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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05606016
• Other study ID #: HSC-SPH-20-1372 Embedded Study
• Secondary ID: 3UL1TR003167-03S
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: April 28, 2023

Study information

• Verified date: November 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Maria E Fernandez, PhD
• Phone: (713) 500-9626
• Email: Maria.E.Fernandez[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1280
• Est. completion date: April 28, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testing completion by each study arm	Percent of participants from each study arm who complete testing (antigen or PCR)	between baseline and 2 months after the intervention
Secondary	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).	baseline
Secondary	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).	2 months after the intervention
Secondary	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.	baseline
Secondary	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.	2 months after the intervention
Secondary	Number of participants who share antigen tests with close contacts who need to test as assessed by survey		baseline, 2 months after the intervention
Secondary	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.	baseline
Secondary	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.	2 months after the intervention