Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study

Detalhes bibliográficos
Autor(a) principal: Grinsztejn, Beatriz
Data de Publicação: 2023
Outros Autores: 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.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/58962
Resumo: 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.
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spelling Grinsztejn, BeatrizTorres, Thiago SilvaHoagland, BrendaJalil, Emilia MoreiraMoreira, Ronaldo IsmerioO'Malley, GabrielleShade, Starley B.Benedetti, Marcos R.Moreira, JulioSimpson, KeilaPimenta, Maria CristinaVeloso, Valdiléa G.2023-06-07T00:17:20Z2023-06-07T00:17:20Z2023GRINSZTEJN, 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. 2023.2369-2960https://www.arca.fiocruz.br/handle/icict/5896210.2196/449612369-2960This 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.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Department of Global Health. Schools of Medicine and Public Health. University of Washington. Seattle, WA, USA.Institute for Global Health Sciences. Department of Epidemiology and Biostatistics. University of California San Francisco. San Francisco, CA, USA.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Grupo Arco-Íris de Cidadania LGBT. Rio de Janeiro, RJ, Brazil.Associação Nacional de Travestis e Transexuais. Salvador, BA, Brazil.Brazilian Ministry of Health. Brasilia, DF, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.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.engJMIR PublicationsLong-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Studyinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleBrazilHIV preventionCabotegravirInjectable PrEPInjectable preexposure prophylaxisSexual and gender minoritiesYounginfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; 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dc.title.en_US.fl_str_mv Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study
title Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study
spellingShingle Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study
Grinsztejn, Beatriz
Brazil
HIV prevention
Cabotegravir
Injectable PrEP
Injectable preexposure prophylaxis
Sexual and gender minorities
Young
title_short Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study
title_full Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study
title_fullStr Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study
title_full_unstemmed Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study
title_sort Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study
author Grinsztejn, Beatriz
author_facet 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.
author_role author
author2 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.
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv 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.
dc.subject.en.en_US.fl_str_mv Brazil
HIV prevention
Cabotegravir
Injectable PrEP
Injectable preexposure prophylaxis
Sexual and gender minorities
Young
topic Brazil
HIV prevention
Cabotegravir
Injectable PrEP
Injectable preexposure prophylaxis
Sexual and gender minorities
Young
description 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.
publishDate 2023
dc.date.accessioned.fl_str_mv 2023-06-07T00:17:20Z
dc.date.available.fl_str_mv 2023-06-07T00:17:20Z
dc.date.issued.fl_str_mv 2023
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv 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.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/58962
dc.identifier.issn.en_US.fl_str_mv 2369-2960
dc.identifier.doi.none.fl_str_mv 10.2196/44961
dc.identifier.eissn.none.fl_str_mv 2369-2960
identifier_str_mv 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
url https://www.arca.fiocruz.br/handle/icict/58962
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv JMIR Publications
publisher.none.fl_str_mv JMIR Publications
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/58962/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/58962/2/ve_Beatriz_Grinsztejn_etal_INI_2023.pdf
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repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
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