A Network Intervention for Prevention of HIV Infection in Chennai, India - 1
Primary Purpose
HIV Infections
Status
Withdrawn
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
psychoeducational
control
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, injection drug use, social networks
Eligibility Criteria
Inclusion Criteria: drug users network members
Sites / Locations
- YRG Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
behavioral social network risk reduction intervention
voluntary counseling and testing (VCT
Outcomes
Primary Outcome Measures
needle sharing
condom use
Secondary Outcome Measures
Full Information
NCT ID
NCT00218686
First Posted
September 16, 2005
Last Updated
September 19, 2022
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT00218686
Brief Title
A Network Intervention for Prevention of HIV Infection in Chennai, India - 1
Official Title
Supplement to the Long-term Impact of a Network Outreach Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
In ability to obtain Indian governmental approval from the study from NACO
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
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 in Chennai India.
Detailed Description
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 Infections
Keywords
HIV, injection drug use, social networks
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
behavioral social network risk reduction intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
voluntary counseling and testing (VCT
Intervention Type
Behavioral
Intervention Name(s)
psychoeducational
Intervention Description
psychoeducational
Intervention Type
Behavioral
Intervention Name(s)
control
Intervention Description
VTC
Primary Outcome Measure Information:
Title
needle sharing
Time Frame
3 month
Title
condom use
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
drug users
network members
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
YRG Care
City
Chennai, Tamil Nadu
ZIP/Postal Code
600 113
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Network Intervention for Prevention of HIV Infection in Chennai, India - 1
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