MTN-025, or HOPE (HIV Open Label Prevention Extension) was an open-label follow-on trial to ASPIRE (MTN-020) in which former ASPIRE participants were offered the opportunity to use the dapivirine ring (there was no placebo) in the context of a study designed to collect additional information about safety and how women would use the ring knowing that it had been shown to reduce the risk of HIV in ASPIRE. HOPE enrolled 1,456 women at 14 sites in Malawi, South Africa, Uganda and Zimbabwe. Women were free to accept the ring or not, and to change their minds at any time during the study. Results, which were presented at IAS 2019, found that ring was well-tolerated, consistent with the safety profile seen in ASPIRE, and the majority of women from ASPIRE chose the ring being offered. Measures of adherence also indicated women’s uptake and use of the ring (adherence) was higher with additional analysis suggesting lower than expected HIV incidence as well.
Results of open-label study of a vaginal ring for HIV prevention suggest women are interested in and willing to use it
Women’s use of vaginal ring is higher in open-label study, as is level of HIV protection
HOPE open-label study of vaginal ring for preventing HIV begins for former ASPIRE participants