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.
*Global Health Research Center of Central Asia, Columbia University School of Social Work, New York City, New York;
†Center for Public Health and Human Rights, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD;
‡School of Social Service Administration, University of Chicago, Chicago, IL; and
§Kazakhstan National AIDS Center, Almaty, Kazakhstan.
Correspondence to: Nabila El-Bassel, PhD, Global Health Research Center of Central Asia, 1255 Amsterdam Avenue, Room 814, New York, NY 10027 (e-mail: email@example.com).
N.E-B. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. M.C. conducted and is responsible for the data analysis.
Supported by the National Institute of Drug Abuse no. R01 DA022914-01A2 to (N.E-B.).
The authors have no conflicts of interest to disclose.
Received February 07, 2014
Accepted May 23, 2014