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Examining How a Facilitated Self-Sampling Intervention and Testing Navigation Intervention Influences COVID-19 Testing

Primary Purpose

COVID-19

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Facilitated Self-Sampling Intervention (FSSI)
Testing Navigation Intervention (TNI).
Control
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19 focused on measuring COVID-19, antigen testing, decision making, testing behaviors, vulnerable populations, social networks

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18 years or older Exclusion Criteria: Having been diagnosed with COVID-19 in the past 30 days based on a positive test (antigen or PCR) or a clinical diagnosis Having tested for COVID-19 with PCR or antigen test within the past 30 days

Sites / Locations

  • The University of Texas Health Science Center, Brownsville
  • The University of Texas Health Science Center, Houston
  • University of Texas Health Science Center,Tyler

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Facilitated Self-Sampling Intervention (FSSI)

Testing Navigation Intervention (TNI).

Control

Arm Description

Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.

Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.

Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.

Outcomes

Primary Outcome Measures

Testing completion by each study arm
Percent of participants from each study arm who complete testing (antigen or PCR)

Secondary Outcome Measures

Number of participants who appropriately used antigen test as assessed by survey
Appropriate use of antigen test is defined as taking the test when a test should have been taken (that is, symptoms present, known exposure to COVID).
Number of participants who appropriately used antigen test as assessed by survey
Appropriate use of antigen test is defined as taking the test when a test should have been taken (that is, symptoms present, known exposure to COVID).
Number of participants with a positive test who took mitigation measures as assessed by survey
Mitigation measures include mask wearing, isolating and notifying close contacts.
Number of participants with a positive test who took mitigation measures as assessed by survey
Mitigation measures include mask wearing, isolating and notifying close contacts.
Number of participants who share antigen tests with close contacts who need to test as assessed by survey
Number of participants who share antigen tests with close contacts who need to test as assessed by survey
Testing is needed for those with symptoms or known exposure to COVID.
Number of participants who share antigen tests with close contacts who need to test as assessed by survey
Testing is needed for those with symptoms or known exposure to COVID.

Full Information

First Posted
August 11, 2022
Last Updated
November 3, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT05606016
Brief Title
Examining How a Facilitated Self-Sampling Intervention and Testing Navigation Intervention Influences COVID-19 Testing
Official Title
Examining How a Facilitated Self-Sampling Intervention and Testing Navigation Intervention Influences COVID-19 Testing in Vulnerable Populations
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 21, 2022 (Anticipated)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
April 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

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

5. Study Description

Brief Summary
Antigen self-testing kits are more available at this stage in the pandemic, but among vulnerable populations, use is still low and instructions for antigen testing are not typically designed for low health literacy populations. Studies are needed to explore access and use of antigen tests among vulnerable populations and examine if low-health-literacy-designed interventions improve COVID-19 testing decisions and behaviors. This study will focus on understanding factors associated with rapid COVID-19 testing, specifically. The primary objectives of the embedded study are to 1) Determine the effectiveness of community-level intervention using door-to-door recruitment and education in increasing COVID-19 testing and 2) Compare the effectiveness of the CHW- Facilitated Self-Sampling Intervention (FSSI) vs. CHW Testing Navigation Intervention (TNI).
Detailed Description
The pandemic landscape and people's experiences with testing, infection, and vaccination have changed dramatically over the past two years. Vaccines have become available, testing access in local communities has waxed and waned, and attitudes toward COVID-19 severity and susceptibility have shifted. Navigating the testing-decision landscape is confusing to the public (test availability for free versus charged or requiring insurance; testing and vaccination locations change; PCR versus antigen testing; home tests versus clinically delivered; symptom-based testing, exposure-driven testing, serial testing, resources to trust or not trust, etc.). This study, referred to as the embedded study, builds off a broader population-based group randomized controlled trial (RCT) to evaluate the effects of a Facilitated Self-Sampling Intervention and Testing Navigation Intervention on testing behaviors. The embedded study will randomly select and assign priority block groups from the RCT to one of three arms - FSSI (n=16), TNI (n=16), or Control (n= 32). The allocation will be at a 2:1:1 rate across the three regions Houston/Harris County, South Texas, and Northeast Texas respectively. Community Health Workers will systematically sample and recruit 20 individuals from each PBG using a random start procedure. Study participants in the intervention arms will be enrolled, complete a baseline survey, receive a brief educational intervention, and complete a follow-up survey. Participants in the control arm will complete a baseline and follow-up survey.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, antigen testing, decision making, testing behaviors, vulnerable populations, social networks

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Facilitated Self-Sampling Intervention (FSSI)
Arm Type
Experimental
Arm Description
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Arm Title
Testing Navigation Intervention (TNI).
Arm Type
Experimental
Arm Description
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Intervention Type
Behavioral
Intervention Name(s)
Facilitated Self-Sampling Intervention (FSSI)
Intervention Description
CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
Intervention Type
Behavioral
Intervention Name(s)
Testing Navigation Intervention (TNI).
Intervention Description
CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Primary Outcome Measure Information:
Title
Testing completion by each study arm
Description
Percent of participants from each study arm who complete testing (antigen or PCR)
Time Frame
between baseline and 2 months after the intervention
Secondary Outcome Measure Information:
Title
Number of participants who appropriately used antigen test as assessed by survey
Description
Appropriate use of antigen test is defined as taking the test when a test should have been taken (that is, symptoms present, known exposure to COVID).
Time Frame
baseline
Title
Number of participants who appropriately used antigen test as assessed by survey
Description
Appropriate use of antigen test is defined as taking the test when a test should have been taken (that is, symptoms present, known exposure to COVID).
Time Frame
2 months after the intervention
Title
Number of participants with a positive test who took mitigation measures as assessed by survey
Description
Mitigation measures include mask wearing, isolating and notifying close contacts.
Time Frame
baseline
Title
Number of participants with a positive test who took mitigation measures as assessed by survey
Description
Mitigation measures include mask wearing, isolating and notifying close contacts.
Time Frame
2 months after the intervention
Title
Number of participants who share antigen tests with close contacts who need to test as assessed by survey
Time Frame
baseline, 2 months after the intervention
Title
Number of participants who share antigen tests with close contacts who need to test as assessed by survey
Description
Testing is needed for those with symptoms or known exposure to COVID.
Time Frame
baseline
Title
Number of participants who share antigen tests with close contacts who need to test as assessed by survey
Description
Testing is needed for those with symptoms or known exposure to COVID.
Time Frame
2 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older Exclusion Criteria: Having been diagnosed with COVID-19 in the past 30 days based on a positive test (antigen or PCR) or a clinical diagnosis Having tested for COVID-19 with PCR or antigen test within the past 30 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria E Fernandez, PhD
Phone
(713) 500-9626
Email
Maria.E.Fernandez@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ibette Cavazos
Phone
(713) 500-9000
Email
Ibette.Cavazos@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria E Fernandez, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Belinda M Reininger, DrPh
Organizational Affiliation
The University of Texas Health Science Center, Brownsville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David D McPherson, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul McGaha, DO
Organizational Affiliation
The University of Texas Health Science Center, Tyler
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcia C de Oliveira Otto, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kayo Fujimoto, PhD
Organizational Affiliation
The University of Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center, Brownsville
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belinda M Reininger, DrPH
Phone
956-755-0654
Email
Belinda.M.Reininger@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Maribel Sifuentes, MS
Phone
(956)203-1089
Email
maribel.sifuentes@uth.tmc.edu
Facility Name
The University of Texas Health Science Center, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria E Fernandez, PhD
Phone
713-500-9626
Email
Maria.E.Fernandez@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Ibette Cavazos
Phone
(713) 500-9000
Email
Ibette.Cavazos@uth.tmc.edu
Facility Name
University of Texas Health Science Center,Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul McGaha, DO
Phone
903-877-7000
Email
Paul.McGaha@uthct.edu
First Name & Middle Initial & Last Name & Degree
Carlton Allen, MS
Phone
(903) 877-1427
Email
Carlton.Allen@uthct.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Examining How a Facilitated Self-Sampling Intervention and Testing Navigation Intervention Influences COVID-19 Testing

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