Preparing for implementation of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis within the Brazilian public health system: The ImPrEP CAB Brasil Study

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Abstract Introduction Although long-acting injectable cabotegravir (CAB-LA) PrEP has proven efficacious for HIV prevention in clinical trials, additional research is needed to guide effective implementation in real world settings. Methods ImPrEP CAB-Brasil is an implementation study of same-day delivery of CAB-LA PrEP for young sexual and gender minorities (SGM; aged 18-30 years) in six existing oral PrEP public health clinics. We conducted formative research to prepare for the implementation of ImPrEP CAB-Brasil through (1) community mobilization; (2) process mapping; and (3) focus group discussions with young SGM (N=92) and health professionals (N=20) to identify facilitators and barriers to injectable PrEP implementation and request feedback on an mHealth education and decision support tool and WhatsApp appointment reminder intervention. Results Community mobilization team collaborated in developing prototype materials for an mHealth intervention to support PrEP-user decision making, participated in study protocol training sessions, and contributed to the planning of peer education activities. We created three process maps for each site to describe the initial visit, follow-up visits and laboratory flow. The main challenge identified for same-day CAB-LA PrEP delivery was the duration of clinic visits due to a high number of laboratory and HIV counseling steps necessary. Proposed solutions included point-of-care HIV rapid tests (with additional training) instead of laboratory tests and the addition of more staff to perform counseling. Identified barriers for CAB-LA PrEP implementation included the training of health professionals, creating a stigma-free environment, and ensuring adherence to injection appointments. The mHealth educational video and WhatsApp messages showed high acceptability by both SGM and health providers. Content analysis on appropriateness of language and for overall clarity of the material contributed to the refinement of the mHealth component. Conclusions Structured formative work with SGM community members and health providers generated important refinements to context-specific materials and plans for the launch of ImPrEP CAB-Brasil in public health clinics. Continuous monitoring of the implementation of mapped processes will help further identify barriers and solutions to CAB-LA PrEP delivery. Summative evaluations are needed to measure the effectiveness of the mHealth educational video and WhatsApp appointment reminders. Trial Registration ClinicalTrials.gov NCT05515770 (29-AUG-2022)

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