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Hepatitis CPhase 2/3NCT00391482

Study to Reduce Intravenous Exposures (STRIVE)

A Phase 2/3 study testing Peer Mentoring Intervention for HCV-Infected IDUs in people with Hepatitis C and HIV Infections, run by National Institute on Drug Abuse (NIDA) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Hepatitis C, HIV Infections
What is being tested?
Peer Mentoring Intervention for HCV-Infected IDUs
How many people
750 participants
Where
3 sitesUnited States
Study dates
Jun 2002to Feb 2005
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Johns Hopkins University, Bloomberg School of Public Health

    Baltimore, Maryland, 21205

  • New York Academy of Medicine, Center for Urban Epidemiologic Studies

    New York, New York, 10029

  • Public Health Seattle & King County

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Behavioral Intervention Trial to Reduce Transmission Risks and Improve HCV Treatment Access Among HCV-infected Injection Drug Users

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

Read the 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.

Being tested
Peer Mentoring Intervention for HCV-Infected IDUs
Keywords
IV Drug Users, Hepatitis C Virus, Human Immunodeficiency Virus, Intervention, HIV Seronegativity
Medical subject headings
Hepatitis C, HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer Mentoring Intervention for HCV-Infected IDUsBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 outcomes (1)

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2006 (estimated)
  2. Study startJun 2002
  3. Study completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
750 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00391482
Sponsor's protocol ID
DESPR DA014499
Other IDs
1R01DA014499
Status last verified
Nov 2008
First submitted
20 Oct 2006
Last updated
11 Jan 2017
Results posted
No

Publications

  • Strathdee SA, Latka M, Campbell J, O'Driscoll PT, Golub ET, Kapadia F, Pollini RA, Garfein RS, Thomas DL, Hagan H; Study to Reduce Intravenous Exposures Project. Factors associated with interest in initiating treatment for hepatitis C Virus (HCV) infection among young HCV-infected injection drug users. Clin Infect Dis. 2005 Apr 15;40 Suppl 5(Suppl 5):S304-12. doi: 10.1086/427445.

    PubMed 15768339

  • Campbell JV, Hagan H, Latka MH, Garfein RS, Golub ET, Coady MH, Thomas DL, Strathdee SA; STRIVE Project. High prevalence of alcohol use among hepatitis C virus antibody positive injection drug users in three US cities. Drug Alcohol Depend. 2006 Feb 28;81(3):259-65. doi: 10.1016/j.drugalcdep.2005.07.005. Epub 2005 Aug 29.

    PubMed 16129567

  • Golub ET, Latka M, Hagan H, Havens JR, Hudson SM, Kapadia F, Campbell JV, Garfein RS, Thomas DL, Strathdee SA; STRIVE Project. Screening for depressive symptoms among HCV-infected injection drug users: examination of the utility of the CES-D and the Beck Depression Inventory. J Urban Health. 2004 Jun;81(2):278-90. doi: 10.1093/jurban/jth114.

    PubMed 15136661

  • Hagan H, Latka MH, Campbell JV, Golub ET, Garfein RS, Thomas DA, Kapadia F, Strathdee SA; Study to Reduce Intravenous Exposures Project Team. Eligibility for treatment of hepatitis C virus infection among young injection drug users in 3 US cities. Clin Infect Dis. 2006 Mar 1;42(5):669-72. doi: 10.1086/499951. Epub 2006 Jan 20.

    PubMed 16447112

  • Drumright LN, Hagan H, Thomas DL, Latka MH, Golub ET, Garfein RS, Clapp JD, Campbell JV, Bonner S, Kapadia F, Thiel TK, Strathdee SA. Predictors and effects of alcohol use on liver function among young HCV-infected injection drug users in a behavioral intervention. J Hepatol. 2011 Jul;55(1):45-52. doi: 10.1016/j.jhep.2010.10.028. Epub 2010 Nov 24.

    PubMed 21145862

  • Kapadia F, Latka MH, Hagan H, Golub ET, Campbell JV, Coady MH, Garfein RS, Thomas DL, Bonner S, Thiel T, Strathdee SA. Design and feasibility of a randomized behavioral intervention to reduce distributive injection risk and improve health-care access among hepatitis C virus positive injection drug users: the Study to Reduce Intravenous Exposures (STRIVE). J Urban Health. 2007 Jan;84(1):99-115. doi: 10.1007/s11524-006-9133-7.

    PubMed 17200799

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Peer Mentoring Intervention for HCV-Infected IDUs in people with Hepatitis C and HIV Infections, run by National Institute on Drug Abuse (NIDA) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00391482, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.

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