NCT00608192

HIV and Hepatitis Care Coordination in Methadone Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 489 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis, Viral, Human
• HIV Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2008-02-06
• Last updated: 2013-01-16

Locations

2 sites across 1 country: United States