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

NCT05606016 | Completed

• 2 other identifiers: HSC-SPH-20-1372 Embedded Study3UL1TR003167-03S3
• Study Type: interventional
• Target: 1,232
• Locations: 1 country
• Sites: 3

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).

Conditions

COVID-19

Keywords

COVID-19; antigen testing; decision making; testing behaviors; vulnerable populations; social networks

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of participants who appropriately used antigen test as assessed by survey

  baseline

• Number of participants who appropriately used antigen test as assessed by survey

  2 months after the intervention

• Number of participants with a positive test who took mitigation measures as assessed by survey

  baseline

• Number of participants with a positive test who took mitigation measures as assessed by survey

  2 months after the intervention

• Number of participants who share antigen tests with close contacts who need to test as assessed by survey

  baseline, 2 months after the intervention

Study Arms (3)

Facilitated Self-Sampling Intervention (FSSI)

EXPERIMENTAL

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.

Behavioral: Facilitated Self-Sampling Intervention (FSSI)

Testing Navigation Intervention (TNI).

EXPERIMENTAL

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.

Behavioral: Testing Navigation Intervention (TNI).

Control

ACTIVE COMPARATOR

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

Behavioral: Control

Interventions

Facilitated Self-Sampling Intervention (FSSI) BEHAVIORAL

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.

Facilitated Self-Sampling Intervention (FSSI)

Testing Navigation Intervention (TNI). BEHAVIORAL

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.

Testing Navigation Intervention (TNI).

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (3)

The University of Texas Health Science Center, Brownsville

Brownsville, Texas, 78520, United States

Location

The University of Texas Health Science Center, Houston

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center,Tyler

Tyler, Texas, 75708, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Troponin I

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Troponin; Multiprotein Complexes; Macromolecular Substances; Microfilament Proteins; Biopolymers; Polymers; Muscle Proteins; Contractile Proteins; Proteins; Amino Acids, Peptides, and Proteins; Cytoskeletal Proteins

Study Officials

• Maria E Fernandez, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Belinda M Reininger, DrPh

  The University of Texas Health Science Center, Brownsville

  PRINCIPAL INVESTIGATOR

• David D McPherson, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Paul McGaha, DO

  The University of Texas Health Science Center, Tyler

  PRINCIPAL INVESTIGATOR

• Marcia C de Oliveira Otto, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Kayo Fujimoto, PhD

  The University of Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lorne Bain Distinguished Professorship in Public Health and Director, Center for Health Promotion and Prevention Research

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: November 4, 2022
• Study Start: March 30, 2023
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)