HIV and Hepatitis Care Coordination in Methadone Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00608192
First received: January 18, 2008
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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 Intervention
Hepatitis, Viral, Human
HIV Infections
Behavioral: Testing, Education, & Counseling (TEC)
Behavioral: Hepatitis Care Coordination (HCC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: HIV and Hepatitis Care Coordination in Methadone Treatment

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Vaccination adherence visits [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Health Care Utilization Survey [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hepatitis A Knowledge Test [ Time Frame: post-intervention & 90 days ] [ Designated as safety issue: No ]
  • Hepatitis B Knowledge Test [ Time Frame: post-intervention & 90 days ] [ Designated as safety issue: No ]
  • Hepatitis C Knowledge Test [ Time Frame: post-intervention & 90 days ] [ Designated as safety issue: No ]
  • HIV Knowledge Test [ Time Frame: post-intervention & 90 days ] [ Designated as safety issue: No ]
  • Risk Behavior Survey [ Time Frame: 3 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Addiction Severity Index [ Time Frame: 3 months, 9 months, 12 months ] [ Designated as safety issue: No ]

Enrollment: 489
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608192

Locations
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
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
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00608192     History of Changes
Other Study ID Numbers: R01 DA020781, R01DA020781
Study First Received: January 18, 2008
Last Updated: January 15, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 20, 2014