PrEP15-19 Choices: an implementation study protocol of HIV prevention with oral and long-acting injectable cabotegravir PrEP in real-world settings among sexual and gender minority adolescents in Brazil
Introduction Long-acting injectable (LAI) cabotegravir is a promising new method for preventing HIV. Safe and effective long-acting agents for pre-exposure prophylaxis (PrEP) for HIV infection are needed to increase preventive options among sexual and gender minority adolescents.Methods and analysis...
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2025-01-01
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| author | Inês Dourado Eliana Miura Zucchi Laio Magno Alexandre D Grangeiro Márcia Thereza Couto Mateus Westin Eduardo Oliveira Maria Mercedes Escuder Dirceu Greco Thais Regis Aranha Rossi Fabiane Soares Lorenza Dezanet Paula Massa Priscilla Caires Ricardo de Paula Vasconcelos Unaí Tupinambas Beo Leite Joilson Nascimento Paim Guilherme Barreto Campos Lucas Miranda Marques Nathalia Suzart Suilan Pedreira DulceAurélia deSouza Ferraz Dyemison Pinheiro Eliane Sala Raphaella Goulart Ana Paula Silva Erica Dumont Pena Gabriella Jomara daSilva Marília Greco Matheus dePaula Alves |
| author_facet | Inês Dourado Eliana Miura Zucchi Laio Magno Alexandre D Grangeiro Márcia Thereza Couto Mateus Westin Eduardo Oliveira Maria Mercedes Escuder Dirceu Greco Thais Regis Aranha Rossi Fabiane Soares Lorenza Dezanet Paula Massa Priscilla Caires Ricardo de Paula Vasconcelos Unaí Tupinambas Beo Leite Joilson Nascimento Paim Guilherme Barreto Campos Lucas Miranda Marques Nathalia Suzart Suilan Pedreira DulceAurélia deSouza Ferraz Dyemison Pinheiro Eliane Sala Raphaella Goulart Ana Paula Silva Erica Dumont Pena Gabriella Jomara daSilva Marília Greco Matheus dePaula Alves |
| collection | DOAJ |
| description | Introduction Long-acting injectable (LAI) cabotegravir is a promising new method for preventing HIV. Safe and effective long-acting agents for pre-exposure prophylaxis (PrEP) for HIV infection are needed to increase preventive options among sexual and gender minority adolescents.Methods and analysis This is a multisite, prospective implementation study of three PrEP modalities (LAI-PrEP, event-driven (ED) and daily oral), using a mixed-method design with quantitative and qualitative approaches. The study will include a sample of 550 HIV-negative adolescent men who have sex with men, non-binary individuals assigned male at birth, transgender men and women, aged 15–19 years, in three Brazilian capital cities. Participants will be allocated into two arms, according to their choice of PrEP modalities, and followed up to 36 months. Switching between oral and LAI-PrEP will be allowed, according to the participants’ needs and preferences. The qualitative studies will focus on investigating the processes involved in linkage and retention in care, switching between PrEP modalities and strategies of the implementation process of LAI-PrEP in the current PrEP programming and acceptability from health providers, policymakers and stakeholders’ perspectives.Ethics and dissemination The adolescent’s autonomy for consenting to their participation and understanding of PrEP will be assessed by the project team before any care is given and will be recorded in their medical record. Adolescents aged 15–17 years will sign an informed assent form, waiving the need for the approval of a legal guardian, except in cases where the adolescent is found not to have the necessary autonomy. The study was approved by the WHO Ethics Review Committee and by the local IRBs from the universities coordinating the study, the University of São Paulo, the Federal University of Bahia and the Federal University of Minas Gerais. This project is part of an effort to expedite the inclusion of new modalities in the Brazilian PrEP Programme, based on the development of studies to evaluate the implementation of LAI-PrEP and ED-PrEP as a choice. The results will be published in peer-reviewed journals and presented to the study participants and communities.Trial registration number https://ensaiosclinicos.gov.br/rg/RBR-104736f4. The trial registration number: RBR-104736f4 |
| format | Article |
| id | doaj-art-d6439cacf14b4bf3a94c2591404e9782 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-d6439cacf14b4bf3a94c2591404e97822025-01-27T21:45:09ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2023-083146PrEP15-19 Choices: an implementation study protocol of HIV prevention with oral and long-acting injectable cabotegravir PrEP in real-world settings among sexual and gender minority adolescents in Brazil Inês Dourado0Eliana Miura Zucchi1Laio Magno2Alexandre D Grangeiro3Márcia Thereza Couto4Mateus Westin5Eduardo OliveiraMaria Mercedes EscuderDirceu Greco6Thais Regis Aranha Rossi7Fabiane Soares8Lorenza Dezanet9Paula Massa10Priscilla Caires11Ricardo de Paula Vasconcelos12Unaí Tupinambas13Beo LeiteJoilson Nascimento PaimGuilherme Barreto CamposLucas Miranda MarquesNathalia SuzartSuilan PedreiraDulceAurélia deSouza FerrazDyemison PinheiroEliane SalaRaphaella GoulartAna Paula SilvaErica Dumont PenaGabriella Jomara daSilvaMarília GrecoMatheus dePaula Alves1 Instituto de Saúde Coletiva, Universidade Federal da Bahia, Salvador, Bahia, Brazil6 Programa de Pós-Graduação em Saúde Coletiva, Universidade Católica de Santos, Santos, São Paulo, Brazil1 Instituto de Saúde Coletiva, Universidade Federal da Bahia, Salvador, Bahia, Brazil7 Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil7 Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil4 Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil4 Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil3 Departamento de Ciências da Vida, Universidade do Estado da Bahia, Salvador, Bahia, Brazil1 Instituto de Saúde Coletiva, Universidade Federal da Bahia, Salvador, Bahia, Brazil2 Instituto René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, Minas Gerais, Brazil5 Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil1 Instituto de Saúde Coletiva, Universidade Federal da Bahia, Salvador, Bahia, Brazil5 Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo, Brazil4 Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, BrazilIntroduction Long-acting injectable (LAI) cabotegravir is a promising new method for preventing HIV. Safe and effective long-acting agents for pre-exposure prophylaxis (PrEP) for HIV infection are needed to increase preventive options among sexual and gender minority adolescents.Methods and analysis This is a multisite, prospective implementation study of three PrEP modalities (LAI-PrEP, event-driven (ED) and daily oral), using a mixed-method design with quantitative and qualitative approaches. The study will include a sample of 550 HIV-negative adolescent men who have sex with men, non-binary individuals assigned male at birth, transgender men and women, aged 15–19 years, in three Brazilian capital cities. Participants will be allocated into two arms, according to their choice of PrEP modalities, and followed up to 36 months. Switching between oral and LAI-PrEP will be allowed, according to the participants’ needs and preferences. The qualitative studies will focus on investigating the processes involved in linkage and retention in care, switching between PrEP modalities and strategies of the implementation process of LAI-PrEP in the current PrEP programming and acceptability from health providers, policymakers and stakeholders’ perspectives.Ethics and dissemination The adolescent’s autonomy for consenting to their participation and understanding of PrEP will be assessed by the project team before any care is given and will be recorded in their medical record. Adolescents aged 15–17 years will sign an informed assent form, waiving the need for the approval of a legal guardian, except in cases where the adolescent is found not to have the necessary autonomy. The study was approved by the WHO Ethics Review Committee and by the local IRBs from the universities coordinating the study, the University of São Paulo, the Federal University of Bahia and the Federal University of Minas Gerais. This project is part of an effort to expedite the inclusion of new modalities in the Brazilian PrEP Programme, based on the development of studies to evaluate the implementation of LAI-PrEP and ED-PrEP as a choice. The results will be published in peer-reviewed journals and presented to the study participants and communities.Trial registration number https://ensaiosclinicos.gov.br/rg/RBR-104736f4. The trial registration number: RBR-104736f4https://bmjopen.bmj.com/content/15/1/e083146.full |
| spellingShingle | Inês Dourado Eliana Miura Zucchi Laio Magno Alexandre D Grangeiro Márcia Thereza Couto Mateus Westin Eduardo Oliveira Maria Mercedes Escuder Dirceu Greco Thais Regis Aranha Rossi Fabiane Soares Lorenza Dezanet Paula Massa Priscilla Caires Ricardo de Paula Vasconcelos Unaí Tupinambas Beo Leite Joilson Nascimento Paim Guilherme Barreto Campos Lucas Miranda Marques Nathalia Suzart Suilan Pedreira DulceAurélia deSouza Ferraz Dyemison Pinheiro Eliane Sala Raphaella Goulart Ana Paula Silva Erica Dumont Pena Gabriella Jomara daSilva Marília Greco Matheus dePaula Alves PrEP15-19 Choices: an implementation study protocol of HIV prevention with oral and long-acting injectable cabotegravir PrEP in real-world settings among sexual and gender minority adolescents in Brazil BMJ Open |
| title | PrEP15-19 Choices: an implementation study protocol of HIV prevention with oral and long-acting injectable cabotegravir PrEP in real-world settings among sexual and gender minority adolescents in Brazil |
| title_full | PrEP15-19 Choices: an implementation study protocol of HIV prevention with oral and long-acting injectable cabotegravir PrEP in real-world settings among sexual and gender minority adolescents in Brazil |
| title_fullStr | PrEP15-19 Choices: an implementation study protocol of HIV prevention with oral and long-acting injectable cabotegravir PrEP in real-world settings among sexual and gender minority adolescents in Brazil |
| title_full_unstemmed | PrEP15-19 Choices: an implementation study protocol of HIV prevention with oral and long-acting injectable cabotegravir PrEP in real-world settings among sexual and gender minority adolescents in Brazil |
| title_short | PrEP15-19 Choices: an implementation study protocol of HIV prevention with oral and long-acting injectable cabotegravir PrEP in real-world settings among sexual and gender minority adolescents in Brazil |
| title_sort | prep15 19 choices an implementation study protocol of hiv prevention with oral and long acting injectable cabotegravir prep in real world settings among sexual and gender minority adolescents in brazil |
| url | https://bmjopen.bmj.com/content/15/1/e083146.full |
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