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Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for
Beatriz Grinsztejn1, Thiago Silva Torres1, Brenda Hoagland1
1Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
JMIR Public Health and Surveillance
|April 19, 2023
Summary
The ImPrEP CAB Brasil study evaluates long-acting injectable cabotegravir (CAB-LA) for HIV pre-exposure prophylaxis (PrEP) in Brazil. It assesses feasibility, acceptability, and effectiveness, particularly for young sexual and gender minorities (SGMs).
Area of Science:
- Implementation Science
- Public Health
- HIV Prevention
Background:
- Long-acting injectable cabotegravir (CAB-LA) for pre-exposure prophylaxis (PrEP) has demonstrated efficacy in clinical trials.
- Real-world effectiveness and implementation strategies for CAB-LA, especially among young sexual and gender minorities (SGMs), require further investigation.
Purpose of the Study:
- To evaluate the feasibility, acceptability, and effectiveness of integrating CAB-LA into public health oral PrEP services in Brazil.
- To assess a mobile health (mHealth) tool, digital reminders, and identify implementation facilitators and barriers for CAB-LA.
Main Methods:
- A type-2 hybrid implementation-effectiveness study using participatory design, qualitative assessments, and clinical steps.
- Enrollment of SGMs aged 18-30 interested in PrEP, with randomization to mHealth/standard of care or standard of care for PrEP choice.
- Comparison of HIV incidence between CAB-LA and oral PrEP cohorts, with effectiveness analysis of mHealth and digital interventions.
Main Results:
- Regulatory approvals obtained, data systems programmed, sites trained, and formative work completed in late 2022.
- Study enrollment is scheduled to commence in the second quarter of 2023.
Conclusions:
- ImPrEP CAB Brasil is the first study in Latin America to evaluate CAB-LA PrEP implementation, a region with high PrEP scale-up needs.
- Findings will inform programmatic strategies for feasible, equitable, and sustainable PrEP alternatives, aiming to reduce HIV incidence among SGMs in Brazil and globally.
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