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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Adeline Nyamathi, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00926146
First received: June 22, 2009
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Hepatitis B
Hepatitis C
HIV
HIV Infections
Behavioral: NCMIT
Behavioral: SCMIT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HBV Prevention for Homeless at Risk for HBV/HCV/HIV

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: July 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nurse Case Management Plus Contingency Management and Tracking and the HBV vaccine
Behavioral: NCMIT
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.
Active Comparator: 2
Standard with Contingency Management and Tracking (SCMT) and HBV vaccine
Behavioral: SCMIT
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926146

Locations
United States, California
Friends Community Center
Los Angeles, California, United States, 90028
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Adeline Nyamathi, PhD University of California, Los Angeles
  More Information

No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adeline Nyamathi, MD, Distinguished Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00926146     History of Changes
Other Study ID Numbers: 090602901, DA016147
Study First Received: June 22, 2009
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Hepatitis B and C
HIV
nurse case management
HIV seronegativity

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis C
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 22, 2014