Background: New injection drug users (IDUs) are at high risk for blood-borne viral infections. Given U.S. policy to only fund proven-effective HIV prevention interventions, insights into conducting intervention trials among young IDUs are provided here by describing methods and participants' characteristics in the CIDUS III/DUIT study. Methods: In 2002-2004, 15-30-year-old IDUs in Baltimore, Chicago, Los Angeles, New York, and Seattle were recruited through community outreach, advertising and coupon-based participant referrals. Baseline interviews assessed sociodemographics, injection, and sexual behaviors. Antibody tests for HIV and hepatitis A, B, and C viruses (HAV, HBV, and HCV) were conducted. IDUs who were HIV and HCV antibody negative at baseline were eligible to participate in a randomized controlled HIV/HCV prevention trial. Follow-up assessments were conducted 3 and 6 months post-intervention. Data were analyzed to identify participant differences at baseline by city, trial enrollment, and trial retention. Results: Baseline assessments were completed by 3285 IDUs. Participants were mean age 23.8 years, 69% male, 64% White, 17% Hispanic, and 8% Black. Seroprevalence of HIV, HCV, HBV, and HAV antibodies were 2.9, 34.4, 22.4, and 19.3%, respectively. Of the 2062 (62.7%) baseline participants who were HIV and HCV antibody negative, 859 (41.7%) were randomized. At least one follow-up assessment was completed by 712 (83%) randomized participants. Contextual factors, primarily homelessness, were associated with lower enrollment and retention. Conclusions: Recruitment and retention of young-adult IDUs for complex intervention trials is complicated, yet feasible. Risk behaviors among participants enrolling in and completing the trial reflected those eligible to enroll.
