Intervention to Prevent Household and Community Spread of COVID-19 Among Latinos

NCT05697068 | Active Not Recruiting

• 1 other identifier: R01MD016324
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effectiveness of a 6-week behavioral intervention for patients who are recently diagnosed with COVID-19. Patients and their households will be randomized to one of two groups (Standard of Care vs. Enhanced Standard of Care). Patients in the Standard-of-Care group will receive established clinical care and follow-up. Patients in the Enhanced Standard-of-Care group will receive standard-of-care plus tailored, real-time text messaging and virtual counseling delivered by promotores/as. The investigators hypothesize that households in the Enhanced Standard-of-Care group will have fewer (any new) household COVID-19 infectivity rates compared to households in the standard-of-care group post-intervention.

Conditions

SARS-CoV-2 Infection

Keywords

SARS-CoV-2; COVID-19; Prevention; Secondary Infection; Hispanics; Latinos; Household; Community; Clinic

Outcome Measures

Primary Outcomes (1)

• Number of households with SARS-CoV-2 Antibodies

  Antibodies assessed by a blood draw collected by a certified phlebotomist. SARS-CoV-2 Nucleocapsid and Spike Protein IgG, used to accurately determine prior infection and/or vaccination.

  Baseline & 1-, 6-, 12-, and 24-months post-baseline.

Secondary Outcomes (1)

• Number of households with SARS-CoV-2 Active Infection

  Baseline, 3-5 days post-baseline, and 7-9 days post-baseline.

Other Outcomes (1)

• Number of participants with risk reduction behaviors

  Baseline & 1-, 6-, 12-, and 24-months post-baseline.

Study Arms (2)

Standard-of-Care

ACTIVE COMPARATOR

Patients who test positive will receive a call from the provider who conducted the test to notify them of the test result and provide standard-of-care counseling (e.g., health education, link them to resources). Index patients are entered into a COVID-19 patient registry in the Federally Qualified Health Center's electronic health record system (which also is linked to the clinic's COVID-19 dashboard) and monitored closely, with telemedicine follow-ups provided by skilled clinical staff every two-to-three days, and in-person follow-ups provided as needed.

Behavioral: COVID Prevention Program (CPP)

Enhanced Standard-of-Care

EXPERIMENTAL

In addition to the aforementioned standard-of-care actions, index patients in the enhanced standard-of-care group will receive tailored phone/mobile counseling (motivational interviewing) focused on implementing strategies to prevent immediate household spread of COVID-19, followed by weekly text messaging for a total of 6 weeks.

Behavioral: COVID Prevention Program (CPP)

Interventions

COVID Prevention Program (CPP) BEHAVIORAL

This project is a promotor/a-led COVID-19 Prevention Program (CPP) for Latino patients of a Federally Qualified Health Center (FQHC) who are recently diagnosed with SARS-CoV-2. The program will implement immediate risk reduction strategies to prevent household spread of COVID-19, followed by risk reduction strategies to prevent community spread. Patients and household members who agree to participate will be patients of the FQHC (the covered entity) and will have completed a broad consent that authorizes program activities (e.g., COVID-19 testing, individualized counseling). Patients are free to refuse to participate in the CPP without impact on other services they may receive at the clinic. Research activities will be managed by study's measurement team, which involves surveys conducted on index patients at baseline, 1-, 6-, 12-, and 24-months. Written informed consent will be obtained for all research activities occurring outside of clinical care.

Enhanced Standard-of-Care; Standard-of-Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients of a federally qualified health center (+18yrs)
• Test positive for COVID-19

You may not qualify if:

• Planning to move out of state in the next year
• Cognitive impairment that is contraindicated to receiving counseling and following behavioral strategies (e.g., schizophrenia, Down syndrome)
• Living in a transitionary home or homeless.

Sponsors & Collaborators

• San Diego State University: lead
• Family Health Centers of San Diego: collaborator

Study Sites (1)

San Diego State University Research Foundation

San Diego, California, 92182, United States

Location

Related Publications (1)

• Crespo NC, Godino J, Behar A, Dionicio P, de la Torre CL, Fraga K, Santoscoy M, Elder JP, Oren E, Lin CD, Arredondo EM, Madanat H, Ramers CB. COVID Prevention Program: Rationale and methodology of a tailored behavioral intervention to prevent household and community spread of COVID-19 among Latinos. Contemp Clin Trials. 2025 Sep;156:108046. doi: 10.1016/j.cct.2025.108046. Epub 2025 Aug 13.

  PMID: 40816435 DERIVED

MeSH Terms

Conditions

COVID-19; Coinfection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Noe C Crespo, M.P.H, Ph.D.

  San Diego State University Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Index patients will be randomly assigned (in real-time) to one of the two experimental groups using a predetermined randomization schedule (blocks of 40 randomly assigned numbers, stratified by study condition). Enrollment and randomization will be conducted in groups/waves of 40 index patients per wave. Enrollment and randomization will continue for each wave until 40 index patients have been randomized.

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 25, 2023
• Study Start: April 11, 2022
• Primary Completion: September 9, 2024
• Study Completion: October 31, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)