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

Primary Purpose

Prevention of SARS-CoV-2 Secondary Infection

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COVID Prevention Program (CPP)
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of SARS-CoV-2 Secondary Infection focused on measuring SARS-CoV-2, COVID-19, Prevention, Secondary Infection, Hispanics, Latinos, Behavior, Household, Community, Clinic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adult patients of a federally qualified health center (+18yrs) who test positive for COVID-19 will be invited to participate in the COVID Prevention Program. Exclusion Criteria: 1) planning to move out of state in the next year, 2) cognitive impairment that is contraindicated to receiving counseling and following behavioral strategies (e.g., schizophrenia, Down syndrome), and 3) living in a transitionary home or homeless.

Sites / Locations

  • San Diego State University Research FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard-of-Care

Enhanced Standard-of-Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 20, 2023
Last Updated
January 20, 2023
Sponsor
San Diego State University
Collaborators
Family Health Centers of San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05697068
Brief Title
Intervention to Prevent Household and Community Spread of COVID-19 Among Latinos
Official Title
Tailored Behavioral Intervention to Prevent Household and Community Spread of COVID-19 Among Latinos
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
Family Health Centers of San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. We 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of SARS-CoV-2 Secondary Infection
Keywords
SARS-CoV-2, COVID-19, Prevention, Secondary Infection, Hispanics, Latinos, Behavior, Household, Community, Clinic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard-of-Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Enhanced Standard-of-Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COVID Prevention Program (CPP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
SARS-CoV-2 Antibodies
Description
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.
Time Frame
Baseline & 1-, 6-, 12-, and 24-months post-baseline.
Secondary Outcome Measure Information:
Title
SARS-CoV-2 Active Infection
Description
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.
Time Frame
Baseline, 3-5 days post-baseline, and 7-9 days post-baseline.
Other Pre-specified Outcome Measures:
Title
Risk reduction behaviors
Description
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.
Time Frame
Baseline & 1-, 6-, 12-, and 24-months post-baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients of a federally qualified health center (+18yrs) who test positive for COVID-19 will be invited to participate in the COVID Prevention Program. Exclusion Criteria: 1) planning to move out of state in the next year, 2) cognitive impairment that is contraindicated to receiving counseling and following behavioral strategies (e.g., schizophrenia, Down syndrome), and 3) living in a transitionary home or homeless.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noe C Crespo, PhD
Phone
(619) 594-5773
Email
ncrespo@sdsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noe C Crespo, M.P.H, Ph.D.
Organizational Affiliation
San Diego State University Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego State University Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92182
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noe C Crespo, M.P.H, Ph.D.
Phone
619-594-5773
Email
ncrespo@sdsu.edu
First Name & Middle Initial & Last Name & Degree
Noe C Crespo, M.P.H, Ph.D.
First Name & Middle Initial & Last Name & Degree
John P Elder, PhD
First Name & Middle Initial & Last Name & Degree
Eyal Oren, PhD
First Name & Middle Initial & Last Name & Degree
C.D. Joey Lin, PhD
First Name & Middle Initial & Last Name & Degree
Elva Arredondo, PhD
First Name & Middle Initial & Last Name & Degree
Hala Madanat, PhD
First Name & Middle Initial & Last Name & Degree
Christian Ramers, MD
First Name & Middle Initial & Last Name & Degree
Job Godino, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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