PREVENT: Preparedness Through Respiratory Virus Epidemiology and Community Engagement

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

⁃ \- All community members are able to participate in the community testing component.

• 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.

⁃ 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.

Locations
United States
California
UC San Diego
RECRUITING
La Jolla
San Ysidro Health
RECRUITING
San Ysidro
Contact Information
Primary
Breanna Reyes, MPH
prevent@health.ucsd.edu
8589454553
Backup
PREVENT Project
prevent@health.ucsd.edu
8589454553
Time Frame
Start Date: 2025-10-08
Estimated Completion Date: 2030-10-30
Participants
Target number of participants: 25000
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Centers for Disease Control and Prevention, San Ysidro Health Center
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov