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Clinical Trials Evidence

Information on Phase III trials, open label extension studies, ring studies involving adolescent girls and young women, and pregnant and breastfeeding women is available below.

  • Between 2012 and 2016, IPM and the Microbicide Trials Network (MTN) conducted two Phase III “sister studies” (called The Ring Study and ASPIRE) to test the ring’s effectiveness. With the help of over 4,500 women participants in Malawi, South Africa, Uganda and Zimbabwe, they found that ring use reduced the rate of new HIV infections by approximately 35 percent overall and by 45 percent among the women who used it at least some of the time. Notably, women older than 21 were more likely than younger women to leave the ring in place. Research is now underway to learn more about how younger women perceive the ring and what might influence their interest in using it.
  • MTN-023/IPM-030, or “iMatter” was the first study to evaluate the Dapivirine Vaginal Ring among adolescent girls. iMatter showed that the ring was acceptable and raised no safety concerns among girls under the age of 18 living in the United States. Results from this randomized, placebo-controlled trial were presented at IAS 2017.
  • A Leap Forward For the Dapivirine Vaginal Ring, the Next Steps Are Critical — In this episode of Px Pulse from AVAC, we reflect on the decades of research and advocacy that has brought the Dapivirine Vaginal Ring one step closer to becoming available as a discreet, woman-initiated HIV prevention option. Hear five different perspectives on how the ring expands HIV prevention options for women, and the most important next steps to bring the ring to women who need it.

Open Label Extension (OLE) Studies

  • Two open-label extension studies, DREAM and HOPE, launched in July 2016 to collect additional data on the ring. DREAM completed in January 2019 and HOPE completed in October 2018. Women in both studies knew that the ring provided to them was the active ring, which was already shown to reduce HIV risk and raised no safety concerns during the Phase III trials, and not a placebo.
  • Results from DREAM, announced during the South Africa AIDS Conference in 2019, showed increased use of the ring among participants. Analyses of DREAM results using statistical modeling also suggest that the overall HIV incidence rate among participants was 63 percent lower than would be expected without use of the Dapivirine Vaginal Ring. Read the IPM press release on the DREAM study.
  • HOPE results were reported at the International AIDS Society 2019 conference in Mexico City. Because women who participated in HOPE were able to accept or decline use of the ring, researchers were also able to assess demand for the ring among participants. Results from HOPE showed that the majority of participants chose the ring throughout their year of participation in the trial; and among those women, a similar trend toward increased ring use was observed as with the DREAM study. Using statistical modeling, HOPE researchers were also able to estimate an HIV risk reduction of approximately 39 percent among all women who participated in the study, including those who chose not to use the Dapivirine Vaginal Ring. Read the MTN press release on HOPE.
  • The REACH study, which launched in early 2019, is exploring how adolescent girls and young women in sub-Saharan Africa use the monthly Dapivirine Vaginal Ring and daily oral PrEP, and their preferences for these approaches. REACH has enrolled 247 young women ages 16 to 21 in South Africa, Uganda, and Zimbabwe. For the first two periods of the study, participants used the ring and oral PrEP each, for six months. In the final six months of the study, the participants could decide which one to use or to use neither. Data presented in 2022 at the Conference on Retroviruses and Opportunistic Infections (CROI) showed:
  • Nearly all (98 percent) of the 227 participants who took part in the choice period opted to use one of the two HIV prevention products being offered.
  • Of these, 67 percent chose to use the ring and 31% chose to use PrEP – only 2 percent didn’t want to use either.
  • Most participants used their product of choice some or most of the time.
  • MTN-042, or the DELIVER study, which launched in January 2020, is assessing the safety of the monthly Dapivirine Vaginal Ring and Truvada as daily oral PrEP in pregnant women. Of the 750 women who will be enrolled, 500 will use the vaginal ring. The study is the first to be conducted of the Dapivirine Vaginal Ring during pregnancy.
  • MTN-043, or the B-PROTECTED study, which launched in August 2020, is evaluating the safety of Dapivirine Vaginal Ring and oral PrEP use by women who are breastfeeding. B-PROTECTED will enroll up to 200 mothers and their breastfed babies.
  • Other Ring Studies

    Implementation Studies