NCT Number: NCT07126392
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.
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Notify Me8 year and older
All sexes
Observational
United Way of Merced California, Merced, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Participants completed the informed consent
Time frame: Up to 2 years
Participants received home test kits that were distributed at various events and locations
Time frame: Baseline; 3 days
Participants completed a survey regarding the reporting of results.
Time frame: 1 hour of reporting positive results
Participant received an email that detailed local services.
Time frame: 1 hour of reporting results
Participants received an email with information on local testing sites
Time frame: 1 hour of reporting results
Participants were sent an email that included local treatment options.
Duke University
Other
Acronym: YMTT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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