NCT07074171

Brief Summary

In this Phase III study, the investigators will build off of the Phase II embedded study with some adjustments to the design to address new research priorities that examine an intervention that is network informed and delivered through community health worker interactions plus digitally-delivered intervention content with the goal of increasing COVID-19 testing and vaccination. This model, if proven effective, can be scaled up to address COVID-19 and other future pandemics. The investigators will utilize the sample of intervention priority census block groups (PBGs) used in Phase II and will recruit and enroll participants not previously enrolled in either phase I or II from these PBGs using convenience sampling methods. The investigators will use a historical control group consisting of participants from our control arm in Phase II who completed both their baseline and follow-up surveys embedded in the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 6, 2026

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

July 16, 2025

Results QC Date

December 12, 2025

Last Update Submit

December 12, 2025

Conditions

Keywords

COVID-19decision makingtesting behaviorsvulnerable populations

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test

    The number of participants who self-reported use of COVID-19 antigen test or PCR Test using individual-level data in the past 60 days

    Baseline

  • Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test

    The number of participants who self-reported use of COVID-19 antigen test or PCR Test using individual-level data in the past 60 days

    8 weeks

Secondary Outcomes (3)

  • Number of Participants Who Self-reported Receiving COVID-19 Vaccination

    Baseline

  • Number of Participants Who Self-reported Receiving COVID-19 Vaccination

    8 weeks

  • Number of Participants Who Self-reported Used Mitigation Measures if a Positive Test is Obtained

    Baseline, 8 weeks

Study Arms (2)

Text message-based education intervention

EXPERIMENTAL

A text message-based COVID-19 education intervention with support from community health workers.

Behavioral: Text message-based education intervention

Historical Control Group

OTHER

Participants in this Historical Control Group completed the prior Phase II embedded study, in which they received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys only.

Other: Historical Control

Interventions

Participants received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys as part of the Phase II embedded study.

Historical Control Group

The intervention consisted of enhanced behavioral and educational text messages, up to three messages each week, providing updates on COVID-19 testing and vaccination. The text messages included digitally delivered intervention content such as a video with low-literacy instructions for administering the rapid antigen tests, guidance if they tested positive (e.g., quarantine, notify contacts, wearing a mask), and other relevant strategies and content focused on increasing COVID-19 testing and vaccination.

Text message-based education intervention

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having a smartphone that accepts text messages

You may not qualify if:

  • having been diagnosed with COVID-19 in the past 30 days based on a positive test (antigen or PCR) or a clinical diagnosis
  • having tested for COVID-19 with PCR or antigen test within the past 30 days
  • not being available in the recruitment area in the next 60 days
  • having been an embedded study participant
  • having been a snowball study participant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The University of Texas Health Science Center at Houston School of Public Health Brownsville Regional Campus

Brownsville, Texas, 78520, United States

Location

The University of Texas Health Science Center at Houston School of Public Health Houston Main Campus

Houston, Texas, 77030, United States

Location

The University of Texas at Tyler

Tyler, Texas, 75799, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Historically Controlled Study

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative Techniques

Results Point of Contact

Title
Belinda M Reininger, DrPH
Organization
The University of Texas Health Science Center at Houston

Study Officials

  • Maria E Fernandez, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Regional Campus Dean in Brownsville

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 20, 2025

Study Start

April 3, 2023

Primary Completion

December 12, 2024

Study Completion

December 12, 2024

Last Updated

January 6, 2026

Results First Posted

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations