Preparedness Through Respiratory Virus Epidemiology and Community Engagement

Not yet recruiting

• Conditions: Respiratory Infection Virus; COVID -19; RSV; FLU

• Registration Number: NCT07147517
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Study Start: 2025-09-01
• Primary Completion: 2030-09-01
• Study Completion: 2030-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Burden and Incident of respiratory illness via infection rates & questionnaires	5 years	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%).
Implementation Effectiveness Questionnaire & Interviews	5 years	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.
Secondary Infection Rates	5 years	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.

Trial Locations

Locations (2)

UC San Diego; 🇺🇸 La Jolla, California, United States

San Ysidro Health; 🇺🇸 San Ysidro, California, United States