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

Antigen self-testing kits are more available at this stage in the pandemic, but amongvulnerable populations, use is still low and instructions for antigen testing are nottypically designed for low health literacy populations. Studies are needed to exploreaccess and use of antigen tests among vulnerable populations and examine iflow-health-literacy-designed interventions improve COVID-19 testing decisions andbehaviors. This study will focus on understanding factors associated with rapid COVID-19testing, specifically. The primary objectives of the embedded study are to 1) Determinethe effectiveness of community-level intervention using door-to-door recruitment andeducation 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.

Unknown status
COVID-19

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.

Behavioral: 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.

Behavioral: Control

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

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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

Contacts

Maria E Fernandez, PhD
(713) 500-9626
Maria.E.Fernandez@uth.tmc.edu

Ibette Cavazos
(713) 500-9000
Ibette.Cavazos@uth.tmc.edu

National Center for Advancing Translational Sciences (NCATS)
NCT Number
Keywords
Covid-19
antigen testing
decision making
testing behaviors
vulnerable populations
social networks
MeSH Terms
COVID-19