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

Phase 2

Completed

• Conditions: HIV; Hepatitis
• Interventions: Behavioral: Intervention Condition; Behavioral: Control Condition

• Registration Number: NCT00218335
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2013-01-25
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-07
• Last Update Submitted: 2013-03-07
• Results First Posted: 2013-04-18
• Last Update Posted: 2013-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1024

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Condition	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.
Control Condition	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.

Primary Outcome Measures

Name	Time	Method
Any Sex Risk	6 months
Talked About HIV-related Topics With Drug Buddies (in the Past Month)	12 months
Showed a Needleless Syringe to Drug Buddies	18 months
Talked About Responding to Overdose to Drug Buddies	6 months
Any Injection Risk (Monthly Versus Never)	18 months
Number of Needle or Cooker Sharers (2 or More Versus None)	18 months
Shared Cooker When Preparing Drugs	18 months
Injecting Drugs	18 months
Talked About HIV-related Topics With Drug Buddies (in Past Month)	18 months
Talked About Hepatitis to Drug Buddies	18 months

Trial Locations

Locations (1)

The Lighthouse; 🇺🇸 Baltimore, Maryland, United States