When given a choice of two proven HIV pre-exposure prophylaxis (PrEP) options, young cisgender women will use both but prefer a monthly vaginal ring, according to data presented at the Conference on Retroviruses and Opportunistic Infections 2022 (CROI 2022).
The current approved biomedical prevention methods for people who have vaginal sex are daily Truvada (tenofovir disoproxil fumarate/emtricitabine) PrEP pills and every-other-month injections (Apretude). Studies have shown that Truvada does not seem to work as well for cisgender women as it does for gay and bisexual men, largely due to suboptimal adherence, but the injections are highly effective for women.
Another option is a vaginal ring containing the antiretroviral drug dapivirine. The World Health Organization recommended the monthly ring for PrEP in areas of high HIV burden in January 2021, but the ring’s maker recently withdrew it from the U.S. regulatory approval process.
The REACH (Reversing the Epidemic in Africa with Choices in HIV prevention) study followed 247 adolescent girls and young women in South Africa, Uganda and Zimbabwe for a year and a half. The women were about 18 years old on average, 87% were unmarried, 40% had ever been pregnant, 77% had completed secondary education and one in five made their own money.
The participants were randomized to use either the monthly vaginal ring or daily oral PrEP. During the first six months, they used the prevention method initially assigned to them, and six months later, they switched to the other one. Then, after another six months, they could choose to use daily oral PrEP, the dapivirine ring or nothing at all. That way, the women got to try out each prevention method for six months before deciding which they’d choose on their own.
In addition, participants also had access to a “diverse menu of adherence support options,” said presenter Kenneth Ngure, PhD, of Jomo Kenyatta University in Nairobi. These included daily text messages, in-person and virtual adherence support groups, drug adherence feedback and custom text messages.
More than nine out of 10 participants completed the first year of the study and got the opportunity to select either PrEP method—or none—for themselves. Interestingly, those who were randomized to start with daily oral PrEP were significantly more likely to choose it in the final leg of the study. The same wasn’t true for the ring. Still, when given a choice, two-thirds of the women (67%) chose the monthly ring while 31% chose daily PrEP pills and 2% chose nothing.
Contrary to previous studies, women in both study arms used their PrEP methods relatively consistently. Blood samples from fewer than 5% of visits showed residual dapivirine or tenofovir drug levels low enough to count as non-use. In the final leg of the study, 66% of those who chose the dapivirine ring had residual drug levels left in the ring at the end of the month that were consistent with daily use. For women using PrEP pills, 58% had tenofovir levels consistent with daily use.
“REACH has taught us that adolescent girls can make informed choices about HIV prevention products and can use products effectively with proper support,” Ngure said.
The results were hailed as a watershed moment in women’s HIV prevention research by AVAC executive director Mitchell Warren, who said the findings “reinforce the power of choice.”
“At a time when regulatory agencies, policymakers and funders are reviewing inclusion of the dapivirine vaginal ring in HIV prevention programs and platforms, we must recognize that the most effective intervention is the one someone picks for themselves among an array of effective choices,” he said. “REACH provides critical endorsement of both the ring and daily oral PrEP as two safe and effective options that many women need and can use, and of the need to provide multiple options from which women can choose.”
Click here to read the study abstract.
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