PATH-PrEP was a controlled, open-label, two-arm, non-randomized clinical demonstration project to evaluate the safety, acceptability and feasibility of delivery of PrEP or PEP as part of combination HIV prevention services for high-risk MSM and transgender women.
Each subject were followed for up to 48 weeks after enrollment of the last subject. The primary endpoint is measured at 48 weeks.
Approximately 375 subjects, 300 in Cohort H and 75 in Cohort LM.
Eligible subjects include HIV-uninfected men who have sex with men (MSM) and male to female (M to F) transgender individuals who have sex with men at least 18 years of age.
Subjects were stratified into two cohorts on the basis of sexual risk behavior: a low-moderate risk cohort (LM) and a high-risk cohort (H).
The program stratified participants into two cohorts on the basis of sexual risk behavior: a low-moderate risk cohort (LM) and a high-risk cohort (H). Participants in the LM cohort were provided a customized prevention package (CPP) including access to post-exposure prophylaxis (PEP) for emergency HIV prevention in the event of unanticipated HIV exposure. Participants in the H cohort were provided a CPP including daily Truvada-based PrEP. All participants were followed for 48 weeks. Participants in the LM cohort who, on longitudinal sexual risk behavior surveillance, report increased levels of sexual risk-taking such that they meet enrollment criteria for the H-cohort will be transitioned to the H-cohort.
At each follow-up visit, a careful safety assessment was made, including signs/symptoms and laboratory assessments. STI testing was performed at 3 month intervals. An escalating-intensity adherence intervention was implemented based on real-time serum tenofovir levels. A computer-assisted self-interview (CASI) was used to capture detailed sexual risk, adherence, and substance use behavior.
TDF 300 mg + FTC 200 mg fixed dose combination was taken orally once daily starting at the baseline visit (week 0) and continued throughout the study.
Number and frequency rate of clinical and laboratory AEs (Gr 2 and above) and SAEs
Daily FTC/Tenofovir adherence, as measured by self-report, medication possession ratio (MPR), and levels of FTC-TP and/or TFV-DP in serum (detectable or undetectable) and erythrocytes via dried blood spots
Changes in sexual risk behavior as assessed via CASI-based self-report questionnaire, measured longitudinally over time
Estimate the per-participant costs for the CPP model, providing a benchmark for comparison with other cities' PrEP demonstration projects, and to allow modeling of cost-efficacy scenarios
Number and rate of HIV seroconversions, and treatment emergent resistance mutations, viral set point, and subsequent response to ART-treatment