Correlates of Dapivirine Vaginal Ring Acceptance among Women Participating in an Open Label Extension Trial

Abstract

MTN-025/HOPE was an open-label trial of the dapivirine vaginal ring conducted in four African countries between 2016 and 2018. Women were first offered one ring monthly (at baseline, months 1 and 2), thereafter, transitioned to a more applicable real-world dispensation schedule, - 3 rings quarterly (at months 3, 6 and 9). Logistic regression analysis was used to assess correlates of ring acceptance at baseline and through follow-up. A total of 1456 women (median age 31 years) enrolled, 1342 (92.2%) accepted the ring at baseline and 1163 (79.9%) accepted the ring(s) at all visits. Changing ring dispensation from a monthly to a quarterly schedule had no negative effect on acceptance. Having a primary partner and him knowing about the ring being offered in HOPE, use of long-acting contraception (implants, injections, IUDs) or sterilization were associated with ring acceptance, along with prior strong intention to use the ring in the future. Efforts should consider these factors when rolling out the ring for HIV prevention.

Keywords: African women; HIV Pre-Exposure Prophylaxis; acceptance; choice; dapivirine vaginal ring; microbicide.

Fig. 1

Consort diagram detailing the ring decisions of enrolled participants recorded throughout the study. Each month at the beginning of the study and each quarter after the fourth visit (Month-3 visit) participants successfully completed a visit where a ring decision was made, completed an interim visit or declined to do the visit (considered non-acceptors) [middle boxes], whereas some participants either missed the visit or were in clinical hold [right boxes]. The number of participants that were censored from our analysis in between visits are detailed in the hexagons [left of figure]. (*) women enrolled late in HOPE were not expected to complete all follow-up visits, and were offered a tailored schedule with PUEV occurring at a visit earlier than the month-12 visit

Fig. 2

Trends in ring acceptance over time, among women who initially accepted the ring in HOPE (N = 1342 at baseline) Blue vertical arrow indicate Month 3 visit when schedule of ring dispensation transitioned from monthly dispensation of 1 ring (baseline, month 1 and 2) to quarterly dispensation of 3 rings (month 3, 6, 9)