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

Not Applicable

Not yet recruiting

• Conditions: COVID-19
• Interventions: Behavioral: Testing Navigation Intervention (TNI).; Behavioral: Control; Behavioral: Facilitated Self-Sampling Intervention (FSSI)

• Registration Number: NCT05606016
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Study Timeline

• Study First Submitted: 2022-08-11
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-03
• Last Update Submitted: 2022-11-03
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04
• Study Start: 2022-11-21
• Primary Completion: 2023-01-31
• Study Completion: 2023-04-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testing Navigation Intervention (TNI).	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.
Control	Control	Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Facilitated Self-Sampling Intervention (FSSI)	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.

Primary Outcome Measures

Name	Time	Method
Testing completion by each study arm	between baseline and 2 months after the intervention	Percent of participants from each study arm who complete testing (antigen or PCR)

Secondary Outcome Measures

Name	Time	Method
Number of participants who share antigen tests with close contacts who need to test as assessed by survey	2 months after the intervention	Testing is needed for those with symptoms or known exposure to COVID.
Number of participants who appropriately used antigen test as assessed by survey	2 months after the intervention	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	2 months after the intervention	Mitigation measures include mask wearing, isolating and notifying close contacts.

Trial Locations

Locations (3)

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