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Completed

NCT Number: NCT00164372

Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Health Research Association, Los Angeles, California, United States

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About this study

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:

  • decrease the shared use of syringes and other injection paraphernalia,
  • decrease sexual risk behaviors associated with HIV and HCV infection, and
  • decrease the incidence of hepatitis C virus (HCV) infection.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 15-30 years old
  • self-reported illicit drug injection within the past 6 months
  • live in the geographic region under study and plan to stay for >12 months
  • willing to provide a blood sample for serologic testing
  • willing to provide basic contact information for follow-up
  • able to communicate in English
  • had not participated in the pilot study or previously enrolled in the trial
  • not concurrently participating in other HIV or HCV intervention trials
  • tested HIV and HCV seronegative at baseline

Exclusion criteria

-

Treatment and study plan

Peer Education Intervention

Behavioral

Primary outcomes

  1. 1. decrease in the number and proportion of times participants practiced vaginal or anal sex without a condom.

  2. 2. decrease in the overall number of persons participants shared syringes or injection equipment with.

  3. 3. decrease in the number and proportion of injections done with a syringe previously used by another person.

  4. 4. decrease in the number and proportion of times participant used another person's equipment to prepare or divide drugs before injecting.

Secondary outcomes

  1. 1. decrease the incidence of HCV infection.

  2. 2. decrease the frequency of injecting in high-risk settings.

  3. 3. increase the frequency of drug treatment entry or decrease the frequency of injection drug use.

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Registry information

Official study title

Collaborative Injection Drug Users Study III/Drug Users Intervention Trial (CIDUS III/DUIT)

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Sep 14, 2005
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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