Access planning activities in 2019 included:
IPM is also working to understand how the dapivirine ring could fit into the HIV prevention portfolio for women at different stages in their lives.
Young women: Young women in Africa face high HIV risk, yet HIV prevention clinical trials, including The Ring Study and ASPIRE, continue to see challenges with product use among this group. In 2019, MTN launched an open-label study called REACH in collaboration with IPM to assess the safety and use of the monthly ring and daily oral PrEP among young women ages 16-21 in Africa. In addition, as part of the EMA’s positive opinion for the ring, IPM is planning a post-authorization efficacy study among women ages 18-25 that will also collect additional resistance data. Results from both studies among young women could inform strategies to support this key group to use the ring consistently.
Adolescents: The REACH study, along with a completed study among adolescents in the United States, may also help support potential expansion of future regulatory approvals in Africa to adolescent girls ages 15-17, who face among the highest risk for HIV.
Pregnant and breastfeeding women: HIV risk is an estimated two to four times higher during pregnancy and postpartum periods, but women who are pregnant or breastfeeding are underrepresented in HIV prevention research. To better understand the ring’s safety when used during these times, IPM is partnering on the MTN-led DELIVER and B-PROTECTED studies of the ring and PrEP among pregnant and breastfeeding women, respectively. Planning for the two studies continued in 2019, and both studies launched in Africa in 2020. Results could inform potential expansion of regulatory approval for these key groups.
Credit: Lisa Rossi for MTN
Realizing the Ring’s Promise
As much effort must go into the delivery of a product as into its development. IPM has been working to establish partnerships and learn from other product introduction efforts to minimize barriers to ring uptake and use, pending approvals.