Hepatitis B Virus (HBV) Prevention for Homeless at Risk for HBV/Hepatitis C Virus (HCV)/HIV
Condition: Hepatitis B; Hepatitis C; HIV; HIV Infections
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis B; Hepatitis
Study type: Interventional

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.
    

Intervention name(s): NCMIT; SCMIT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B and C; HIV; nurse case management; HIV seronegativity