Share

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

Title
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
Presenter
Christina Psaros
Authors
C. Psaros * (1), R.J. Landovitz (2), W. Rice (3,4), C.F. Kelley (5,4), T. Oyedele (6,7), L. Coelho (8), N. Phanuphak (9), Y. Singh (10), K. Middelkoop (10), S. Griffith (11), M. McCauley (11), G. Goodman (1,12), J. Rooney (13), A. Rinehart (14), N. Van de Velde (15), J. Clark (16), V. Go (17), J. Sugarman (18), S. Fields (19), C. Gordon (20), A. Adeyeye (21), B. Grinsztejn (8), S.A. Safren (22), HPTN 083-02 Study Team.
Institutions
(1) Massachusetts General Hospital, Department of Psychiatry, Boston, United States, (2) UCLA Center for Clinical AIDS Research & Education, Division of Infectious Diseases, Los Angeles, United States, (3) Rollins School of Public Health, Emory University, Department of Behavioral, Social and Health Education Sciences, Atlanta, United States, (4) The Hope Clinic of the Emory Vaccine Center, Decatur, United States, (5) Emory University School of Medicine, Division of Infectious Diseases, Atlanta, United States, (6) Ruth M. Rothstein CORE Center, Adolescent & Young Adult Research, Chicago, United States, (7) Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County, Division of Infectious Diseases, Chicago, United States, (8) Instituto Nacional de Infectologia Evandro Chagas, Fiocruz, Rio de Janeiro, Brazil, (9) Thai Red Cross AIDS Research Center, Bangkok, Thailand, (10) University of Cape Town, The Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine and Department of Medicine, Cape Town, South Africa, (11) FHI 360, HIV Prevention Trials Network, Durham, United States, (12) The Fenway Institute, Fenway Health, Boston, United States, (13) Gilead Sciences, Foster City, United States, (14) ViiV Healthcare, Durham, United States, (15) ViiV Healthcare, Brentford, United Kingdom, (16) UCLA David Geffen School of Medicine, Department of Medicine, Division of Infectious Diseases, Los Angeles, United States, (17) University of North Carolina at Chapel Hill Gillings School of Global Public Health, Department of Health Behavior, Chapel Hill, United States, (18) Berman Institute of Bioethics, School of Medicine, and Bloomberg School of Public Health, Johns Hopkins University, Baltimore, United States, (19) Penn State College of Nursing, University Park, United States, (20) National Institute of Mental Health, National Institutes of Health, HIV Prevention and Care Continuum, Co-Morbidities, and Translational Research Branch, Rockville, United States, (21) National Institute of Allergy and Infectious Diseases, National Institutes of Health, Division of AIDS, Rockville, United States, (22) University of Miami, Department of Psychology, Coral Gables, United States

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.