Experiences with HPTN 067/ADAPT Study-Provided Open-Label PrEP Among Women in Cape Town: Facilitators and Barriers Within a Mutuality Framework

Abstract

Placebo-controlled trials of pre-exposure prophylaxis (PrEP) have reported challenges with study-product uptake and use, with the greatest challenges reported in studies with young women in sub-Saharan Africa. We conducted a qualitative sub-study to explore experiences with open-label PrEP among young women in Cape Town, South Africa participating in HTPN 067/Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking (ADAPT). HPTN 067/ADAPT provided open label oral FTC/TDF PrEP to young women in Cape Town, South Africa who were randomized to daily and non-daily PrEP regimens. Following completion of study participation, women were invited into a qualitative sub-study including focus groups and in-depth interviews. Interviews and groups followed a semi-structured guide, were recorded, transcribed, and translated to English from isiXhosa, and coded using framework analysis. Sixty of the 179 women enrolled in HPTN 067/ADAPT participated in either a focus group (six groups for a total of 42 participants) or an in-depth interview (n = 18). This sample of mostly young, unmarried women identified facilitators of and barriers to PrEP use, as well as factors influencing study participation. Cross-cutting themes characterizing discourse suggested that women placed high value on contributing to the well-being of one’s community (Ubuntu), experienced a degree of skepticism towards PrEP and the study more generally, and reported a wide range of approaches towards PrEP (ranging from active avoidance to high levels of persistence and adherence). A Mutuality Framework is proposed that identifies four dynamics (distrust, uncertainty, alignment, and mutuality) that represent distinct interactions between self, community and study and serve to contextualize women’s experiences. Implications for better understanding PrEP use, and non-use, and intervention opportunities are discussed. In this sample of women, PrEP use in the context of an open-label research trial was heavily influenced by underlying beliefs about safety, reciprocity of contributions to community, and trust in transparency and integrity of the research. Greater attention to factors positioning women in the different dynamics of the proposed Mutuality Framework could direct intervention approaches in clinical trials, as well as open-label PrEP scale-up.

Prioritizing Risk in Preparation for a Demonstration Project: A Mixed Methods Feasibility Study of Oral Pre-Exposure Prophylaxis (PREP) among Female Sex Workers in South India

“…These findings align with previous research that uncovered how collectivization surrounding interventions (structural, bio-medical, behavioural) shape community identities and collective security strategies [36]. Furthermore, qualitative research on PrEP use in Sub-Sahara Africa found that women placed a high level of importance on contributing to the well-being of their community [37]. Our findings point to the importance of situating PrEP scale-up within the trusted spaces of community-based organizations as a means of supporting PrEP uptake and adherence.…”

Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial

“…The difficulty for women in adhering to the post-sex dose in our study was confirmed by qualitative data. 24 Pre-sex and post-sex dosing of a vaginal gel was effective in CAPRISA 004, 25 although this finding was not replicated in the FACTS 001 trial. 26 At the time that the HPTN 067/ADAPT study was being implemented, only daily dosing of PrEP had evidence for efficacy, as described in information provided to participants.…”

“Since both of us are using antiretrovirals, we have been supportive to each other”: facilitators and barriers of pre‐exposure prophylaxis use in heterosexual HIV serodiscordant couples in Kisumu, Kenya

“…Therefore, training providers to counsel about the benefits and risks is key to wide-scale implementation of PrEP, particularly in the context of combination HIV prevention. Although medical or research mistrust emerged as a less common theme in our study, which was conducted within an implementation study of a PrEP delivery model, as compared with PrEP clinical trials testing product efficacy [13,15,17], local ownership of PrEP implementation should help abate any perceptions of experimentation, racism or neocolonialism.…”

“…Barriers include drug-related issues, such as side effects and pill characteristics; logistical issues around drug use, such as timely refills and travel; and social stigma, related to being mistakenly identified as HIV-infected and disclosure of use with sexual partners. Furthermore, clinical trials focused on HIV prevention among women have found that experiences with clinic personnel, mistrust of research, and the influence of male partners can either support or deter study participation and PrEP use [13–17]. However, it remains unclear if heterosexual couples participating in an open-label implementation project in resource-limited settings identify similar themes.…”