Preparedness through community respiratory virus testing and engagement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: prevent@health.ucsd.edu
• Phone: 8589454553

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) in Adults

  This study tests and compares the immune responses and tolerability of the latest COVID-19 vaccines from Novavax and Pfizer/BioNTech in adults at risk for severe COVID-19.

  Recruiting Phase 4 Henry M. Jackson Foundation for the Advancement of Military Medicine · Bethesda, Maryland · NCT07287137

• Monitoring and detection of influenza, RSV, and COVID-19 in adults with and without HIV in Lusaka

  This project will test methods to detect influenza, RSV, and COVID-19 in adults with and without HIV who have recent respiratory symptoms in Lusaka.

  Recruiting at 2 sites Centre for Infectious Disease Research in Zambia · Lusaka, Lusaka Province and 1 other locations · NCT07030075

• Evaluation of a new test for detecting flu and COVID-19 in patients with respiratory symptoms

  This study is testing a new nasal swab test to see if it can accurately tell the difference between flu, RSV, and COVID-19 in people who have respiratory symptoms.

  Recruiting at 3 sites DiaSorin Molecular LLC · Henderson, Nevada and 2 other locations · NCT06672692

• Zelicapavir versus placebo in adults at high risk for severe RSV

  This study tests whether zelicapavir, taken by mouth, can help adults with RSV who are at high risk for severe disease compared to placebo.

  Recruiting at 4 sites Phase 2/3 Enanta Pharmaceuticals, Inc · Cape Coral, Florida and 3 other locations · NCT07908381

• Omicron-based COVID-19 vaccine with Matrix-M given as a single dose in older adults and high-risk individuals

  A single-dose Omicron-subvariant vaccine with Matrix-M is tested to see if it is safe and can induce an immune response in adults 65+ and in younger adults with conditions that raise the risk of severe COVID-19, who were previously vaccinated.

  Recruiting at 20 sites Phase 4 Sanofi · Fair Oaks, California and 19 other locations · NCT07861542

• Secutrelvir for nonhospitalized COVID-19 in teens and adults

  This study tests whether secutrelvir can help nonhospitalized people with COVID-19 see faster symptom relief compared with a placebo.

  Recruiting Phase 3 Shionogi Inc. · Multiple Locations · NCT07746544

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.