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Background: Adherence is a critical factor for efficacy of emtricitabine/tenofovir (FTC/TDF) for PrEP. Strategies for improving, supporting, motivating and sustaining adherence to PrEP are of great importance in maximizing the impact of PrEP in high-risk populations. We evaluated self-reported PrEP adherence and its perceived barriers and facilitators among MSM and TGW retained though 48 weeks in the PrEP Brasil study.
Methods: PrEP Brasil was a prospective, open-label demonstration project with HIV-uninfected MSM and TGW from 3 referral centers in Rio de Janeiro (RJ) and São Paulo (SP). Participants were followed-up for 48 weeks and daily FTC/TDF was provided. PrEP adherence (30-days recall), facilitators and barriers were assessed by the pharmacist using a questionnaire upon study completion (week 48). Logistic regression was used to evaluate predictors for optimal (=100%) adherence in the past 30-days.
Results: From April/2014 to July/2016, 450 participants initiated PrEP, 375(83.3%) participants were followed through 48 weeks. Of these, 354(94.4%) were dispensed FTC/TDF in the previous 3 months and 338 (90.1%) answered the questionnaire. Median age was 30 years (IQR: 25-35). A total of 27(8.0%), 51(15.1%) and 53(15.7%) reported not missing any dose of FTC/TDF in the past week, 1-2 weeks and 3-4 weeks, respectively. Median adherence in the past 30-days was 100%(IQR:96-100); 60.6% of participants (205/338) reported optimal adherence. The majority (82.2%; 278/338) of participants reported not having difficulty with taking FTC/TDF and 81.3% (274/338) reported excellent or very good capacity to take FTC/TDF in the past 30-days. Perceived barriers and facilitators were reported by 38.2%(129/338) and 98.5%(333/338), respectively; main reasons reported by these participants are depicted in Figure 1. In multivariate analysis, being from RJ, TGW, stimulant use and having perceived barriers to adherence were associated with decreased odds of optimal adherence.

  Number of participants N=338Optimal adherence (=100%) N=205 (60.6%)OR (95%CI) (adjusted for site only)p-valueAOR (95%CI)p-value
Site LocationRJ (vs. SP)118(34.9)55(46.6)0.41(0.26-0.64)0.00010.38(0.20-0.73)0.004
GenderTranswomen (vs. male)18(5.3)6(33.3)0.41(0.14-1.14)0.090.22(0.07-0.73)0.01
Sex with HIV positive partnersYes (vs. no)140(41.4)93(66.4)1.46(0.92-2.32)0.100.90(0.48-1.70)0.75
Stimulants in last 3 monthsYes (vs. no)73(21.6)40(54.8)0.58(0.33-1.00)0.050.40(0.20-0.80)0.01
Depression PHQ scorePHQ-2 score ≥ 3 (vs. PHQ-2 score < 3)20(5.9)8(40.0)0.39(0.15-1.01)0.050.41(0.14-1.22)0.11
GI symptomsYes (vs. no)140(41.4)83(59.3)0.64(0.39-1.05)0.081.02(0.54-1.93)0.95
Perceived barriersYes (vs. no)129(38.2)35(27.1)0.09(0.05-0.15)<.00010.12(0.07-0.23)<.0001
[Table 1. Unadjusted and adjusted odds ratios and 95% confidence interval for factors associated with optimal self-reported adherence at week 48.]



Perceived barriers and facilitators to adherence
[Perceived barriers and facilitators to adherence]


Conclusions: High levels of self-reported adherence were reported among those retained through 48 weeks in the PrEP Brasil study. Our findings provide information for elaboration, reinforcement and/or update of strategies to improve adherence, especially among TGW and stimulant users, and for developing the best practices to promote PrEP adherence in our context. Interventions to reduce patient forgetfulness may be beneficial.

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