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Adherence, safety, and feasibility of HIV pre-exposure prophylaxis among adolescent men who have sex with men and transgender women in Brazil

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BACKGROUND: Despite reports of worrisome trends in HIV incidence among men 15-19 years old (yo) in Brazil the country does not yet have PrEP guidelines for adolescents. Thus, we aimed to evaluate the adherence, safety, and feasibility of PrEP in real-world settings among adolescent men who have sex with men (aMSM) and transgender women (aTGW).
METHODS: PrEP1519 is a single-arm, demonstration cohort study of daily TDF/FTC as PrEP among aMSM/aTGW aged 15-19 yo. It is ongoing in Brazil and eligible are those HIV uninfected, at high risk of HIV, and with no risk of kidney and liver damage. Follow-up data is from February 2019-February 2021 (96 weeks). Study visits occurred at baseline, weeks 4, 12, and then quarterly. Demographic/sociobehavioural data were collected by a questionnaire. A mixed logistic model for longitudinal data evaluated the factors associated with high adherence, measured by medication possession ratio (i.e., MPR '¥ 1).
RESULTS: The intention-to-treat population included 684 adolescents enrolled in PrEP, who initiated PrEP on the same day. Most MSM (91.9%), 18-19 yo (80.8%), self-identified as black/brown (69.7%). There was no significant increase in creatinine clearance and two participants had grade III TGO-AST. Incident HIV infection occurred in nine participants (overall incidence rate (IR)= 1.85 per 100 person-years (PY); 95%CI: 0.64'3.05): 4 in 15-17 yo (IR= 4.46 per 100 PY; 95%CI: 0.07'8.85) and 5 in 18-19 yo (IR= 1.26 per 100 PY; 95%CI: 0.15'2.36). Multivariate analysis showed that MPR '¥ 1 was higher among those in a lover like relation (OR=1.31; 95%CI: 1.08'1.57), who perceived themselves at high risk of an HIV infection (OR=1.35; 95%CI: 1.02'1.67), and among aMSM (vs. aTGW) (OR=1.22; 95%CI: 0.84'1.79).
CONCLUSIONS: IR was higher among young adolescents enrolled in PrEP. But, lower when compared to an IR of 7.78% among MSM and TGW aged 30 years or less tested in Rio de Janeiro. PrEP adherence seems lower among aTWG, indicating the need for greater monitoring and care for TGW. Effective PrEP use must consider that adolescents are dynamic and fluid and, therefore, continually adapt to their context to improve adherence to PrEP.

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