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

SARS-CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05697068
• Other study ID #: R01MD016324
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: October 31, 2025

Study information

• Verified date: June 2024
• Source: San Diego State University
• Contact: Noe C Crespo, PhD
• Phone: (619) 594-5773
• Email: ncrespo[@]sdsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study team will develop and test a novel tailored behavioral intervention for patients of a Federally Qualified Health Center who are recently diagnosed with COVID-19. The study is a pragmatic, quality improvement randomized controlled trial (RCT). This research is looking to enroll 256 index patients and their households. Index patients and their households will be invited to participate in the COVID Prevention Program, which includes free COVID-19 testing for exposed household members. Index patients will be randomized to one of two groups: (a) the Standard-of-Care comparison group who will receive established clinical care and follow-up, or (b) the Enhanced Standard-of-Care group, who will receive standard-of-care plus tailored, real-time mobile/virtual counseling delivered by promotores/as. The intervention will use theory- and evidence-based strategies for behavior change and maximize the use of mobile phone applications and technologies to capture real-time behavioral, social, and contextual data (via Ecological Momentary Assessment). The intervention will utilize motivational interviewing techniques to tailor strategies to index patients' home environment/context and social/emotional needs. The intervention will target immediate risk of household spread, followed by risk of community spread. The primary outcome assessed will be a new positive antibody test within a household (post-baseline), as assessed by a blood draw collected by a certified phlebotomist. Secondary research outcomes will be assessed via self-report surveys. Surveys will include socioeconomic status indicators and demographics, as well as measures of mental health (e.g., depression), physical health (chronic conditions), health behaviors (social distancing, hand washing & wearing face covering), as well as comorbidities and risk factors for severe COVID-19 outcomes. Primary and secondary outcomes will be measured at 5 timepoints: baseline, 6-weeks, 6-months, 12-months, and 24-months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: October 31, 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Behavioral:
• COVID Prevention Program (CPP)
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.

Locations

Country	Name	City	State
United States	San Diego State University Research Foundation	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	Family Health Centers of San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with risk reduction behaviors	Secondary outcomes measured via self-report surveys. Surveys include socioeconomic status indicators and demographics, measures of mental health (e.g., depression), physical health (chronic conditions) and health behaviors (social distancing, hand washing & wearing face covering), comorbidities, and risk factors for severe COVID-19 outcomes.	Baseline & 1-, 6-, 12-, and 24-months post-baseline.
Primary	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	Number of households with SARS-CoV-2 Active Infection	Active infection assessed by self-administered anterior nasal swab. SARS-CoV-2 RT-PCR used to determine if exposed household member has been infected and/or can exit quarantine early.	Baseline, 3-5 days post-baseline, and 7-9 days post-baseline.