OBJECTIVE: Project Renaissance is a randomized controlled trial of an HIV/hepatitis C virus (HCV)/sexually transmitted infection (STI) prevention intervention conducted in Almaty, Kazakhstan. We hypothesized that couples assigned to the intervention of interest will have lower incidence of HIV, HCV, STIs, rates of unprotected sex, and unsafe injection over the 12-month follow-up period compared with those assigned to an attention control arm. DESIGN: A total of 300 couples (600 participants) where one or both partners reported injecting drugs in the past 90 days were randomized to 1 of 2 arms: (1) a 5-session HIV/HCV/STI prevention intervention (risk reduction: RR) or (2) a 5-session Wellness Promotion (WP) intervention. RESULTS: Over the 12-month follow-up period, assignment to RR compared with WP significantly lowered the incidence of HCV infection by 69% [incidence rate ratios (IRR) = 0.31, 95% (CI) confidence interval: 0.10 to 0.90, P = 0.031]. Although differences were not statistically significant, RR participants had a lower incidence of HIV infection by 51% (IRR = 0.49, 95% CI: 0.16 to 1.48, P = 0.204) and any STI by 37% (IRR = 0.63, 95% CI: 0.21 to 1.93, P = 0.418) than WP participants. RR participants reported significantly fewer numbers of unprotected vaginal sex acts with their study partners (IRR = 0.58, 95% CI: 0.36 to 0.93, P = 0.024) and more consistent condom use (odds ratios = 2.30, 95% CI: 1.33 to 4.00, P = 0.003) over the entire follow-up period compared with WP participants. CONCLUSIONS: Project Renaissance demonstrated a significant effect for biological and behavioral endpoints. Findings draw attention to an HIV/HCV/STI prevention intervention strategy that can be scaled up for drug-involved couples in harm reduction programs, drug treatment, and criminal justice settings.
RCT Entities:
OBJECTIVE: Project Renaissance is a randomized controlled trial of an HIV/hepatitis C virus (HCV)/sexually transmitted infection (STI) prevention intervention conducted in Almaty, Kazakhstan. We hypothesized that couples assigned to the intervention of interest will have lower incidence of HIV, HCV, STIs, rates of unprotected sex, and unsafe injection over the 12-month follow-up period compared with those assigned to an attention control arm. DESIGN: A total of 300 couples (600 participants) where one or both partners reported injecting drugs in the past 90 days were randomized to 1 of 2 arms: (1) a 5-session HIV/HCV/STI prevention intervention (risk reduction: RR) or (2) a 5-session Wellness Promotion (WP) intervention. RESULTS: Over the 12-month follow-up period, assignment to RR compared with WP significantly lowered the incidence of HCV infection by 69% [incidence rate ratios (IRR) = 0.31, 95% (CI) confidence interval: 0.10 to 0.90, P = 0.031]. Although differences were not statistically significant, RR participants had a lower incidence of HIV infection by 51% (IRR = 0.49, 95% CI: 0.16 to 1.48, P = 0.204) and any STI by 37% (IRR = 0.63, 95% CI: 0.21 to 1.93, P = 0.418) than WP participants. RR participants reported significantly fewer numbers of unprotected vaginal sex acts with their study partners (IRR = 0.58, 95% CI: 0.36 to 0.93, P = 0.024) and more consistent condom use (odds ratios = 2.30, 95% CI: 1.33 to 4.00, P = 0.003) over the entire follow-up period compared with WP participants. CONCLUSIONS: Project Renaissance demonstrated a significant effect for biological and behavioral endpoints. Findings draw attention to an HIV/HCV/STI prevention intervention strategy that can be scaled up for drug-involved couples in harm reduction programs, drug treatment, and criminal justice settings.
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