You and Me Healthy: Test to Treat

NCT07126392 | Completed

• 2 other identifiers: Pro001124791U01MD018294-01
• Study Type: observational
• Target: 913
• Locations: 1 country
• Sites: 2

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 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.

Conditions

COVID - 19

Outcome Measures

Primary Outcomes (6)

• Number of consented participants

  Participants completed the informed consent

  Baseline

• Total number of home test kits distributed.

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

  Up to 2 years

• Proportion of at-home test results that were reported

  Participants completed a survey regarding the reporting of results.

  Baseline; 3 days

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

  Participant received an email that detailed local services.

  1 hour of reporting positive results

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

  Participants received an email with information on local testing sites

  1 hour of reporting results

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

  Participants were sent an email that included local treatment options.

  1 hour of reporting results

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

United Way of Merced California

Merced, California, 95340, United States

Location

Pitt County Health Department

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Emily M D'Agostino, DPH, MS, MEd, MA

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 17, 2025
• Study Start: April 5, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)