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
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).
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 visitsHealth Care Utilization Survey Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases
Secondary outcome: Hepatitis A Knowledge TestHepatitis 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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
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