HIV and Hepatitis Care Coordination in Methadone Treatment

HIV Infections Clinical Trial

Official title:

HIV and Hepatitis Care Coordination in Methadone Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608192
• Other study ID #: R01DA020781
• Secondary ID: R01DA020781
• Status: Completed
• Phase: N/A
• First received: January 18, 2008
• Last updated: January 15, 2013
• Start date: January 2008
• Est. completion date: June 2011

Study information

• Verified date: January 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Viral, Human
• HIV Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Medical Center Methadone Maintenance Program	New York	New York
United States	San Francisco General Hospital Opiate Treatment Outpatient Program	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccination adherence visits		30 days	No
Primary	Health Care Utilization Survey		12 months	No
Primary	Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases		12 months	No
Secondary	Hepatitis A Knowledge Test		post-intervention & 90 days	No
Secondary	Hepatitis B Knowledge Test		post-intervention & 90 days	No
Secondary	Hepatitis C Knowledge Test		post-intervention & 90 days	No
Secondary	HIV Knowledge Test		post-intervention & 90 days	No
Secondary	Risk Behavior Survey		3 months, 9 months, 12 months	No
Secondary	Addiction Severity Index		3 months, 9 months, 12 months	No