França, Marcus http://orcid.org/0000-0003-1644-2746
Dourado, Inês http://orcid.org/0000-0003-1675-2146
Grangeiro, Alexandre http://orcid.org/0000-0001-5157-0597
Greco, Dirceu http://orcid.org/0000-0002-4419-5634
Magno, Laio http://orcid.org/0000-0003-3752-0782
Funding for this research was provided by:
UNITAID (#2017-15-FIOTECPrEP)
Ministério da Saúde (NA)
Article History
Accepted: 16 February 2024
First Online: 25 March 2024
Declarations
:
: The authors have no competing interests to declare that are relevant to the content of this article.
: This study was conducted in accordance with the guidelines of Resolution 466/2012 of Brazilian National Ethics Research Council and approved by the Research Ethics Committee (REC) of the University of São Paulo (#70798017.3.0000.0065), Federal University of Bahia (UFBA) (#01691718.1.0000.5030), and Federal University of Minas Gerais (#17750313.0.0000.5149) — and by the REC from the WHO (protocol identification: ‘Fiotec-PrEP Adolescent study’).
: Participants were instructed regarding the study, and those who agreed to participate signed a written informed consent (WIC) form when they were aged ≥ 18 years or an informed written assent (WA) form when they were aged < 18 years. For those aged < 18 years, a different protocol was used in each city, as per the local court decisions: in Belo Horizonte, the WIC had to be signed by the parents or guardian, followed by the WA form signed by the adolescents; in Salvador, there were two possibilities: (i) WIC had to be signed by a parent or guardian and WA by the adolescent; or (ii) just WA had to be signed by the adolescent, in which case the team’s psychologist and social worker judged that their family ties had been broken or that they were at risk of physical, psychological, or moral violence owing to their sexual orientation; in São Paulo a judicial decision allowed a waiver of parental consent, indicating that the WA signed by the adolescents was enough to enable them participate in the study.