Article
Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study
Registro en:
GRINSZTEJN, Beatriz et al. Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study. JMIR Public Health and Surveillance, v. 9, p. 1-22, Apr. 2023.
2369-2960
10.2196/44961
2369-2960
Autor
Grinsztejn, Beatriz
Torres, Thiago Silva
Hoagland, Brenda
Jalil, Emilia Moreira
Moreira, Ronaldo Ismerio
O'Malley, Gabrielle
Shade, Starley B.
Benedetti, Marcos R.
Moreira, Julio
Simpson, Keila
Pimenta, Maria Cristina
Veloso, Valdiléa G.
Resumen
This project was made possible thanks to Unitaid’s funding and support. Unitaid accelerates access to innovative health products and lays the foundation for their scale-up by countries and partners. Unitaid is a hosted partnership of the World Health Organization. ViiV Healthcare will provide the study medication. BG and TST are funded by the National Council of Technological and Scientific Development and Carlos Chagas Filho Foundation for Research Support in the State of Rio de Janeiro. The authors would like to thank the Ministry of Health of Brazil for their support. The contributors associated with ImPrEP CAB Brasil Study Group are as follows: Anna Hellstrom, Alessandro Farias, Marcus V Lacerda, José Valdez Madruga, Josué N de Lima, Ronaldo Zonta, Roberta Trefiglio, Renato Lima, Antonio Carvalho, Sandra Wagner Cardoso, Débora Marra Faber Barreto, Egydio Sampaio Pessanha, Sandro Nazer, Carla de Barcellos Rocha, Claudio Gruber Mann, Nilo M Fernandes, Cristina Jalil, Lucilene Freitas, Eduardo Carvalheira Netto, Mônica Derrico, Flávia Lessa, Larissa Vilela, Laylla Monteiro, Josias Freitas, Toni Araújo, Daniel R B Bezerra, Luana M S Marins, Robson Pierre N. Silva. Background: Long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) has proven efficacious in randomized controlled trials. Further research is critical to evaluate its effectiveness in real-world settings and identify effective implementation approaches, especially among young sexual and gender minorities (SGMs). Objective: ImPrEP CAB Brasil is an implementation study aiming to generate critical evidence on the feasibility, acceptability, and effectiveness of incorporating CAB-LA into the existing public health oral PrEP services in 6 Brazilian cities. It will also evaluate a mobile health (mHealth) education and decision support tool, digital injection appointment reminders, and the facilitators of and barriers to integrating CAB-LA into the existing services. Methods: This type-2 hybrid implementation-effectiveness study includes formative work, qualitative assessments, and clinical steps 1 to 4. For formative work, we will use participatory design methods to develop an initial CAB-LA implementation package and process mapping at each site to facilitate optimal client flow. SGMs aged 18 to 30 years arriving at a study clinic interested in PrEP (naive) will be invited for step 1. Individuals who tested HIV negative will receive mHealth intervention and standard of care (SOC) counseling or SOC for PrEP choice (oral or CAB-LA). Participants interested in CAB-LA will be invited for step 2, and those with undetectable HIV viral load will receive same-day CAB-LA injection and will be randomized to receive digital appointment reminders or SOC. Clinical appointments and CAB-LA injection are scheduled after 1 month and every 2 months thereafter (25-month follow-up). Participants will be invited to a 1-year follow-up to step 3 if they decide to change to oral PrEP or discontinue CAB-LA and to step 4 if diagnosed with HIV during the study. Outcomes of interest include PrEP acceptability, choice, effectiveness, implementation, and feasibility. HIV incidence in the CAB-LA cohort (n=1200) will be compared with that in a similar oral PrEP cohort from the public health system. The effectiveness of the mHealth and digital interventions will be assessed using interrupted time series analysis and logistic mixed models, respectively. Results: During the third and fourth quarters of 2022, we obtained regulatory approvals; programmed data entry and management systems; trained sites; and performed community consultancy and formative work. Study enrollment is programmed for the second quarter of 2023. Conclusions: ImPrEP CAB Brasil is the first study to evaluate CAB-LA PrEP implementation in Latin America, one of the regions where PrEP scale-up is most needed. This study will be fundamental to designing programmatic strategies for implementing and scaling up feasible, equitable, cost-effective, sustainable, and comprehensive alternatives for PrEP programs. It will also contribute to maximizing the impact of a public health approach to reducing HIV incidence among SGMs in Brazil and other countries in the Global South.