Accepted for/Published in: JMIR Public Health and Surveillance
Date Submitted: Dec 10, 2022
Date Accepted: Jan 31, 2023
An implementation study of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis among sexual and gender minorities: The ImPrEP CAB Brasil Study Protocol
ABSTRACT
Background:
Long-acting injectable Cabotegravir (CAB-LA) for HIV pre-exposure prophylaxis (PrEP) has been proven efficacious in randomized controlled trials. Additional research is critical to evaluate effectiveness in real world settings and to identify effective implementation approaches.
Objective:
ImPrEP CAB Brasil is an implementation study whose main objective is to generate critical evidence on the feasibility, acceptability, and effectiveness of incorporating CAB-LA PrEP into existing oral PrEP services offered to cisgender men and transgender or gender non-binary individuals who have sex with persons assigned male at birth. The study will also evaluate: (1) an mHealth education and decision support tool, (2) digital injection appointment reminders, and (3) facilitators and barriers to integrating CAB-LA into existing HIV prevention services.
Methods:
This hybrid Type 2 implementation-effectiveness study which equally prioritizes clinical and implementation outcomes will be conducted at six public health PrEP clinics in six Brazilian cities. Relevant outcomes of interest and their level of evaluation include acceptability (individual health provider and participant); reach (choice and uptake at level of individual participant); effectiveness (individual participant); implementation (setting level, overall delivery); maintenance (individual participant); feasibility (setting level). We will use both quantitative (surveys, laboratory tests, service statistics) and qualitative (in-depth interviews and focus group discussions) methods. HIV incidence in the CAB-LA cohort (N=1200) will be compared with a similar cohort accessing oral PrEP through the public health system. The effectiveness of the mHealth intervention will be assessed using interrupted time series analysis. The digital intervention will be randomized at the individual level, and data analyzed using logistic mixed models.
Results:
During the third quarter of 2022, we obtained regulatory approvals, programmed data entry and management, prepared sites equipping, standard operational procedures, study specific plan and staff selection. The study enrollment is anticipated for the first quarter of 2023.
Conclusions:
The ImPrEP CAB Brasil will be fundamental to design programmatic strategies to implement and scale up feasible, equitable, cost-effective, sustainable, and comprehensive alternatives for PrEP programs. The study will also contribute to maximizing the impact of a public health approach to reducing HIV incidence among sexual and gender minorities in Brazil and other developing countries, both within the region and globally. Clinical Trial: NCT 05515770 (clinicaltrials.gov)
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