Study to Reduce Intravenous Exposures (STRIVE)

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00391482
First received: October 20, 2006
Last updated: November 13, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Hepatitis C
HIV Infections
Behavioral: Peer Mentoring Intervention for HCV-Infected IDUs
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Behavioral Intervention Trial to Reduce Transmission Risks and Improve HCV Treatment Access Among HCV-Infected Injection Drug Users

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 750
Study Start Date: June 2002
Estimated Study Completion Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00391482

Locations
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
Investigators
Principal Investigator: Steffanie A Strathdee, PhD Johns Hopkins University, Bloomberg School of Public Health,
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00391482     History of Changes
Other Study ID Numbers: DESPR DA014499, 1 R01 DA14499
Study First Received: October 20, 2006
Last Updated: November 13, 2008
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 29, 2014