Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial

Abstract

Background: The monthly dapivirine vaginal ring provides partial protection against HIV, and a longer duration ring may reduce user burden and improve adherence. We examined acceptability and preference for 3-month versus 1-month rings for HIV-1 risk reduction in a phase 1 clinical trial. Materials and Methods: In Microbicide Trials Network-036/International Partnership for Microbicides 047, 49 HIV-negative participants aged 18–45 were randomized to one of two 3-month rings or the 1-month ring. Acceptability ratings were collected at enrollment, week 4, and study exit (week 13). At exit, ring preference was assessed quantitatively among all participants and a randomly selected subset of 24 participants completed in-depth interviews. Quantitative and qualitative findings were integrated to explore factors influencing acceptability and preference. Results: Acceptability of each ring was initially moderate and increased during the trial. Ratings were lower in the 3-month ring arms than the 1-month arm at each time point, including baseline. Most participants (34/47; 72%) preferred a 3-month ring at exit; however, this proportion was significantly lower within some subgroups characterized by site, education, race/ethnicity, and experiences with ring use. Qualitative interviews revealed reservations about hygiene and safety of the 3-month ring, including discomfort with use during menses, but these were usually outweighed by its increased convenience. Conclusions: Both ring durations were highly acceptable at study exit. Although most participants preferred a 3-month ring, preference was more divided in certain subgroups, highlighting the benefit of offering different duration options. Providing additional support to address concerns about hygiene and safety may improve acceptability of a 3-month vaginal ring.

Long-acting refillable nanofluidic implant confers protection against SHIV infection in nonhuman primates

“…However, the need for regular replacement every month poses adherence challenges especially in women under 25 years old (11). This prompted the development of a longer-acting ring (3 months) (12). Numerous subdermal long-acting implants are under preclinical investigation for HIV PrEP (10,(13)(14)(15).…”

Incorporating end-users’ voices into the development of an implant for HIV prevention: a discrete choice experiment in South Africa and Zimbabwe

“…Similar to other PrEP studies, implant choices were primarily shaped by preference for less frequent dosing [ 22 , 28 – 32 ]. Although women noted that several other implant features were also important and, when asked directly, two-thirds indicated a feature other than duration was most important, women were ultimately not willing to forgo 6-months of protection in order to have other desired characteristics.…”

Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial

“…Some women also reported that partners could feel the ring, leading some to preemptively remove the ring prior to sex (28). While studies in women and providers in a range of geographies reported preinsertion concerns about a partner's discomfort during sex, actual reported impacts on daily life and sexual experience were minimal (17,18,29,30). Nevertheless, for some women an intravaginal ring will not be a viable option due to challenges with ring insertion, perceptions of anatomical incompatibility, and/or perceived or experienced discomfort by a sexual partner.…”