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

January 18, 2008
January 15, 2013
January 2008
June 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Vaccination adherence visits
  • Health Service Utilization Survey
  • Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases
  • Hepatitis C Knowledge Test
  • Risk Behavior Survey
  • Addiction Severity Index
  • Urine toxicology tests
Complete list of historical versions of study NCT00608192 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Hepatitis A Knowledge Test
  • Hepatitis B Knowledge Test
  • Hepatitis C Knowledge Test
  • HIV Knowledge Test
Not Provided
Not Provided
 
HIV and Hepatitis Care Coordination in Methadone Treatment
HIV and Hepatitis Care Coordination in Methadone Treatment

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Hepatitis, Viral, Human
  • HIV Infections
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Testing, Education, & Counseling (TEC)
  • 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.
    Intervention: Behavioral: Hepatitis Care Coordination (HCC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
489
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00608192
R01 DA020781, R01DA020781
Yes
University of California, San Francisco
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
University of California, San Francisco
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP