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

NCT05606003 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1280

Last updated 2022-11-04

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Multi-Level Multi-Component Intervention (MLI)

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.

BEHAVIORAL

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

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.

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH
  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Maria Fernandez, PhD · The University of Texas Health Science Center, Houston

  • Belinda E Reininger, DrPh · The University of Texas Health Science Center, Brownsville

  • David D McPherson, MD · The University of Texas Health Science Center, Houston

  • Paul McGaha, DO · The University of Texas Health Science Center, Tyler

  • Marcia C de Oliveira Otto, PhD · The University of Texas Health Science Center, Houston

  • Kayo Fujimoto, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2022-06-30
Completion
2022-12-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05606003 on ClinicalTrials.gov