NCT00164372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started May 2002

Typical duration for phase_2 hiv-infections

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

4.6 years

First QC Date

September 9, 2005

Last Update Submit

September 26, 2012

Conditions

HIV InfectionsHepatitis C

Keywords

IV Drug usersHIVhepatitis C virusHIV Seronegativity

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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.

Interventions

Peer Education InterventionBEHAVIORAL

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Health Research Association

Los Angeles, California, 90010, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

New York Academy of Medicine

New York, New York, 10029, United States

Location

Public Health Seattle and King County

Seattle, Washington, 98104, United States

Location

Related Publications (3)

  • 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.

    PMID: 21182555DERIVED

  • 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.

    PMID: 17721100DERIVED

  • 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.

    PMID: 17582705DERIVED

MeSH Terms

Conditions

HIV InfectionsHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Richard S. Garfein, PhD, MPH

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

May 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

US(5)