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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Network & Dyad HIV Prevention Intervention for IDU's

Conditions
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Hepatitis, HIV

Intervention / Treatment
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* Behavioral: Intervention Condition
* Behavioral: Control Condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Condition<br>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. | Behavioral: Intervention Condition<br>* 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.<br>* Other names: STEP into action;|
| Active Comparator: Control Condition<br>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. | Behavioral: Control Condition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network