Uganda has started recruiting women for a clinical trial of a long-lasting injectable pre-exposure prophylaxis (PrEP).
The study is part of large-scale trials of an anti-retroviral (ARV) drug that will also be conducted in six other African countries. They are Kenya, Malawi, Botswana, Zimbabwe, South Africa and Swaziland.
A total of 3,200 participants are expected to be recruited across the seven countries. The study will run over a five-year period.
The trial, known as HPTN084, will examine whether the drug cabotegravir injected once every eight weeks can safely protect women at risk of HIV infection.
Cabotegravir, if efficacious, could become the medication of choice for use as a PrEP, instead of the only licenced anti-HIV drug Truvada that is taken daily as an oral tablet.
Dr Amanda Wanyana, a researcher with the International Aids Vaccine Initiative, at the Uganda Virus Research Institute -- one of the sites where the trial will be conducted -- said in Uganda and Kenya, the study will be carried out among HIV-negative women at high risk of contracting HIV.
She added that the women of reproductive age of between 18 to 45 will mainly be drawn from fishing communities.
However, in the southern Africa countries the trials will be conduct among HIV-negative sexually active women and gay men, Dr Wanyana noted.
The study participants will be assigned randomly to either cabotegravir or a placebo in a blind-experiment where the participant will not know what she is receiving.
According to Dr Wanyana, trial participants will receive the injections once in each of the first two months, and thereafter, once every two months during the study period.
Women who take part are expected to be on long-term contraception, be in good clinical health, and not pregnant at the time of recruitment and during the trial.
“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.
Health experts say use of the HIV prevention drug Truvada that must be swallowed daily has resulted in poor adherence in many cases, and the injectable PrEP could be easier and more desirable.
“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 to take their medication as required,” said Dr Wanyana.
Truvada is already in use in Kenya and South Africa as a prevention medication for high risk HIV-negative individuals.
Although Uganda is one of the countries where Truvada trials were conducted out, the country has been slow to roll out the drug to those who need it. Currently, the drug is only available to sex workers and discordant couples through a pilot programme in selected health facilities.
Gertrude Nanyonjo, a community engagement officer, said sensitisation programmes are currently being undertaken in communities where the injectable PrEP trials will be conducted to tell women about the benefits of taking part in the study.
“We are emphasising the fact that women are more vulnerable to contracting HIV and how they will benefit from the research,” said Ms Nanyonjo.
Girls and women make up more than half of the 36.7 million people currently living with the virus, according to estimates from the Joint United Nations Programme on HIV/Aids (UNAIDS).