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HIV and Hepatitis Care Coordination in Methadone Treatment

Primary Purpose

Hepatitis, Viral, Human, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Testing, Education, & Counseling (TEC)
Hepatitis Care Coordination (HCC)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hepatitis, Viral, Human focused on measuring HIV, viral hepatitis, methadone maintenance, case management, costs, vaccination, risk reduction education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco General Hospital Opiate Treatment Outpatient Program
  • Beth Israel Medical Center Methadone Maintenance Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Testing, Education, & Counseling (TEC)

Hepatitis Care Coordination (HCC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Vaccination adherence visits
Health Care Utilization Survey
Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases

Secondary Outcome Measures

Hepatitis A Knowledge Test
Hepatitis B Knowledge Test
Hepatitis C Knowledge Test
HIV Knowledge Test
Risk Behavior Survey
Addiction Severity Index

Full Information

First Posted
January 18, 2008
Last Updated
January 15, 2013
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00608192
Brief Title
HIV and Hepatitis Care Coordination in Methadone Treatment
Official Title
HIV and Hepatitis Care Coordination in Methadone Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Viral, Human, HIV Infections
Keywords
HIV, viral hepatitis, methadone maintenance, case management, costs, vaccination, risk reduction education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
489 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testing, Education, & Counseling (TEC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hepatitis Care Coordination (HCC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Testing, Education, & Counseling (TEC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hepatitis Care Coordination (HCC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vaccination adherence visits
Time Frame
30 days
Title
Health Care Utilization Survey
Time Frame
12 months
Title
Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hepatitis A Knowledge Test
Time Frame
post-intervention & 90 days
Title
Hepatitis B Knowledge Test
Time Frame
post-intervention & 90 days
Title
Hepatitis C Knowledge Test
Time Frame
post-intervention & 90 days
Title
HIV Knowledge Test
Time Frame
post-intervention & 90 days
Title
Risk Behavior Survey
Time Frame
3 months, 9 months, 12 months
Title
Addiction Severity Index
Time Frame
3 months, 9 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen L Masson, Ph.D.
Organizational Affiliation
Univerisity of California, San Francisco, Dept. of Psychiatry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Perlman, MD
Organizational Affiliation
Chemical Dependency Institute at Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital Opiate Treatment Outpatient Program
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Beth Israel Medical Center Methadone Maintenance Program
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Learn more about this trial

HIV and Hepatitis Care Coordination in Methadone Treatment

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