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HIV and Hepatitis Care Coordination in Methadone Treatment

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis, Viral, Human; HIV Infections

Intervention: Testing, Education, & Counseling (TEC) (Behavioral); Hepatitis Care Coordination (HCC) (Behavioral)

Phase: N/A

Status: Completed

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Carmen L Masson, Ph.D., Principal Investigator, Affiliation: Univerisity of California, San Francisco, Dept. of Psychiatry
David Perlman, MD, Principal Investigator, Affiliation: Chemical Dependency Institute at Beth Israel Medical Center


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).

Clinical Details

Official title: HIV and Hepatitis Care Coordination in Methadone Treatment

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome:

Vaccination adherence visits

Health Care Utilization Survey

Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases

Secondary outcome:

Hepatitis A Knowledge Test

Hepatitis B Knowledge Test

Hepatitis C Knowledge Test

HIV Knowledge Test

Risk Behavior Survey

Addiction Severity Index

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- HCV negative, of unknown HCV status, or have not received any previous medical care

for HCV 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

Locations and Contacts

San Francisco General Hospital Opiate Treatment Outpatient Program, San Francisco, California 94110, United States

Beth Israel Medical Center Methadone Maintenance Program, New York, New York 10003, United States

Additional Information

Starting date: January 2008
Last updated: January 15, 2013

Page last updated: August 20, 2015

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