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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90028
- Friends Community Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:NCMIT
Nurse Case Management Plus Contingency Management and Tracking and the HBV vaccine
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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.
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有源比较器:SCMIT
Standard with Contingency Management and Tracking (SCMT) and HBV vaccine
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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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.
大体时间:5 years
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5 years
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次要结果测量
结果测量 |
大体时间 |
---|---|
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.
大体时间:5 years
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5 years
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合作者和调查者
调查人员
- 首席研究员:Adeline Nyamathi, PhD、University of California, Los Angeles
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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