Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial

Abstract

We evaluated the acceptability of the 25 mg dapivirine vaginal ring (DVR) as an HIV prevention intervention and its influence on DVR adherence in the MTN-020/ASPIRE phase III trial. Acceptability measures were captured using ACASI at month 3 and end of product use (median 24 months, IQR 15–30). Monthly returned rings were classified as nonadherent if dapivirine release rate was ≤ 0.9 mg/month. Associations between acceptability measures and nonadherence were estimated using Poisson regression models with robust standard errors. At month 3 (N = 2334), 88% reported DVR was comfortable, 80% were unaware of it during daily activities, and 74% never felt it during sex. At exit, 66% were ‘very likely’ to use DVR in the future. Acceptability was found to differ significantly by country across several measures including wearing the ring during sex, during menses, partner acceptability, impact on sexual pleasure and willingness to use the ring in the future. Risk of nonadherence at month 12 was elevated if DVR was felt during sex at month 3 (aRR 1.67, 95% CI 1.26, 2.23). Risk of nonadherence in the last year of study participation was elevated if, at exit, participants minded wearing during sex (aRR 2.08, 95% CI 1.52, 2.85), during menses (aRR 1.57, 95% CI 1.06, 2.32), reported a problematic change to the vaginal environment (aRR 1.57, 95% CI 1.12, 2.21), and were not “very likely” to use DVR in the future (aRR 1.31, 95% CI 1.02, 1.68). DVR acceptability was overall high yet varied by country. Addressing perceived ring interference with sex, menses, or problematic changes to the vaginal environment in future interventions could help improve adherence, as could embracing sex-positive messaging related to ring use and increased pleasure.Trial Registration ClinicalTrials.gov Identifier: NCT01617096.

Vaginal ring acceptability: A systematic review and meta-analysis of vaginal ring experiences from around the world

“…The studies included 51 countries, with 28 studies from Europe [33,34,37,39,40,43,, 47 from North and South America and Australia [29-32, 36, 38, 42, 47, 48, 72-113], 18 from the Asia-Pacific [35,[114][115][116][117][118][119][120][121][122][123][124][125][126][127][128][129], 17 from North and sub-Saharan Africa [10,28,44,46,[130][131][132][133][134][135][136][137][138][139][140][141][142][143], and 13 from multiple regions [41,45,[144][145][146][147][148...…”

Introducing the Dapivirine Vaginal Ring in Sub-Saharan Africa: What Can We Learn from Oral PrEP?

“…To support uptake and effective use, HCWs will also need to address cultural dynamics around vaginally inserted products. Comfort with a vaginally inserted product is generally high (e.g., over 50%) but varies by age and geography [ 65 , 66 ]. Evidence from the clinical trials and OLEs also suggests that potential DVR users will be confronted with a wide range of myths and misconceptions about vaginally inserted products, including links to witchcraft, potential severe side effects such as cancer and infertility, shame around menstruation, and concern about the cleanliness of the vagina [ 67 – 71 ].…”

“…These efforts will remain critical and will be especially important for the DVR, as a new product formulation. Evidence from the clinical trials and OLEs suggests that women who use the DVR find it highly acceptable, but initial reactions to the product can include confusion and expectations of discomfort [ 65 , 74 ]. Potential DVR users will benefit from additional information and counseling on the DVR and engagement with peers who have used the product to support initial uptake [ 55 , 65 , 74 ].…”

“…Evidence from the clinical trials and OLEs suggests that women who use the DVR find it highly acceptable, but initial reactions to the product can include confusion and expectations of discomfort [ 65 , 74 ]. Potential DVR users will benefit from additional information and counseling on the DVR and engagement with peers who have used the product to support initial uptake [ 55 , 65 , 74 ]. In addition, early experiences with oral PrEP highlight the importance of engaging partners and community members, who are critical to establishing a support system for HIV prevention use.…”

Preferences and Acceptability for Long-Acting PrEP Agents Among Pregnant and Postpartum Women with Experience Using Daily Oral PrEP in South Africa and Kenya

“…Few pregnant and postpartum women reported preference for the PrEP vaginal ring over oral PrEP, which may be due to unfamiliarity with the method as well as its lower efficacy. Existing acceptability and demonstration studies of the dapivirine ring for HIV prevention show that despite similar initial concerns regarding insertion into the vagina and potential side effects, women in Sub-Saharan Africa who began using vaginal rings for HIV prevention developed familiarity with the method, found it easy to integrate into their lives, and reported willingness to use the method in the future [51][52][53][54]. Our data in the context of these studies indicate the importance of education regarding vaginal ring insertion and anticipated side effects when counseling about available HIV prevention modalities, and reemphasize the need for available choice in HIV prevention methods that can be used individually or in combination.…”