The lancet. HIV · 2026
Integrating long-acting injectable cabotegravir for HIV prevention into the Brazilian public health system (ImPrEP CAB Brasil): a hybrid type-2 implementation-effectiveness cohort study.
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Grinsztejn Beatriz, Torres Thiago Silva, Hoagland Brenda, Coutinho Carolina, Silva Mayara Secco Torres, Leite Iuri Costa, Cunha Marcelo, Derrico Monica, Jalil Emilia M, Cardoso Sandra Wagner, Trefiglio Roberta, Farias Alessandro, Mourão Maria Paula G, Madruga José Valdez, de Lima Josué N, Zonta Ronaldo, O'Malley Gabrielle, Moreira Julio, Simpson Keila, Rinehart Alex R, Pilgrim Nanlesta, Hellstrom Anna, Cameron Anne-Isabelle, Luz Paula Mendes, Landovitz Raphael J, Benedetti Marcos, Pimenta Cristina, Moreira Ronaldo Ismério, Veloso Valdilea Gonçalves, ImPrEP CAB Brasil Study Group
Аннотация
BACKGROUND: Daily oral pre-exposure prophylaxis (PrEP) requires sustained adherence, which remains challenging in real-world settings. Although long-acting injectable cabotegravir (CAB-LA) could improve prevention coverage, implementation evidence in Latin America is scant. We evaluated the feasibility of integrating same-day CAB-LA delivery within Sistema Único de Saúde (SUS), the Brazilian public health system.
METHODS: ImPrEP CAB Brasil was a multicentre, hybrid type-2 implementation-effectiveness, open-label cohort study done at 14 PrEP public health services in six Brazilian cities. Eligible participants were cisgender men, non-binary people assigned male at birth, and transgender men and women who have sex with men, aged 18-30 years, who tested HIV negative, and were PrEP-naive. Participants could choose either CAB-LA (CAB-LA choice cohort) or oral PrEP with tenofovir disoproxil fumarate and emtricitabine (oral PrEP choice cohort), We included a comparison cohort of people initiating PrEP in SUS (oral PrEP SUS cohort). The main outcomes were HIV incidence and follow-up days covered by PrEP. For CAB-LA, we evaluated on-time injection adherence, switching, loss to follow-up, and safety. Participants were given the option to switch PrEP modalities or remain off PrEP during follow-up. Adverse events of special interest in participants using CAB-LA were assessed at every study visit. The study was registered at ClinicalTrials.gov (NCT05515770) and is ongoing.
FINDINGS: Participants were enrolled from Oct 17, 2023, to Sept 16, 2024, and followed up until Oct 16, 2025. 3096 participants were included in this analysis: 1201 (38·8%) in the CAB-LA choice cohort, 246 (7·9%) in the oral PrEP choice cohort, and 1649 (53·3%) in the oral PrEP SUS cohort. Most participants were cisgender men (2893 [90·9%]), Pardo or Black (1663 [53·7%]), and completed secondary education or higher (2517 [81·3%]). Median age was 26 years (IQR 23-28). HIV incidence was 0·20 per 100 person-years (95% CI 0·04-0·57) for the CAB-LA cohort (three new HIV infections), 0·87 (0·11-3·16) for the oral PrEP choice cohort (two new HIV infections), and 1·48 (0·88-2·33) for the oral PrEP SUS cohort (18 new HIV infections). 590 091 (90·8%) follow-up days were covered by PrEP in the CAB-LA cohort versus 69 491 (47·3%) in the oral PrEP choice cohort and 328 025 (35·5%) in the oral PrEP SUS cohort (p<0·0001). 107 (8·8%) of 1220 participants were lost to follow-up in the CAB-LA cohort, and were mainly people who were non-White, had lower levels of education, and had moderate or severe depressive symptoms. On-time injection adherence was high (92%). Injection-site reactions were the most frequent adverse event (4212 events in 1067 [87·5%] participants) and were generally mild to moderate. 80 serious adverse events were reported: 43 adverse events of interest (one related to CAB-LA) and 37 other events (none related to CAB-LA).
INTERPRETATION: Same-day CAB-LA delivery effectively reduced HIV incidence and increased PrEP coverage, supporting the implementation of long-acting options within SUS in Brazil.
FUNDING: Unitaid, WHO, and Ministry of Health of Brazil.
TRANSLATIONS: For the Portuguese and Spanish translations of the abstract see Supplementary Materials section.
METHODS: ImPrEP CAB Brasil was a multicentre, hybrid type-2 implementation-effectiveness, open-label cohort study done at 14 PrEP public health services in six Brazilian cities. Eligible participants were cisgender men, non-binary people assigned male at birth, and transgender men and women who have sex with men, aged 18-30 years, who tested HIV negative, and were PrEP-naive. Participants could choose either CAB-LA (CAB-LA choice cohort) or oral PrEP with tenofovir disoproxil fumarate and emtricitabine (oral PrEP choice cohort), We included a comparison cohort of people initiating PrEP in SUS (oral PrEP SUS cohort). The main outcomes were HIV incidence and follow-up days covered by PrEP. For CAB-LA, we evaluated on-time injection adherence, switching, loss to follow-up, and safety. Participants were given the option to switch PrEP modalities or remain off PrEP during follow-up. Adverse events of special interest in participants using CAB-LA were assessed at every study visit. The study was registered at ClinicalTrials.gov (NCT05515770) and is ongoing.
FINDINGS: Participants were enrolled from Oct 17, 2023, to Sept 16, 2024, and followed up until Oct 16, 2025. 3096 participants were included in this analysis: 1201 (38·8%) in the CAB-LA choice cohort, 246 (7·9%) in the oral PrEP choice cohort, and 1649 (53·3%) in the oral PrEP SUS cohort. Most participants were cisgender men (2893 [90·9%]), Pardo or Black (1663 [53·7%]), and completed secondary education or higher (2517 [81·3%]). Median age was 26 years (IQR 23-28). HIV incidence was 0·20 per 100 person-years (95% CI 0·04-0·57) for the CAB-LA cohort (three new HIV infections), 0·87 (0·11-3·16) for the oral PrEP choice cohort (two new HIV infections), and 1·48 (0·88-2·33) for the oral PrEP SUS cohort (18 new HIV infections). 590 091 (90·8%) follow-up days were covered by PrEP in the CAB-LA cohort versus 69 491 (47·3%) in the oral PrEP choice cohort and 328 025 (35·5%) in the oral PrEP SUS cohort (p<0·0001). 107 (8·8%) of 1220 participants were lost to follow-up in the CAB-LA cohort, and were mainly people who were non-White, had lower levels of education, and had moderate or severe depressive symptoms. On-time injection adherence was high (92%). Injection-site reactions were the most frequent adverse event (4212 events in 1067 [87·5%] participants) and were generally mild to moderate. 80 serious adverse events were reported: 43 adverse events of interest (one related to CAB-LA) and 37 other events (none related to CAB-LA).
INTERPRETATION: Same-day CAB-LA delivery effectively reduced HIV incidence and increased PrEP coverage, supporting the implementation of long-acting options within SUS in Brazil.
FUNDING: Unitaid, WHO, and Ministry of Health of Brazil.
TRANSLATIONS: For the Portuguese and Spanish translations of the abstract see Supplementary Materials section.