HIV and Hepatitis Care Coordination in Methadone Treatment - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00608192

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

MedlinePlus related topics: AIDS Hepatitis Hepatitis A

Drug Information available for: Methadone Methadone hydrochloride Hepatitis A Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	HIV and Hepatitis Care Coordination in Methadone Treatment

Further study details as provided by National Institute on Drug Abuse (NIDA):

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 ]

Estimated Enrollment:	460
Study Start Date:	January 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TEC: Active Comparator Hepatitis screening is done on site, but vaccination and medical care will be provided by off site referral. TEC participants will receive standard HIV/Hepatitis education & counseling. TEC participants will not receive case management services.	Behavioral: HIV and Hepatitis Testing, Education, and 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.
HCC: Experimental Participants will receive HIV and 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 case management to promote adherence to HIV and HCV evaluation.	Behavioral: HIV and 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.

Arms

Assigned Interventions

TEC: Active Comparator

Hepatitis screening is done on site, but vaccination and medical care will be provided by off site referral. TEC participants will receive standard HIV/Hepatitis education & counseling. TEC participants will not receive case management services.

Behavioral: HIV and Hepatitis Testing, Education, and 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.

HCC: Experimental

Participants will receive HIV and 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 case management to promote adherence to HIV and HCV evaluation.

Behavioral: HIV and 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 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.

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

Contacts

Contact: Carmen L Masson, Ph.D.	(415) 206-8404	carmen.masson@ucsf.edu
Contact: Nicole E Pepper, MSSW	(415) 206-3979	nicole.pepper@ucsf.edu

Locations

United States, California
San Francisco General Hospital Opiate Treatment Outpatient Program	Recruiting
San Francisco, California, United States, 94110
Contact: Carmen L Masson, Ph.D. 415-206-8404 carmen.masson@ucsf.edu
Contact: Nicole E Pepper, MSSW (415) 206-3979 nicole.pepper@ucsf.edu
Principal Investigator: Carmen L Masson, Ph.D.
United States, New York
Beth Israel Medical Center Methadone Maintenance Program	Recruiting
New York, New York, United States, 10003
Contact: Courtney McKnight 212-844-8551 cmcknigh@chpnet.org
Principal Investigator: David Perlman, MD

Sponsors and Collaborators

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

More Information

Responsible Party:	Services Research Branch, DESPR ( Bennett Fletcher, PhD, Sr Research Psychologist )
Study ID Numbers:	R01 DA020781
Study First Received:	January 18, 2008
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00608192
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

HIV
viral hepatitis
methadone maintenance
case management

costs
vaccination
risk reduction education

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Liver Diseases
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Immunologic Deficiency Syndromes
Naphazoline
Hepatitis
Virus Diseases
Oxymetazoline

Methadone
Digestive System Diseases
Guaifenesin
HIV Infections
Phenylephrine
Sexually Transmitted Diseases
Phenylpropanolamine
Retroviridae Infections

Additional relevant MeSH terms:

Respiratory System Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Infection
Pharmacologic Actions

Sensory System Agents
Therapeutic Uses
Lentivirus Infections
Peripheral Nervous System Agents
Analgesics
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009