利用社区卫生工作者改进 CJI 中的 COVID-19 测试和缓解措施 访问以惩教为重点的 CBO
2026年5月29日 更新者：Montefiore Medical Center
利用社区卫生工作者改进 COVID-19 测试和缓解涉及刑事司法的个人访问以惩教为重点的社区组织
鉴于 COVID-19 可能仍然是高危人群中的地方病，建立有效的缓解干预措施对于阻止社区传播至关重要。
参与刑事司法的个人对于减少基于社区的 SARS-CoV-2 传播极为重要，因为他们在被监禁期间感染 SARS-CoV-2 的风险增加，而且他们在监禁后可能生活在聚集环境中。
研究人员将评估一个以矫正为中心的社区组织中的现场护理点 SARS-CoV-2 测试和教育策略及其对提高测试采用率、缓解行为（例如
戴口罩、手部卫生、社交距离、接种疫苗（如有）和成本效益。
研究概览
详细说明
由于 COVID-19，美国 (U.S.) 的死亡率高于任何其他国家，有近 1350 万例病例和超过 268,103 例死亡。
由于社交距离能力有限、通风不良和卫生用品有限，美国监狱和看守所观察到 SARS-CoV-2 的爆炸性传播，占美国 10 大爆发的原因。
因为 95% 涉及刑事司法的个人重新进入社会，COVID-19 的传播范围超出了目前被监禁的人。
随着涉及正义的个人重新进入社区，他们面临着很高的无家可归率，许多其他人住在其他聚集的环境中，例如改建的旅馆和中途宿舍。
被监禁期间感染 SARS-CoV-2 的风险增加，加上监禁后生活在聚集环境中的可能性，为 COVID-19 的快速传播创造了成熟的条件，这对于在美国控制 COVID-19 至关重要。本研究的目的是测试一项干预措施的影响和成本效益，以减轻最近从监禁中释放的涉及司法的个人之间的 SARS-CoV-2 传播。
研究人员将进行一项随机试验，以比较以社区卫生工作者 (CHW) 作为中心组成部分的现场护理点 SARS-CoV-2 检测和教育干预与基于社区的护理标准相比的有效性为纽约市涉及司法的个人提供服务的组织 (CBO)。
研究人员将衡量测试、教育和导航的成本，并探索现场护理点干预与护理标准相比的成本效益。
具体目标是：1) 在以惩戒为重点的 CBO 中测试现场 PoC SARS-CoV-2 干预的有效性； 2) 与 SoC 相比，对 CJI 中现场 PoC SARS-CoV-2 干预的成本效益进行建模。
由于 CHW 将在文化敏感的环境中提供测试、教育和导航，并且将在几分钟（而不是几天）内收到测试结果，因此研究人员假设 O-PoC 将与改进的测试采用和接收测试相关联结果、缓解行为（戴口罩、手部卫生、社交距离）以及参加更多 O-PoC 会议的人将更好地遵守缓解行为。
研究类型
介入性
注册 (实际的)
250
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New York
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Long Island City、New York、美国、11101
- Fortune Society
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The Bronx、New York、美国、10467
- Montefiore Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 1）财富客户
- >18 岁
- 流利的英语或西班牙语
- 纽约市居民
- 90 天内从监狱或监狱获释
排除标准：
- 无法提供知情同意
- 无法完成超过 12 个月的研究访问
- 明年不打算居住在纽约市地区。
- 绝症
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 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：现场护理点 (o-POC)
CHW 将与参与者联系以安排 O-PoC 访问。
在 O-PoC 访问中，社区卫生工作者将提供： 1. COVID-19 教育； 2. PoC Cepheid XpertXpressSARS-CoV-2PCR 测试； 3. 需求评估和便利获取口罩和卫生用品； 4. 导航到疫苗接种点（如果可用）和 Fortune 支持性住房地点的单间住房和合作庇护所或其他策略，这些策略将最大限度地提高 PCR 检测呈阳性的人与社会保持距离的能力； 5. 支持性咨询。
由于 SCT 强调社会影响、外部和内部社会强化，我们提出我们的 O-PoC 干预在 12 个月的时间里由 CHWs 在 Fortune 地点现场提供，将导致缓解行为的采用增加。
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在社会认知理论的指导下，O-PoC 将聘请具有监禁经验的社区卫生工作者提供：1) COVID-19 教育； 2) 在 Fortune 设施使用 Cepheid XpertXpress PCR 测试进行 SARS-CoV-2 测试； 3) 需求评估和便利获取口罩和卫生用品； 4) 导航到疫苗接种点（如果可用）和财富支持性住房站点和合作庇护所的单人房，或其他策略，以最大限度地提高 PCR 检测呈阳性的人的社交距离； 5) 支持性咨询。
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无干预：护理标准 (SOC)
Fortune 客户的 SARS-CoV-2 检测的当前护理标准 (SoC) 是转介到异地社区检测站点和非正式、非结构化的教育。
在 SoC 部门，《财富》杂志的工作人员将为客户提供一份非现场 SARS-CoV-2 检测地点的清单，该清单已在线发布并可供所有纽约市居民使用。
没有保险的人无需支付共付额。
SoC 的参与者将继续获得《财富》在参与研究时提供的（远程和/或面对面）服务套件。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Testing Uptake
大体时间：Up to 12 months
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Testing uptake will be defined as the number and percentage of participants who had tests performed and will be determined using program logs and healthcare record extraction.
To measure testing uptake, a dichotomous outcome of having at least one complete SARS-CoV-2 test over the 12-month study period, defined as having a test performed with results received by participants within two weeks of the test being conducted, was used.
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Up to 12 months
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Number of Participants Who Completed SARS-CoV-2 Tests
大体时间：Up to 12 months
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The number/percentage of participants who completed at least one SARS-CoV-2 test for the whole 12-month study period (up to 5 tests available) is summarized by study arm.
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Up to 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Masking Adherence
大体时间：12 months post-enrollment
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Masking adherence behavior was measured using a composite weighted variable estimating how frequently participants engaged in activities with potential COVID-19 exposure and how often they wore a mask during those activities in the previous two weeks.
Initial response options were 1=Always, 2=Most of the time, 3=Sometimes, 4=Rarely or 5=Never.
Responses were combined and standardized to a scale of 1 to 100 with higher scores indicating greater masking adherence.
Results are summarized by study arm using descriptive statistics.
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12 months post-enrollment
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Social Distancing Behavior
大体时间：12 months post-enrollment
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Social distancing measured the participants' social distancing behavior by their responses to the following question: "Overall, on a scale of 1-100, how often did you stay greater than 6 feet away from others when you were not masked in the past 2 weeks?
Higher scores were indicative of more frequent social distancing.
Results are summarized by study arm using descriptive statistics.
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12 months post-enrollment
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Hand Washing Adherence
大体时间：12 months post-enrollment
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Participants' hand washing behavior was measured by the following question: Overall, on a scale of 1-100, how often did you wash hands after shaking hands with or touching surfaces that were touched by someone else in the past two weeks?
Higher scores were indicative of more frequent hand washing behavior.
Results are summarized by study arm using descriptive statistics.
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12 months post-enrollment
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Mitigation Measures
大体时间：12 months post-enrollment
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The number/percentage of participants who reported mitigation behaviors in at least one biweekly smartphone survey is summarized by study arm.
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12 months post-enrollment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Matthew Akiyama, MD MSc、ALBERT EINSTEIN COLLEGE OF MEDICINE Montefiore Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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- Rosenberg ES, Dufort EM, Blog DS, Hall EW, Hoefer D, Backenson BP, Muse AT, Kirkwood JN, St George K, Holtgrave DR, Hutton BJ, Zucker HA; New York State Coronavirus 2019 Response Team. COVID-19 Testing, Epidemic Features, Hospital Outcomes, and Household Prevalence, New York State-March 2020. Clin Infect Dis. 2020 Nov 5;71(8):1953-1959. doi: 10.1093/cid/ciaa549.
- Jing QL, Liu MJ, Zhang ZB, Fang LQ, Yuan J, Zhang AR, Dean NE, Luo L, Ma MM, Longini I, Kenah E, Lu Y, Ma Y, Jalali N, Yang ZC, Yang Y. Household secondary attack rate of COVID-19 and associated determinants in Guangzhou, China: a retrospective cohort study. Lancet Infect Dis. 2020 Oct;20(10):1141-1150. doi: 10.1016/S1473-3099(20)30471-0. Epub 2020 Jun 17.
- Dinnes J, Deeks JJ, Adriano A, Berhane S, Davenport C, Dittrich S, Emperador D, Takwoingi Y, Cunningham J, Beese S, Dretzke J, Ferrante di Ruffano L, Harris IM, Price MJ, Taylor-Phillips S, Hooft L, Leeflang MM, Spijker R, Van den Bruel A; Cochrane COVID-19 Diagnostic Test Accuracy Group. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2020 Aug 26;8(8):CD013705. doi: 10.1002/14651858.CD013705.
- Pasomsub E, Watcharananan SP, Boonyawat K, Janchompoo P, Wongtabtim G, Suksuwan W, Sungkanuparph S, Phuphuakrat A. Saliva sample as a non-invasive specimen for the diagnosis of coronavirus disease 2019: a cross-sectional study. Clin Microbiol Infect. 2021 Feb;27(2):285.e1-285.e4. doi: 10.1016/j.cmi.2020.05.001. Epub 2020 May 15.
- Akiyama MJ, Kaba-Diakite F, Dimaulaluan M, Riback LR, Antigua JR, Holmes CS, Ackerman MF, Castillo A, Linder M, Day RF, Travers A, Cunningham CO, Deng Y, Zhang C, Fox AD. Mitigation of COVID-19 through onsite testing and education among formerly incarcerated individuals (the MOSAIC study): an open-label, single-centre, randomised controlled trial. Lancet Public Health. 2026 Jul;11(7):e457-e467. doi: 10.1016/S2468-2667(26)00093-9.
有用的网址
- Johns Hopkins University. COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU)
- Federal Bureau of Prisons - Inmate Ethnicity Statistics
- The Marshall Project. A State-by-State Look at Coronavirus in Prisons
- American Civil Liberties Union. COVID-19 Model Finds Nearly 100,000 More Deaths Than Current Estimates, Due to Failures to Reduce Jails
- Prison Policy Initiative - Jails versus Prison
- Covid-19: Testing Inequality in New York City
- No COVID-19 tests available for prisoners at center of New York outbreak, court documents show
- Audit of Brooklyn federal jail claims lack of COVID-19 tests may have masked size of outbreak New York Daily News.
- Nelson J. House Appropriations Committee Approves '21 Funding for DOJ Programs
- Cepheid. Sars-cov-2-test-development-information
- Evidence-Based, Cost-Effective Interventions To Suppress The COVID-19 Pandemic: A Systematic Review
- Facemasks and similar barriers to prevent respiratory illness such as COVID-19
- The Institute for Health Metrics and Evaluation - Daily deaths during the pandemic
- The National Reentry Resource Center. Reentry Services Directory
- Estimating QALY losses associated with deaths in hospital (COVID-19)
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年4月14日
初级完成 (实际的)
2025年5月22日
研究完成 (实际的)
2025年5月22日
研究注册日期
首次提交
2021年4月30日
首先提交符合 QC 标准的
2021年5月4日
首次发布 (实际的)
2021年5月7日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年5月29日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.