search
Back to results

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

Primary Purpose

COVID-19

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-Level Multi-Component Intervention (MLI)
Community Just-In-Time Adaptive Intervention (Community JITAI)
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19 focused on measuring COVID-19 testing, decision making, testing behaviors, vulnerable populations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center, Brownsville
  • The University of Texas Health Science Center at Houston
  • The University of Texas Health Science Center at Tyler

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Multi-level Multi-Component Intervention (MLI)

Community Just-in-Time-Adaptive Intervention (JITAI)

Comparison Condition

Arm Description

Individuals receive COVID-19 CHW-delivered education and navigation, 2-1-1 helpline referrals, and social marketing messaging.

Individuals receive MLI intervention components that are informed by real-time data and community stakeholder feedback.

Individuals receive standard exposure to ongoing city and county COVID-19 communication and testing.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Disparities in Testing
Explore impact on testing disparities by race/ethnicity and SES

Full Information

First Posted
September 19, 2022
Last Updated
November 3, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
search

1. Study Identification

Unique Protocol Identification Number
NCT05606003
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19 testing, decision making, testing behaviors, vulnerable populations

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-level Multi-Component Intervention (MLI)
Arm Type
Experimental
Arm Description
Individuals receive COVID-19 CHW-delivered education and navigation, 2-1-1 helpline referrals, and social marketing messaging.
Arm Title
Community Just-in-Time-Adaptive Intervention (JITAI)
Arm Type
Experimental
Arm Description
Individuals receive MLI intervention components that are informed by real-time data and community stakeholder feedback.
Arm Title
Comparison Condition
Arm Type
No Intervention
Arm Description
Individuals receive standard exposure to ongoing city and county COVID-19 communication and testing.
Intervention Type
Behavioral
Intervention Name(s)
Multi-Level Multi-Component Intervention (MLI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community Just-In-Time Adaptive Intervention (Community JITAI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Testing Uptake
Description
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)
Time Frame
Baseline through study completion (26 months)
Secondary Outcome Measure Information:
Title
Disparities in Testing
Description
Explore impact on testing disparities by race/ethnicity and SES
Time Frame
Baseline through study completion (26 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Fernandez, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Belinda E Reininger, DrPh
Organizational Affiliation
The University of Texas Health Science Center, Brownsville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David D McPherson, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul McGaha, DO
Organizational Affiliation
The University of Texas Health Science Center, Tyler
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcia C de Oliveira Otto, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kayo Fujimoto, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center, Brownsville
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs