HIV and Hepatitis Care Coordination in Methadone Treatment

University of California San Francisco (UCSF)

Status: Completed

Conditions: Hepatitis, Viral, Human; HIV Infections

Treatments: Behavioral: Testing, Education, & Counseling (TEC); Behavioral: Hepatitis Care Coordination (HCC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00608192

R01DA020781 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 489 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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489 participants in 2 patient groups

Testing, Education, & Counseling (TEC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Testing, Education, & Counseling (TEC)

Hepatitis Care Coordination (HCC)

Experimental group

Description:

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.

Treatment:

Behavioral: Hepatitis Care Coordination (HCC)