HIV and Hepatitis Care Coordination in Methadone Treatment

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT00608192

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

489

Enrollment

Locations

Arms

Duration (Months)

244.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hepatitis, Viral, Human HIV Infections	Behavioral: Testing, Education, & Counseling (TEC) Behavioral: Hepatitis Care Coordination (HCC)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

489 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

HIV and Hepatitis Care Coordination in Methadone Treatment

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	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.

Arm

Intervention/Treatment

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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

Vaccination adherence visits [30 days]
Health Care Utilization Survey [12 months]
Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases [12 months]

Secondary Outcome Measures

Hepatitis A Knowledge Test [post-intervention & 90 days]
Hepatitis B Knowledge Test [post-intervention & 90 days]
Hepatitis C Knowledge Test [post-intervention & 90 days]
HIV Knowledge Test [post-intervention & 90 days]
Risk Behavior Survey [3 months, 9 months, 12 months]
Addiction Severity Index [3 months, 9 months, 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco General Hospital Opiate Treatment Outpatient Program	San Francisco	California	United States	94110
2	Beth Israel Medical Center Methadone Maintenance Program	New York	New York	United States	10003

Sponsors and Collaborators

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

Investigators

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