Study to Reduce Intravenous Exposures (STRIVE)

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00391482

Collaborator

(none)

750

Enrollment

Locations

32.1

Duration (Months)

250

Patients Per Site

7.8

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jun 1, 2002

Study Completion Date :

Feb 1, 2005

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University, Bloomberg School of Public Health	Baltimore	Maryland	United States	21205
2	New York Academy of Medicine, Center for Urban Epidemiologic Studies	New York	New York	United States	10029
3	Public Health Seattle & King County	Seattle	Washington	United States	98104