Examining How a Facilitated Self-Sampling Intervention and Testing Navigation Intervention Influences COVID-19 Testing
NCT ID: NCT05606016
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1232 participants
INTERVENTIONAL
2023-03-30
2024-08-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Facilitated Self-Sampling Intervention (FSSI)
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.
Facilitated Self-Sampling Intervention (FSSI)
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.
Testing Navigation Intervention (TNI).
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.
Testing Navigation Intervention (TNI).
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.
Control
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control
Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Interventions
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Facilitated Self-Sampling Intervention (FSSI)
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.
Testing Navigation Intervention (TNI).
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.
Control
Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Having tested for COVID-19 with PCR or antigen test within the past 30 days
18 Years
ALL
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Maria E Fernandez
Lorne Bain Distinguished Professorship in Public Health and Director, Center for Health Promotion and Prevention Research
Principal Investigators
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Maria E Fernandez, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Belinda M Reininger, DrPh
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Brownsville
David D McPherson, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Paul McGaha, DO
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Tyler
Marcia C de Oliveira Otto, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Kayo Fujimoto, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Health Science Center, Houston
Locations
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The University of Texas Health Science Center, Brownsville
Brownsville, Texas, United States
The University of Texas Health Science Center, Houston
Houston, Texas, United States
University of Texas Health Science Center,Tyler
Tyler, Texas, United States
Countries
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Other Identifiers
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HSC-SPH-20-1372 Embedded Study
Identifier Type: -
Identifier Source: org_study_id
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