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A Network & Dyad HIV Prevention Intervention for IDU's - 1

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
Information provided by (Responsible Party):
Carl Latkin, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00218335
First received: September 16, 2005
Last updated: March 7, 2013
Last verified: March 2013

September 16, 2005
March 7, 2013
June 2003
May 2008   (final data collection date for primary outcome measure)
  • Any Sex Risk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Talked About HIV-related Topics With Drug Buddies (in the Past Month) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Showed a Needleless Syringe to Drug Buddies [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Talked About Responding to Overdose to Drug Buddies [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Any Injection Risk (Monthly Versus Never) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of Needle or Cooker Sharers (2 or More Versus None) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Talked About HIV-related Topics With Drug Buddies (in the Past Month) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Showed a Needleless Syringe to Drug Buddies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Any Injection Risk (Monthly Versus Never) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Shared Cooker When Preparing Drugs [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Number of Needle or Cooker Sharers (2 or More Versus None) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Injecting Drugs [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Talked About HIV-related Topics With Drug Buddies (in Past Month) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Showed a Needleless Syringe to Drug Buddies [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Talked About Hepatitis to Drug Buddies [ Time Frame: 18 months ] [ Designated as safety issue: No ]
HIV risk behaviors
Complete list of historical versions of study NCT00218335 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Network & Dyad HIV Prevention Intervention for IDU's - 1
A Network & Dyad HIV Prevention Intervention for IDU's

The purpose of this study is to evaluate a peer-based HIV prevention intervention that targets active injection drug users and their drug and sex partners.

HIV seroincidence among injection drug users remains high, with unprotected sexual contact substantially contributing to new HIV infections among injection drug users (IDUs). Interventions that are culturally competent and target drug users' main sex and drug partners may be especially effective for HIV/STI and HCV control and prevention.

The intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Specifically, through group and individual focused sessions, participants learn and practice skills designed to reduce drug and sex related risk behaviors. Furthermore, individuals and their main risk partners attend a training session that focuses on risk reduction within their relationship.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • HIV
  • Hepatitis
  • Behavioral: Intervention Condition
    In the intervention Condition participants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
    Other Name: STEP into action
  • Behavioral: Control Condition
    The control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
  • Experimental: Intervention Condition
    Participants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
    Intervention: Behavioral: Intervention Condition
  • Active Comparator: Control Condition
    The control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
    Intervention: Behavioral: Control Condition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1024
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

(i)Self reported injection drug use within the prior 6 months; (ii)Willingness to invite a risk network member into the study and to talk about HIV prevention; (iii)Age 18 or older

Exclusion Criteria:

  • Not concurrently enrolled in another HIV prevention intervention
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218335
DESPR DA016555-1, 5R01DA016555-05, 5R01DA016555-04, 5R01DA016555-03, 3R01DA016555-03S1, 3R01DA016555-02S1, 5R01DA016555-02, 3R01DA016555-01S1, 1R01DA016555-01, R01-16555-1, NIDA-16555-1
No
Carl Latkin, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
  • National Institute on Drug Abuse (NIDA)
  • Johns Hopkins University
Principal Investigator: Carl Latkin, Ph.D. Johns Hopkins University
Johns Hopkins Bloomberg School of Public Health
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP