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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Johns Hopkins Bloomberg School of Public Health

Collaborator
National Institute on Drug Abuse (NIDA)
Johns Hopkins University

Information provided by (Responsible Party)
Carl Latkin, Johns Hopkins Bloomberg School of Public Health

ClinicalTrials.gov Identifier
NCT00218335

First received: September 16, 2005
Last updated: March 7, 2013
Last Verified: March 2013
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV
Hepatitis

Behavioral : Intervention Condition
Behavioral : Control Condition
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Network & Dyad HIV Prevention Intervention for IDU's

Further study details as provided by Carl Latkin, Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures

  • Any Sex Risk [ Time Frame: 6 months ]
  • Talked About HIV-related Topics With Drug Buddies (in the Past Month) [ Time Frame: 6 months ]
  • Showed a Needleless Syringe to Drug Buddies [ Time Frame: 6 months ]
  • Talked About Responding to Overdose to Drug Buddies [ Time Frame: 6 months ]
  • Any Injection Risk (Monthly Versus Never) [ Time Frame: 12 months ]
  • Number of Needle or Cooker Sharers (2 or More Versus None) [ Time Frame: 12 months ]
  • Talked About HIV-related Topics With Drug Buddies (in the Past Month) [ Time Frame: 12 months ]
  • Showed a Needleless Syringe to Drug Buddies [ Time Frame: 12 months ]
  • Any Injection Risk (Monthly Versus Never) [ Time Frame: 18 months ]
  • Shared Cooker When Preparing Drugs [ Time Frame: 18 months ]
  • Number of Needle or Cooker Sharers (2 or More Versus None) [ Time Frame: 18 months ]
  • Injecting Drugs [ Time Frame: 18 months ]
  • Talked About HIV-related Topics With Drug Buddies (in Past Month) [ Time Frame: 18 months ]
  • Showed a Needleless Syringe to Drug Buddies [ Time Frame: 18 months ]
  • Talked About Hepatitis to Drug Buddies [ Time Frame: 18 months ]

Enrollment: 1024
Study Start Date: June 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: 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.

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

Eligibility

Ages Eligible for Study: 18 Years to 75 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218335

Locations

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

Sponsors and Collaborators

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

Investigators

Principal Investigator: Carl Latkin, Ph.D. Johns Hopkins University
More Information

More Information


Responsible Party: Carl Latkin, Professor, Johns Hopkins Bloomberg School of Public Health  
ClinicalTrials.gov Identifier: NCT00218335   History of Changes  
Other Study ID Numbers: DESPR DA016555-1  
  5R01DA016555-05  
  5R01DA016555-04  
  5R01DA016555-03  
  3R01DA016555-03S1  
  3R01DA016555-02S1  
  5R01DA016555-02  
  3R01DA016555-01S1  
  1R01DA016555-01  
  R01-16555-1  
  NIDA-16555-1  
Study First Received: September 16, 2005  
Last Updated: March 7, 2013  

Keywords provided by Carl Latkin, Johns Hopkins Bloomberg School of Public Health:

HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.