Using a Community-level Just-in-Time Adaptive Intervention to Address COVID-19 Testing Disparities

Not Applicable

Active, not recruiting

• Conditions: COVID-19
• Interventions: Behavioral: Multi-Level Multi-Component Intervention (MLI); Behavioral: Community Just-In-Time Adaptive Intervention (Community JITAI)

• Registration Number: NCT05606003
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

In the U.S. vulnerable populations experience significant disparities in terms of both COVID-19 infection and mortality rates, especially in Texas, where Hispanic, African Americans, and other groups have experienced substantial disparities in both incidence and mortality. Building on the partnerships and resources of the Center for Clinical and Translational Science (CCTS), the goal of the proposed project is to identify dynamic COVID-19 disease hotspots and testing deserts in racially diverse regions of South Texas, Houston/Harris County, Texas, and Northeast Texas to inform the rapid adaptation and deployment of multilevel level just-in-time adaptive intervention strategies to reduce testing disparities among vulnerable populations.

A group-randomized controlled trial (RCT) will be conducted to evaluate the reach, effectiveness, and implementation of a community-level Just-In-Time-Adaptive-Intervention (JITAI) to increase COVID-19 testing in identified high-risk priority neighborhoods. To conduct the RCT, 120 priority census blocks groups will be identified and randomized to each condition using a community risk index score that balances distribution in the three study arms with respect to important characteristics including population density, demographics, and baseline testing rates.

In Intervention Condition 1 - Multi-Level Multi-Component Intervention (MLI), individuals will receive a multilevel, multi-component intervention comprising of 1) Building testing access for vulnerable populations, 2) Community Health Worker (CHW)-delivered navigation to COVID-19 testing and access and reinforcing risk mitigation recommendations; 3) 2-1-1 helpline-referrals and navigation to testing and 4) social marketing and small media campaign to provide geo-targeted messages promoting testing and COVID-19 risk mitigation behaviors. In Intervention Condition 2 - Community JITAI individuals will receive the same MLI intervention components but with an added JITAI approach informed by real-time data related to testing and other relevant information based on community and stakeholder experience and tacit knowledge about factors influencing testing determinants. The Comparison Condition will receive standard exposure to ongoing city and county communication and access to testing.

Study Timeline

• Study Start: 2021-06-07
• Primary Completion: 2022-06-30
• Study First Submitted: 2022-09-19
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-03
• Last Update Submitted: 2022-11-03
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1280

Inclusion Criteria

• residing in identified COVID-19 hotspots and testing deserts within study regions
• aged 18 years or older

Exclusion Criteria

• aged under 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-level Multi-Component Intervention (MLI)	Multi-Level Multi-Component Intervention (MLI)	Individuals receive COVID-19 CHW-delivered education and navigation, 2-1-1 helpline referrals, and social marketing messaging.
Community Just-in-Time-Adaptive Intervention (JITAI)	Community Just-In-Time Adaptive Intervention (Community JITAI)	Individuals receive MLI intervention components that are informed by real-time data and community stakeholder feedback.

Primary Outcome Measures

Name	Time	Method
Testing Uptake	Baseline through study completion (26 months)	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)

Secondary Outcome Measures

Name	Time	Method
Disparities in Testing	Baseline through study completion (26 months)	Explore impact on testing disparities by race/ethnicity and SES

Trial Locations

Locations (3)

The University of Texas Health Science Center at Tyler; 🇺🇸 Tyler, Texas, United States

The University of Texas Health Science Center, Brownsville; 🇺🇸 Brownsville, Texas, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States