It was never a surprise to Allen Kakiza, a 44-year-old primary school teacher, when the women in her community returned from a visit to the local clinic with a diagnosis of HIV. But it was always heartbreaking, she said, speaking from the crowded neighborhood where she lives in Uganda’s capital, Kampala.
Many of her friends and neighbors are married or have an exclusive boyfriend, and they follow the HIV prevention lesson that has been drummed into their heads from a young age: be faithful. The same isn’t always true of their partners, though.
“Most of our partners, they move out looking for other women,” she said, her voice rising with anger. “So you find a woman who spends all of her time at home is infected.” They often feel powerless to combat the threat, she said. Even if a woman suspects her partner of having unprotected sex with someone else, there is bound to be an argument — maybe even violence — if she suggests that he use a condom.
“I saw people suffering with HIV,” Kakiza said. In the patriarchal Ugandan society, families often assume it is the woman who first acquired the virus, despite any evidence to the contrary. That often becomes a justification for shunning her. Stigma follows her through daily life either way.
What women need, Kakiza said decisively, is an HIV prevention method that they control.
With her simple demand, Kakiza hits on a critical issue confronting researchers. The global HIV epidemic is increasingly becoming feminized. In sub-Saharan Africa, the heart of the pandemic, adolescent girls and young women account for 71 percent of all new infections among young people. While prevention tools exist, researchers haven’t yet found one that women actually want to — and are able to discreetly — use.
There is a need “for self-initiated products that women, especially young women, can and will use consistently. Women need practical and discreet tools that they can use to protect themselves from HIV infection,” said Dr. Flavia Matovu, an epidemiologist and investigator with the Makerere University-Johns Hopkins University Research Collaboration, based in Uganda.
Now, researchers including Matovu hope they may have an option in the vaginal ring, a flexible piece of silicon laced with an antiretroviral medication. Women insert it near their cervix, where it can safely remain for about a month, slowing releasing the drug at the site of a potential infection. The method is being tested in two crucial “open label” extension studies, wherein all willing participants will receive the medicated ring, rather than a placebo.
If the trials show both that women want to use the ring and that, when they do, it is effective, this intervention has the potential to transform the way the global health community fights the spread of HIV.
The right product
“All previous HIV prevention efforts in women have been curtailed by poor adherence,” Matovu told Devex, laying out the challenge. She is the investigator of record for one of two recent clinical trials to determine the efficacy and safety of the ring.
Creating effective prevention tools for women has confounded researchers for years, a result of social, but also biological realities. It is difficult to create a barrier or design a tool that protects the highly susceptible vaginal cells from becoming infected, but that is simultaneously undetectable to a sexual partner. At the same time, researchers know any interventions they introduce cannot reduce a woman’s sexual pleasure, or they are unlikely to be used.
“It’s not [just about] the greatest science, necessarily, but also the product,” said Dr. Sharon Hillier, a microbiologist who calls herself a “vagina ecologist”. “We’re paying attention to putting the best product with the best science there is.”
As an example of a high-profile failure, Matovu pointed to a gel-based microbicide that women could insert into their vaginas. Recent trial results were disappointing, demonstrating little effectiveness. Subsequent analysis seemed to indicate that may have been because women who participated in the trial did not actually use the gel.
Another promising new intervention, pre-exposure prophylaxis (PrEP), encourages people at high risk of contracting HIV to pre-emptively take antiretrovirals, which can dramatically reduce their risk of infection. But it requires them to travel to a clinic and refill the medication once a month — not the most discreet activity.
The ring could be different, Matovu said, calling it “a major step toward new, self-initiated HIV prevention options for women.” Unlike the gel, it doesn’t need to be inserted on a daily basis or before and after sexual activity. And, more discreet than a gel or a bottle of medicine, it’s also much less likely to be discovered by a sexual partner. Researchers are already considering rings that would last for three months, which would also help limit the number of times a woman would have to travel to a clinic for a new one.
A rough start
The results of Matovu’s initial studies of the ring were not exactly what she and other researchers were hoping for, though. The trial, which ran from August 2012 to June 2015, found the ring reduced HIV infections among users by 27 percent, compared to a placebo. The other study, run by the International Partnership for Microbicides showed a 31 percent overall reduction. The results were startlingly low among young women. In Matovu’s study, the ring had no benefit for women between 18 and 21 years old, while the other trial showed only 15 percent protection.
A more granular examination of the results, though, seemed to indicate the main problem was a familiar one: Participants didn’t actually use the ring enough.
Women who used the ring consistently saw their HIV risk cut by at least 56 percent. Those who used the ring the most demonstrated a 75 percent risk reduction. Though additional analysis is ongoing, the results seem to confirm the ring’s scientific viability.
“It doesn’t work perfectly,” said Hillier, who helped coordinate one of the studies. “But if you use it, it works.”
Kakiza is among the women who did use the tool — and now champions its effect. She was one of the Ugandan participants in the study Matovu ran and said the ring lived up to its billing. Her husband couldn’t feel it during sex, she said, and even she forgot about it after a while, until it was time to replace it at the end of the month.
“It was wonderful,” she said. “I hope every woman gets it.”
Now, HIV prevention researchers and programmers need to figure out why more women didn’t feel the same — and possibly change the product or the way it is marketed accordingly.
Ears to the ground
The best data researchers may collect going forward may come from talking to women such as Kakiza about what they want and need. Once researchers better understand the worries, they and programmatic partners can start to think about how to more strategically address them.
“The barriers to use are just as important as whether it works,” said Dr. Zeda Rosenberg, the chief executive officer of IPM. Her research organization, which developed the ring, is also running one of the extension trials. “The most important thing for us is, if she can’t use it, [is for her] to tell us why she can’t use it.”
Rosenberg said researchers already have an idea what some of those reasons for non-use might be, including the concern that a partner might discover the ring during intercourse. Kakiza said there were also rumors circulating among participants that the ring might cause cervical cancer.
Another complaint is already being amended in the next set of clinical trials. In the first tests, women weren’t sure if they had received the real ring or an identical placebo. Kakiza said she believes her peers might be more willing to use it if they are certain they are getting a real product. In the two new open label studies, which are already underway, participants in the previous clinical trials will have the chance to continue, but now with certainty they are receiving a ring infused with an ARV.
If, after these new studies and more nuanced interventions, women remain uninterested in the ring, Hillier said, that signals that researchers should move on to their next idea.
“If nobody will use the ring once they know it works, it shouldn’t move forward,” she said.
If they do use it, though, it could be transformative, not just in equipping prevention activists with another tool to help stem the spread of HIV. But finally with an intervention that recognizes and overcomes many of the challenges women specifically face when it comes to protecting themselves.
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