COVID-19NCT05606016
Examining How a Facilitated Self-Sampling Intervention and Testing Navigation Intervention Influences COVID-19 Testing
A study testing Facilitated Self-Sampling Intervention (FSSI) and Testing Navigation Intervention (TNI). in people with COVID-19, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Facilitated Self-Sampling Intervention (FSSI) and Testing Navigation Intervention (TNI).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,232 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Mar 2023to 14 Aug 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Texas Health Science Center, Brownsville
Brownsville, Texas, 78520
The University of Texas Health Science Center, Houston
Houston, Texas, 77030
University of Texas Health Science Center,Tyler
Tyler, Texas, 75708
About this study
Official title: Examining How a Facilitated Self-Sampling Intervention and Testing Navigation Intervention Influences COVID-19 Testing in Vulnerable Populations
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).
Read the 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.
- Conditions
- COVID-19
- Being tested
- Facilitated Self-Sampling Intervention (FSSI), Testing Navigation Intervention (TNI)., Control
- Keywords
- COVID-19, antigen testing, decision making, testing behaviors, vulnerable populations, social networks
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated Self-Sampling Intervention (FSSI)Behavioural
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).Behavioural
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.
ControlBehavioural
Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Complete Testing (Antigen or PCR)
Percent of participants from each study arm who complete testing (antigen or PCR)
Measured: between baseline and 2 months after the intervention
Secondary outcomes (11)
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).
Measured: baseline
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).
Measured: 2 months after the intervention
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.
Measured: baseline
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.
Measured: 2 months after the intervention
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.
Measured: baseline
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.
Measured: 2 months after the intervention
Number of Participants Who Tested Positive for COVID-19 in the Past 30 Days
Measured: baseline
Number of Participants Vaccinated Against COVID-19
Measured: Baseline
Percentage of Community Members Reported to Have Tested Positive for COVID-19
The percentage of individuals within each participant's self-identified community network who have tested positive for COVID-19. Participants provide a list of individuals they regularly communicate with (community network). The percentage is calculated for each participant as:
(Number of community members reported positive for COVID-19 ÷ Total number of community members listed) × 100.
Higher percentages indicate greater COVID-19 exposure within the participant's community network.
Measured: Baseline
Percentage of Community Members Reported to Be Vaccinated Against COVID-19
The percentage of individuals within each participant's self-identified community network who are reported to be vaccinated against COVID-19. Participants provide a list of individuals they regularly communicate with (community network). The percentage is calculated for each participant as:
(Number of community members reported to be vaccinated against COVID-19 ÷ Total number of community members listed) × 100.
Higher percentages indicate greater COVID-19 vaccination coverage within the participant's community network.
Measured: Baseline
Number of Participants Reporting Trust in National Government Regarding COVID-19 Information
Trust in national government COVID-19 information was assessed using the survey question: "What level of trust do you have in the information about COVID-19 from your national government?. Responses were reported on a 5 point likert scale ranging from 1 (none at all) to 5(a great deal), a higher score indicating greater trust.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start30 Mar 2023
- Primary completion14 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,232 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Maria E Fernandez, The University of Texas Health Science Center, Houston
- Investigators
- Maria E Fernandez, PhD, Principal investigator, The University of Texas Health Science Center, HoustonBelinda M Reininger, DrPh, Principal investigator, The University of Texas Health Science Center, BrownsvilleDavid D McPherson, MD, Principal investigator, The University of Texas Health Science Center, HoustonPaul McGaha, DO, Principal investigator, The University of Texas Health Science Center, TylerMarcia C de Oliveira Otto, PhD, Principal investigator, The University of Texas Health Science Center, HoustonKayo Fujimoto, PhD, Principal investigator, The University of Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606016
- Sponsor's protocol ID
- HSC-SPH-20-1372 Embedded Study
- Other IDs
- 3UL1TR003167-03S3
- Status last verified
- Jun 2026
- First submitted
- 11 Aug 2022
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No