COVID - 19YMTTNCT07126392
You and Me Healthy: Test to Treat
An observational study of COVID - 19, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID - 19
- How many people
- 913 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Apr 2023to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Self-reported primary residence within the pre-identified communities
- Age≥ 8 years at enrollment
- Provision of signed and dated informed consent form
Who cannot join
- Under 8 years old
- Resides outside of pre-identified communities
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pitt County Health Department
Greenville, North Carolina, 27834
United Way of Merced California
Merced, California, 95340
About this study
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.
Read the 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.
- Conditions
- COVID - 19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of consented participants
Participants completed the informed consent
Measured: Baseline
Total number of home test kits distributed.
Participants received home test kits that were distributed at various events and locations
Measured: Up to 2 years
Proportion of at-home test results that were reported
Participants completed a survey regarding the reporting of results.
Measured: Baseline; 3 days
Proportion of positive test participants receiving information on COVID-19 next steps.
Participant received an email that detailed local services.
Measured: 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
Measured: 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.
Measured: 1 hour of reporting results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start5 Apr 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID - 19Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 913 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Emily M D'Agostino, DPH, MS, MEd, MA, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126392
- Sponsor's protocol ID
- Pro00112479
- Other IDs
- 1U01MD018294-01
- Acronym
- YMTT
- Status last verified
- Aug 2025
- First submitted
- 3 Jul 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- You and Me Healthy: Test to Treat
- ClinicalTrials.gov ID
- NCT07126392
- Acronym / sponsor ID
- YMTT / Pro00112479
- Conditions
- COVID - 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 913 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Self-reported primary residence within the pre-identified communities
- Age≥ 8 years at enrollment
- Provision of signed and dated informed consent form
Key exclusion criteria (2 listed)
- Under 8 years old
- Resides outside of pre-identified communities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of consented participants
Time frame: Baseline
Participants completed the informed consent
Total number of home test kits distributed.
Time frame: Up to 2 years
Participants received home test kits that were distributed at various events and locations
Proportion of at-home test results that were reported
Time frame: Baseline; 3 days
Participants completed a survey regarding the reporting of results.
Proportion of positive test participants receiving information on COVID-19 next steps.
Time frame: 1 hour of reporting positive results
Participant received an email that detailed local services.
Proportion of participants with positive test results who receive a link to a community testing site
Time frame: 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
Time frame: 1 hour of reporting results
Participants were sent an email that included local treatment options.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily M D'Agostino, DPH, MS, MEd, MA principal investigator
Duke Clinical Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID - 19, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of consented participants (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.