Preparedness Through Respiratory Virus Epidemiology and Community Engagement

Official title

PREVENT: Preparedness Through Respiratory Virus Epidemiology and Community Engagement

Overview

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

• Other Component 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 instruction
• Other Component 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.
• Other Component 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 objecti
• Other Component 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

Primary outcome measures

• Burden and Incident of respiratory illness via infection rates & questionnaires [Time frame: 5 years]
• Implementation Effectiveness Questionnaire & Interviews [Time frame: 5 years]
• Secondary Infection Rates [Time frame: 5 years]

Eligibility 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 exclusion criteria

Household contacts:

• Has been hospitalized any time since date of primary case symptom onset
• Meets any A1 exclusion criteria

Household:

• The enrollment visit occurs >6 days after the first symptom onset of primary case
• The primary case in the household is not enrolled
• The primary case has been hospitalized any time after the date of symptom onset

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

United States · 2 centers

• UC San Diego — La Jolla
• San Ysidro Health — San Ysidro

Identifiers

NCT: NCT07147517 · 812427

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗