Clinical trial NCT00218335: A Network & Dyad HIV Prevention Intervention for IDU's - 1
Official title: A Network & Dyad HIV Prevention Intervention for IDU's
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Hepatitis
Keywords: HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Johns Hopkins University
First posted: 2005-09-22
Enrollment: 1024
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Any Sex Risk
timeFrame: 6 months
measure: Talked About HIV-related Topics With Drug Buddies (in the Past Month)
timeFrame: 6 months
measure: Showed a Needleless Syringe to Drug Buddies
timeFrame: 6 months
measure: Talked About Responding to Overdose to Drug Buddies
timeFrame: 6 months
measure: Any Injection Risk (Monthly Versus Never)
timeFrame: 12 months
measure: Number of Needle or Cooker Sharers (2 or More Versus None)
timeFrame: 12 months
measure: Talked About HIV-related Topics With Drug Buddies (in the Past Month)
timeFrame: 12 months
measure: Showed a Needleless Syringe to Drug Buddies
timeFrame: 12 months
measure: Any Injection Risk (Monthly Versus Never)
timeFrame: 18 months
measure: Shared Cooker When Preparing Drugs
timeFrame: 18 months
measure: Number of Needle or Cooker Sharers (2 or More Versus None)
timeFrame: 18 months
measure: Injecting Drugs
timeFrame: 18 months
measure: Talked About HIV-related Topics With Drug Buddies (in Past Month)
timeFrame: 18 months
measure: Showed a Needleless Syringe to Drug Buddies
timeFrame: 18 months
measure: Talked About Hepatitis to Drug Buddies
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Lighthouse
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Carl Latkin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: