HIV and Hepatitis Care Coordination in Methadone Treatment
This study has been completed.
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00608192
First received: January 18, 2008
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
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 | Intervention |
|---|---|
|
Hepatitis, Viral, Human HIV Infections |
Behavioral: Testing, Education, & Counseling (TEC) Behavioral: Hepatitis Care Coordination (HCC) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | HIV and Hepatitis Care Coordination in Methadone Treatment |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Vaccination adherence visits [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Health Care Utilization Survey [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hepatitis A Knowledge Test [ Time Frame: post-intervention & 90 days ] [ Designated as safety issue: No ]
- Hepatitis B Knowledge Test [ Time Frame: post-intervention & 90 days ] [ Designated as safety issue: No ]
- Hepatitis C Knowledge Test [ Time Frame: post-intervention & 90 days ] [ Designated as safety issue: No ]
- HIV Knowledge Test [ Time Frame: post-intervention & 90 days ] [ Designated as safety issue: No ]
- Risk Behavior Survey [ Time Frame: 3 months, 9 months, 12 months ] [ Designated as safety issue: No ]
- Addiction Severity Index [ Time Frame: 3 months, 9 months, 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 489 |
| Study Start Date: | January 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608192
Locations
| United States, California | |
| San Francisco General Hospital Opiate Treatment Outpatient Program | |
| San Francisco, California, United States, 94110 | |
| United States, New York | |
| Beth Israel Medical Center Methadone Maintenance Program | |
| New York, New York, United States, 10003 | |
Sponsors and Collaborators
University of California, San Francisco
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 |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00608192 History of Changes |
| Other Study ID Numbers: | R01 DA020781, R01DA020781 |
| Study First Received: | January 18, 2008 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of California, San Francisco:
|
HIV viral hepatitis methadone maintenance case management |
costs vaccination risk reduction education |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis, Viral, Human Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases |
Digestive System Diseases Enterovirus Infections Picornaviridae Infections Methadone Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 23, 2013