HIV and Hepatitis Care Coordination in Methadone Treatment

January 15, 2013 updated by: University of California, San Francisco
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

489

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital Opiate Treatment Outpatient Program
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Medical Center Methadone Maintenance Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: Testing, Education, & Counseling (TEC)
Trained research staff will provide a two-session HIV/hepatitis education class. Participants will also be offered serological testing for hepatitis A, B and C, and HIV (optional), and off-site referrals for vaccination and hepatitis care. The content of the TEC intervention is evidence based. The TEC condition is comparable to screening and education methods commonly used in many drug treatment settings. Those in the TEC intervention group who do not adhere to needed off site vaccinations will be offered on site vaccination 30 days after vaccination referral.
Experimental: 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.
Behavioral: Hepatitis Care Coordination (HCC)
HCC Participants will be offered serological testing and counseling for hepatitis A, B and C, and HIV (optional). HCC participants will be offered on-site hepatitis A and B combination vaccination at the methadone clinic. They will also receive a two-session HIV/hepatitis education class with Motivational Interviewing. In addition, participants will receive 6 months of weekly case management to facilitate entry into hepatitis care.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Carmen L Masson, Ph.D., Univerisity of California, San Francisco, Dept. of Psychiatry
  • Principal Investigator: David Perlman, MD, Chemical Dependency Institute at Beth Israel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 18, 2008

First Submitted That Met QC Criteria

January 31, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA020781 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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