Preparedness Through Respiratory Virus Epidemiology and Community Engagement

Conditions

• COVID -19
• FLU
• RSV
• Respiratory Infection Virus

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Accepted

Interventions

• Component A0 — OTHER
  It will be implemented as a recruitment strategy. This strategy will enable members of the community to access no cost testing for respiratory infections. If a participant feels sick or thinks they have been exposed to a respiratory infection and wants to be tested, they can complete a symptoms and exposure survey in the PREVENT APP, retrieve a PCR test kit from a vending machine using a unique code received through the PREVENT APP, self-collect an anterior nares nasal swab following instructions provided, and return the test kit at one of the vending machines or drop off locations for the EXCITE lab to pick up and process. The anterior nares nasal swab will be tested for SARS-CoV-2, influenza, Respiratory Syncytial Virus, and other germs (viruses or bacteria) that cause respiratory infections. At the time of consent and registration for the Community Testing Component, participants will be used to screen for Cohorts A/B.
• Component A1 — OTHER
  Participants will be invited to 'test' out the PREVENT App and a provide a 'baseline' sample to ensure competency for requesting a nasal swab, retrieving the test kit from a vending machine, self-collecting a sample, and returning the test for PCR testing, with the assistance of study staff. Weekly Symptom Surveys, Annual Surveys, and immunization status.
• Component A2 — OTHER
  Investigators will collect immunologic specimens from a subset of participants in Component A (the subset herein referred to as Component A immunologic sub-study). Investigators will combine testing data from these immunologic specimens with multiple data elements already captured in Component A (such as data from pathogen testing and sequencing, survey data, medical records, or immunization services) and Component B (serum obtained at enrollment and 28 post-enrollment) to meet sub-study objectives. Overall, the Component A sub-study will provide critical insight into the immune response to respiratory pathogen infections and immunizations.
• Component B — OTHER
  Participants will be asked to complete the enrollment survey after enrolling in Component B if the survey has not already been completed as part of Component A. They will also be asked to complete: 1. Daily anterior nares nasal swab collection 2. All household participants, including the index case, will be asked to self-collect an enrollment swab and daily nasal swab specimens for 14 days and return them for testing. 3. Mucosal specimen collection 4. Survey data collection

Study Details

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 (UW)-along with their subcontracting institutions. At UCSD and partner sites, the CHARM network will be implemented via the PREVENT project. All PREVENT participants will be consented in to Component A0 (Community Testing) and a subset of A0 participants will be invited to participate and will be consented into the other components: Component A (Ongoing Testing); Component A Sub-study (Immunology); Component B (Household Transmission). Component A0 participants (Community testing) will be members of the community who are interested in accessing testing for respiratory infections and will be asked to provide limited information that will then be used for screening for study Components A and/or B. Participants in Component A (Ongoing Testing ) will undergo weekly symptom screening. If they report symptoms, they will be asked to provide a nasal swab and complete illness questionnaires on the day they report symptoms (Day 0) and again on Days 7 and 14. Participants in Component A Sub-study (Immunology) will provide blood and saliva/nasal fluid samples twice a year, as well as before and after infection and/or immunization against priority pathogens. Participants in Component B (Household Transmission) will complete daily symptom questionnaires and nasal swabs for 14 days following enrollment, regardless of symptoms. Those who are symptomatic at enrollment will also complete retrospective daily diaries from symptom onset to the enrollment date. Additionally, they provide blood and/or saliva/nasal fluid samples at enrollment and again 28 days later. For all Components, UCSD will provide PCR test results for SARS-CoV-2, Influenza A/B, and RSV for nasal swab samples.

Key Dates

Start date

Oct 8, 2025

Status verified

Oct 2025

Primary completion

Sep 1, 2030

Completion

Oct 30, 2030

Study Design

Enrollment

25,000 participants (estimated)

Arms

• Arm: Community Testing (A0)
  Component A0 participants (Community testing) will be members of the community who are interested in accessing testing for respiratory infections and will be asked to provide information that will then be used for screening for study Components A and/or B.
• Arm: Ongoing Testing (A)
  Participants in Component A (Ongoing Testing ) will undergo weekly symptom screening. If they report symptoms, they will be asked to provide a nasal swab and complete illness questionnaires on the day they report symptoms (Day 0) and again on Days 7 and 14.
• Arm: Immunology (A2)
  Participants in Component A Sub-study (Immunology) will provide blood and saliva/nasal fluid samples twice a year, as well as before and after infection and/or immunization against priority pathogens.
• Arm: Household Transmission (B)
  Participants in Component B (Household Transmission) will complete daily symptom questionnaires and nasal swabs for 14 days following enrollment, regardless of symptoms. Those who are symptomatic at enrollment will also complete retrospective daily diaries from symptom onset to the enrollment date. Additionally, they provide blood and/or saliva/nasal fluid samples at enrollment and again 28 days later.

Primary Outcome Measure

Burden and Incident of respiratory illness via infection rates & questionnaires [ Time Frame: 5 years ]

Central Contacts

• Breanna Reyes, MPH
  8589454553
  [email protected]
• PREVENT Project
  8589454553
  [email protected]

Locations (2)

Find similar trials in La Jolla, CA

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