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.

End‐user preference for and choice of four vaginally deliveredHIVprevention methods among young women in South Africa and Zimbabwe: the Quatro Clinical Crossover Study

“…Nevertheless, biomarkers of adherence and qualitative data indicate that some women do not consistently use the ring, in particular young women. Consistent with previous trials of candidate microbicide gels and cervical barriers, ring nonadherence may have been caused by various contextual reasons such as perceived interference with sex, menses, short-term periods of abstinence and nondisclosure to male partners [9][10][11][12][13][14]. As with oral PrEP, and other antiretroviral-based approaches in development, use of a licensed dapivirine ring would require regular clinic visits and monitoring.…”

“…Although this study was not designed to measure a specific behavioural framework, the observed trajectory is reflective of a stages of change model , which describes behavioural transitions from knowledge to action; and models based on the theory of diffusion of innovations which similarly describe the process through which new innovations, such as these novel vaginal products, are accepted at a societal level. Research with participants from clinical trials of the dapivirine ring has highlighted that this novel technology required several months of use to build comfort and to dispel fears and concerns . Peer and research staff support were critical for overcoming this early adoption period.…”

Impact of the Dapivirine Vaginal Ring on Sexual Experiences and Intimate Partnerships of Women in an HIV Prevention Clinical Trial: Managing Ring Detection and Hot Sex

“…Women were also instructed to use condoms during the trial. Qualitative data were collected in a nested qualitative component in each of the four study countries (Malawi, South Africa, Uganda, Zimbabwe) at a total of six sites that were located in a range of rural, urban and suburban settings [2]. Qualitative participants (n = 214) were enrolled into a single in-depth interview (IDI) (n = 34), 3 serial IDIs (n = 80), or an exit focus group discussion (FGD) (n = 100).…”

“…Using semi-structured interview guides administered in English or local languages, all interviews were audio-recorded, transcribed, translated, coded, and analyzed. Participants also completed Audio Computer Assisted Self-Interviews (ACASIs) at month 3 and final visits which included questions about experiences with the ring during sex [2]. …”

Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial

“…27 Salient findings showed first that although participants initially feared use of the vaginal ring, they grew to like it and had a sense of ownership and ease of use over time. Second, support by staff and their peers aided in the uptake and sustained use of the ring.…”