Clinical trial NCT05606003: Using a Community-level Just-in-Time Adaptive Intervention to Address COVID-19 Testing Disparities
Official title: Using a Community-level Just-in-Time Adaptive Intervention to Address COVID-19 Testing Disparities: A Population-based Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: COVID-19 testing
decision making
testing behaviors
vulnerable populations
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-11-04
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Testing Uptake
timeFrame: Baseline through study completion (26 months)
Secondary outcomes:
measure: Disparities in Testing
timeFrame: Baseline through study completion (26 months)
Other outcomes:
Locations:
city: Brownsville
country: United States
facility: The University of Texas Health Science Center, Brownsville
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Maria Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Brownsville
name: Belinda E Reininger, DrPh
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: David D McPherson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Tyler
name: Paul McGaha, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Marcia C de Oliveira Otto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Kayo Fujimoto, PhD
role: PRINCIPAL_INVESTIGATOR
References: