Acceptability and use of a dapivirine vaginal ring in a phase III trial

Abstract

Background: The MTN-020/ASPIRE trial evaluated the safety and effectiveness of the dapivirine vaginal ring for prevention of HIV-1 infection among African women. A nested qualitative component was conducted at six of 15 study sites in Uganda, Malawi, Zimbabwe and South Africa to evaluate acceptability of and adherence to the ring.

Method: Qualitative study participants (n = 214) were interviewed with one of three modalities: single in-depth interview, up to three serial interviews or an exit Focus Group Discussion. Using semistructured guides administered in local languages, 280 interviews were audio-recorded, transcribed, translated, coded and analyzed.

Results: We identified three key findings: first, despite initial fears about the ring's appearance and potential side effects, participants grew to like it and developed a sense of ownership of the ring once they had used it. Second, uptake and sustained adherence challenges were generally overcome with staff and peer support. Participants developed gradual familiarity with ring use through trial progression, and most reported that it was easy to use and integrate into their lives. Using the ring in ASPIRE was akin to joining a team and contributing to a broader, communal good. Third, the actual or perceived dynamics of participants' male partner relationship(s) were the most consistently described influence (which ranged from positive to negative) on participants' acceptability and use of the ring.

Conclusion: It is critical that demonstration projects address challenges during the early adoption stages of ring diffusion to help achieve its potential public health impact as an effective, long-acting, female-initiated HIV prevention option addressing women's disproportionate HIV burden.

Fig. 1

MTN-020 ASPIRE qualitative component: participant disposition. *IDI averaged 61 min, FGD were 159 min on average. **Reasons for single IDI women terminating product use early were (n = 34): 29, seroconversion to HIV-1; three, partner objection; two, pregnancy. Reasons for purposive selection in serial IDI (n — 19): four, lack of adherence; seven, overcoming obstacles; six, partner issues; one, trauma; one, vocal about others' non-use; two, exceptional adherer; one, chronic health issues. ***There were five seroconverters in the SIDI sample and one in the FGD sample.