Status:
RECRUITING
Preparedness Through Respiratory Virus Epidemiology and Community Engagement
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
San Ysidro Health Center
Centers for Disease Control and Prevention
Conditions:
Respiratory Infection Virus
COVID -19
Eligibility:
All Genders
Brief Summary
The CHARM network will be established through three primary institutions-Beth Israel Deaconess Medical Center (BIDMC), the University of California San Diego (UCSD), and the University of Washington (...
Eligibility Criteria
Inclusion
- Community Testing Component:
- Inclusion:
- \- All community members are able to participate in the community testing component.
- Exclusion:
- \- There is no exclusion criteria and participants will not be excluded based on pregnancy status or age.
- For Component A:
- Inclusion:
- All ages
- AND Lives in service area of a recruitment center (i.e., within range of courier pick up)
- AND Plans to remain living in a recruitment area for the next 2 years.
- Exclusion:
- Inability to communicate in a language in which consent forms, materials, etc. are available
- OR Incarcerated
- OR Living in a congregate setting (e.g., assisted living, nursing home, university dormitories with shared bathroom and communal eating facilities)
- OR Unable/unwilling to participate in planned data and specimen collections
- OR Unable to comply with study procedures, as determined by study investigators
- OR Participation in clinical trials of investigational agents for respiratory viral infections during the three months prior to enrollment and for the duration of the study.
- For Component B:
- Inclusion:
- Index case:
- Detection of priority respiratory pathogen via laboratory or point-of-care test on the day of eligibility screening or in the previous 5 days, AND
- Lives in service area of a recruitment center (i.e., within range of courier pick up), AND
- Lives in a household with ≥1 other person and plans to remain in the household for at least the duration of specimen collection (i.e., 14 days), AND
- Has not been hospitalized since the date of symptom onset.
- Household contacts:
- Routinely sleep in the same household as index case and slept in household ≥1 night in the 7 days before index case symptom onset, AND
- Plan to remain in the household for at least the duration of specimen collection (i.e., 14 days).
- Household:
- There is ≥1 non-ill household member (i.e., asymptomatic and has not tested positive for the virus of the index case) on the day of eligibility screening or in the previous 5 days,
- AND all symptomatic persons in the household had a symptom or diagnosis onset date on the day of eligibility screening or in the previous 5 days.
- Exclusion:
- Index case:
- Lives in a congregate setting (e.g., assisted living, nursing home, university dormitories with shared bathroom and communal eating facilities)
- Meet any A1 exclusion criteria
- Household contacts:
- Has been hospitalized any time since date of primary case symptom onset
- Meets any A1 exclusion criteria
- Household:
- The enrollment visit occurs \>6 days after the first symptom onset of primary case
- The primary case in the household is not enrolled
- The primary case has been hospitalized any time after the date of symptom onset
Exclusion
Key Trial Info
Start Date :
October 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2030
Estimated Enrollment :
25000 Patients enrolled
Trial Details
Trial ID
NCT07147517
Start Date
October 8 2025
End Date
October 30 2030
Last Update
November 4 2025
Active Locations (2)
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1
UC San Diego
La Jolla, California, United States, 92093
2
San Ysidro Health
San Ysidro, California, United States, 92173