Acceptability of a Tenofovir Disoproxil Fumarate Vaginal Ring for HIV Prevention Among Women in New York City

Abstract

Vaginal rings for pre-exposure prophylaxis are a female-initiated HIV prevention method that does not require daily or coitally-dependent dosing. As part of a randomized placebo-controlled trial of a tenofovir disoproxil fumarate intravaginal ring, we assessed product acceptability through in-depth interviews with 18 women during and after 14 days of continuous use. Women reported that the ring was comfortable with few side effects, regardless of experimental arm. However, interest in future use by this cohort was modest for several reasons including: low self-perceived HIV risk; concern that use implied promiscuity; potential for interference with relationship formation and trust; concern for interference with menstruation and cleanliness; and worries about partners' acceptability and sexual pleasure. Potential issues were raised with duration of use prior to ring exchange. Future studies should continue to identify and address individual and relationship factors that influence acceptability, early in the product development process.

“You Never Know What Could Happen”: Women’s Perspectives of Pre-Exposure Prophylaxis in the Context of Recent Intimate Partner Violence

“…In particular, some women did not feel that PrEP was necessary unless their current relationship ended and they began dating other people. This finding is consistent with two qualitative studies that found women stopped using PrEP because their perceived season of risk ended (Namey et al, 2016;Watnick, Keller, Stein, & Bauman, 2018). Season of risk recognizes that a person may only use PrEP during perceived times of increased risk of HIV infection such as during the dating period, the beginning of a relationship, and when trying to conceive (Namey et al, 2016).…”

Use of simulated vaginal and menstrual fluids to model in vivo discolouration of silicone elastomer vaginal rings

“…However, the extent of vaginal ring staining is highly variable among women. Since women can easily remove and inspect rings, any observed discolouration may be a concern for some users ( van der Straten et al, 2016 ; Duby et al, 2020 ; Watnick et al, 2018 ; Stifani et al, 2018 ). Patient education may help to reduce the levels of concern or non-adherence associated with discolouration.…”

“…Acceptability studies have demonstrated that vaginal rings releasing steroid hormones or antiretrovirals are generally well-accepted, particularly after women have gained experience using the products ( Montgomery et al, 2017 ; RamaRao et al, 2018 ; van der Straten et al, 2012 ; Novák et al, 2003 ; Kestelyn et al, 2018 ; Nel et al, 2016b ). However, some women have voiced concerns regarding vaginal ring hygiene, particularly during menses ( van der Straten et al, 2016 ; Duby et al, 2020 ; Watnick et al, 2018 ). Surface discolouration of silicone elastomer vaginal rings during clinical use has been reported in the scientific literature ( Kiser et al, 2012 ; van der Straten et al, 2016 ; Kestelyn et al, 2018 ; Ballagh, 2001 ; Murphy et al, 2019a ; Das et al, 2015 ; Murphy et al, 2019b ).…”

“…In the absence of confirmatory studies, it has been widely assumed that this discolouration is due to cervicovaginal fluid and/or menstrual blood; in truth, little is known about the causes of discolouration. Although there is no evidence that discolouration affects the clinical performance of rings (including drug release and mechanical performance), women have expressed concerns about rings absorbing blood, rings getting “dirty” or stained, and ring malodour ( van der Straten et al, 2016 ; Duby et al, 2020 ; Watnick et al, 2018 ; Stifani et al, 2018 ). As a consequence, some women report removing rings for cleaning, particularly during menses, which can lead to non-compliance ( van der Straten et al, 2016 ; Montgomery et al, 2017 ; Nel et al, 2016b ; Duby et al, 2020 ; Montgomery et al, 2012 ; Guthrie et al, 2015 ).…”

Drug stability and product performance characteristics of a dapivirine-releasing vaginal ring under simulated real-world conditions

“…Exposure of rings to other household or personal hygiene products could potentially affect their in vivo performance. In studies examining acceptability of a tenofovir disoproxil fumarate ring among women from New York, users were concerned about the ring potentially absorbing blood and getting dirty if it remained inserted during menses (Watnick et al, 2018). In a previous study, between 4 and 18% of women reported removing the ring either during menses or for periodic cleaning (Montgomery et al, 2012).…”