Adherence, Safety, and Feasibility of HIV Pre-Exposure Prophylaxis Among Adolescent Men Who Have Sex With Men and Transgender Women in Brazil (PrEP1519 Study).

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.

Important steps for PrEP uptake among adolescent men who have sex with men and transgender women in Brazil.

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.