Study to Reduce Intravenous Exposures (STRIVE)

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. Identifier: NCT00391482
Recruitment Status : Completed
First Posted : October 24, 2006
Last Update Posted : January 11, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
The purpose of this study is to determine whether a six-session, small group behavioral intervention based on "peer-volunteer activism" is effective in (1) decreasing distributive sharing of syringes and other injection paraphernalia and (2) increasing utilization of HCV-related healthcare services among HCV-infected injection drug users

Condition or disease Intervention/treatment Phase
Hepatitis C HIV Infections Behavioral: Peer Mentoring Intervention for HCV-Infected IDUs Phase 2 Phase 3

Detailed Description:

The purpose of this study is to determine the efficacy of a peer-volunteer intervention to reduce high-risk transmission behaviors among hepatitis C virus (HCV)-infected young adult injection drug users (IDUs), and to identify the proportion of these individuals who would be eligible and willing to undergo treatment to eradicate HCV infection. HCV is one of the most frequently occurring human viral infections, having an estimated worldwide prevalence of 3%. In many regions of the United States, between 65% and 95% of IDUs are HCV-seropositive and capable of transmitting the infection. To date, research studies targeting infected individuals to prevent secondary transmission of chronic blood-borne viral infection have generally been limited to post-test counseling and case management. In addition, recent data suggest that medical treatment of HCV infection may be most effective when offered soon after HCV seroconversion. However, the proportion of HCV-infected IDUs who meet strict national guidelines for HCV treatment is likely to be small because treatment is usually postponed while drug use continues. Determining the proportion of infected individuals who may be both eligible and willing to undergo HCV therapy is highly important for guiding national standards and objectives to achieve greater numbers of IDUs in HCV therapy. We have previously reported that fewer than 1% of HCV-infected IDUs in Baltimore are currently receiving such therapy. Early initiation of HCV treatment among young IDUs in conjunction with a reduction in HCV transmission risk behaviors may ultimately lead to a reduction in incident HCV infection at the individual and the community levels.

This study is a randomized controlled trial to determine the efficacy of a "peer-volunteer activism" intervention to reduce distributive syringe and injection paraphernalia sharing behaviors among HCV positive IDUs and promote the uptake of HCV care and treatment. If proven effective, this intervention would substantially decrease the risk of HCV infection in the community. To address these aims, we plan to recruit, screen, and randomly assign 750 IDUs age 18-35 years who are HCV-seropositive but HIV-seronegative in Baltimore, New York and Seattle to a behavioral intervention (250 per site), and prospectively monitor participants behavior at 3- and 6-month follow-up visits.

Study Type : Interventional  (Clinical Trial)
Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Behavioral Intervention Trial to Reduce Transmission Risks and Improve HCV Treatment Access Among HCV-infected Injection Drug Users
Study Start Date : June 2002
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Self-reported frequency of distributive sharing of injection and non-injection drug equipment (i.e., lending, giving or selling used needles, syringes or paraphernalia to others)

Secondary Outcome Measures :
  1. Alcohol use; disposal of syringes and paraphernalia; increased condom use; syringe exchange program use; readiness for HCV therapy and drug use cessation; and discussing HCV therapy options at a medical care visit.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HCV antibody positive
  • age between 18 and 35 years old;
  • reported injection drug use in the past 6 months
  • willing to provide a blood sample for liver function testing

Exclusion Criteria:

  • HIV antibody positive
  • planned on moving from city within the next 12 months;
  • unable to comprehend English well enough to complete English-only assessments and group sessions

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 identifier (NCT number): NCT00391482

United States, Maryland
Johns Hopkins University, Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
United States, New York
New York Academy of Medicine, Center for Urban Epidemiologic Studies
New York, New York, United States, 10029
United States, Washington
Public Health Seattle & King County
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Steffanie A Strathdee, PhD Johns Hopkins University, Bloomberg School of Public Health,

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00391482     History of Changes
Other Study ID Numbers: DESPR DA014499
1R01DA014499 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2006    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: November 2008

Keywords provided by National Institute on Drug Abuse (NIDA):
IV Drug Users
Hepatitis C Virus
Human Immunodeficiency Virus
HIV Seronegativity

Additional relevant MeSH terms:
Hepatitis C
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases