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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00218335
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : April 18, 2013
Last Update Posted : April 18, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
HIV Hepatitis Behavioral: Intervention Condition Behavioral: Control Condition Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1024 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Network & Dyad HIV Prevention Intervention for IDU's
Study Start Date : June 2003
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

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 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.


Outcome Measures

Primary Outcome Measures :
  1. Any Sex Risk [ Time Frame: 6 months ]
  2. Talked About HIV-related Topics With Drug Buddies (in the Past Month) [ Time Frame: 6 months ]
  3. Showed a Needleless Syringe to Drug Buddies [ Time Frame: 6 months ]
  4. Talked About Responding to Overdose to Drug Buddies [ Time Frame: 6 months ]
  5. Any Injection Risk (Monthly Versus Never) [ Time Frame: 12 months ]
  6. Number of Needle or Cooker Sharers (2 or More Versus None) [ Time Frame: 12 months ]
  7. Talked About HIV-related Topics With Drug Buddies (in the Past Month) [ Time Frame: 12 months ]
  8. Showed a Needleless Syringe to Drug Buddies [ Time Frame: 12 months ]
  9. Any Injection Risk (Monthly Versus Never) [ Time Frame: 18 months ]
  10. Shared Cooker When Preparing Drugs [ Time Frame: 18 months ]
  11. Number of Needle or Cooker Sharers (2 or More Versus None) [ Time Frame: 18 months ]
  12. Injecting Drugs [ Time Frame: 18 months ]
  13. Talked About HIV-related Topics With Drug Buddies (in Past Month) [ Time Frame: 18 months ]
  14. Showed a Needleless Syringe to Drug Buddies [ Time Frame: 18 months ]
  15. Talked About Hepatitis to Drug Buddies [ Time Frame: 18 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( 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
First Posted: September 22, 2005    Key Record Dates
Results First Posted: April 18, 2013
Last Update Posted: April 18, 2013
Last Verified: March 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