Official Title
You and Me Healthy: Test to Treat
Brief Summary

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 deathsdisproportionately affect underserved populations. Novel treatments early in disease maytransform the pandemic's course, but strategies that address disparities in timelytesting and treatment access are essential to maximize impact. To address profoundCOVID-19 disparities, testing strategies should be developed together withcommunity-trusted organizations in high-need areas identified with risk assessmentstrategies to address barriers to test access, determine infrastructure needs, andposition testing to promote timely access, awareness and education, and engagement withhealth systems and local resources. The You & Me Healthy (YMH) Toolkit is a guide todevelop academic-community partnerships in underserved communities in response to publichealth threats. In this application, the investigators will evaluate the toolkit's rolein preparing community-based test distribution and test and treat responses to the nextphase of the COVID-19 pandemic in underserved populations.Widening COVID-19 health and education disparities will have a profound impact forgenerations, with infections and deaths disproportionally affecting underservedpopulations that have been historically marginalized. Inequitable risk of COVID-19infection and unequal access to care have been observed among lower socio-economic andracial/ethnic minorities with higher hospitalization rates, lower recovery rates, andhigher mortality. As outlined at the core of Public Health 3.0, local communities willlead the charge in taking public health to the next level and ensure its continuedsuccess. Within this framework community members serve as partners for research, and bothcommunity and research resources are leveraged to address social, environmental, andeconomic conditions that magnify health disparities in communities. Community engagementis increasingly being recognized as enhancing research quality and relevance to publichealth practice. Benefits of engaging communities have been reported in all stages ofresearch including 1) identifying key research questions based on firsthand knowledge andinsight from the field; 2) designing informed consent processes and research protocolsthat meet the needs of the community; 3) adapting public health interventions to becontext-relevant; 4) identifying implementation processes to promote public healthintervention feasibility and adoption; and 5) disseminating research results to makeinformation more accessible.

Detailed Description

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.

Completed
COVID - 19
Eligibility Criteria

Inclusion Criteria:

- Self-reported primary residence within the pre-identified communities

- Age≥ 8 years at enrollment

- Provision of signed and dated informed consent form

Exclusion Criteria:

- Under 8 years old

- Resides outside of pre-identified communities

Eligibility Gender
All
Eligibility Age
Minimum: 8 Years ~ Maximum: N/A
Countries
United States
Locations

United Way of Merced California
Merced 5372253, California 5332921, United States

Pitt County Health Department
Greenville 4469160, North Carolina 4482348, United States

Emily M D'Agostino, DPH, MS, MEd, MA, Principal Investigator
Duke Clinical Research Institute

National Institute on Minority Health and Health Disparities (NIMHD)
NCT Number
MeSH Terms
COVID-19