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

Primary Purpose

HIV, Hepatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intervention Condition
Control Condition
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Lighthouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Condition

Control Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
March 7, 2013
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute on Drug Abuse (NIDA), Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00218335
Brief Title
A Network & Dyad HIV Prevention Intervention for IDU's - 1
Official Title
A Network & Dyad HIV Prevention Intervention for IDU's
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute on Drug Abuse (NIDA), Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Hepatitis
Keywords
HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1024 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Condition
Other Intervention Name(s)
STEP into action
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Condition
Intervention Description
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 Measure Information:
Title
Any Sex Risk
Time Frame
6 months
Title
Talked About HIV-related Topics With Drug Buddies (in the Past Month)
Time Frame
6 months
Title
Showed a Needleless Syringe to Drug Buddies
Time Frame
6 months
Title
Talked About Responding to Overdose to Drug Buddies
Time Frame
6 months
Title
Any Injection Risk (Monthly Versus Never)
Time Frame
12 months
Title
Number of Needle or Cooker Sharers (2 or More Versus None)
Time Frame
12 months
Title
Talked About HIV-related Topics With Drug Buddies (in the Past Month)
Time Frame
12 months
Title
Showed a Needleless Syringe to Drug Buddies
Time Frame
12 months
Title
Any Injection Risk (Monthly Versus Never)
Time Frame
18 months
Title
Shared Cooker When Preparing Drugs
Time Frame
18 months
Title
Number of Needle or Cooker Sharers (2 or More Versus None)
Time Frame
18 months
Title
Injecting Drugs
Time Frame
18 months
Title
Talked About HIV-related Topics With Drug Buddies (in Past Month)
Time Frame
18 months
Title
Showed a Needleless Syringe to Drug Buddies
Time Frame
18 months
Title
Talked About Hepatitis to Drug Buddies
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Latkin, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Lighthouse
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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