COVID -19, FLU, Respiratory Infection Virus, RSV
Conditions
Keywords
respiratory pathogen testing, vending machine, implementation
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.
Interventions
OTHERComponent A0
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.
OTHERComponent A1
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.
OTHERComponent A2
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.
OTHERComponent B
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
Sponsors
San Ysidro Health Center
Centers for Disease Control and Prevention
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactBreanna Reyes, MPH
Backup ContactPREVENT Project
Outcome results
None listed