NCT00218192

Brief Summary

The purpose of this study is to examine the efficacy of a brief motivational intervention on the cumulative incidence of Hepatitis C.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
277

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

September 1, 2000

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

May 22, 2015

Status Verified

April 1, 2013

Enrollment Period

6.2 years

First QC Date

September 16, 2005

Last Update Submit

May 21, 2015

Conditions

HCV Negative StatusHCV Risk Behavior

Keywords

hepatitis cinjection drug use

Outcome Measures

Primary Outcomes (1)

  • Hepatitis C seroconversion

Secondary Outcomes (1)

  • Substance use

Interventions

Behavior TherapyBEHAVIORAL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • current opiate or cocaine use
  • HCV seronegative
  • able to complete the study procedures in English

You may not qualify if:

  • current enrollment in a formal substance abuse treatment program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Stein MD, Herman DS, Anderson BJ. A trial to reduce hepatitis C seroincidence in drug users. J Addict Dis. 2009 Oct;28(4):389-98. doi: 10.1080/10550880903183034.

    PMID: 20155608DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael Stein, M.D.

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

September 1, 2000

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

May 22, 2015

Record last verified: 2013-04

Locations

US(1)