Using a Community-level Just-in-Time Adaptive Intervention to Address COVID-19 Testing Disparities
2 other identifiers
interventional
1,280
1 country
3
Brief Summary
In collaboration with community partners, this study will identify disparities and dynamics of COVID-19 testing and infections in three Texas regions; and implement a multilevel intervention that increases access to testing and referrals to follow-up care among vulnerable populations. Using a three-arm group-randomized controlled trial, this study will assess the impact of multi-level interventions influencing motivation and access to testing. The outcomes of this study are measured at the population level and no individual data will be gathered. Analyses of de-identified PHI data from local and regional health departments on COVID testing and infection rates will be used to assess intervention outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Jun 2021
Typical duration for not_applicable covid19
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedFirst Submitted
Initial submission to the registry
September 19, 2022
CompletedFirst Posted
Study publicly available on registry
November 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedNovember 4, 2022
November 1, 2022
1.1 years
September 19, 2022
November 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Testing Uptake
Examine the short and long-term change in testing proportion from baseline in the CBGs adjusted for testing capacity (testing proportion in the county during the same time period)
Baseline through study completion (26 months)
Secondary Outcomes (1)
Disparities in Testing
Baseline through study completion (26 months)
Study Arms (3)
Multi-level Multi-Component Intervention (MLI)
EXPERIMENTALIndividuals receive COVID-19 CHW-delivered education and navigation, 2-1-1 helpline referrals, and social marketing messaging.
Community Just-in-Time-Adaptive Intervention (JITAI)
EXPERIMENTALIndividuals receive MLI intervention components that are informed by real-time data and community stakeholder feedback.
Comparison Condition
NO INTERVENTIONIndividuals receive standard exposure to ongoing city and county COVID-19 communication and testing.
Interventions
The strategic components of our multi-level, multi-component intervention (MLI) include: 1. Building testing access for vulnerable populations, 2) Community Health Worker (CHW)-delivered navigation to SARSCoV- 2 testing and access and reinforce risk mitigation recommendations, 3) 2-1-1 helpline-referrals and navigation to FDA approved SARSCoV- 2 testing (and self sampling once approved) and risk mitigation education, and 4) social marketing and small media campaign to provide geo-targeted messages promoting testing and COVID risk mitigation behaviors. We selected these components because of their evidence base, their current use by partners in response to COVID 19, and confidence that they can be adapted through a community engaged process as described.
This intervention includes the same MLI components described above, with an added JITAI approach. Community and stakeholder partners will use real-time data related to testing and other relevant information generated by the Epidemiologic Surveillance and Analysis team (ESA) in Aim 1, as well as other information based on their community and stakeholder experience and tacit knowledge about factors influencing testing determinants, to adapt intervention activities as needed to optimize access to testing.
Eligibility Criteria
You may qualify if:
- residing in identified COVID-19 hotspots and testing deserts within study regions
- aged 18 years or older
You may not qualify if:
- aged under 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The University of Texas Health Science Center, Brownsville
Brownsville, Texas, 78520, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Fernandez, PhD
The University of Texas Health Science Center, Houston
- PRINCIPAL INVESTIGATOR
Belinda E 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 Texas Health Science Center, Houston
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
September 19, 2022
First Posted
November 4, 2022
Study Start
June 7, 2021
Primary Completion
June 30, 2022
Study Completion
December 30, 2022
Last Updated
November 4, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share