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

HIV Clinical Trial

Official title:

A Network & Dyad HIV Prevention Intervention for IDU's

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218335
• Other study ID #: DESPR DA016555-1
• Secondary ID: 5R01DA016555-055
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: March 7, 2013
• Start date: June 2003
• Est. completion date: May 2008

Study information

• Verified date: March 2013
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00597155

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1024
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• HIV

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Lighthouse	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Johns Hopkins University, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any Sex Risk		6 months	No
Primary	Talked About HIV-related Topics With Drug Buddies (in the Past Month)		6 months	No
Primary	Showed a Needleless Syringe to Drug Buddies		6 months	No
Primary	Talked About Responding to Overdose to Drug Buddies		6 months	No
Primary	Any Injection Risk (Monthly Versus Never)		12 months	No
Primary	Number of Needle or Cooker Sharers (2 or More Versus None)		12 months	No
Primary	Talked About HIV-related Topics With Drug Buddies (in the Past Month)		12 months	No
Primary	Showed a Needleless Syringe to Drug Buddies		12 months	No
Primary	Any Injection Risk (Monthly Versus Never)		18 months	No
Primary	Shared Cooker When Preparing Drugs		18 months	No
Primary	Number of Needle or Cooker Sharers (2 or More Versus None)		18 months	No
Primary	Injecting Drugs		18 months	No
Primary	Talked About HIV-related Topics With Drug Buddies (in Past Month)		18 months	No
Primary	Showed a Needleless Syringe to Drug Buddies		18 months	No
Primary	Talked About Hepatitis to Drug Buddies		18 months	No