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Trial record 1 of 1 for:    nct02474043
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A Community-based, Behavioral Intervention to Improve Screening for Hepatitis C Among High-risk Young Adults in Wisconsin (Hep-Net)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AIDS Resource Center of Wisconsin
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT02474043
First received: June 15, 2015
Last updated: May 1, 2017
Last verified: May 2017
  Purpose
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).

Condition Intervention
Hepatitis C
Behavioral: Hep-Net Intervention
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Screening
Official Title: A Community-based, Behavioral Intervention to Improve Screening for Hepatitis C Among High-risk Young Adults in Wisconsin

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Screening for hepatitis C infection [ Time Frame: 12 months ]
    Participants will be followed for 12 months to determine whether they undergo repeated screening for hepatitis C


Estimated Enrollment: 225
Study Start Date: August 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual care
Standard health education and prevention counseling by trained staff
Behavioral: Usual Care
Clients receive health education and risk reduction counseling from a trained prevention specialist.
Experimental: Hep-Net Intervention
Computerized tailored behavioral intervention
Behavioral: Hep-Net Intervention
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.
Behavioral: Usual Care
Clients receive health education and risk reduction counseling from a trained prevention specialist.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02474043

Sponsors and Collaborators
University of Wisconsin, Madison
AIDS Resource Center of Wisconsin
Investigators
Principal Investigator: Ryan Westergaard, MD, PhD University of Wisconsin, Madison
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02474043     History of Changes
Other Study ID Numbers: 2013-1360
Study First Received: June 15, 2015
Last Updated: May 1, 2017

Keywords provided by University of Wisconsin, Madison:
Injection drug use

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 23, 2017