The Aurum Institute is preparing to start two clinical trials to help prevent HIV in women and girls, who are still disproportionately impacted by the diseases.
Heeran Makkan, Aurum Clinical Research Division Programme Manager said the Impower-022 and PURPOSE trials are aimed at testing the safety and efficacy of new pre-exposure prophylaxis (PrEP) drugs to preventing HIV infection in adolescent girls and women.
Impower-022 and PURPOSE studies
The Impower study will test the Islatravir drug in a tablet form taken orally once a month, in comparison to the daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets.
The PURPOSE study will test the longer-acting Lenacapavir injectable drug, which will be administered every 6 months. Both drugs have been designed with the aim of providing women who require long-acting PrEP options, allowing for choice in PrEP that meets their lifestyles and enhanced adherence.
Targets
The Impower-022 study aims to recruit 4500 women in sub-Saharan African, with Aurum’s Rustenburg and Klerksdorp Clinical Research Sites each looking to contribute 200 trial participants
The same number of women per site will be recruited to participate in the trials at Aurum Rustenburg, Klerksdorp, Pretoria and Tembisa sites. The PURPOSE study aims to recruit a total of 5010 women from the same region.
Impower-022 is taken once every month orally while PURPOSE will be administered once every 6 months and is injectable.
Participants
The four-year Impower study will enrol women between 16-45 years old, at high risk of HIV infection while PURPOSE will run for six years and focus more closely on adolescent girls and young women between the ages of 16 and 25 years, also at high risk of HIV infection.
Dr Pearl Selepe is the Clinical Research Site Leader in Klerksdorp. As principal investigator at the site, she is responsible for overseeing successful execution of both studies by ensuring that participants' rights, health and wellbeing are protected, protocol executed as per protocol requirements, ethical principles of Good Clinical Practice are adhered to. This is all to ensure that good quality data is generated from the studies, which can help women prevent HIV.
“Women make up more than 60% of HIV infections and are disproportionately affected and infected by HIV when compared to their male counterparts. This is of course due to several societal factors such as patriarchal social norms, poverty, and gender inequality. Women are also mainly faced with providing food for their children in many female single-headed families,” said Selepe.
She is especially excited to be part of these two upcoming PrEP trials and very hopeful that they will yield results that will make HIV prevention easier for women and girls.
