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.

Study Overview

• Status: Completed
• Conditions: Hepatitis; HIV
• Intervention / Treatment: Behavioral: Intervention Condition; Behavioral: Control Condition

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 Type: Interventional
• Enrollment (Actual): 1024
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • The Lighthouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: STEP into action
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Institute on Drug Abuse (NIDA); Johns Hopkins University
• Investigators: Principal Investigator: Carl Latkin, Ph.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: September 16, 2005
• First Submitted That Met QC Criteria: September 16, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): April 18, 2013
• Last Update Submitted That Met QC Criteria: March 7, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hepatitis
• Other Study ID Numbers: DESPR DA016555-1; 5R01DA016555-05 (U.S. NIH Grant/Contract); 5R01DA016555-04 (U.S. NIH Grant/Contract); 5R01DA016555-03 (U.S. NIH Grant/Contract); 3R01DA016555-03S1 (U.S. NIH Grant/Contract); 3R01DA016555-02S1 (U.S. NIH Grant/Contract); 5R01DA016555-02 (U.S. NIH Grant/Contract); 3R01DA016555-01S1 (U.S. NIH Grant/Contract); 1R01DA016555-01 (U.S. NIH Grant/Contract); R01-16555-1; NIDA-16555-1