883. Qualitative Patient-Participant Perspectives on Implementation of Monthly Cabotegravir and Rilpivirine Long Acting (CAB+RPV LA) Injectable in the United States (CUSTOMIZE)
Authors: Garris Cindy , Stassek Larissa , D’Amico Ronald , Dalessandro Marybeth , Adkins Sheila , Thedinger Blair , Brock James B , Chiriboga-Salazar Daniela M , Czarnogorski Maggie 
Published: December 2021

Abstract

Background
CAB+RPV LA administered monthly for HIV treatment is non-inferior to daily oral ART at maintaining viral suppression and preferred by most participants in clinical trials over daily ART. CUSTOMIZE, an implementation-effectiveness study, evaluated facilitators and barriers to clinic implementation of CAB+RPV LA from the patient perspective.

Methods
115 participants were enrolled across 8 HIV clinics. Semi-structured phone interviews were conducted with a randomized subgroup of 3-6 participants per site, prior to the 1st (Baseline [BL], N=34) and 12th CAB+RPV LA injections (Month 12 [M12], N=31). Consolidated Framework for Implementation Research-guided interviews were recorded, transcribed, and coded using ATLAS.ti.

Results
At BL, 97% (n=33) of those interviewed indicated ≥1 challenge taking daily oral ART, including concerns about adherence (n=19; 56%), dosing frequency (n=13; 38%) and side effects (n=12; 35%). Twenty-seven (79%) reported anticipated challenges of CAB+RPV LA such as worry about side effects (n=15; 44%) and discomfort from injections (n=14; 41%). Participants reported at BL that CAB+RPV LA may help with adherence (n=17; 50%) or reduce fears of HIV status disclosure (n=10; 29%). At M12, 35% (n=11) reported some pain/discomfort from injections, but 87% (n=27) reported satisfaction with CAB+RPV LA, most commonly due to preferring the monthly regimen over the daily pill (n=15; 48%). Facilitators reported by participants as most helpful during early implementation were verbal education by clinic staff (14%), reminder texts/calls (13%), and an educational video about the regimen (6%). Most (n=25; 81%) indicated clinic hours were not a barrier, but 19% (n=6) noted taking time off work for the visits. Many participants (n=21; 68%) described positive aspects of going to the clinic each month, none complained about visit length, and 94% (n=29) reported intent to continue CAB+RPV LA after the study.

Conclusion
Interviewed participants reported several challenges with daily oral ART that monthly CAB+RPV LA may help overcome. Some initial concerns about receiving CAB+RPV LA were reported at BL, but most participants were satisfied with the regimen after one year and plan to continue receiving CAB+RPV LA following the study.

Disclosures
Cindy Garris, MS, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Larissa Stassek, MPH, GlaxoSmithKline (Consultant, Other Financial or Material Support, My company (Evidera) received funding from GSK to conduct this research. We did not receive funding for work on this abstract.) Ronald D’Amico, DO, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Marybeth Dalessandro, BS, ViiV Healthcare (Employee, Shareholder) Sheila Adkins, BS, GSK (Employee)GSK (Employee, Stock) Maggie Czarnogorski, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)