Study shows why it matters to young African women
Kampala, Uganda | RONALD MUSOKE | A new HIV prevention study has found that when young women have access to two biomedical prevention options, the dapivirine vaginal ring (DVR) and Truvada, an oral pre-exposure prophylaxis (PrEP) drug, almost all choose to continue using one of them.
The study found that most of the girls enrolled in the trial preferred the dapivirine vaginal ring. The results of the third phase of the study, in which participants could choose between the dapivirine ring and daily oral PrEP after experimenting with the use of each product, were presented on February 15 at the Conference on Retroviruses and Opportunistic Infections (CROI 2022), which took place virtually from February 12-16.
The “Reversing the Epidemic in Africa with Choices in HIV prevention” or REACH study was conducted by the Microbicide Trials Network (MTN) at four clinical research sites in Uganda, South Africa and Zimbabwe. It was designed to fill important gaps in information about the safety and acceptability of the dapivirine ring and oral PrEP, particularly in girls under 18.
The study which took place between February 2019 and September 2021 and was funded by the US National Institutes of Health also sought to understand what kind of support adolescent girls and young women need to use these products. best, and their preferences for each.
REACH recruited 247 participants aged 16 to 21 who were assigned a female at birth, 86 of whom were younger than 18. All participants used both Truvada as oral PrEP and the dapivirine ring, each for six months, the order of which was determined by randomization. During the last six months of the study, participants could choose which of the two products to use, or could decide not to use one or the other, and could change their minds at any time.
Of the 247 participants, 227 participated in the choice period. When asked which product they wanted to use, 152 participants (67%) chose the ring, 71 (31%) chose oral PrEP, and only four participants (2%) chose to use neither the neither.
Thirty participants switched products or changed their minds at least once over the six months, although these data were not presented at the conference. Interestingly, participants who chose oral PrEP over the ring were among those who used it most consistently during the six-month period they were assigned to this regimen.
While determining adherence, or how participants used each product, for oral PrEP, the researchers looked at drug levels in blood samples taken at each monthly visit, and for the ring, the amount of residual drug left in the rings that participants returned to after one month of use.
During the first two periods of the study, when participants each used the ring and oral PrEP, adherence to both products was higher than seen in previous trials involving young women. , which the researchers reported at the 11th IAS Conference on HIV Science. which was held almost last year.
Data reported at the conference over the study’s elective period revealed that participants also used the ring or PrEP some or most of the time. Truvada as oral PrEP (or its generic equivalent, emtricitabine/tenofovir disoproxil fumarate) is approved in many countries and available for adolescent girls and young women.
“We know that with contraceptives, having a range of options makes it more likely that there is one that meets an individual’s needs and preferences and that they can and will be used,” said Kenneth Ngure (PhD), chairman of the department. of Community Health at the Jomo Kenyatta University of Agriculture and Technology in Nairobi, Kenya, and co-chair of the REACH protocol, who presented the latest study results at the conference.
“REACH is just one small example of what the potential impact could be in the field of HIV prevention, simply by allowing young women and girls to choose. »
Worrying HIV rates
According to UNAIDS, the joint United Nations program on HIV/AIDS, 7,500 young women around the world contract HIV every week. Young women are more than twice as likely to contract HIV as young men. UNAIDS says the medical advances that have transformed HIV treatment have yet to change the harsh reality for young people, especially in low- and middle-income countries, such as those in sub-Saharan Africa.
Under REACH, study participants received frequent support and guidance tailored to meet individual needs and focused on helping them make the best use of their assigned or chosen product while ensuring that they make their own decisions.
“The approaches we used seemed to work well for young women and girls in REACH. What may be feasible or scalable at the community level and by health systems remains to be determined and will likely depend very much on capacity,” said Dr. Gonasagrie Nair, REACH protocol chair and senior lecturer at the Center for Medical Ethics and Law. , at the Faculty of Medicine of the University of Stellenbosch in South Africa.
She added: “But if there’s one thing to consider, it’s that young women need to be allowed to make their own informed decisions about what they think is best for them.”
“It’s not for us to judge whether one product is better than another,” said Connie Celum, professor of global health and medicine and director of the University of Washington’s International Center for Clinical Research in Seattle, and REACH co-protocol. chair.
Winifred Ikilai, an HIV, health, research and rights advocate working with the National Forum of Uganda Networks of People Living with HIV/AIDS (NAFOPHANU) welcomed the findings of the study.
“I welcome the study because it has directly exposed what young women and girls want. Indeed, choice matters because ultimately it impacts prevention product use. We cannot not emphasize the role of oral PrEP in prevention, but while the vast majority of women are comfortable with the dapivirine vaginal ring, they should be supported and not restricted.
ikilai said The Independent that the power to choose determines the effectiveness of the use of HIV prevention technologies.
“We can’t force someone to consume what they’re not comfortable with,” she says, “choice affects demand and use. My body my right. Why? Because we are different. She says it is important for the Ministry of Health to promote HIV prevention services across their full range to avoid resistance.
“If a young person finds it always easier for her to use condoms, let’s support her decision. If another prefers PREP, all the better and if the other prefers the ring, again their decision must be supported,” she says.
ikilai said The Independent in an email that the study results came at a critical time for young women who have had difficulty adhering to oral PrEP.
“The stigma has been too great because the difference between PrEP and ARVs is not there. Some young women, for example, were not comfortable swallowing the pills daily due to certain side effects. But now that the DVR is available, they don’t have to worry anymore,” she said.
Mitchell Warren, director of the New York-based AIDS Vaccine Advocacy Coalition (AVAC), noted that new data from the REACH study has strengthened the power of choice.
The data, Warren said, shows that when young women had access to and experienced two biomedical prevention options, nearly all chose to continue using one of them — and most did. of them actually chose to use the dapivirine vaginal ring.
“At a time when regulators, policymakers and funders are considering the inclusion of the dapivirine vaginal ring in HIV prevention programs and platforms, we must recognize that the most effective intervention is the one that someone chooses for themselves from a range of effective choices,” he said.
“REACH provides critical endorsement of both ring PrEP and daily oral PrEP as two safe and effective options that many women need and can use, and the need to provide multiple options among which women can choose. »
Although the number of young women taking and continuing to take oral PrEP is lower than some would like, REACH has demonstrated that among those who have a preference for oral PrEP, it can work very well.
The dapivirine ring is the first biomedical HIV prevention product designed specifically for women as well as the first long-acting method. In 2020, the ring received a positive scientific opinion from the European Medicines Agency (EMA) for use in developing countries in women at high risk of HIV who cannot or choose not to use PrEP oral daily, and in 2021 the World Health Organization (WHO) recommended the ring as an additional prevention choice for women.
The ring’s developer, the non-profit International Partnership for Microbicides (IPM), is seeking approval in Eastern and Southern Africa, with approvals received in Zimbabwe and several other countries, and additional regulatory reviews underway. .
However, since phase III trials of the product were conducted in women between the ages of 18 and 45, additional safety data is needed to support the use of the ring in women under 18. Interim results from the first two periods, also reported at IAS 2021, revealed both the dapivirine ring and Truvada as oral PrEP were well tolerated with no safety concerns.
In the future, IPM will submit data from REACH, as well as the MTN-023/IPM 030 study of adolescent girls aged 15-17 in the United States, to both the EMA and the African regulators so that they can consider expanding the use of the ring. to include adolescent girls where the product is approved.
ikilai said The Independent that policies, clear guidelines and resources must be made available to ensure timely product introduction.
“Don’t see us deciding for the girls what works better than the other. Clear information and awareness must be made to young girls about the prevention options available so that they make informed decisions and not about what is on the table,” she said. The Independent.