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临床试验/NCT07126392
NCT07126392已完成不适用

You and Me Healthy: Test to Treat

Duke University2 个研究点 分布在 1 个国家目标入组 913 人开始时间: 2023年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
913
试验地点
2
主要终点
Proportion of at-home test results that were reported

研究概览

简要总结

The COVID-19 pandemic dramatically increased health disparities. In the United States, >79 million have been infected with SARS-CoV-2 and >900,000 died, but cases and deaths disproportionately affect underserved populations. Novel treatments early in disease may transform the pandemic's course, but strategies that address disparities in timely testing and treatment access are essential to maximize impact. To address profound COVID-19 disparities, testing strategies should be developed together with community-trusted organizations in high-need areas identified with risk assessment strategies to address barriers to test access, determine infrastructure needs, and position testing to promote timely access, awareness and education, and engagement with health systems and local resources. The You & Me Healthy (YMH) Toolkit is a guide to develop academic-community partnerships in underserved communities in response to public health threats. In this application, the investigators will evaluate the toolkit's role in preparing community-based test distribution and test and treat responses to the next phase of the COVID-19 pandemic in underserved populations.

Widening COVID-19 health and education disparities will have a profound impact for generations, with infections and deaths disproportionally affecting underserved populations that have been historically marginalized. Inequitable risk of COVID-19 infection and unequal access to care have been observed among lower socio-economic and racial/ethnic minorities with higher hospitalization rates, lower recovery rates, and higher mortality. As outlined at the core of Public Health 3.0, local communities will lead the charge in taking public health to the next level and ensure its continued success. Within this framework community members serve as partners for research, and both community and research resources are leveraged to address social, environmental, and economic conditions that magnify health disparities in communities. Community engagement is increasingly being recognized as enhancing research quality and relevance to public health practice. Benefits of engaging communities have been reported in all stages of research including 1) identifying key research questions based on firsthand knowledge and insight from the field; 2) designing informed consent processes and research protocols that meet the needs of the community; 3) adapting public health interventions to be context-relevant; 4) identifying implementation processes to promote public health intervention feasibility and adoption; and 5) disseminating research results to make information more accessible.

详细描述

This observational study is a direct-to-participant study that distributes at-home, self-administered, COVID-19 testing kits to people in designated communities. The investigators are working together with two anchor partners (Merced County United Way and Pitt County Health Department), who will coordinate directly with 10 local partners each to distribute 10,000 COVID test kits each (20,000 tests) at community-based testing events (location and timing based on community partner guidance) over a 15-month period. All eligible and consented participants at testing events will complete basic data collection including demographics, COVID-19 questions, additional testing satisfaction survey questions and contact information using the Colectiv. Community partners will also complete community partner engagement surveys using the app. Participants will also receive guidance on COVID-19 mitigation, health-promoting resource linkage, and accessible/affordable therapeutics if they test positive for COVID-19.

This proposal will evaluate a systematic and scalable community-engaged test and treat protocol that provides rapid access to COVID-19 at-home tests for self-administration, "next steps" guidance and education, and information on local resources to facilitate treatment in underserved populations. The protocol will be designed and implemented in two communities, Pitt County, NC, and Merced County, CA, in collaboration with key community partners over a 15-month period. As part of this test and treat protocol, the investigators will evaluate a community engagement toolkit, the You & Me Healthy (YMH) Toolkit, as a resource to implement community-based test distribution and test and treat responses in underserved populations. The central hypothesis is that the YMH Toolkit will enable rapid design and implementation of a community driven, scientifically robust, and impactful COVID-19 test and public health intervention.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Self-reported primary residence within the pre-identified communities
  • •Age≥ 8 years at enrollment
  • •Provision of signed and dated informed consent form

排除标准

  • •Under 8 years old
  • •Resides outside of pre-identified communities

结局指标

主要结局

Proportion of at-home test results that were reported

时间窗: Baseline; 3 days

Participants completed a survey regarding the reporting of results.

Number of consented participants

时间窗: Baseline

Participants completed the informed consent

Proportion of participants with positive test results who receive a link to a community testing site

时间窗: 1 hour of reporting results

Participants received an email with information on local testing sites

Proportion of positive test participants who are provided a link to treatment

时间窗: 1 hour of reporting results

Participants were sent an email that included local treatment options.

Total number of home test kits distributed.

时间窗: Up to 2 years

Participants received home test kits that were distributed at various events and locations

Proportion of positive test participants receiving information on COVID-19 next steps.

时间窗: 1 hour of reporting positive results

Participant received an email that detailed local services.

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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