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
About this trial
This is an interventional screening trial for Hepatitis C focused on measuring Injection drug use
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
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
NCT ID
NCT02474043
First Posted
June 15, 2015
Last Updated
January 9, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
AIDS Resource Center of Wisconsin
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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