Preparedness Through Respiratory Virus Epidemiology and Community Engagement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Component A0
Other interventionIt 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 interventionParticipants 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 interventionInvestigators 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 interventionParticipants 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
Treatment groups
25,000 Participants
are divided into 4 treatment groupsGroup A: Community Testing (A0)1 intervention
Group B: Ongoing Testing (A)1 intervention
Group C: Immunology (A2)1 intervention
Group D: Household Transmission (B)1 intervention
Trial outcomes
Primary outcomes
1
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%).
Time frame
5 years2
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.
Time frame
5 years3
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.
Time frame
5 yearsSponsors and contacts
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University of California, San Diego
Lead sponsor
San Ysidro Health Center
Collaborator
Centers for Disease Control and Prevention
Collaborator
Source ClinicalTrials.gov