Uganda has started enrolling women in a major clinical trial of a long-acting injectable antiretroviral drug for HIV prevention. The study is part of a wider effort across seven African countries.
The phase III trial, known as HPTN084, will also take place in Kenya, Malawi, Botswana, Zimbabwe, South Africa and Swaziland. Researchers expect to recruit 3,200 participants in total over five years.
The drug under study is Cabotegravir, an injectable ARV that would be given every two months if it proves safe and effective. The goal is to determine whether it can lower the risk of HIV infection after exposure and offer an alternative to Truvada, the current oral PrEP pill taken daily.
Dr Amanda Wanyana, a researcher with the International Aids Vaccine Initiatives at the Uganda Virus Research Institute, said the trial will focus differently depending on the country. In Southern Africa, participants will include HIV-negative people from high-risk groups such as gays, while in Uganda and Kenya the study will target HIV-negative, healthy women aged 18 to 45, mainly from fishing communities.
The study will be blinded. One group will receive the active injection, while the other will be given a placebo.
Participants will first receive injections once a month for two months before moving to one injection every two months for the rest of the study period. Women joining the trial must be on long-term contraception, in good clinical health, and not pregnant at recruitment or during the study.
Dr Wanyana said the researchers are also looking at reproductive effects and possible drug resistance. She said: “Besides issues of efficacy, we also want to know how the drug affects reproduction in women, and if there are cases of drug resistance. In the long run, if the injectable ARV works as well, it will be an option as PrEP,” said Dr Wanyana.
Truvada remains the main PrEP drug used by HIV-negative people to reduce infection risk after exposure, but health experts say daily dosing has led to poor adherence in many cases. Dr Wanyana said a long-lasting injectable option could help people who struggle to take pills every day.
“A long-lasting injectable PrEP, which can be administered every two months, can therefore help people who are unable to adhere to daily oral pills,” said Dr Wanyana.
In Kenya and South Africa, Truvada is already being used as PrEP. Uganda, which helped pioneer the demonstration study on Truvada’s effectiveness, has been slower to roll it out widely. At present, it is being given to high-risk groups such as sex workers and couples in discordant relationships through a pilot programme in selected health facilities.
Gertrude Nanyonjo, a community engagement officer, said sensitisation campaigns are underway in the communities where the trials will be carried out. She said the aim is to inform women about the benefits of participating in the research.
“We emphasise the fact that women are more vulnerable to acquiring HIV and how they will benefit from the research,” said Ms Nanyonjo.
Girls and women account for more than half of the 36.7 million people living with HIV, according to Joint United Nations Programme on HIV/Aids estimates.
