Spoiled for choice? What's blocking uptake of HIV prevention tools

With the recent advent of new HIV prevention tools, including the star of last month’s International AIDS Conference — a promising injectable that appears to offer six months of protection, providers are moving closer to being able to offer a variety of HIV prevention services. It is increasingly clear, though, that simply expanding choice will not be enough to hit global targets of having 10 million people on some form of preexposure prophylaxis, or PrEP, by 2025. An estimated 3.5 million people accessed PrEP in 2023. In addition to widening the selection, experts are calling for lower prices, faster regulatory approval of the tools, and, perhaps most critically, engagement with communities to make sure there will actually be demand for the methods when they become available. Advocates have long been pressing for this diversity of prevention tools, arguing that choice is critical if the world is to stand any chance of meeting the 2025 target of fewer than 370,000 new HIV infections. Reducing new infections is key to achieving the UNAIDS goal of ending AIDS as a public health threat by 2030. Globally, 1.3 million people were infected in 2023. The new six-month injectable form of PrEP, lenacapavir, could eventually join an existing two-month injectable, a monthly vaginal ring, and daily oral versions of PrEP, as part of a suite of prevention services. And researchers are at work on developing additional tools in the form of patches, gels, douches, implants, films, and vaginal and rectal inserts. “The availability of choice puts users in control,” Elizabeth Irungu, a regional technical adviser for the international health nonprofit Jhpiego, said during a plenary session at the AIDS conference in Munich. “Making active choices… helps users have greater ownership and makes them more likely to follow through. PrEP is becoming a reality, but very slowly.” Developing these tools is not enough, though, experts say. They must also be made accessible. Regulators approved the bi-monthly injectable CAB-LA, for instance, for use in the United States in 2021, but it has yet to reach most communities in sub-Saharan Africa. That includes Kenya, which was one of the countries where researchers conducted the studies that led to the approval of the injectables, not only by the U.S. Food and Drug Administration but also recommended by the World Health Organization in 2022. Patriciah Jeckonia, who is part of the research team at LVCT Health helping the Kenyan Ministry of Health to prepare for the rollout of CAB-LA, said she doesn’t expect the injectable to be widely available in the country until 2027. In part, that is due to the slow process of getting regulatory approval for CAB-LA. She expects national regulators to finally sign off on the injectable in a matter of months. “It’s been very frustrating at a country level where we took so long to finalize the registration process,” she told Devex. Though both ViiV Healthcare, the company that retains the patent to CAB-LA, and regulators have kept quiet on why it has taken so long, Jeckonia suspects that there is not a lot of pressure from national authorities to fast-track the prevention method knowing that the country will not actually be able to afford to widely distribute CAB-LA until generic versions become available, likely only in 2027. ViiV did grant a voluntary license to the Medicines Patent Pool in 2022 to allow for generic production of CAB-LA, which can then be distributed in 90 low- and middle-income countries and territories, including most of the countries with the highest rates of infection. But the company has been faulted for waiting so long to grant the license — which has slowed access across much of the global south — and for not granting all LMICs access to the generic version of the injectable. In the meantime, Jeckonia said she has heard from Ministry of Health officials that ViiV has priced the injectable at about $30 per vial, which renders it essentially unaffordable unless the country gets support from donors. “If the price remains the same, our countries will definitely not put in an investment in it,” she said. Policymakers and activists are looking to Gilead, the patent holder of lenacapavir, to learn from the CAB-LA rollout, and start the process of issuing a voluntary license on the longer-acting injectable now so that the wait time in the global south for a generic version is shorter. “We need to make it available to all who need it fast,” Irungu said, which means expediting submissions to regulatory bodies, launching price negotiations and securing guarantees from donors and governments about how many doses they plan to purchase so that manufacturers can start production. Securing the availability of a PrEP product is only an intermediate step, though. Just as important, experts said, is working with communities during the initial research to develop the tools in a way that they will actually meet the needs of the people that use them, and then rolling them out in a deliberate fashion, with campaigns that engage distinct communities. “Most of the research only considers community once they have an idea,” Yvette Raphael, who leads the South African organization Advocacy for the Prevention of HIV and AIDS, said during a panel. “They don’t develop the idea with the community.” Panel members pointed to the ongoing development of a film that is inserted in the vagina, where it dissolves and releases the antiretroviral dapivirine. Researchers engaged community members in Kenya, South Africa, and Zimbabwe around the design of the film. They learned that the women were leery about the initial prototype, which had straight corners, and pushed for a design that was rounded, which was then trialed. Yvonne Wangũi Machira, the director for socio-behavioral research at the vaccine and antibody developer IAVI, told Devex that engagement with communities needs to then continue through the rollout of the prevention methods. She is also based in Kenya, where the government began a national rollout of free oral PrEP in 2017 from public clinics and hospitals. “But when oral PrEP rolled out in Kenya and many other African countries, the messaging was that it’s targeting certain key populations, targeting gay men, targeting sex workers. And there’s already so much stigma around those populations,” she said. “So what happened is that we’ve had a black market in Nairobi evolve around oral PrEP, where people actually buy the oral PrEP instead of accessing it for free in a public health facility because there’s less stigma, less questions asked.” She said the messaging may have contributed to a gap that has emerged between people who are aware of PrEP and those who are actually using it. She presented findings at the AIDS conference from the UPTAKE study, which uses behavioral science to inform access to long-acting sexual and reproductive health technologies. The researchers found that 61% of adolescent girls and young women were aware of oral PrEP, but only 12% were using it. That underlines the need for additional choice, she said, but also for a better understanding of what is keeping these girls and women from choosing oral PrEP and whether researchers and policymakers might be able to overcome hesitancy because of messaging or distribution. The AIDS conference offered no shortage of ideas for how to improve access to PrEP for specific communities, including fully virtual models for subscribing to PrEP in the Philippines and a model in Malaysia that relies on community pharmacies to distribute the tools. The outstanding question, though, is whether there will be enough money available to do the granular research on how to involve and inform communities around PrEP and then offer differentiated delivery services that best meet their needs, all on top of maintaining the full suite of PrEP choices. “Not doing HIV prevention work is a luxury we cannot afford,” Irungu said. “Each new infection needs care and treatment for that individual for life and this is not inexpensive. It has been repeated many times, but we cannot treat ourselves out of this epidemic.”