Qualitative Perceptions of Dapivirine VR Adherence and Drug Level Feedback Following an Open-Label Extension Trial

Abstract

Background: There continues to be a need for HIV prevention options that women can initiate and use autonomously. The dapivirine vaginal ring (VR) has been shown to have a favorable safety profile and reduce the risk of HIV-1 acquisition. We report on women's experiences with VR adherence during the MTN-025/HIV Open-label Prevention Extension (HOPE) study and responses to Residual Drug Level (RDL) results. Setting: Ten women at each of the 6 HOPE research sites in Lilongwe, Malawi; Durban (2 sites) and Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza, Zimbabwe, were randomly selected (n = 60). Methods: After confirmation of eligibility criteria, in-depth interviews were conducted where available RDL results were presented. Results: Many women with low RDL release measurements deflected blame onto other factors (the ring, the drug, and faulty testing machines) and distrust of the testing method. The disclosure of RDL results enabled some users to discuss their challenges experienced (fear of partner objections, perceived side effects, and removals during menses). Consistent users reported important motivators (support from others, protection from HIV, and enhanced sexual experiences from the VR). Conclusion: The VR provided a sense of security for some women; however, adherence was still challenging for others regardless of it being a female controlled, long-acting HIV prevention technology. Adherence measurements may not be sustainable in the real-world implementation of the VR, although they can be seen as a benefit as they provide a better understanding of actual product use and provide women with a platform to discuss their experiences.

Qualitative Study on the Acceptability of and Adherence to a Vaginal Ring for HIV Prophylaxis Among Adolescent Girls

“…Informing young women that it is not necessary to clean the VR during menstruation may be particularly important; results from in-depth interviews among adult women in sub-Saharan Africa with low-reported VR adherence in a 12-month open-label extension of the dapivirine VR indicate that VR removal during menses was a frequent challenge to adherence. 30 Clinic staff should counsel girls to assure them that the VR is not unhygienic to use during menstruation, tampons can still be used, and it is not necessary to clean or rinse the VR.…”

Male Partner Opinions of the Dapivirine Vaginal Ring Used During an Open-Label Extension HIV Prevention Trial in KwaZulu-Natal, South Africa

“…The AHA study methods have been reported previously. 11,16 Male partners were recruited based on permission to contact from HOPE participants, and they provided written informed consent before data collection. FGD data collected by trained male interviewers in the local language (isiZulu) were transcribed and translated in English.…”

“…While the ring is user initiated, most trial participants have stated a preference to discuss its use with male partners, to maintain trust in the relationship, to prevent social harms, and opposition linked to male partners potentially feeling the ring during sexual intercourse. 10,11 Current and previous HIV prevention research studies have reported that male partners have expressed a keen interest to be informed of their partner's study participation and product use. 12–15…”

Key population perceptions and opinions about long-acting antiretrovirals for prevention and treatment: a scoping review

“…Primary healthcare services, sexual and reproductive health services, and services for mother and children are important opportunities for discussing HIV risk and offering combined prevention, not only in sub-Saharan Africa, but also in other countries, for any women who may be at risk [22]. In our search, we identified 4 articles [23][24][25][26] focused solely on women, and another 3 articles included females with males [15,16,27]. HPTN 076 [23] was a Phase II study to evaluate if rilpivirine (RPV) LA was safe as a PrEP strategy.…”

“…In Africa, Naidoo et al evaluated 58 women that participated in the study HIV Open-label Prevention Study (HOPE), a posttrial of the dapivirine vaginal ring [25]. The study revealed positive and negative male roles affecting the ring use, which explained some situations of nonadherence.…”