Clinical trial NCT05606016: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
antigen testing
decision making
testing behaviors
vulnerable populations
social networks
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-11-04
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Testing completion by each study arm
timeFrame: between baseline and 2 months after the intervention
Secondary outcomes:
measure: Number of participants who appropriately used antigen test as assessed by survey
timeFrame: baseline
measure: Number of participants who appropriately used antigen test as assessed by survey
timeFrame: 2 months after the intervention
measure: Number of participants with a positive test who took mitigation measures as assessed by survey
timeFrame: baseline
measure: Number of participants with a positive test who took mitigation measures as assessed by survey
timeFrame: 2 months after the intervention
measure: Number of participants who share antigen tests with close contacts who need to test as assessed by survey
timeFrame: baseline, 2 months after the intervention
measure: Number of participants who share antigen tests with close contacts who need to test as assessed by survey
timeFrame: baseline
measure: Number of participants who share antigen tests with close contacts who need to test as assessed by survey
timeFrame: 2 months after the intervention
Other outcomes:
Locations:
city: Brownsville
country: United States
facility: The University of Texas Health Science Center, Brownsville
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center, Houston
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Science Center,Tyler
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Maria E Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Brownsville
name: Belinda M Reininger, DrPh
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: David D McPherson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Tyler
name: Paul McGaha, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Marcia C de Oliveira Otto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Health Science Center, Houston
name: Kayo Fujimoto, PhD
role: PRINCIPAL_INVESTIGATOR
References: