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Purpose: This study analyzed the sociodemographic and behavioral characteristics of adolescent men who have sex with men (aMSM) and transgender women (aTGW) initiating oral pre-exposure prophylaxis (PrEP) in human immunodeficiency virus (HIV) prevention clinics., Methods: PrEP1519 is a prospective, multicenter, open-label PrEP demonstration cohort study of aMSM and aTGW aged 15-19 years living in three large Brazilian capital cities. For this analysis, we included adolescents who enrolled in PrEP1519 from February 2019 to August 2021. Adolescents who visited PrEP clinics were classified into four groups based on PrEP eligibility and on their decision to use PrEP: (1) ineligible for same-day PrEP initiation; (2) eligible for same-day PrEP initiation, initiated PrEP at first visit; (3) eligible for PrEP initiation, initiated PrEP after the first visit; and (4) eligible for same-day PrEP initiation but declined. The groups that were eligible for same-day PrEP initiation were compared using the Chi-square and Fisher's exact tests., Results: Of the 1,254 adolescents enrolled in the PrEP1519 study, 61 (4.9%) were considered ineligible for same-day PrEP initiation. Of the 1,193 eligible for same-day PrEP initiation, 1,113 (93.3%) initiated PrEP [1,054 initiated PrEP in the first visit (88.3%) and 59 in subsequent visits (4.9%)] and 80 (6.7%) did not. Despite 90% of the PrEP decliners reporting a low risk of HIV infection, most reported condomless anal sex in the past six months (70%)., Discussion: Same-day PrEP initiation among aMSM and aTGW was high, highlighting that this strategy was important to promote PrEP initiation among adolescents with increased vulnerability to HIV in Brazil., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: This study aimed to describe pre-exposure prophylaxis (PrEP) for HIV discontinuation in adolescent men who have sex with men (aMSM) and adolescent transgender women (aTGW) and to identify factors associated with discontinuation., Methods: The PrEP1519 study included a cohort of aMSM and aTGW aged 15-19 years old, and it was conducted in three large Brazilian capital cities. For this analysis, we included adolescents who initiated PrEP. PrEP discontinuation was defined as no possession of PrEP pills for >90 days. Kaplan-Meier curves were used to analyze the probabilities of discontinuation, and survival distributions stratified by covariates were compared using log-rank or Wilcoxon tests. Cox regression models were used to estimate the adjusted hazard ratio (aHR) with a 95% confidence interval (95% CI)., Results: We included 908 adolescents, 829 (91.30%) aMSM and 79 (8.70%) aTGW, most of whom were 18-19 years (80.29%). The incidence rate of discontinuation was 75.6 per 100 person-years. The probability of discontinuation was 52.61% in the first year. The multivariate analysis demonstrated that the aTGW (aHR = 1.63; 95% CI: 1.02-1.64) and adolescents with a medium (aHR = 1.29; 95% CI: 1.02-1.64) or low (aHR = 1.65; 95% CI: 1.29-2.12) perceived risk of HIV infection had an increased risk of discontinuation, whereas the adolescents with a partner living with HIV had a lower risk of discontinuation (aHR = 0.57; 95% CI: 0.35-0.91)., Discussion: Adolescents with a high risk for discontinuation may need additional support that emphasizes the value of PrEP as a tool for HIV prevention because PrEP discontinuation was associated with a disconnect between HIV risk perception and HIV prevention., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: This study aimed at describing the prevalence of symptoms of depression among 15-19 year old adolescent men who have sex with men (aMSM) and transgender women (aTGW), who were recruited in an HIV pre-exposure prophylaxis cohort study in three Brazilian capital cities. The study also examined potential associations, including violence and discrimination, with severe symptoms of depression among aMSM., Methods: This is a cross-sectional study of baseline data among 730 aMSM and 56 aTGW recruited between February 2019 and February 2021. Sociodemographic and behavioral data were collected. The 20-item Center for Epidemiologic Studies Depression scale was used to screen for symptoms of depression. Scores of ≥22 points indicate the presence of severe symptoms associated with major depression. Logistic regression was used to assess independent associations among aMSM, adjusting for sociodemographic variables., Results: Our findings indicate a high prevalence of symptoms of depression (overall prevalence = 58.5% and 69.6%; 21.2% and 25.0% for mild/moderate, and 37.3% and 44.6% for severe) among these aMSM and aTGW, respectively. Psychological violence (aOR = 1.74; 95% CI = 1.12-2.70), sexual violence (aOR = 1.79; 95% CI = 1.07-2.98), and discrimination due to sexual orientation (aOR = 1.71; 95% CI = 1.23-2.38) were independently associated with severe symptoms of depression in aMSM., Discussion: The high prevalence of severe symptoms of depression and its association with psychological and sexual violence and discrimination creates cycles of vulnerability and carries important public health implications. Thus, our findings indicate public policies should consider assessing depression, psychological and sexual violence, as well as discrimination, especially in populations that will be targeted by interventions, such as the use of pre-exposure prophylaxis., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: To explore legal and ethical challenges related to adolescents' participation in human immunodeficiency virus (HIV) research that may affect their best interests., Methods: We analyzed the ethical principles and legal aspects of the participation of 15-17-year-old men who have sex with men and transgender women in the pre-exposure prophylaxis (PrEP) 1519 study, a PrEP demonstration cohort study in three Brazilian cities. The analyses of ethics review committees' (ERCs) evaluations and court decisions followed ethical and human rights principles. An HIV vulnerability score was created, and descriptive statistics and multivariate logistic regression were performed using data from 347 participants., Results: The ERCs evaluated the benefits and risks of research participation, all finding that the benefits outweighed the risks. ERCs deferred responsibility for decisions about waiving parental consent to the judiciary. State courts reached different decisions about waiving parental consent, reflecting variation in recognition of adolescents' evolving capacities and the adolescent as a subject of sexual rights and the primary agent capable of deciding on their health and best interests. The most vulnerable adolescent participants were found in sites where the blanket waiver was in place., Discussion: Judicializing the ethical review process is detrimental to fulfilling the ethical principle of justice and vulnerable adolescents' access to health research. ERCs must be sufficiently independent and autonomous and have the capacity to respect, protect, and help fulfill the rights of participants while ensuring the generation of adequate evidence to inform public health practice., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the adherence, safety, and feasibility of pre-exposure prophylaxis (PrEP) in real-world settings among adolescent men who have sex with men (AMSM) and transgender women (ATGW)., Methods: PrEP1519 is a single-arm, multicentric demonstration cohort study of daily oral PrEP among AMSM and ATGW aged 15 to 19 years in Brazil. Study visits occurred at baseline, weeks 4, 12, and then quarterly until 96 weeks. Descriptive statistics and a mixed logistic model for longitudinal data evaluated the factors associated with high adherence., Results: One thousand sixteen AMSM and ATGW accessed the PrEP1519 clinics. Of those, 998 (98.2%) underwent clinical triage. Forty one were diagnosed with human immunodeficiency viruses (HIV) at baseline (4.0%) and 79 (7.9%) were not eligible for PrEP. Of the 878, 795 (90.5%) enrolled in PrEP, 82 (10.3%) were lost to follow-up, and 713 were included. There was no significant decrease in creatinine clearance; only two participants had grade-III aspartate aminotransferase elevation. Incident HIV infection occurred in eight participants (incidence rate [IR] = 1.64 per 100 person-years [PY]): two in 15-17 years (IR = 2.24 per 100 PY) and six in 18-20 years (IR = 1.51 per 100 PY). PrEP adherence was higher among those with more years of schooling, those reporting no difficulties in PrEP use due to side effects, and who had low HIV risk perception in the past three months., Discussion: PrEP for AMSM and ATGW was safe and feasible in real-world settings. However, a higher IR among young adolescents and a higher adherence among less vulnerable people indicate the need for greater care, considering the specificities of this age group., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

HIV Pre-exposure prophylaxis (PrEP) is an effective prevention tool, but there are still few studies about PrEP uptake among adolescents. We aimed to analyze the PrEP uptake process and factors associated with daily oral PrEP initiation among adolescent men who have sex with men (aMSM) and transgender women (aTGW) in Brazil. Baseline data from the first demonstration PrEP cohort study among aMSM and aTGW 15-19 years old (yo) ongoing in three large Brazilian cities (PrEP1519). After completing informed consent procedures, participants were enrolled in the cohort from February/2019 to February/2021. A socio-behavioral questionnaire was applied. Factors associated with PrEP initiation were assessed using a logistic regression model with adjusted prevalence ratios (aPR) and 95% confidence intervals (95%CI). Among recruited participants, 174 (19,2%) were aged 15-17 yo and 734 (80,8%) 18-19 yo. The rate of PrEP initiation was 78.2% and 77.4% for 15-17 yo and 18-19 yo, respectively. Factors associated with PrEP initiation were: black or mixed race (aPR 2.31; 95%CI: 1.10-4.84) among the younger adolescents 15-17 yo; experienced violence and/or discrimination due to their sexual orientation or gender identity (aPR 1.21; 95%CI: 1.01-1.46); transactional sex (aPR 1.32; 95%CI: 1.04-1.68); and having had between 2 to 5 sexual partners in the previous three months (aPR 1.39; 95%CI: 1.15-1.68) among those 18-19 yo. Unprotected receptive anal intercourse in the previous six months was associated with PrEP initiation in both age groups (aPR 1.98; 95%CI: 1.02-3.85 and aPR 1.45; 95%CI: 1.19-1.76 among 15-17 yo and 18-19 yo, respectively). The biggest challenge to promoting PrEP use for aMSM and aTGW was in the first steps of the PrEP uptake process. Once they were linked to the PrEP clinic, initiation rates were high., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Soares et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Syphilis has reemerged as a serious public health problem in Brazil and worldwide, disproportionately affecting men who have sex with men (MSM) and travestis and transgender women (TrTGW). Studies on sexually transmitted infections (STI) in adolescents from these key populations are relatively scarce. This is a Brazilian multi-center, cross study with prevalence analysis, using as baseline the PrEP1519 cohort of sexually active MSM and TrTGW adolescents, recruited from April 2019 to December 2020. Analyses were made using the dimensions of vulnerability to STI/HIV and logistic regression models were conducted to estimate the odds ratios of the association between the predictor variables and positive treponemal test for syphilis at the moment of entry in the study. In total, 677 participants were analyzed; participants' median age was 18.9 years (IQR: 18.1-19.5); 70.5% (477) self-declared as black; 70.5% (474), as homosexuals/gays; and 48 (7.1%), as trans women or travestis. The baseline prevalence of syphilis was 21.3%. In the final logistic regression model, higher chance of syphilis was associated with: self-reported episode of STI in the last 12 months (OR = 5.92; 95%CI: 3.74-9.37), sex worker (OR = 3.39; 95%CI: 1.32-8.78), and < 11 years of schooling (OR = 1.76; 95%CI: 1.13-2.74). The prevalence of syphilis among MSM/TrTGW adolescents aged from 15 to 19 years was alarming, much higher than the described for the general population within this age range and associated with vulnerability factors. This reinforces the urgent need to strengthen public health programs to debate about race, gender, sexuality, and prevention.

At the end of 2017, Brazil adopted HIV pre-exposure prophylaxis (PrEP) as part of a combination prevention strategy for the most at-risk populations. However, Brazil does not have specific guidelines for PrEP use among adolescents aged < 18 years. Therefore, researchers from different health disciplines conducted PrEP1519, the first PrEP demonstration cohort study, ongoing in three Brazilian cities - Salvador, Belo Horizonte, and São Paulo - among adolescent men who have sex with men and transgender women, aged 15-19 years. This study aims to evaluate the effectiveness of PrEP in real-world settings. Quantitative and qualitative methods were integrated to obtain data on PrEP acceptability, uptake, use, and adherence. Moreover, comprehensive services and friendly environments were implemented in the PrEP1519 clinics. This study aims to describe the collaborative efforts of interdisciplinary practices in the development of the PrEP1519 study. The articulation of researchers from different institutions and areas is challenging; but it also allows for a broader outlook on questions regarding the direction of the research, while enriching the decisions needed to be taken during the interactions and negotiations among the different individuals, including the youth team and participants. Furthermore, it reflects on the communication process between cultures and languages considering the trans-epistemic arena of knowledge production about HIV, sexually transmitted infections, PrEP, and other combination prevention strategies for adolescents.

Based on the incorporation of pre-exposure prophylaxis (PrEP) as an HIV prevention strategy and considering the need to comprehend the use of medication among young people, this article analyzes narratives of gay men and transgender women from Belo Horizonte, Minas Gerais State, Brazil, participating in the PrEP1519 study. This is a qualitative research, based on the interpretative anthropology, developed by 10 in-depth interviews with PrEP users followed-up for at least three months between October and November 2019. The results showed that the drug was seen as the main motivation for participating in the study and as a strategy combined with the use of condoms, whether as additional prevention, or assuming the leading role. The medication revealed signs built by the gender performances and their relation to other medications, especially the experience of trans girls in hormonal therapy. Regarding the socialization of the use of PrEP, the narratives showed that there was no secret between the couples, which did not meant that stigmas on the association with HIV did not exist, mainly in the virtual context. In the family environment, they reported questions about the preventive function of the medication and the voluntary nature of the participation in the study. The youth's narratives revealed plural meanings of the medication and its social use, composing both the boys' and girls' performances. The signs attributed to the medication indicated that in addition to maintenance of health, the medication improves life and sexual freedom.

Using baseline data from the PrEP1519 cohort, in this article we aimed to analyze: (i) the effectiveness of demand creation strategies (DCS) to enroll adolescent men who have sex with men (AMSM) and adolescent transgender women (ATGW) into an HIV combination prevention study in Brazil; (ii) the predictors of DCS for adolescents' enrollment; and (iii) the factors associated with DCS by comparing online and face-to-face strategies for enrollment. The DCS included peer recruitment (i.e., online and face-to-face) and referrals from health services and non-governmental organizations (NGOs). AMSM and ATGW who agreed to participate in the study could opt to enroll in either PrEP (PrEP arm) or to use other prevention methods (non-PrEP arm). Bivariate and multivariate analyses were conducted and logistic regression odds ratios were estimated. The DCS reached 4529 AMSM and ATGW, the majority of which were derived online (73.8%). Of this total, 935 (20.6%) enrolled to participate (76.6% in PrEP arm and 23.4% in non-PrEP arm). The effectiveness of enrolling adolescents into both arms was greater via direct referrals (235/382 and 84/382, respectively) and face-to-face peer recruitment (139/670 and 35/670, respectively) than online (328/3342). We found that a combination under DCS was required for successful enrollment in PrEP, with online strategies majorly tending to enroll adolescents of a higher socioeconomic status. Our findings reinforce the need for DCS that actively reaches out to all adolescents at the greatest risk for HIV infection, irrespective of their socioeconomic status., (© 2022. The Author(s).)