A Phase 2/3 interventional study of Peer Education Intervention in HIV Infections and Hepatitis C, sponsored by Centers for Disease Control and Prevention. Completed at 5 sites in United States. Open to participants aged 15 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-27.
Sponsored by Centers for Disease Control and Prevention · Phase 2/3, Interventional, and Prevention
The purpose of this study is to test whether a six-session behavioral intervention for HIV and HCV seronegative injection drug users is effective in reducing sexual and injection risk behaviors that could lead to primary HIV and HCV infection.
CIDUS III/DUIT is a five-city (Baltimore, Chicago, Los Angeles, New York, and Seattle) randomized controlled trial to develop and evaluate the efficacy of a six-session behavioral intervention for HIV and HCV uninfected injection drug users between the ages of 15 and 30 years. The primary goals of the intervention are to:
The intervention arm consists of six small-group training and skills-building sessions to teach and reinforce peer education activities around decreasing sex and injection risk behaviors for HIV and HCV infection. In the fifth session, participants practice peer education around sex or injection risk behaviors within their community. The control arm consists of six video and discussion sessions to control for attention. Prior to study enrollment, all participants in both arms receive HIV and HCV testing with client-centered pre- and post-test counseling to also control for the demand for risk reduction information. Behavioral assessments (by audio computer assisted self interviewing) and blood draws (for serologic testing) occur at baseline, 3 and 6 month follow-up. 3285 participants completed the baseline visit, of whom 1564 tested HIV and HCV seronegative and returned for test results making them eligible to enroll in the intervention trial. Of the eligible participants, 854 were randomized into the trial. 606 and 591 returned for 3 and 6 month follow-up assessments, respectively, and 712 participants completed at least one follow-up visit.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 1,400 is above the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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1. decrease in the number and proportion of times participants practiced vaginal or anal sex without a condom.
2. decrease in the overall number of persons participants shared syringes or injection equipment with.
3. decrease in the number and proportion of injections done with a syringe previously used by another person.
4. decrease in the number and proportion of times participant used another person's equipment to prepare or divide drugs before injecting.
1. decrease the incidence of HCV infection.
2. decrease the frequency of injecting in high-risk settings.
3. increase the frequency of drug treatment entry or decrease the frequency of injection drug use.
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Centers for Disease Control and Prevention