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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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE January 18, 2008
First Posted Date  ICMJE February 6, 2008
Last Update Posted Date January 16, 2013
Study Start Date  ICMJE January 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2008)
  • Vaccination adherence visits [ Time Frame: 30 days ]
  • Health Care Utilization Survey [ Time Frame: 12 months ]
  • Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2008)
  • Vaccination adherence visits
  • Health Service Utilization Survey
  • Hepatitis C Knowledge Test
  • Risk Behavior Survey
  • Addiction Severity Index
  • Urine toxicology tests
  • Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2008)
  • Hepatitis A Knowledge Test [ Time Frame: post-intervention & 90 days ]
  • Hepatitis B Knowledge Test [ Time Frame: post-intervention & 90 days ]
  • Hepatitis C Knowledge Test [ Time Frame: post-intervention & 90 days ]
  • HIV Knowledge Test [ Time Frame: post-intervention & 90 days ]
  • Risk Behavior Survey [ Time Frame: 3 months, 9 months, 12 months ]
  • Addiction Severity Index [ Time Frame: 3 months, 9 months, 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2008)
  • Hepatitis A Knowledge Test
  • Hepatitis B Knowledge Test
  • Hepatitis C Knowledge Test
  • HIV Knowledge Test
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HIV and Hepatitis Care Coordination in Methadone Treatment
Official Title  ICMJE HIV and Hepatitis Care Coordination in Methadone Treatment
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Hepatitis, Viral, Human
  • HIV Infections
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2013)
489
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2008)
460
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00608192
Other Study ID Numbers  ICMJE R01DA020781( U.S. NIH Grant/Contract )
R01DA020781 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
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
PRS Account University of California, San Francisco
Verification Date January 2013

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