Clinical trial NCT00608192: HIV and Hepatitis Care Coordination in Methadone Treatment
Official title: HIV and Hepatitis Care Coordination in Methadone Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis, Viral, Human
HIV Infections
Keywords: HIV
viral hepatitis
methadone maintenance
case management
costs
vaccination
risk reduction education
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-02-06
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Vaccination adherence visits
timeFrame: 30 days
measure: Health Care Utilization Survey
timeFrame: 12 months
measure: Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases
timeFrame: 12 months
Secondary outcomes:
measure: Hepatitis A Knowledge Test
timeFrame: post-intervention & 90 days
measure: Hepatitis B Knowledge Test
timeFrame: post-intervention & 90 days
measure: Hepatitis C Knowledge Test
timeFrame: post-intervention & 90 days
measure: HIV Knowledge Test
timeFrame: post-intervention & 90 days
measure: Risk Behavior Survey
timeFrame: 3 months, 9 months, 12 months
measure: Addiction Severity Index
timeFrame: 3 months, 9 months, 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital Opiate Treatment Outpatient Program
state: California
city: New York
country: United States
facility: Beth Israel Medical Center Methadone Maintenance Program
state: New York
Study officials:
affiliation: Univerisity of California, San Francisco, Dept. of Psychiatry
name: Carmen L Masson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chemical Dependency Institute at Beth Israel Medical Center
name: David Perlman, MD
role: PRINCIPAL_INVESTIGATOR
References: