Background: The HIV epidemic in Latin America persists unabated among men who have sex with men (MSM) and transgender women (TGW). Pre-exposure prophylaxis (PrEP) implementation in the region is still very limited. Same day PrEP initiation can increase PrEP uptake where access to health care services for key populations is scarce. ImPrEP is an ongoing demonstration study that aims to assess safety and feasibility of same day PrEP (daily oral tenofovir+emtricitabine [TDF/FTC]) for MSM and TGW at high risk for HIV infection in Brazil, Peru and Mexico. We herein report results on same day PrEP initiation, safety, early continuation and adherence.
Methods: MSM and TWG eligible for recruitment (i.e. HIV uninfected, ≥18 years old, reporting 1+ risk criteria) were screened and enrolled on the same day and received a 30-day supply of TDF/FTC. Creatinine, hepatitis B, C and STI testing were performed. Main outcomes were PrEP early continuation defined as attendance to the first 2 follow-up visits within 120 days of PrEP initiation; and PrEP adherence using pharmacy refill data defined as having at least 16 days of PrEP medication filled per 30-day period (medication possession ratio ≥0.53).
Results: From February 2018 until April 2019, 4954 individuals were enrolled in Brazil (3205), Peru (1010) and Mexico (739), accumulating 1329.6 person-years of PrEP use. Median age was 29 years (IQR 24-36); 94% (4648/4954) were MSM and 6% (306/4954) TGW; 44 (1.1%) had an eGFR < 60 mL/min. Baseline active syphilis, rectal chlamydia and rectal gonorrhea prevalence were, respectively, 9.9% (95%CI: 9.0-10.8), 11.7% (95%CI: 10.7-12.7) and 7.4% (95%CI: 6.6-8.2). Overall, early continuation was achieved by 79.8% of participants and PrEP adherence was 96.9%. Early continuation was significantly lower among TGW, 56% (OR=0.29; CI 95%: 0.21-0.40), and young MSM, 71 %(OR=0.52;CI 95%: 0.40-0.67).HIV incidence was 0.8 per 100 person years (CI 95% 0.4-1.4).
Conclusions: Our study offers evidence that same day PrEP initiation in Latin America is feasible and safe, with overall good levels of early continuation and adherence. TGW and young MSM may require differentiated care to improve PrEP continuation.