COVID-19
Conditions
Keywords
COVID-19, antigen testing, decision making, testing behaviors, vulnerable populations, social networks
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.
Interventions
BEHAVIORALFacilitated 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.
BEHAVIORALTesting 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.
BEHAVIORALControl
Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Sponsors
The University of Texas Health Science Center, Houston
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Complete Testing (Antigen or PCR) | between baseline and 2 months after the intervention | Percent of participants from each study arm who complete testing (antigen or PCR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Appropriately Used Antigen Test as Assessed by Survey | baseline | 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 | baseline | Mitigation measures include mask wearing, isolating and notifying close contacts. |
| Number of Participants Who Share Antigen Tests With Close Contacts Who Need to Test as Assessed by Survey | baseline | Testing is needed for those with symptoms or known exposure to COVID. |
| Number of Participants Who Tested Positive for COVID-19 in the Past 30 Days | baseline | — |
| Number of Participants Vaccinated Against COVID-19 | Baseline | — |
| Percentage of Community Members Reported to Have Tested Positive for COVID-19 | Baseline | 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. |
| Percentage of Community Members Reported to Be Vaccinated Against COVID-19 | Baseline | 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. |
| Number of Participants Reporting Trust in National Government Regarding COVID-19 Information | Baseline | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMaria E Fernandez, PhD
The University of Texas Health Science Center, Houston
PRINCIPAL_INVESTIGATORBelinda M Reininger, DrPh
The University of Texas Health Science Center, Brownsville
PRINCIPAL_INVESTIGATORDavid D McPherson, MD
The University of Texas Health Science Center, Houston
PRINCIPAL_INVESTIGATORPaul McGaha, DO
The University of Texas Health Science Center, Tyler
PRINCIPAL_INVESTIGATORMarcia C de Oliveira Otto, PhD
The University of Texas Health Science Center, Houston
PRINCIPAL_INVESTIGATORKayo Fujimoto, PhD
The University of Health Science Center, Houston
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 21 Participants |
| Age, Categorical >=65 years | 114 Participants |
| Age, Categorical Between 18 and 65 years | 879 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 333 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 139 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 77 Participants |
| Race (NIH/OMB) More than one race | 101 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) White | 832 Participants |
| Region of Enrollment United States | 579 participants |
| Sex: Female, Male Female | 774 Participants |
| Sex: Female, Male Male | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 320 | 0 / 333 | 0 / 579 |
| other Total, other adverse events | 0 / 320 | 0 / 333 | 0 / 579 |
| serious Total, serious adverse events | 0 / 320 | 0 / 333 | 0 / 579 |
Outcome results
None listed