Background: The MTN-020/ASPIRE trial evaluated the safety and effectiveness of the dapivirine vaginal ring for prevention of HIV infection among African women. Participants'' acceptability of and use-adherence to novel biomedical study products are essential for assessing their true effectiveness and yield important insights regarding future uptake, sustained use, and potential public health impact.
Methods: The qualitative component of ASPIRE was conducted at 6 of 15 study sites in Uganda, Malawi, Zimbabwe and South Africa. Qualitative study participants (n=214) were enrolled into one of 3 interview modalities: single in-depth interview (IDI; n=34), up to 3 serial IDIs (n=80), or exit Focus Group Discussion (n=100). Using semi-structured guides administered in local languages, 280 interviews were audio-recorded, transcribed, translated, coded and analyzed with Nvivo using matrices and code summary reports. Guided by a conceptual framework, we evaluated how well the ring was liked, used and integrated into participants'' lives.
Results: Participants were on average 26 years, 45% were married, and 73% had completed secondary school. The majority disclosed trial involvement (72%) or ring use (59%) to male partners. We identified three key findings: 1) Participants liked both the ring and trial participation. Using the ring felt like being part of a “team” and doing something for a broader, communal good. They valued study benefits (e.g. free healthcare) and were encouraged by study-supported participant engagement activities and feedback about site-level adherence performance. 2) Despite initial fears about the ring''s diameter and thickness and potential side effects, participants found the ring easy to use and used it consistently. Fears were overcome with ongoing group discussion, counseling and gradual familiarity with ring use through trial progression. 3) The actual or perceived dynamics of participants'' male partner relationship(s) were the most consistently described influence (which ranged from positive, negative and neutral) on participants'' acceptability and use of the ring.
Conclusions: Participants liked the ring and found it easy to use. Initial concerns with the physical attributes of the ring and perceived side effects could be proactively addressed in future activities. Factors beyond the level of the individual woman, like partners and peers, were important for encouraging positive attitudes and adherence behaviors.