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HIV and Hepatitis Care Coordination in Methadone Treatment

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ClinicalTrials.gov Identifier: NCT00608192
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : January 16, 2013
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment
Hepatitis, Viral, Human HIV Infections Behavioral: Testing, Education, & Counseling (TEC) Behavioral: Hepatitis Care Coordination (HCC)

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 489 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: HIV and Hepatitis Care Coordination in Methadone Treatment
Study Start Date : January 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

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U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. Vaccination adherence visits [ Time Frame: 30 days ]
  2. Health Care Utilization Survey [ Time Frame: 12 months ]
  3. Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Hepatitis A Knowledge Test [ Time Frame: post-intervention & 90 days ]
  2. Hepatitis B Knowledge Test [ Time Frame: post-intervention & 90 days ]
  3. Hepatitis C Knowledge Test [ Time Frame: post-intervention & 90 days ]
  4. HIV Knowledge Test [ Time Frame: post-intervention & 90 days ]
  5. Risk Behavior Survey [ Time Frame: 3 months, 9 months, 12 months ]
  6. Addiction Severity Index [ Time Frame: 3 months, 9 months, 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608192

United States, California
San Francisco General Hospital Opiate Treatment Outpatient Program
San Francisco, California, United States, 94110
United States, New York
Beth Israel Medical Center Methadone Maintenance Program
New York, New York, United States, 10003
Sponsors and Collaborators
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
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
More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00608192     History of Changes
Other Study ID Numbers: R01DA020781 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by University of California, San Francisco:
viral hepatitis
methadone maintenance
case management
risk reduction education

Additional relevant MeSH terms:
Hepatitis A
HIV Infections
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents