Understanding participant experiences and preferences in an injectable PrEP trial: a qualitative sub-study of barriers, facilitators, and preferences for PrEP use among MSM and TGW


BACKGROUND: HPTN083, a randomized, double-blind international clinical trial of long-acting injectable cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) for HIV prevention among cisgender men and transgender women who have sex with men (MSM/TGW), demonstrated a 66% reduction in HIV incidence in participants randomized to CAB-LA versus TDF/FTC. Participants' experiences prior to unblinding in May 2020 provide initial insights into preferences and best practices for implementing injectable PrEP.
METHODS: Participants enrolled in HPTN083 were purposively sampled for individual qualitative interviews (n=35) during the injection phase from three study sites (two U.S., one international), and categorized as adherent (n=24), non-adherent (n=10), or early-discontinuers (n=1). Data were organized using NVivo (version 12) and analyzed using content analysis.
RESULTS: Reasons for enrolling in HPTN083 and using PrEP included a preference for using medication for HIV prevention versus for HIV treatment, that study participation was believed to be a means to enhance health via education and access to services, and a sense of contributing to community via research participation. Interviewees contrasted experiences with study staff and research sites with available clinical care, and emphasized increased scheduling flexibility, frequent and thorough communication, and the open, affirming environment of research sites (e.g., compassion, encouragement, less stigma). Injection experiences were positive overall with respect to ease of use; some described early anxiety around injections and shared perceptions about the study product (e.g., that efficacy would wane over time and/or before the next scheduled injection) and strategies for managing injection site discomfort. Facilitators of injection visit adherence generally centered around motivational factors (e.g., preservation of health, desire to contribute to research), use of reminder strategies, social support, and clinic factors (e.g., flexibility). Barriers included structural factors (e.g., financial constraints, distance to clinic, homelessness) and competing demands (e.g., work schedules).
CONCLUSIONS: MSM/TGW viewed their participation in an injectable PrEP trial as a positive experience and a means by which to enhance wellbeing. Site/clinic flexibility and an open and affirming clinic environment were key facilitators to adherence. To support injection adherence over time, interventions that target structural barriers and flexible means of injection delivery may be most effective.