Given the choice between a monthly vaginal ring and daily oral pre-exposure prophylaxis (PrEP) a course of HIV drugs taken by HIV-negative people to protect them against HIV infection, young African women overwhelmingly chose the ring.
A study, known as REACH (Reversing the Epidemic in Africa with Choices in HIV prevention) and conducted by the Microbicide Trials Network, found that 67 percent of adolescent girls and young women preferred to use the dapivirine vaginal ring, 31 percent were happy with oral PrEP.
Just 2 percent were not interested in either method, after having experienced using both of the products, each for six months. Participants then chose which option they wanted to use for the remaining six months of the study, or alternatively, to choose neither.
The trial assessed preference and adherence to the ring and Truvada (daily oral PrEP), among 247 HIV-negative, non-pregnant adolescent girls and young women aged 16 to 21 years in four clinical research sites in Uganda, South Africa and Zimbabwe.
The 247 participants were randomly assigned to either the ring or daily oral PrEP for the first six months before switching to the other product for the next six.
After that, 227 participants in the choice phase were asked to choose one — or neither — to use for another six months of the 18-month trial.
The choice phase of REACH is ongoing, with approximately 50 participants.
In his presentation at the virtual Conference on Retroviruses and Opportunistic Infections (CROI), on February 15, co-researcher Associate Professor of Global Health and the Chair Department of Community Health of Jomo Kenyatta University of Agriculture and Technology, Prof Kenneth Ngure, said the results showed that viable option for those who cannot or choose not to use daily oral PrEP to prevent HIV infection.
He added, “Having a range of options makes it more likely of there being one that will meet an individual’s needs and preferences and that it can and will be used. Indeed, REACH is just a small example of what the potential impact could be in the realm of HIV prevention, simply by allowing young women and girls the ability to choose.”
“Daily oral PrEP is approved in many countries, but it’s only one biomedical method, and for many adolescent girls and young women in Africa, it’s not a method they find easy or desirable to use especially if other methods are available,” Prof Ngure, who is REACH protocol co-chair, told the CROI.
The intravaginal silicone ring, developed by the International Partnership for Microbicides for HIV prevention, must be inserted inside the vagina for 28 days and then replaced. It works by slowly delivering an antiretroviral drug — dapivirine, directly to the vaginal tissue over the course of the one month hence reducing the risk of infection with HIV for the user.
Little of the drug is absorbed elsewhere in the body resulting in low systemic uptake. Thus, the drug is unlikely to be found in high concentrations in the bloodstream and other body tissues, which may reduce side effects and risk of developing HIV resistance. It would be the first biomedical prevention method designed specifically for women, and the first long-acting method.
“The ring contains 25mg of the ARV dapivirine, but releases about 4 mg of the drug into the vagina when used continuously for 28 days,” Prof Ngure said.
“Initially when people see the ring they think it might be a challenge inserting it and having it in there… but you can see after experience with it the young women chose it. We’ve tried to empower them by teaching them how to use it and letting them take control of their own health and behaviours and to make their own decisions. If participants don’t want to or cannot use either, we simply want to understand the reasons why, while also seeing what kind of support may help.”
“It has always been a challenge for young women to take and adhere to these products,” Prof Ngure told The EastAfrican in an interview later, “Ensuring that young women and girls can have access to a range of safe and effective HIV prevention methods is vitally important, because as has been seen with contraceptives, the more options that are available, the more likely there will be one that can and will be used.”
Mitchell Warren, executive director of the global Aids advocacy organisation AVAC said in a statement. “The (study) shows that when young women had access to and experience with two biomedical prevention options, almost all chose to continue using one of them – but majority actually preferred the dapivirine vaginal ring.”
“At a time when regulatory agencies, policymakers and funders are reviewing inclusion of the dapivirine vaginal ring in HIV prevention programmes and platforms, we must recognise that the most effective intervention is the one someone picks from an array of effective choices,” said Warren. “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.”
Earlier trials were conducted among cisgender (sometimes cissexual or shortened to cis) describes a person whose gender identity is the same as their sex assigned at birth. It’s an antonym of transgender) women aged 18-45. The ring is not available on the market yet but this additional data will be submitted to regulators to consider approving the ring for adolescent girls. “In future it is something people could get at pharmacies,” said Prof Ngure.
Over the past two years, WHO has prequalified the dapivirine ring and recommended its use among women at substantial risk of contracting HIV. Once available in the market, the ring will enrich the comprehensive toolbox of readily available protective methods.
Around the world, girls and women are disproportionally affected by HIV making up more than half the number of patients. In sub-Saharan Africa, women account for more than 60 percent of adults with HIV. Rates of infection are especially high among adolescent girls and young women. According to UNAids, in 2020, one in four new infections in sub-Saharan Africa were women in the 15-24 age-group despite making up only 10 percent of the population.
“We are making a lot of progress on all other groups but for adolescent girls and young women is where there’s a real challenge. Adherence to prevention methods has been a challenge in this group,” noted Prof Ngure.
REACH also sought to understand what kind of support adolescent girls and young women need to use these products consistently. The study, which took place between February 2019 and September 2021, was funded by the US National Institutes of Health.
Although the number of young women adopting and staying on oral PrEP is lower, REACH has demonstrated that among those with a preference for oral PrEP, it’s a method that can work very well also.