Preparedness through community respiratory virus testing and engagement

PREVENT: Preparedness Through Respiratory Virus Epidemiology and Community Engagement

This program will offer community members regular testing for respiratory viruses like COVID-19, flu, and RSV and invite some people to join longer-term monitoring and household transmission follow-up.

Quick facts

• Study type: Observational
• Enrollment: 25000 (estimated)
• Sex: All
• Sponsor: University of California, San Diego (Academic / other)
• Locations: 2 sites (La Jolla, California and 1 other locations)
• Trial ID: NCT07147517 on ClinicalTrials.gov

What this trial studies

The project sets up the CHARM network across UC San Diego, Beth Israel Deaconess, and the University of Washington to deliver community-based respiratory pathogen testing and linked substudies. All participants who join community testing (Component A0) provide limited information for screening and some will be invited into ongoing weekly testing (Component A), an immunology sub-study, or a household transmission component. Enrollment is open to community members, with ongoing-participant eligibility requiring residence within the courier pickup/service area and willingness to remain in the area for up to two years. Data and specimen collection are performed regularly and participants are consented into the appropriate components.

Who should consider this trial

Good fit: Ideal participants are community members of any age who live within the recruitment center service and courier pickup area and are willing to provide regular symptom reports and specimens.

Not a fit: People who are incarcerated, living in congregate settings, unable to use available consent languages, unwilling/unable to provide specimens, or who live outside the courier/service area are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the program could improve early detection and tracking of respiratory viruses in the community and inform public health responses that reduce spread.

How similar studies have performed: Similar community-based respiratory surveillance programs have been used successfully to detect and monitor outbreaks, so this approach builds on established methods.

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

Where this trial is running

La Jolla, California and 1 other locations

• UC San Diego — La Jolla, California, United States (Recruiting)
• San Ysidro Health — San Ysidro, California, United States (Recruiting)

Study contacts

• Study coordinator: Breanna Reyes, MPH

Conditions Respiratory Infection Virus; COVID -19; RSV; FLU; respiratory pathogen testing; vending machine; implementation