HIV and Hepatitis Care Coordination in Methadone Treatment

Not Applicable

Completed

• Conditions: Hepatitis, Viral, Human; HIV Infections
• Interventions: Behavioral: Testing, Education, & Counseling (TEC); Behavioral: Hepatitis Care Coordination (HCC)

• Registration Number: NCT00608192
• Lead Sponsor: University of California, San Francisco

Brief Summary

This randomized clinical trial will examine the effectiveness of a strategy of HIV and Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and vaccination for methadone maintenance patients compared with standard Testing, Education, and Counseling (TEC).

Detailed Description

In the HCC model, HIV and hepatitis screening, and HAV and HBV vaccination will be done on site and participants receive on site theory-based HIV and hepatitis education, counseling, and case management to promote adherence to HIV and HCV evaluation; in TEC hepatitis screening is done on site, but vaccination and medical care will be provided by off site referral. Primary aims are to assess the impact of the HCC intervention on adherence to hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination and attendance at an initial appointment with an HIV and/or HCV care provider. Secondary aims include examining intervention effects on HIV and hepatitis knowledge, risky behaviors, alcohol use; follow-up with later stages of HIV and hepatitis C care; to identify psychological mediators of intervention outcomes; and to estimate the incremental cost of the HCC intervention to facilitate fuller economic evaluations of the intervention if proven effective.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-18
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 489

Inclusion Criteria

• >=18 years of age
• be able to provide informed consent
• agree to participate in hepatitis/HIV intervention
• expect to be available to participate in the study for the entire duration of the study
• HCV negative, of unknown HCV status, or have not received any previous medical care for HCV

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Exclusion Criteria

• have already had a formal hepatitis C evaluation
• are obtaining medical care for hepatitis C
• not interested in obtaining medical care for hepatitis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testing, Education, & Counseling (TEC)	Testing, Education, & Counseling (TEC)	HIV and hepatitis screening is done on-site, but vaccination and medical care will be provided by off-site referral. HIV and Hepatitis, Testing, Education, \& Counseling (TEC) participants will receive standard HIV and hepatitis education \& counseling. TEC participants will not receive case management services.
Hepatitis Care Coordination (HCC)	Hepatitis Care Coordination (HCC)	Participants will receive on-site HIV and viral hepatitis screening. Hepatitis A and B combination vaccination will be provided on-site. Participants will receive on-site theory-based HIV and hepatitis education, counseling, and 6 months of case management to promote adherence to HIV and HCV evaluation.

Primary Outcome Measures

Name	Time	Method
Vaccination adherence visits	30 days
Health Care Utilization Survey	12 months
Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases	12 months

Secondary Outcome Measures

Name	Time	Method
Hepatitis A Knowledge Test	post-intervention & 90 days
Hepatitis B Knowledge Test	post-intervention & 90 days
Hepatitis C Knowledge Test	post-intervention & 90 days
HIV Knowledge Test	post-intervention & 90 days
Risk Behavior Survey	3 months, 9 months, 12 months
Addiction Severity Index	3 months, 9 months, 12 months

Trial Locations

Locations (2)

Beth Israel Medical Center Methadone Maintenance Program; 🇺🇸 New York, New York, United States

San Francisco General Hospital Opiate Treatment Outpatient Program; 🇺🇸 San Francisco, California, United States