NCT02474043

Brief Summary

The goal of this study is to evaluate the effectiveness of a brief, computerized behavioral intervention for promoting screening for hepatitis C and reducing risky behavior for people who inject drugs (PWID).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

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

August 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

June 15, 2015

Last Update Submit

January 9, 2019

Conditions

Keywords

Injection drug use

Outcome Measures

Primary Outcomes (1)

  • Screening for hepatitis C infection

    Participants will be followed for 12 months to determine whether they undergo repeated screening for hepatitis C

    12 months

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Standard health education and prevention counseling by trained staff

Behavioral: Usual Care

Hep-Net Intervention

EXPERIMENTAL

Computerized tailored behavioral intervention

Behavioral: Hep-Net InterventionBehavioral: Usual Care

Interventions

The Hep-Net Intervention is a web-based questionnaire and tailored feedback system designed to increase readiness to change with respect to several behaviors. The behaviors include (1) reducing or quitting drug use; (2) using sterile equipment every time one injects drugs; (3) undergoing screening for hepatitis C; (4) receiving training to use naloxone to prevent death due to opioid overdose.

Hep-Net Intervention
Usual CareBEHAVIORAL

Clients receive health education and risk reduction counseling from a trained prevention specialist.

Hep-Net InterventionUsual care

Eligibility Criteria

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

You may qualify if:

  • Age 18 or over
  • English-speaking
  • Reports injection of illicit drugs in the past month

You may not qualify if:

  • Unable to provide informed consent due to cognitive impairment
  • Unwilling to provide personal locator information and consent to be contacted for follow-up after 3 months.
  • Currently known to be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Hochstatter KR, Hull SJ, Sethi AK, Burns ME, Mundt MP, Westergaard RP. Promoting Safe Injection Practices, Substance Use Reduction, Hepatitis C Testing, and Overdose Prevention Among Syringe Service Program Clients Using a Computer-Tailored Intervention: Pilot Randomized Controlled Trial. J Med Internet Res. 2020 Sep 29;22(9):e19703. doi: 10.2196/19703.

  • Westergaard RP, Hull SJ, Merkow A, Stephens LK, Hochstatter KR, Olson-Streed HK, Baker LM, Hess TM. Computerized Tailored Interventions to Enhance Prevention and Screening for Hepatitis C Virus Among People Who Inject Drugs: Protocol for a Randomized Pilot Study. JMIR Res Protoc. 2016 Jan 22;5(1):e15. doi: 10.2196/resprot.4830.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ryan Westergaard, MD, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 17, 2015

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

January 11, 2019

Record last verified: 2019-01