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A Community-based, Behavioral Intervention to Improve Screening for Hepatitis C Among High-risk Young Adults in Wisconsin (Hep-Net)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hep-Net Intervention
Usual Care
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis C focused on measuring Injection drug use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Usual care

    Hep-Net Intervention

    Arm Description

    Standard health education and prevention counseling by trained staff

    Computerized tailored behavioral intervention

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2015
    Last Updated
    January 9, 2019
    Sponsor
    University of Wisconsin, Madison
    Collaborators
    AIDS Resource Center of Wisconsin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02474043
    Brief Title
    A Community-based, Behavioral Intervention to Improve Screening for Hepatitis C Among High-risk Young Adults in Wisconsin
    Acronym
    Hep-Net
    Official Title
    A Community-based, Behavioral Intervention to Improve Screening for Hepatitis C Among High-risk Young Adults in Wisconsin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2014 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison
    Collaborators
    AIDS Resource Center of Wisconsin

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).
    Detailed Description
    People who inject drugs (PWID) are at high risk for hepatitis C virus (HCV) infection if they share contaminated injection equipment with others. Many are infected but are unaware of it, making it likely they will transmit the virus to others if they share contaminated injecting equipment. Problems related to hepatitis C can be avoided if people know their status by getting tested and referred to treatment. In this study, the investigators will recruit eligible PWID in several cities in Wisconsin using a social networks strategy, in which clients who receive services at a syringe exchange program are asked to refer peers who also inject drugs to participate in the study. All participants will undergo a baseline computerized risk assessment that elicits information about hepatitis C status, previous testing, transmission risk behaviors, and overdose risk. Participants will then be randomly-assigned to receive either standard risk reduction counseling from a prevention specialist, or computerized tailored risk reduction messages that are specific to their reported risk behaviors, attitudes and beliefs. A follow-up assessment will be completed after 3 months to evaluate changes in behavioral risk and intention to undergo HCV screening. A database will be searched to determine which participants returned for HCV screening within 12 months of enrollment, and of those, which ones tested positive for HCV.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C
    Keywords
    Injection drug use

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    235 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual care
    Arm Type
    Active Comparator
    Arm Description
    Standard health education and prevention counseling by trained staff
    Arm Title
    Hep-Net Intervention
    Arm Type
    Experimental
    Arm Description
    Computerized tailored behavioral intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Hep-Net Intervention
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual Care
    Intervention Description
    Clients receive health education and risk reduction counseling from a trained prevention specialist.
    Primary Outcome Measure Information:
    Title
    Screening for hepatitis C infection
    Description
    Participants will be followed for 12 months to determine whether they undergo repeated screening for hepatitis C
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 or over English-speaking Reports injection of illicit drugs in the past month Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ryan Westergaard, MD, PhD
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32990630
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    26800903
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    A Community-based, Behavioral Intervention to Improve Screening for Hepatitis C Among High-risk Young Adults in Wisconsin

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