Hepatitis B Virus (HBV) Prevention for Homeless at Risk for HBV/Hepatitis C Virus (HCV)/HIV
HBV
HBV Prevention for Homeless at Risk for HBV/HCV/HIV
2 other identifiers
interventional
451
1 country
1
Brief Summary
In this study, researchers from UCLA and Friends Community Center will work together in designing a program to assist young homeless stimulant-using gay and bisexual homeless men to complete the hepatitis vaccine and in reducing drug and sexual activity. Using nurse case management strategies, found successful with homeless adults as well as contingency management strategies, found successful with gay and bisexual homeless adults by the community partners, the investigators will evaluate the effectiveness of a program that combines both strategies. As stimulant use threatens to increase homeless persons' risk of exposure to hepatitis A and B viruses, particularly among young users who may not yet be HBV-infected, this research is targeted to engage this group in treatment, until they are suitably protected from HBV, and hopefully reduce risk for HCV and HIV as well.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2009
CompletedFirst Posted
Study publicly available on registry
June 23, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJanuary 30, 2017
January 1, 2017
4.5 years
June 22, 2009
January 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare the NCMIT and SCMT programs among homeless young gay and bisexual stimulant using men with respect to completion of a HBV vaccination series administered in three doses over a four-month period.
5 years
Secondary Outcomes (1)
Document the occurrences of HCV and HIV infections as baseline among these homeless HBV antibody negative stimulant users, and the factors associated with these infections at baseline.
5 years
Study Arms (2)
NCMIT
EXPERIMENTALNurse Case Management Plus Contingency Management and Tracking and the HBV vaccine
SCMIT
ACTIVE COMPARATORStandard with Contingency Management and Tracking (SCMT) and HBV vaccine
Interventions
Nurse Case Management Plus Contingency Management and Tracking (NCCMT) Program includes 20 minute case management, delivered by the NCCMT nurse and a separate 45 minute culturally competent specialized education, delivered by the two assigned nurses and research assistants weekly over 8 weeks. Participants of this group will also receive the HBV vaccine subsequently at one month and four months after baseline and incentives for three-weekly urine samples.
Standard with Contingency Management and Tracking (SCMT) Program. Participants in the SCMT group will interact three times a week over the four-month intervention period with the research nurse and research assistant and will be offered: 1) a brief HBV/HCV education program; 2) receipt of the vaccine subsequently at one month and four months after baseline; and 3) voucher incentives for three-weekly urine samples. The SCMT participants will not receive the specialized education sessions nor the case management delivered weekly over the first 8 weeks sessions.
Eligibility Criteria
You may qualify if:
- homeless males self-reporting gay or bisexual behaviors in the last 12 months
- age 18-39
- methamphetamine and/or cocaine/crack use currently or in the last three months
- no self-reported participation in drug treatment in the last 30 days
- willing to provide informed consent
- willing to undergo hepatitis B and C and HIV antibody testing at baseline
- found to be HBV antibody negative
You may not qualify if:
- persons with Guillian Barre, or allergy to yeast or neomycin
- monolingual speakers of languages other than English or Spanish
- persons judged to be cognitively impaired by the nurse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Friends Community Center
Los Angeles, California, 90028, United States
Related Publications (3)
Nyamathi A, Shoptaw S, Cohen A, Greengold B, Nyamathi K, Marfisee M, de Castro V, Khalilifard F, George D, Leake B. Effect of motivational interviewing on reduction of alcohol use. Drug Alcohol Depend. 2010 Feb 1;107(1):23-30. doi: 10.1016/j.drugalcdep.2009.08.021.
PMID: 19836904BACKGROUNDNyamathi A, Reback CJ, Shoptaw S, Salem BE, Zhang S, Yadav K. Impact of Tailored Interventions to Reduce Drug Use and Sexual Risk Behaviors Among Homeless Gay and Bisexual Men. Am J Mens Health. 2017 Mar;11(2):208-220. doi: 10.1177/1557988315590837. Epub 2016 Jul 8.
PMID: 26130725DERIVEDNyamathi AM, Nandy K, Greengold B, Marfisee M, Khalilifard F, Cohen A, Leake B. Effectiveness of intervention on improvement of drug use among methadone maintained adults. J Addict Dis. 2011 Jan;30(1):6-16. doi: 10.1080/10550887.2010.531669.
PMID: 21218306DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adeline Nyamathi, PhD
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor
Study Record Dates
First Submitted
June 22, 2009
First Posted
June 23, 2009
Study Start
July 1, 2009
Primary Completion
January 1, 2014
Study Completion
February 1, 2015
Last Updated
January 30, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share