Preparedness Through Respiratory Virus Epidemiology and Community Engagement
PREVENT
PREVENT: Preparedness Through Respiratory Virus Epidemiology and Community Engagement
1 other identifier
observational
25,000
1 country
2
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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2025
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2025
CompletedFirst Posted
Study publicly available on registry
August 29, 2025
CompletedStudy Start
First participant enrolled
October 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2030
November 4, 2025
October 1, 2025
4.9 years
August 14, 2025
October 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Burden and Incident of respiratory illness via infection rates & questionnaires
Estimate the burden and incidence of respiratory illness in a community-based cohort of children and adults. A primary objective is to estimate the annual incidence of laboratory-confirmed symptomatic infection for primary respiratory viruses of interest (e.g., SARS-CoV-2, influenza A/B, and RSV A/B) stratified by age group (6 months-4 years, 5-17 years, 18-64 years, 65 or more years). The sample size and precision analysis assumes that the annual incidence of symptomatic laboratory-confirmed infections for priority respiratory viruses will range from 2% to 20%. Based on these assumptions, investigators plan to recruit 1,500 participants per age group. For each age group, sample size is calculated to provide a 95% confidence interval for the estimated annual incidence of symptomatic laboratory-confirmed infection with a precision ranging from ±0.5% to ±2% of the point estimate. This precision is contingent on the assumed annual incidence within the specified range (2% to 20%).
5 years
Implementation Effectiveness Questionnaire & Interviews
Assess implementation and effectiveness of interventions for respiratory pathogens. Investigators will describe the use of preventive behaviors, vaccination, and use of pharmaceutical interventions among the study participants. Investigators will explore associations between return of test result and preventive behaviors, healthcare seeking, and treatment via qualitative interviews and surveys.
5 years
Secondary Infection Rates
Estimate the secondary infection rates of respiratory pathogens in households and evaluate the effect of household, household member characteristics, and behaviors on household transmission. Sites will aim to recruit between 100 and 150 households per site, for a total of 450 households across the network. Assuming an average household size of 5 persons, research staff would recruit 450 index cases and 1800 household contacts.
5 years
Study Arms (4)
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.
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.
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.
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.
Interventions
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.
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.
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.
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
Eligibility Criteria
Investigators will include a large portion of San Diego County, which resides in HHS Region 9 and is the Southwestern-most county in the continental U.S, abutting the U.S./Mexico border.
You may qualify if:
- \- All community members are able to participate in the community testing component.
You may not qualify if:
- For Component A:
- 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.
- 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:
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- San Ysidro Health Centercollaborator
- Centers for Disease Control and Preventioncollaborator
Study Sites (2)
UC San Diego
La Jolla, California, 92093, United States
San Ysidro Health
San Ysidro, California, 92173, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 14, 2025
First Posted
August 29, 2025
Study Start
October 8, 2025
Primary Completion (Estimated)
September 1, 2030
Study Completion (Estimated)
October 30, 2030
Last Updated
November 4, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Limited datasets with HIPAA data restricted to date of birth, date of study activities, and residence at the level of ZIP code/census tract will be shared with the study sponsor (CDC) and other investigators in the CHARM network, through a joint MTA/DUA and shared study Protocol and Dana Management Plan.