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



Status:Completed
Conditions:HIV / AIDS, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 39
Updated:1/1/2014
Start Date:July 2009
End Date:March 2014
Contact:Cathy Reback, PhD
Email:reback@friendsresearch.org
Phone:323-463-1601

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HBV Prevention for Homeless at Risk for HBV/HCV/HIV

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.

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.

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
We found this trial at
1
site
Los Angeles, California 90028
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from
Los Angeles, CA
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