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Gilead Sciences: Designing Inclusive Clinical Trials in an Effort To Upend the HIV Epidemic

NORTHAMPTON, MA / ACCESSWIRE / November 26, 2024 / Women - especially teen girls and young women living in sub-Saharan Africa - are disproportionately impacted by HIV globally, with about 3,100 acquiring HIV each week. They've also historically been excluded from or underrepresented in HIV clinical trials. That's why Gilead's PURPOSE 1 trial, which studied the safety and efficacy of an investigational HIV pre-exposure prophylaxis or PrEP medication, set out to exclusively focus on young African women and adolescent girls.

Lead PURPOSE researcher Moupali Das, Vice President, Clinical Development, HIV Prevention & Pediatrics, designed the PURPOSE program with Gilead's person-centric approach in mind to reach underserved communities and groups around the world. In all, there are currently five PURPOSE clinical trials, with more in design phases, and the program is the most comprehensive and diverse program for an investigational HIV prevention medication ever conducted.

"Whenever we study a new innovation, we must be intentional about both the scientific and health equity aspects of it to ensure that it doesn't exacerbate existing disparities," explains Moupali. "Based on this approach, it's critical to ensure that we include people in our trials who are most disproportionately affected by HIV and who most need new choices for PrEP."

Thousands of cisgender women and girls between the ages of 16 and 25 in South Africa and Uganda were enrolled in the trial, which studied a medication that is administered once every six months via injection. Encouraging preliminary results were released earlier this year.

"As a researcher, you dream of these ‘pinch-me' moments that help provide a pathway toward new opportunities," says Moupali.

Before the trial was launched in 2021, Moupali and her colleagues worked closely with Global Community Accountability Groups. The groups' members are active in HIV advocacy and clinical development work and provide important insights on recruitment, retention, communication and how to best support participants while also taking into account cultural considerations. Based on input from these community partners, the PURPOSE 1 trial included pregnant and lactating women - making it the first Phase 3 HIV prevention trial to do so.

PURPOSE 1 has set a new standard for HIV prevention trials, demonstrating what can happen when a drug candidate, a thoughtful scientific and community-focused trial design, and an inclusive trial implementation plan come together.

"I'm filled with such hope as I think about what the PURPOSE program could mean for people who are members of groups that are disproportionally affected by HIV," Moupali says. "Potential new PrEP choices could be a key resource in helping to end the epidemic."

Originally published by Gilead Sciences