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Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users

Primary Purpose

HIV Infections, Hepatitis C

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Peer Education Intervention
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring IV Drug users, HIV, hepatitis C virus, HIV Seronegativity

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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: -

Sites / Locations

  • Health Research Association
  • University of Illinois at Chicago
  • Johns Hopkins University
  • New York Academy of Medicine
  • Public Health Seattle and King County

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 9, 2005
Last Updated
September 26, 2012
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00164372
Brief Title
Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users
Official Title
Collaborative Injection Drug Users Study III/Drug Users Intervention Trial (CIDUS III/DUIT)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hepatitis C
Keywords
IV Drug users, HIV, hepatitis C virus, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Peer Education Intervention
Primary Outcome Measure Information:
Title
1. decrease in the number and proportion of times participants practiced vaginal or anal sex without a condom.
Title
2. decrease in the overall number of persons participants shared syringes or injection equipment with.
Title
3. decrease in the number and proportion of injections done with a syringe previously used by another person.
Title
4. decrease in the number and proportion of times participant used another person's equipment to prepare or divide drugs before injecting.
Secondary Outcome Measure Information:
Title
1. decrease the incidence of HCV infection.
Title
2. decrease the frequency of injecting in high-risk settings.
Title
3. increase the frequency of drug treatment entry or decrease the frequency of injection drug use.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard S. Garfein, PhD, MPH
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Research Association
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
New York Academy of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Public Health Seattle and King County
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21182555
Citation
Mackesy-Amiti ME, Ouellet LJ, Golub ET, Hudson S, Hagan H, Garfein RS. Predictors and correlates of reduced frequency or cessation of injection drug use during a randomized HIV prevention intervention trial. Addiction. 2011 Mar;106(3):601-8. doi: 10.1111/j.1360-0443.2010.03251.x. Epub 2010 Dec 23.
Results Reference
derived
PubMed Identifier
17721100
Citation
Garfein RS, Golub ET, Greenberg AE, Hagan H, Hanson DL, Hudson SM, Kapadia F, Latka MH, Ouellet LJ, Purcell DW, Strathdee SA, Thiede H; DUIT Study Team. A peer-education intervention to reduce injection risk behaviors for HIV and hepatitis C virus infection in young injection drug users. AIDS. 2007 Sep 12;21(14):1923-32. doi: 10.1097/QAD.0b013e32823f9066.
Results Reference
derived
PubMed Identifier
17582705
Citation
Garfein RS, Swartzendruber A, Ouellet LJ, Kapadia F, Hudson SM, Thiede H, Strathdee SA, Williams IT, Bailey SL, Hagan H, Golub ET, Kerndt P, Hanson DL, Latka MH; DUIT Study Team. Methods to recruit and retain a cohort of young-adult injection drug users for the Third Collaborative Injection Drug Users Study/Drug Users Intervention Trial (CIDUS III/DUIT). Drug Alcohol Depend. 2007 Nov;91 Suppl 1:S4-17. doi: 10.1016/j.drugalcdep.2007.05.007. Epub 2007 Jun 19.
Results Reference
derived

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Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users

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