Launch of first open-label studies for an HIV prevention ring
The first open-label studies of a vaginal ring shown to reduce HIV transmission began in July 2016. The two studies, DREAM and HOPE, are providing the dapivirine ring to former Ring Study and ASPIRE participants, respectively. The data collected will help us understand how women use the ring now that they know its safety and efficacy.
IPM’s DREAM study recently expanded enrollment to include 600 young women ages 18-25 who have not previously used the ring. Given that 4,500 young women in Africa are newly infected every week, this expansion will provide crucial insights into how young women might incorporate the dapivirine ring into their lives and will help inform adherence support strategies. In all, DREAM is expected to enroll about 1,700 participants.
Taking place at six former Ring Study locations in South Africa and Uganda, IPM’s DREAM study is exploring the feasibility of a three-monthly follow-up schedule where women visit the clinic to receive a new ring and take two new rings to insert at home. Similarly designed, MTN’s HOPE study is implementing a three-monthly schedule among an expected 1,500 to 2,000 women at 15 former ASPIRE sites in Malawi, South Africa, Uganda and Zimbabwe. Both studies will collect data on why some participants choose not to use the ring, and HOPE will also explore alternative markers of adherence. Building on the foundation laid by the Phase III trials, community briefings, information sessions and sporting events will continue to play an important role in engaging women and trial communities in both open-label studies.
“I feel very protected and more relaxed with the ring with medication in it. That makes my sex life more interesting. I am very happy to be in the DREAM study.”
– DREAM participant
In addition, to better understand HIV prevention product preferences and adherence challenges among adolescent girls and young women, IPM is partnering with MTN to conduct a new study called REACH. To begin in 2017, the study will assess the safety of and adherence to the monthly dapivirine ring and daily oral pre-exposure prophylaxis (PrEP) among 300 young African women ages 16-21. This important study will support platforms for conversations about young women’s lives and HIV prevention needs.