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

This study has been completed.
Sponsor:
Collaborators:
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

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Network & Dyad HIV Prevention Intervention for IDU's

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Any Sex Risk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Talked About HIV-related Topics With Drug Buddies (in the Past Month) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Showed a Needleless Syringe to Drug Buddies [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Talked About Responding to Overdose to Drug Buddies [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Any Injection Risk (Monthly Versus Never) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of Needle or Cooker Sharers (2 or More Versus None) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Talked About HIV-related Topics With Drug Buddies (in the Past Month) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Showed a Needleless Syringe to Drug Buddies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Any Injection Risk (Monthly Versus Never) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Shared Cooker When Preparing Drugs [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Number of Needle or Cooker Sharers (2 or More Versus None) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Injecting Drugs [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Talked About HIV-related Topics With Drug Buddies (in Past Month) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Showed a Needleless Syringe to Drug Buddies [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Talked About Hepatitis to Drug Buddies [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Carl Latkin, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00218335     History of Changes
Obsolete Identifiers: NCT00597155
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
Results First Received: January 25, 2013
Last Updated: March 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on May 16, 2013