HIV and Hepatitis Care Coordination in Methadone Treatment

NCT00608192 | Completed DMC

• 1 other identifier: R01DA020781
• Study Type: interventional
• Target: 489
• Locations: 1 country
• Sites: 2

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).

Conditions

Hepatitis, Viral, Human; HIV Infections

Keywords

HIV; viral hepatitis; methadone maintenance; case management; costs; vaccination; risk reduction education

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Study Arms (2)

Testing, Education, & Counseling (TEC)

ACTIVE COMPARATOR

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)

Hepatitis Care Coordination (HCC)

EXPERIMENTAL

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)

Interventions

Testing, Education, & Counseling (TEC) BEHAVIORAL

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.

Testing, Education, & Counseling (TEC)

Hepatitis Care Coordination (HCC) BEHAVIORAL

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.

Hepatitis Care Coordination (HCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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

You may not qualify if:

• have already had a formal hepatitis C evaluation
• are obtaining medical care for hepatitis C
• not interested in obtaining medical care for hepatitis

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

San Francisco General Hospital Opiate Treatment Outpatient Program

San Francisco, California, 94110, United States

Location

Beth Israel Medical Center Methadone Maintenance Program

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Hepatitis, Viral, Human; HIV Infections

Interventions

Educational Status; Counseling

Condition Hierarchy (Ancestors)

Virus Diseases; Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: February 6, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (2)