NCT00391482

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
Last Updated

January 11, 2017

Status Verified

November 1, 2008

First QC Date

October 20, 2006

Last Update Submit

January 10, 2017

Conditions

Keywords

IV Drug UsersHepatitis C VirusHuman Immunodeficiency VirusInterventionHIV Seronegativity

Outcome Measures

Primary Outcomes (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)

  • 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.

Interventions

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins University, Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

New York Academy of Medicine, Center for Urban Epidemiologic Studies

New York, New York, 10029, United States

Location

Public Health Seattle & King County

Seattle, Washington, 98104, United States

Location

Related Publications (6)

  • 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.

    PMID: 15768339BACKGROUND
  • 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.

    PMID: 16129567BACKGROUND
  • 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.

    PMID: 15136661BACKGROUND
  • 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.

    PMID: 16447112BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Hepatitis CHIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Steffanie A Strathdee, PhD

    Johns Hopkins University, Bloomberg School of Public Health,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 20, 2006

First Posted

October 24, 2006

Study Start

June 1, 2002

Study Completion

February 1, 2005

Last Updated

January 11, 2017

Record last verified: 2008-11

Locations