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

Hepatitis C Clinical Trial

— Hep-Net  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474043
• Other study ID #: 2013-1360
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: January 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	AIDS Resource Center of Wisconsin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening for hepatitis C infection	Participants will be followed for 12 months to determine whether they undergo repeated screening for hepatitis C	12 months