Analysis Sexual Health

New Study Suggests HIV Risk with Hormonal Contraceptives: What It Means for Family Planning Policy and Programs

Ruwaida Salem

new study published this week in The Lancet Infectious Diseases suggests that use of hormonal contraceptives, particularly injectables, may double the risk of uninfected women acquiring HIV. 

Cross-posted with permission from K4Health.

A new study published this week in The Lancet Infectious Diseases suggests that use of hormonal contraceptives, particularly injectables, may double the risk of uninfected women acquiring HIV. The study also suggests that use of injectables may double the risk of HIV-infected women transmitting the virus to their uninfected partners. The large study followed 3,790 HIV-discordant couples, in which only one partner had HIV infection, in seven African countries. (Rewire initially reported on the study here.)

 

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News of the study findings, reported in the New York Times and elsewhere, sent ripples of concern among the international public health community. Family planning programs and service providers want to know what this means for their programs and for the women and couples they serve.

For now, international health organizations and donors, including the World Health Organization (WHO), the Joint United Nations Programme on HIV/AIDS (UNAIDS), and the U.S. Agency for International Development (USAID), caution against making hasty changes to contraceptive policy or practice. WHO is convening a Technical Consultation of a multi-disciplinary group of experts from 31 January to 1 February 2012 to examine all evidence related to the potential effects of hormonal contraception on HIV acquisition, transmission, and disease progression. The experts will decide through consensus whether modifications need to be made to the current WHO guidance for hormonal method use among women with HIV or AIDS, or women at risk of HIV.

Hormonal methods are the most commonly used contraceptives in sub‑Saharan Africa. The Guttmacher Institute reports that 12 million women use injectables and 8 million use oral contraceptive pills, while 11 million women use non-hormonal methods. Over the past 15 years, the number of women choosing to use injectables has grown substantially because the method appeals to many women who want a highly effective method that does not require daily action and that can be used privately.

Several strengths of the new study are making the international public health community pay close attention to the findings. Charles Morrison and Kavita Nanda of FHI 360 note that the main strength of the study is it provided direct data on the risk of hormonal method users acquiring HIV from their infected male partners and, conversely, of hormonal method users with HIV transmitting the virus to their uninfected partners, because only one partner in the couple had HIV infection when they were enrolled. In addition, the study used sophisticated analytical techniques.

However, WHO and USAID stress the importance of reviewing the new study in context of the entire body of published evidence on this issue, especially because the study had several limitations despite its strengths:

  • Study participants chose whether they wanted to use contraception and which method they wanted to use. Participants who chose hormonal contraceptive methods may differ in important ways from non-hormonal method users. For example, hormonal method users could potentially have sex more frequently or use condoms less often than non-hormonal method users. Only a randomized controlled trial, in which participants would be randomly assigned to use a particular method, could provide definitive answers. Some experts are calling for such a study.
  • The study was not designed specifically to examine HIV risk with hormonal method use. Rather, it was a secondary analysis of data from an HIV prevention trial.
  • Few women in the study used hormonal methods: 624 women used hormonal methods at enrollment among the 3,790 total women enrolled (16 percent).
  • There were few new HIV infections among hormonal method users (10 new HIV infections among users of injectables and 3 new HIV infections among pill users).
  • Contraceptive use was self-reported by study participants and not confirmed by clinical records.
  • Contraceptives were not provided at all 14 sites in the seven African countries.
  • Study participants commonly switched contraceptive methods: almost half of the participants who used hormonal methods, either at enrollment or at some later point during the study, used a non-hormonal method or no method at some other point during the follow-up period.

While the public health community anxiously waits for definitive answers from the WHO Technical Consultation in January 2012, they emphasize that the study does drive home certain points that they have been advocating for years:

The public health community will need to consider the evidence published this week carefully, balancing the potential risk of HIV with the real risk of unintended pregnancy, which contributes to maternal disease and death. This is especially true in the context of sub-Saharan Africa, the region that bears the largest share of the global HIV burden, where 60 percent of those living with HIV are women and 39 percent of pregnancies in the region already are unintended.

Roundups Sexual Health

This Week in Sex: News From the HIV Epidemic

Martha Kempner

This week in sex: Scientists report the first case of HIV transmission to a patient adhering to PrEP protocols, two studies show a new vaginal ring can help women prevent HIV, and young people still aren't getting tested for the virus.

This Week in Sex is a weekly summary of news and research related to sexual behavior, sexuality education, contraception, STIs, and more.

With the death of Nancy Reagan, the 1980s AIDS crisis is back in the national spotlight. But, of course, HIV and AIDS are still ongoing problems that affect millions of people. This week in sex, we review scientists reporting the first case of HIV transmission to a patient adhering to PrEP protocols, two studies showing a new vaginal ring can help women prevent HIV, and evidence that young people still aren’t getting tested for the virus.

First Case of HIV Transmission While on Truvada

Last week, Canadian scientists reported on what they believe to be the first HIV infection in a patient who was following a PreP (Pre-Exposure Prophylaxis) regimen.

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PrEP is a method of HIV prevention. By taking a daily pill that contains two HIV medicines, sold under the name Truvada, individuals who are HIV-negative but considered to be at high risk of contracting the virus can prevent infection. Studies have found that PrEP is very effective—the Centers for Disease Control and Prevention estimates that people who take the medication every day can reduce their risk of infection by more than 90 percent from sex and by more than 70 percent from injection drug use. One study of men taking PrEP found no infections over a two-and-a-half-year period.

PrEP is less effective when not taken regularly, but the new case of reported PrEP failure involves a 43-year-old man who said that he took his medication daily. His pharmacy records back up that assertion. The man’s partner has HIV, but is on a drug regimen and has an undetectable viral load. The man did report other sexual encounters without condoms with casual partners in the weeks leading up to his diagnosis.

Dr. David Knox, the lead author of this case study, notes that it is difficult to know if a patient really did adhere to the drug regimen, but the evidence in this case suggests that he did. He concluded, “Failure of PrEP in this case was likely due to the transmission of a PrEP-resistant, multi-class resistant strain of HIV 1.”

Experts say, however, that they never expected PrEP to be infallible. As Richard Harrigan of the British Columbia Center for Excellence in HIV/AIDS told Pink News, “I certainly don’t think that this is a situation which calls for panic …. It is an example that demonstrates that PrEP can sometimes be ineffective in the face of drug resistant virus, in the same way that treatment itself can sometimes be ineffective in the face of drug resistant virus.”

Still, some fear that the new study will add to the ongoing debate and apathy that seem to surround PrEP. While some experts see it as a must-have prevention tool, others worry that it will encourage men who have sex with men to forgo using condoms and perhaps increase their risk for other sexually transmitted infections. Still, only 30,000 people in the United States are taking the drug—an estimated one-twentieth of those who could benefit from it.

A New Vaginal Ring Could Help Women Prevent HIV Infection

Researchers have announced promising results from two studies looking at new technology that could help women prevent HIV. The dapivirine ring, named after the drug it contains, was developed by the International Partnership for Microbicides. It looks like the contraceptive ring, Nuvaring, and is similarly inserted high up into the vagina for a month at a time. Instead of releasing hormones to prevent ovulation, however, this ring releases an antiretroviral drug to prevent HIV from reproducing in healthy cells. (A ring that could prevent both pregnancy and HIV is being developed.)

The two studies of the ring are being conducted in Africa. One study recruited about 2,600 women in Malawi, South Africa, Uganda, and Zimbabwe. It found that the ring reduced HIV infection by 27 percent overall and 61 percent for women over age 25. The other study, which is still underway, involves just under 2,000 women in seven sites in South Africa and Uganda. Early results suggest that the ring reduced infection by 31 percent overall when compared to the placebo.

Both studies found that the ring provided little protection to women ages 18-to-21. Researchers are now working to determine how adherence and other biological factors may have impacted such an outcome.

Young People Not Getting Tested for HIV

A study in the February issue of Pediatrics found that HIV testing rates among young people have not increased in the last decade. The researchers looked at data from the Youth Risk Behavior Survey (YRBS), which asks current high school students about sexual behaviors in addition to questions about drugs and alcohol, violence, nutrition, and personal safety (such as using bike helmets and seat belts). Specifically, the YRBS asks students if they’ve ever been tested for HIV.

Using YRBS data collected between 2005 and 2013, the researchers estimated that 22 percent of teens who had ever had sex had been tested for HIV. The percent who had received HIV tests was higher (34 percent) among those who reported four or more lifetime partners. Overall, male teens (17 percent) were less likely than their female peers (27 percent) to have been tested.

Researchers also looked at data from the Behavioral Risk Factor Surveillance System, which asks similar questions to young adults ages 18 to 24. Among people in this age group, between the years of 2011 to 2013, an average of 33 percent had ever been tested. This review of data also found that the percentage of young women who get tested for HIV has been decreasing in recent years—from 42.4 percent in 2011 to 39.5 percent in 2013.

The authors simply conclude, “HIV testing programs do not appear to be successfully reaching high school students and young adults.” They go on to suggest, “Multipronged testing strategies, including provider education, system-level interventions in clinical settings, adolescent-friendly testing services, and sexual health education will likely be needed to increase testing and reduce the percentage of adolescents and young adults living with HIV infection.”

News Abortion

Texas Official Forced Out After Peer-Reviewed Study Critiques GOP’s Contraceptive Policy

Teddy Wilson

Rick Allgeyer was one of five co-authors of a study that found negative consequences for contraceptive users after Republicans banned Planned Parenthood from the Texas family planning program.

A Texas official is being forced to retire due to pressure from Republican legislators who took exception to a study he co-authored. The study found GOP efforts to exclude Planned Parenthood from the state’s family planning programs had a detrimental effect on access to reproductive health care.

Rick Allgeyer, director of research at the Texas Health and Human Services Commission, was one of five co-authors of a study that found widespread negative consequences for contraceptive users after Republicans in 2013 banned Planned Parenthood from the Texas family planning program.

The study, published in The New England Journal of Medicine, found that after Planned Parenthood affiliates were excluded from the Texas Medicaid program beginning in 2013, delivery of the most effective reversible methods of contraception, including IUDs, implants, and injectable contraception, declined.

There was a substantial reduction, for example, in use of injectable contraception among patients reliant on this method of birth control and a 27 percent increase in births covered by Medicaid.

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State Sen. Jane Nelson (R-Flower Mound) told ABC News that state employees should not have been co-authors of the study.

“It’s one thing for an agency to provide data upon request. It’s quite another to be listed as a ‘co-author’ on a deeply flawed and highly political report,” Nelson said. “I’ve communicated strong concerns to the agency. This should not have happened, and we need to make sure it doesn’t happen again.”

Nelson wrote a letter to Chris Traylor, executive commissioner of the Health and Human Services Commission, requesting that the commission review the study. “While I appreciate efforts to shine light on policy challenges, it is important for that information to paint an accurate picture,” Nelson wrote.

“Critical evaluation is essential to good government,” Nelson continued. “But women should not be misled into thinking the services they need are not available to them. Those services are readily available, and Texas women need to know that.”

Nelson has a long history of supporting policies that choke off access to reproductive health care, and Nelson has defended these policies against mounting evidence that they have had a detrimental impact on women’s health in the state.

Bryan Black, spokesperson for the state health commission, told the Texas Tribune that Allgeyer violated the agency’s policy for working part-time outside of the agency, without explicit permission.

“Rick Allgeyer is eligible for retirement and has decided to retire from the Health and Human Services Commission,” Black said in an email. “His retirement is effective March 31.”

Black wrote that Allgeyer “broke policy by working on the study during his workday. He should have never been putting in time on this study during the normal business day, he was paid to perform state business.”