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 and experience with two biomedical prevention options, the Dapivirine Vaginal Ring (DVR) and Truvada, an oral pre-exposure prophylaxis (PrEP) drug, almost all of them choose to continue using one of them.
The study found that most of the girls enrolled for the trial preferred the dapivirine vaginal ring. The results from the study’s third phase, during which participants were able to choose between the dapivirine ring and daily oral PrEP after having experienced using each product, were presented on Feb.15 during the Conference for Retroviruses and Opportunistic Infections (CROI 2022), which took place virtually February 12-16.
The ‘Reversing the Epidemic in Africa with Choices in HIV prevention’ study or REACH 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, especially in girls younger than 18.
The study which took place between February 2019 and September 2021 and was funded by the U.S. National Institutes of Health also sought to understand what kind of support adolescent girls and young women need to use these products as best they can, and their preferences for each.
REACH enrolled 247 participants aged 16-21 who were assigned female at birth, 86 of whom were under age 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. For the final six months of the study, participants were able to choose which of the two products to use, or could decide not to use either, and could change their minds at any time.
Out of the 247 participants, 227 took part 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%) opted to use neither.
Thirty participants switched products or changed their minds at least once during the six months, although this data was not presented at the conference. Interestingly, the participants who chose oral PrEP over the ring were among those who had used it most regularly during the six-month period when they were assigned to that regimen.
While determining adherence, or how well participants used each product, for oral PrEP, researchers looked at the levels of drug in blood samples taken at each monthly visit, and for the ring, at the amount of residual drug left in rings participants returned after a month of use.
During the first two periods of the study, when participants used each, the ring and oral PrEP, adherence to both products was higher than what had been seen in previous trials involving young women, which the researchers reported at the 11th IAS Conference on HIV Science which was held virtually last year.
Data reported at the conference from the study’s choice period found participants had 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 to adolescent girls and young women.
“We know that with contraceptives, 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,” said Kenneth Ngure (PhD), the chair of the department of community health at Jomo Kenyatta University of Agriculture & Technology in Nairobi, Kenya, and REACH protocol co-chair, who reported the study’s latest results at the conference.
“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.”
Worrying HIV rates
According to the UNAIDS, the joint United Nations programme on HIV/AIDS, 7,500 young women across the world acquire HIV every week. Young women are more than twice as likely to acquire HIV as young men. The UNAIDS says medical advances that have transformed HIV treatment have yet to alter the stark reality for young people, particularly in low to middle-income countries, such as those in sub-Saharan Africa.
As part of REACH, study participants received frequent support and counseling tailored to meet individual needs and focused on helping them to use their assigned or chosen product as best they could while also ensuring they made their own decisions.
“The approaches we used seemed to work well for the young women and girls in REACH. What may be feasible or scalable at the community level and by health systems is still to be determined, and will likely depend a lot on capacity,” said Dr. Gonasagrie Nair, the REACH protocol chair and senior lecturer at the Centre for Medical Ethics and Law, in the Faculty of Medicine, Stellenbosch University in South Africa.
She added: “But if there’s one thing that must be considered, it’s that young women need to be allowed to make their own informed decisions about what they feel is best for them.”
“It’s not up to us to judge whether one product is better than another,” said Connie Celum, a professor of global health and medicine and director of the International Clinical Research Centre at the University of Washington in Seattle, and a REACH protocol co-chair.
Winifred Ikilai, an HIV, health, research and rights advocate working with the National Forum of People Living with HIV/AIDS Networks Uganda (NAFOPHANU) welcomed the study findings.
“I commend the study because it directly unearthed what young women and girls want. Indeed, choice matters because at the end of the day it has an impact on usage of the prevention product. We cannot underscore the role of oral PrEP in prevention, but if the vast majority of the women are comfortable with the vaginal dapivirine ring, they should be supported and not restricted.”
Ikilai told The Independent that the power of choice determines efficacy in usage of HIV prevention technologies.
“We cannot force someone to consume what they are not comfortable with,” she says, “Choice affects demand and utilization. My body my right. Why? Because we are different.” She says it is important that the Ministry of Health promotes HIV prevention services in their full range to avoid resistance.
“If a young person finds using condoms consistently easier for her, let us support her decision. If another prefers PREP, well and good and if the other prefers the ring, again her decision should be supported,” she says.
Ikilai told The Independent in an email that the study findings have come at a critical point in time for the young women who have been finding challenges with adhering to oral PrEP.
“The stigma has been too much because the difference between PrEP and ARVs is not there. Some young women for instance have not been comfortable with swallowing the pills daily due to some side effects. But now that the DVR is available, they do not have to worry,” she said.
Mitchell Warren, the director of the New York-based AIDS Vaccine Advocacy Coalition (AVAC) noted that the new data from the REACH study has reinforced the power of choice.
The data, Warren said, shows that when young women had access to and experience with two biomedical prevention options, almost all of them chose to continue using one of them—and most of them actually chose to use the dapivirine vaginal ring.
“At a time when regulatory agencies, policy makers 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 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.”
Although the number of young women adopting and staying on oral PrEP is lower than some would like, REACH has demonstrated that among those with a preference for oral PrEP, it’s a method that 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 its use in developing countries among women at high risk for HIV who cannot or choose not to use daily oral PrEP, and in 2021, the World Health Organisation (WHO) recommended the ring as an additional prevention choice for women.
The ring’s developer, the nonprofit International Partnership for Microbicides (IPM), is seeking its approval in eastern and southern Africa, with approvals received in Zimbabwe and several other countries, and additional regulatory reviews underway.
However, since the product’s Phase III trials were conducted among women ages 18-45, additional safety data are needed to support the ring’s use in women younger than 18. Interim results from the first two periods, also reported at IAS 2021, found both the dapivirine ring and Truvada as oral PrEP were well tolerated with no safety concerns.
Going forward, IPM will submit data from REACH, as well as from the MTN-023/IPM 030 study among adolescent girls ages 15 to 17 in the United States, to both the EMA and African regulators so that they may consider expanding the ring’s use to include adolescent girls where the product is approved.
Ikilai told The Independent that policies, clear guidelines and resources should be made available to ensure timely product introduction.
“We should not be seen deciding for the girls on what works better than the other. Clear information and sensitisation should be done to the young girls about the available prevention options such that they make informed decisions and not what is on the table,” she told The Independent.