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Hepatitis B Virus (HBV) Prevention for Homeless at Risk for HBV/Hepatitis C Virus (HCV)/HIV (HBV)

Primary Purpose

Hepatitis B, Hepatitis C, HIV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NCMIT
SCMIT
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B and C, HIV, nurse case management, HIV seronegativity

Eligibility Criteria

18 Years - 39 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. homeless males self-reporting gay or bisexual behaviors in the last 12 months
  2. age 18-39
  3. methamphetamine and/or cocaine/crack use currently or in the last three months
  4. no self-reported participation in drug treatment in the last 30 days
  5. willing to provide informed consent
  6. willing to undergo hepatitis B and C and HIV antibody testing at baseline
  7. found to be HBV antibody negative

Exclusion Criteria:

  1. persons with Guillian Barre, or allergy to yeast or neomycin
  2. monolingual speakers of languages other than English or Spanish
  3. persons judged to be cognitively impaired by the nurse

Sites / Locations

  • Friends Community Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NCMIT

SCMIT

Arm Description

Nurse Case Management Plus Contingency Management and Tracking and the HBV vaccine

Standard with Contingency Management and Tracking (SCMT) and HBV vaccine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 22, 2009
Last Updated
January 26, 2017
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00926146
Brief Title
Hepatitis B Virus (HBV) Prevention for Homeless at Risk for HBV/Hepatitis C Virus (HCV)/HIV
Acronym
HBV
Official Title
HBV Prevention for Homeless at Risk for HBV/HCV/HIV
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Homeless adults are at high risk for Hepatitis B virus (HBV), Hepatitis C virus (HCV) and HIV infection due to high rates of injection drug use and unprotected sexual activity. Our NIDA-funded RO1 award has enabled us to implement a successful intervention designed to evaluate the effectiveness of a HBV vaccination intervention with homeless adults. Our findings revealed that a greater percent of homeless adults randomized to the Nurse Case Managed Plus Incentive and Tracking group completed the HAV/HBV vaccine series compared to a Standard program without tracking. Homeless persons least likely to complete the vaccine series were young (< 40), and were men having sex with men (MSM); a significant number of these young adults also reported methamphetamine (MA) and cocaine/crack use. Stimulants (SAs), including MA and cocaine/crack are commonly used by homeless MSM, who contend with disorganized lives, unemployment, and little access to health and social services; thus, HBV vaccination is particularly challenging in this population. HAV/HBV vaccination and effective behavioral treatment are two of the most important strategies for reducing HBV infection among this at-risk group of SA users. Based upon advice from our community partners who have successfully treated SA-using gay and bisexual men (GBM), we will incorporate contingency management into our vaccination completion program, which had lower completion rates among young adults and MSMs. Thus, in this competitive renewal, we propose a randomized, experimental, two-group design to evaluate the effectiveness of a Nurse Case Managed Program, which includes specialized education and Contingency Management and Tracking (NCCMT), with a Standard Program, including brief education, Contingency Management and Tracking (SCMT) with 500 homeless, young (18-39), SA-using GBM, on completion of the Twinrix HAV/HBV vaccine and, secondarily, on reduction of risk for hepatitis and HIV. This study is innovative in that it will allow us to look at the effect of an enhanced case management and contingency management program versus a standard contingency management program. The proposed study combines optimal strategies to approach, engage and intervene with a hidden and high-risk population to assess the feasibility and efficacy of interventions that may prove beneficial in preventing HBV and HAV infections. We will also assess the relative cost of these programs in terms of completion of the HAV/HBV vaccination series. As use of SAs threatens to intensify homeless persons' risk of exposure to HAV and HBV, particularly among young users who may not yet be HBV-infected, research targeted to engage this group in treatment, until they are suitably protected from HBV, is critical.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Hepatitis C, HIV, HIV Infections
Keywords
Hepatitis B and C, HIV, nurse case management, HIV seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
451 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NCMIT
Arm Type
Experimental
Arm Description
Nurse Case Management Plus Contingency Management and Tracking and the HBV vaccine
Arm Title
SCMIT
Arm Type
Active Comparator
Arm Description
Standard with Contingency Management and Tracking (SCMT) and HBV vaccine
Intervention Type
Behavioral
Intervention Name(s)
NCMIT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SCMIT
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
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.
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeline Nyamathi, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Community Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19836904
Citation
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.
Results Reference
background
PubMed Identifier
26130725
Citation
Nyamathi 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.
Results Reference
derived
PubMed Identifier
21218306
Citation
Nyamathi 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.
Results Reference
derived

Learn more about this trial

Hepatitis B Virus (HBV) Prevention for Homeless at Risk for HBV/Hepatitis C Virus (HCV)/HIV

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