Open-label research
IPM is conducting research to gather insights into how women might use the ring in the context of known clinical efficacy. Two open-label extension studies (OLEs) that provided the active ring to former Phase III participants completed in late 2018 and early 2019. The OLEs, called DREAM and HOPE, saw higher product use with no safety concerns, and suggested greater risk reduction compared to the Phase III trials. The results, along with acceptability data, will be used to inform the strategy for the ring’s rollout if it is approved.
DREAM and HOPE: Key findings from the OLEs
Understanding the motivators and challenges to using different types of HIV prevention products is critical to ensuring women can choose the one that works best for them. IPM is collaborating with the US National Institutes of Health-funded Microbicide Trials Network (MTN), which led the ASPIRE and HOPE trials, on additional studies to explore the dapivirine ring’s use by women at different times in their lives.
In 2018, IPM and MTN continued preparing for safety and acceptability studies of the monthly ring and daily oral PrEP among key groups in Africa that remain at extremely high risk for HIV. A study called REACH began in 2019 to assess use of and preferences for both products among adolescent girls and young women, and similar studies among pregnant and breastfeeding women are planned to begin in late 2019 and early 2020, respectively. If the monthly ring is approved, results from these studies will inform potential expansion of regulatory approvals for the ring’s use by these key groups.