began to hear from female colleagues about how neglected women’s reproductive health is in medical science. 

“It is something I became sensitive to and realized this is just the starting point,” Dr. Ingber says.

Take bacterial vaginosis, for example. Since 1982, treatment has revolved around the same two antibiotics. That’s partly because there is no animal model to study. No other species has the same vaginal bacterial community as humans do.

That makes developing any new therapy “incredibly challenging,” explains Caroline Mitchell, MD, MPH, an ob.gyn. at Massachusetts General Hospital, Boston, and a member of the consortium. 

It turns out, replicating the vagina in a lab dish is, to use the technical term, very hard. 

“That’s where a vagina chip offers an opportunity,” Dr. Mitchell says. “It’s not super-high throughput, but it’s way more high throughput than a [human] clinical trial.” 

As such, the vagina chip could help scientists find new treatments much faster. 

Like Dr. Ingber, Dr. Mitchell also sees the chip as a way to bring more attention to the largely unmet needs in female reproductive medicine.

“Women’s reproductive health has been under-resourced, under-prioritized, and largely disregarded for decades,” she says. And the time may be ripe for change: Dr. Mitchell says she was encouraged by the National Institutes of Health’s Advancing NIH Research on the Health of Women conference, held in 2021 in response to a congressional request to address women’s health research efforts.  

Beyond bacterial vaginosis, Dr. Mitchell imagines the chip could help scientists find new treatments for vaginal yeast infection (candidiasis), chlamydia, and endometriosis. As with bacterial vaginosis, medicines for vaginal yeast infections have not advanced in decades, Dr. Mitchell says.  Efforts to develop a vaccine for chlamydia – which can cause permanent damage to a woman’s reproductive system – have dragged on for many years. And endometriosis, an often painful condition in which the tissue that makes up the uterine lining grows outside the uterus, remains under-researched despite affecting 10% of childbearing-age women.

While some mouse models are used in chlamydia research, it’s hard to say if they’ll translate to humans, given the vaginal and cervical bacterial differences. 

“Our understanding of the basic physiology of the environment of the vagina and cervix is another area where we’re woefully ignorant,” Dr. Mitchell says.

To that end, Dr. Ingber’s team is developing more complex chips mimicking the vagina and the cervix. One of his team members wants to use the chips to study infertility. The researchers have already used the chips to see how bacterial vaginosis and mucous changes impact the way sperm migrates up the reproductive tract. 

The lab is now linking vagina and cervix chips together to study viral infections of the cervix, like HPV, and all types of bacterial diseases of the vaginal tract. By applying cervical mucus to the vagina chip, they hope to learn more about how female reproductive tissues respond to infection and inflammation.

“I always say that organ chips are like synthetic biology at the cell tissue and organ level,” says Dr. Ingber. “You start simple and see if you [can] mimic a clinical situation.” 

As they make the chips more complex – perhaps by adding blood vessel cells and female hormones – Dr. Ingber foresees being able to study the response to hormonal changes during the menstrual cycle.

“We can begin to explore the effects of cycling over time as well as other types of hormonal effects,” he says.

Dr. Ingber also envisions linking the vagina chip to other organ chips – he’s already succeeded in linking eight different organ types together. But for now, the team hopes the vagina chip will enhance our understanding of basic female reproductive biology and speed up the process of developing new treatments for women’s health. 

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

The only HIV vaccine nearing the completion of testing trials is not effective at preventing HIV, officials announced Wednesday.

The vaccine had been in development since 2019 and was given to 3,900 study participants through October 2022, but data shows it does not protect against HIV compared with a placebo, according to developer Janssen Pharmaceutical.

Experts estimate the failure means there won’t be another potential vaccine on the horizon for 3 to 5 years, the New York Times reported.

“It’s obviously disappointing,” Anthony Fauci, MD, former head of the National Institute of Allergy and Infectious Diseases, told MSNBC, noting that other areas of HIV treatment research are promising. “I don’t think that people should give up on the field of the HIV vaccine.”

No safety issues had been identified with the vaccine during the trial, which studied the experimental treatment in men who have sex with men or with transgender people.

There is no cure for HIV, but disease progression can be managed with existing treatments. HIV attacks the body’s immune system and destroys white blood cells, increasing the risk of other infections. More than 1.5 million people worldwide were infected with HIV in 2021 and 38.4 million people are living with the virus, according to UNAIDS.

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

The only HIV vaccine nearing the completion of testing trials is not effective at preventing HIV, officials announced Wednesday.

The vaccine had been in development since 2019 and was given to 3,900 study participants through October 2022, but data shows it does not protect against HIV compared with a placebo, according to developer Janssen Pharmaceutical.

Experts estimate the failure means there won’t be another potential vaccine on the horizon for 3 to 5 years, the New York Times reported.

“It’s obviously disappointing,” Anthony Fauci, MD, former head of the National Institute of Allergy and Infectious Diseases, told MSNBC, noting that other areas of HIV treatment research are promising. “I don’t think that people should give up on the field of the HIV vaccine.”

No safety issues had been identified with the vaccine during the trial, which studied the experimental treatment in men who have sex with men or with transgender people.

There is no cure for HIV, but disease progression can be managed with existing treatments. HIV attacks the body’s immune system and destroys white blood cells, increasing the risk of other infections. More than 1.5 million people worldwide were infected with HIV in 2021 and 38.4 million people are living with the virus, according to UNAIDS.

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

The only HIV vaccine nearing the completion of testing trials is not effective at preventing HIV, officials announced Wednesday.

The vaccine had been in development since 2019 and was given to 3,900 study participants through October 2022, but data shows it does not protect against HIV compared with a placebo, according to developer Janssen Pharmaceutical.

Experts estimate the failure means there won’t be another potential vaccine on the horizon for 3 to 5 years, the New York Times reported.

“It’s obviously disappointing,” Anthony Fauci, MD, former head of the National Institute of Allergy and Infectious Diseases, told MSNBC, noting that other areas of HIV treatment research are promising. “I don’t think that people should give up on the field of the HIV vaccine.”

No safety issues had been identified with the vaccine during the trial, which studied the experimental treatment in men who have sex with men or with transgender people.

There is no cure for HIV, but disease progression can be managed with existing treatments. HIV attacks the body’s immune system and destroys white blood cells, increasing the risk of other infections. More than 1.5 million people worldwide were infected with HIV in 2021 and 38.4 million people are living with the virus, according to UNAIDS.

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

PARIS – All the way back in 1907, The Lancet published an article on a gonorrhea vaccine trial. Today, after continuous research throughout the intervening 110-plus years, scientists may finally have achieved success. Sébastien Fouéré, MD, discussed the details at a press conference that focused on the highlights of the Dermatology Days of Paris conference. Dr. Fouéré is the head of the genital dermatology and sexually transmitted infections unit at Saint-Louis Hospital, Paris.

Twin bacteria

Although the gonorrhea vaccine has long been the subject of research, Dr. Fouéré views 2017 as a turning point. This was when the results of a study led by Helen Petousis-Harris, PhD, were published.

“She tried to formalize the not completely indisputable results published by Cuba, where it seemed there were fewer gonococci in individuals vaccinated against meningococcal group B,” he noted.

Dr. Petousis-Harris, an immunologist, conducted a retrospective case-control study involving 11 clinics in New Zealand. The participants were aged 15-30 years, were eligible to receive the meningococcal B vaccine, and had been diagnosed with gonorrhea, chlamydia, or both. The researchers found that receiving the meningococcal B vaccine in childhood provides around 30% protection against Neisseria gonorrhoeae infections.

“It’s not perhaps a coincidence that a meningococcal B vaccine would be protective against gonorrhea,” Dr. Fouéré pointed out. He considers this protection logical, even expected, insofar as “meningococcus and gonococcus are almost twins.” There is 90% and 100% homology between membrane proteins of the two bacteria.
 

Vaccine is effective

Two retrospective case-control studies confirm that the vaccine is protective. One of the studies, carried out by an Australian team, found that the effectiveness was 32%, quite close to that reported by Petousis-Harris. In the other study, a U.S. team brought to light a dose-response relationship. A partial vaccination series (single serogroup B meningococcal outer membrane vesicle vaccine dose) was 26% effective against gonorrhea, while a complete vaccination series (two MenB-4C doses) was 40% effective.

Prospective studies are in progress, which will provide a higher level of evidence. The ANRS DOXYVAC trial has been underway since January 2021. The participants are men who have sex with men, who are highly exposed to the risk of sexually transmitted infections, and who presented with at least one STI in the year before their participation in the study. “The study is being conducted by Jean-Michel Molina of Saint-Louis Hospital. What they’re trying to do is protect our cohort of pre-exposure prophylaxis patients with meningococcal vaccine,” explained Dr. Fouéré.

Initial findings demonstrated the efficacy of a meningococcal B vaccine in reducing the risk of gonorrhea and the efficacy of doxycycline as preventive intervention for STIs when taken within 72 hours after sexual intercourse. In light of these results, a decision was made at the end of October to discontinue the trial and to recommend providing both interventions to all ANRS DOXYVAC participants. The follow-up of the participants will continue until the end of 2023. The results that led to stopping the study in its current form will be presented in early 2023.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

PARIS – All the way back in 1907, The Lancet published an article on a gonorrhea vaccine trial. Today, after continuous research throughout the intervening 110-plus years, scientists may finally have achieved success. Sébastien Fouéré, MD, discussed the details at a press conference that focused on the highlights of the Dermatology Days of Paris conference. Dr. Fouéré is the head of the genital dermatology and sexually transmitted infections unit at Saint-Louis Hospital, Paris.

Twin bacteria

Although the gonorrhea vaccine has long been the subject of research, Dr. Fouéré views 2017 as a turning point. This was when the results of a study led by Helen Petousis-Harris, PhD, were published.

“She tried to formalize the not completely indisputable results published by Cuba, where it seemed there were fewer gonococci in individuals vaccinated against meningococcal group B,” he noted.

Dr. Petousis-Harris, an immunologist, conducted a retrospective case-control study involving 11 clinics in New Zealand. The participants were aged 15-30 years, were eligible to receive the meningococcal B vaccine, and had been diagnosed with gonorrhea, chlamydia, or both. The researchers found that receiving the meningococcal B vaccine in childhood provides around 30% protection against Neisseria gonorrhoeae infections.

“It’s not perhaps a coincidence that a meningococcal B vaccine would be protective against gonorrhea,” Dr. Fouéré pointed out. He considers this protection logical, even expected, insofar as “meningococcus and gonococcus are almost twins.” There is 90% and 100% homology between membrane proteins of the two bacteria.
 

Vaccine is effective

Two retrospective case-control studies confirm that the vaccine is protective. One of the studies, carried out by an Australian team, found that the effectiveness was 32%, quite close to that reported by Petousis-Harris. In the other study, a U.S. team brought to light a dose-response relationship. A partial vaccination series (single serogroup B meningococcal outer membrane vesicle vaccine dose) was 26% effective against gonorrhea, while a complete vaccination series (two MenB-4C doses) was 40% effective.

Prospective studies are in progress, which will provide a higher level of evidence. The ANRS DOXYVAC trial has been underway since January 2021. The participants are men who have sex with men, who are highly exposed to the risk of sexually transmitted infections, and who presented with at least one STI in the year before their participation in the study. “The study is being conducted by Jean-Michel Molina of Saint-Louis Hospital. What they’re trying to do is protect our cohort of pre-exposure prophylaxis patients with meningococcal vaccine,” explained Dr. Fouéré.

Initial findings demonstrated the efficacy of a meningococcal B vaccine in reducing the risk of gonorrhea and the efficacy of doxycycline as preventive intervention for STIs when taken within 72 hours after sexual intercourse. In light of these results, a decision was made at the end of October to discontinue the trial and to recommend providing both interventions to all ANRS DOXYVAC participants. The follow-up of the participants will continue until the end of 2023. The results that led to stopping the study in its current form will be presented in early 2023.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

PARIS – All the way back in 1907, The Lancet published an article on a gonorrhea vaccine trial. Today, after continuous research throughout the intervening 110-plus years, scientists may finally have achieved success. Sébastien Fouéré, MD, discussed the details at a press conference that focused on the highlights of the Dermatology Days of Paris conference. Dr. Fouéré is the head of the genital dermatology and sexually transmitted infections unit at Saint-Louis Hospital, Paris.

Twin bacteria

Although the gonorrhea vaccine has long been the subject of research, Dr. Fouéré views 2017 as a turning point. This was when the results of a study led by Helen Petousis-Harris, PhD, were published.

“She tried to formalize the not completely indisputable results published by Cuba, where it seemed there were fewer gonococci in individuals vaccinated against meningococcal group B,” he noted.

Dr. Petousis-Harris, an immunologist, conducted a retrospective case-control study involving 11 clinics in New Zealand. The participants were aged 15-30 years, were eligible to receive the meningococcal B vaccine, and had been diagnosed with gonorrhea, chlamydia, or both. The researchers found that receiving the meningococcal B vaccine in childhood provides around 30% protection against Neisseria gonorrhoeae infections.

“It’s not perhaps a coincidence that a meningococcal B vaccine would be protective against gonorrhea,” Dr. Fouéré pointed out. He considers this protection logical, even expected, insofar as “meningococcus and gonococcus are almost twins.” There is 90% and 100% homology between membrane proteins of the two bacteria.
 

Vaccine is effective

Two retrospective case-control studies confirm that the vaccine is protective. One of the studies, carried out by an Australian team, found that the effectiveness was 32%, quite close to that reported by Petousis-Harris. In the other study, a U.S. team brought to light a dose-response relationship. A partial vaccination series (single serogroup B meningococcal outer membrane vesicle vaccine dose) was 26% effective against gonorrhea, while a complete vaccination series (two MenB-4C doses) was 40% effective.

Prospective studies are in progress, which will provide a higher level of evidence. The ANRS DOXYVAC trial has been underway since January 2021. The participants are men who have sex with men, who are highly exposed to the risk of sexually transmitted infections, and who presented with at least one STI in the year before their participation in the study. “The study is being conducted by Jean-Michel Molina of Saint-Louis Hospital. What they’re trying to do is protect our cohort of pre-exposure prophylaxis patients with meningococcal vaccine,” explained Dr. Fouéré.

Initial findings demonstrated the efficacy of a meningococcal B vaccine in reducing the risk of gonorrhea and the efficacy of doxycycline as preventive intervention for STIs when taken within 72 hours after sexual intercourse. In light of these results, a decision was made at the end of October to discontinue the trial and to recommend providing both interventions to all ANRS DOXYVAC participants. The follow-up of the participants will continue until the end of 2023. The results that led to stopping the study in its current form will be presented in early 2023.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

TAMPA – Boosting screening for sexually transmitted infections in primary care settings could help alleviate some of the barriers to optimal testing and treatment, a new quality improvement initiative suggests.

Many primary care doctors are challenged for time and send people to other health care settings, such as a local health department or a clinic that specializes in STI diagnosis and treatment, said Wendy Kays, DNP, APRN, AGNP-BC, AAHIVS, a nurse practitioner and researcher at Care Resource, Miami.

However, for multiple reasons, many patients do not follow up and are not screened or treated, Dr. Kays said at the Association of Nurses in AIDS Care annual meeting. Some people can afford the copay to see a primary care provider, for example, but do not have the resources to pay for a second clinical visit or laboratory testing.

In other instances, transportation can be a problem. “People, especially in the neighborhood where we are located, depend a lot on buses to go to their primary care,” Dr. Kays told this news organization. But “follow-up is very important. It can promote early treatment and prevent the spread of disease.”

Primary care is critical as a gateway into health care that could help address low rates of STI screening, she said. There is also evidence that STIs are on the rise because of the COVID-19 pandemic.

If more primary care doctors tested and treated STIs using standardized Centers for Disease Control and Prevention guidelines, patients would not have to make a trip to another location, Dr. Kays said.

“The primary health setting … is actually the perfect place to get your screening,” said Jimmie Leckliter, MSN-Ed, RN, PHN, in an interview. He was not affiliated with the presentation. “I’m a former ER nurse, and a lot of people are using the ER as primary care, and it’s not really set up to do that screening.”

Mr. Leckliter suggested that primary care doctors incorporate some questions about sexual health during a regular head-to-toe checkup and ask questions in a very clinical, nonjudgmental way.

He also acknowledged that for some physicians it can be uncomfortable to raise the issues. “Unfortunately, I think in our society, talking to people about sex is taboo, and people become uncomfortable. We need to be able to learn to put our biases aside and treat our patients. That’s what our job is, added Mr. Leckliter, an adjunct faculty member at the College of the Desert’s School of Nursing and Allied Health Programs, Palm Springs, Calif.

Clinicians should be aware of the stigma associated with sending a person to an STD clinic for further workup, Mr. Leckliter advised. “You have to look at the stigma in the community in which you’re located. It makes a big difference,” he said. “Is it mainly a Latino or African American community?”
 

Compliance was a challenge

Dr. Kays and colleague performed a quality improvement project focused on implementing the CDC’s STI treatment guidelines at Care Resource. One goal was to educate a multidisciplinary team on the importance of screening in the primary care setting. The clientele at Care Resource consists primarily of underprivileged minorities, including the Latino, Black, gay, and transgender communities.

Six health care providers participated – two medical doctors and four advanced-practice providers. They evaluated patient charts from the electronic health record system 4 weeks before the intervention and 4 weeks after.

The education had a positive impact, the researchers reported, even though three providers were compliant with the CDC-recommended screening protocol and three others were not.

The quality improvement initiative had some limitations, Dr. Kays noted. “The hope is that the [quality improvement] process will continue moving forward, and early diagnosis and treatment of STIs will be standardized in this primary care practice.”

An evidence-based tool to screen for STIs in primary care is “crucial,” she added. Using a standardized, evidence-based protocol in primary care “can create positive change in patients’ outcomes.”

The study was independently supported. Dr. Kays and Mr. Leckliter report no relevant financial relationships.

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

TAMPA – Boosting screening for sexually transmitted infections in primary care settings could help alleviate some of the barriers to optimal testing and treatment, a new quality improvement initiative suggests.

Many primary care doctors are challenged for time and send people to other health care settings, such as a local health department or a clinic that specializes in STI diagnosis and treatment, said Wendy Kays, DNP, APRN, AGNP-BC, AAHIVS, a nurse practitioner and researcher at Care Resource, Miami.

However, for multiple reasons, many patients do not follow up and are not screened or treated, Dr. Kays said at the Association of Nurses in AIDS Care annual meeting. Some people can afford the copay to see a primary care provider, for example, but do not have the resources to pay for a second clinical visit or laboratory testing.

In other instances, transportation can be a problem. “People, especially in the neighborhood where we are located, depend a lot on buses to go to their primary care,” Dr. Kays told this news organization. But “follow-up is very important. It can promote early treatment and prevent the spread of disease.”

Primary care is critical as a gateway into health care that could help address low rates of STI screening, she said. There is also evidence that STIs are on the rise because of the COVID-19 pandemic.

If more primary care doctors tested and treated STIs using standardized Centers for Disease Control and Prevention guidelines, patients would not have to make a trip to another location, Dr. Kays said.

“The primary health setting … is actually the perfect place to get your screening,” said Jimmie Leckliter, MSN-Ed, RN, PHN, in an interview. He was not affiliated with the presentation. “I’m a former ER nurse, and a lot of people are using the ER as primary care, and it’s not really set up to do that screening.”

Mr. Leckliter suggested that primary care doctors incorporate some questions about sexual health during a regular head-to-toe checkup and ask questions in a very clinical, nonjudgmental way.

He also acknowledged that for some physicians it can be uncomfortable to raise the issues. “Unfortunately, I think in our society, talking to people about sex is taboo, and people become uncomfortable. We need to be able to learn to put our biases aside and treat our patients. That’s what our job is, added Mr. Leckliter, an adjunct faculty member at the College of the Desert’s School of Nursing and Allied Health Programs, Palm Springs, Calif.

Clinicians should be aware of the stigma associated with sending a person to an STD clinic for further workup, Mr. Leckliter advised. “You have to look at the stigma in the community in which you’re located. It makes a big difference,” he said. “Is it mainly a Latino or African American community?”
 

Compliance was a challenge

Dr. Kays and colleague performed a quality improvement project focused on implementing the CDC’s STI treatment guidelines at Care Resource. One goal was to educate a multidisciplinary team on the importance of screening in the primary care setting. The clientele at Care Resource consists primarily of underprivileged minorities, including the Latino, Black, gay, and transgender communities.

Six health care providers participated – two medical doctors and four advanced-practice providers. They evaluated patient charts from the electronic health record system 4 weeks before the intervention and 4 weeks after.

The education had a positive impact, the researchers reported, even though three providers were compliant with the CDC-recommended screening protocol and three others were not.

The quality improvement initiative had some limitations, Dr. Kays noted. “The hope is that the [quality improvement] process will continue moving forward, and early diagnosis and treatment of STIs will be standardized in this primary care practice.”

An evidence-based tool to screen for STIs in primary care is “crucial,” she added. Using a standardized, evidence-based protocol in primary care “can create positive change in patients’ outcomes.”

The study was independently supported. Dr. Kays and Mr. Leckliter report no relevant financial relationships.

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

TAMPA – Boosting screening for sexually transmitted infections in primary care settings could help alleviate some of the barriers to optimal testing and treatment, a new quality improvement initiative suggests.

Many primary care doctors are challenged for time and send people to other health care settings, such as a local health department or a clinic that specializes in STI diagnosis and treatment, said Wendy Kays, DNP, APRN, AGNP-BC, AAHIVS, a nurse practitioner and researcher at Care Resource, Miami.

However, for multiple reasons, many patients do not follow up and are not screened or treated, Dr. Kays said at the Association of Nurses in AIDS Care annual meeting. Some people can afford the copay to see a primary care provider, for example, but do not have the resources to pay for a second clinical visit or laboratory testing.

In other instances, transportation can be a problem. “People, especially in the neighborhood where we are located, depend a lot on buses to go to their primary care,” Dr. Kays told this news organization. But “follow-up is very important. It can promote early treatment and prevent the spread of disease.”

Primary care is critical as a gateway into health care that could help address low rates of STI screening, she said. There is also evidence that STIs are on the rise because of the COVID-19 pandemic.

If more primary care doctors tested and treated STIs using standardized Centers for Disease Control and Prevention guidelines, patients would not have to make a trip to another location, Dr. Kays said.

“The primary health setting … is actually the perfect place to get your screening,” said Jimmie Leckliter, MSN-Ed, RN, PHN, in an interview. He was not affiliated with the presentation. “I’m a former ER nurse, and a lot of people are using the ER as primary care, and it’s not really set up to do that screening.”

Mr. Leckliter suggested that primary care doctors incorporate some questions about sexual health during a regular head-to-toe checkup and ask questions in a very clinical, nonjudgmental way.

He also acknowledged that for some physicians it can be uncomfortable to raise the issues. “Unfortunately, I think in our society, talking to people about sex is taboo, and people become uncomfortable. We need to be able to learn to put our biases aside and treat our patients. That’s what our job is, added Mr. Leckliter, an adjunct faculty member at the College of the Desert’s School of Nursing and Allied Health Programs, Palm Springs, Calif.

Clinicians should be aware of the stigma associated with sending a person to an STD clinic for further workup, Mr. Leckliter advised. “You have to look at the stigma in the community in which you’re located. It makes a big difference,” he said. “Is it mainly a Latino or African American community?”
 

Compliance was a challenge

Dr. Kays and colleague performed a quality improvement project focused on implementing the CDC’s STI treatment guidelines at Care Resource. One goal was to educate a multidisciplinary team on the importance of screening in the primary care setting. The clientele at Care Resource consists primarily of underprivileged minorities, including the Latino, Black, gay, and transgender communities.

Six health care providers participated – two medical doctors and four advanced-practice providers. They evaluated patient charts from the electronic health record system 4 weeks before the intervention and 4 weeks after.

The education had a positive impact, the researchers reported, even though three providers were compliant with the CDC-recommended screening protocol and three others were not.

The quality improvement initiative had some limitations, Dr. Kays noted. “The hope is that the [quality improvement] process will continue moving forward, and early diagnosis and treatment of STIs will be standardized in this primary care practice.”

An evidence-based tool to screen for STIs in primary care is “crucial,” she added. Using a standardized, evidence-based protocol in primary care “can create positive change in patients’ outcomes.”

The study was independently supported. Dr. Kays and Mr. Leckliter report no relevant financial relationships.

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