HIV and Hepatitis Care Coordination in Methadone Treatment

Condition(s) targeted: Hepatitis, Viral, Human; HIV Infections

Intervention: HIV and Hepatitis Testing, Education, and Counseling (TEC) (Behavioral); HIV and Hepatitis Care Coordination (HCC) (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Carmen L Masson, Ph.D., Principal Investigator, Affiliation: Univerisity of California, San Francisco, Dept. of Psychiatry
David Perlman, MD, Principal Investigator, Affiliation: Chemical Dependency Institute at Beth Israel Medical Center

Overall contact:
Carmen L Masson, Ph.D., Phone: (415) 206-8404, Email: carmen.masson@ucsf.edu

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).

Official title: HIV and Hepatitis Care Coordination in Methadone Treatment

Study design: Health Services Research, Randomized, Open Label, Parallel Assignment, Efficacy Study

Primary outcome:

Vaccination adherence visits

Health Care Utilization Survey

Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases

Secondary outcome:

Hepatitis A Knowledge Test

Hepatitis B Knowledge Test

Hepatitis C Knowledge Test

HIV Knowledge Test

Risk Behavior Survey

Addiction Severity Index

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 HAV and 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Carmen L Masson, Ph.D., Phone: (415) 206-8404, Email: carmen.masson@ucsf.edu

San Francisco General Hospital Opiate Treatment Outpatient Program, San Francisco, California 94110, United States; Recruiting
Carmen L Masson, Ph.D., Phone: 415-206-8404, Email: carmen.masson@ucsf.edu
Nicole E Pepper, MSSW, Phone: (415) 206-3979, Email: nicole.pepper@ucsf.edu
Carmen L Masson, Ph.D., Principal Investigator

Beth Israel Medical Center Methadone Maintenance Program, New York, New York 10003, United States; Recruiting
Courtney McKnight, Phone: 212-844-8551, Email: cmcknigh@chpnet.org
David Perlman, MD, Principal Investigator

Starting date: January 2008
Ending date: May 2011
Last updated: August 28, 2008