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Sponsored by: |
Centers for Disease Control and Prevention |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00164372 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Hepatitis C |
Behavioral: Peer Education Intervention |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Collaborative Injection Drug Users Study III/Drug Users Intervention Trial (CIDUS III/DUIT) |
Estimated Enrollment: | 1400 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | September 2004 |
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.
Ages Eligible for Study: | 15 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
-
United States, California | |
Health Research Association | |
Los Angeles, California, United States, 90010 | |
United States, Illinois | |
University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205 | |
United States, New York | |
New York Academy of Medicine | |
New York, New York, United States, 10029 | |
United States, Washington | |
Public Health Seattle and King County | |
Seattle, Washington, United States, 98104 |
Principal Investigator: | Richard S. Garfein, PhD, MPH | Centers for Disease Control and Prevention |
Study ID Numbers: | CDC-NCHSTP-2934, U64/CCU317662,, U64/CCU517656,, U64/CCU917655,, U64 CCU217659,, U64/CCU071615 |
Study First Received: | September 9, 2005 |
Last Updated: | October 20, 2005 |
ClinicalTrials.gov Identifier: | NCT00164372 History of Changes |
Health Authority: | United States: Federal Government |
IV Drug users HIV hepatitis C virus HIV Seronegativity |
Virus Diseases Hepatitis Liver Diseases Sexually Transmitted Diseases, Viral Digestive System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Hepatitis C Retroviridae Infections Immunologic Deficiency Syndromes |
Liver Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Flaviviridae Infections Immune System Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Infection |
Immunologic Deficiency Syndromes Hepatitis Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Hepatitis C Retroviridae Infections |