COVID-19 Testing and Vaccine Literacy for Women With Criminal Legal System Involvement (COVID-19)

January 7, 2025 updated by: Jason E Glenn, PhD, University of Kansas Medical Center

Localized mHealth Approach to Boosting COVID-19 Testing and Vaccine Literacy, Access, and Uptake Among Women With Criminal Legal System Involvement

The objective of this research is to use a localized mHealth intervention to boost COVID-19 testing and vaccine literacy, access, and uptake among women with CLSI

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Based on our prior work with CLSI women, mHealth strategies are an excellent way to keep in touch and push just-in-time content. During the pandemic, we were forced to close field sites and stop any in-person follow-up visits. Even prior to the pandemic, telephone follow-up surveys were conducted with 60% of participants. Post-pandemic, we conducted 95% of those surveys over the phone, with the remaining over email or mail correspondence. Most participants use text messaging regularly and can access the Web on their phones. Our ongoing RCT (N=73 participants completed) of an mHealth intervention on women's health shows this modality is feasible for delivering information and engaging participants. Specifically, we found that 81% of women who initiate can complete the intervention. The average time for completion of one module, for example on sexually transmitted infections, took 19 minutes, whereas cervical cancer took 13 minutes to complete. We estimate the proposed module on COVID-19 testing and vaccine will take on average between 15 to 20 minutes to complete. This time for intervention completion, combined with text message information about any new COVID-19 mitigation news (e.g., boosters, vaccine for children, new testing recommendations, testing locations, etc.), should result in about 30-60 minutes of total formal engagement during the study.

What we propose will be brief, but targeted messaging intervention from verified sources, delivered in an adequate lay language and using spokespersons that are relatable and familiar, and can be trusted, has been proven effective in changing targeted behaviors.32,33 Our intervention design also draws on lessons learned from evidence-based interventions to improve vaccination uptake among adults, for example a meta-analysis conducted in 2021 on public response to health messages encouraging vaccination.34 Our mHealth intervention allows participants to attend to the information at their own pace, while ensuring that they are prompted to complete the module. To avoid unidirectionality and promote engagement, they will be able to use an asynchronous messaging component to ask questions and receive answers from the research team. There is no question that such an intervention is necessary for a population with likely low uptake of both testing and vaccination, especially when that population is not the explicit target of most public health messaging. To the critique of whether the intervention is sufficient, we don't know. We hypothesize that the intervention will be effective at boosting COVID-19 testing and vaccine literacy, access, and uptake, and the goal of this study is to test that hypothesis. One advantage of this approach is the ability for nimbleness, that is, being able to adapt in real-time to new information about the pandemic and being able to push that new information out to women using the proposed intervention platform. Another unique advantage is the scalability of such an intervention, and its ability to be made widely available to all CLSI women in the United States

Study Type

Interventional

Enrollment (Actual)

295

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • currently enrolled in the Tri-City C.R.E.W. study (R01CA226838)

Exclusion Criteria:

  • Unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: COVID-19 mHealth Intervention
We are using a pre-post study design, given the low risk of the educational intervention and expected benefit.
Behavioral: Tri-City COVID Attitudes Study
We propose a two-year study to rapidly assess (Aim 1), build and push (Aim 2), evaluate and disseminate (Aim 3) an mHealth intervention to boost COVID-19 testing and vaccine literacy, access, and uptake among women with CLSI in three cities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 Testing and Vaccine Knowledge
Time Frame: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.

Nine multiple-choice items developed by study team and corresponding to intervention content, which regarding COVID-19 transmission, risk, mitigation, vaccine risk, and testing in a pandemic environment .

The sum of scores on all 9 items has a possible total score ranges from 0 (minimum) to 9 (maximum), a higher score represents a higher level of COVID-19 testing and vaccine knowledge (i.e., better outcome).
Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
COVID-19 Mistrust Score
Time Frame: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.

General COVID-19 Mistrust Scale (PMID: 33196555) Adopted 4-items COVID-19 Mistrust Scale, which focus on public information advanced by the government and public health care providers.

Each item was on 5-point Likert Scare range from 1 (strongly disagree) to 5 (strongly agree).

A mean score of 4 items represent participants' mistrust level towards government and public health care providers, which ranges from 1 (minimum) to 5 (maximum).

A higher score means a higher mistrust score (i.e., worse outcome).
Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
COVID-19 Testing Accessibility - Ease of Access
Time Frame: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.

Self-reported perceived accessibility of COVID-19 testing. A 5-point Likert scale item ranges from 1 (strongly disagree) to 5 (strongly agree).

A higher score represent participants' higher level of perceived accessibility (i.e., a better outcome).
Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
COVID-19 Testing Accessibility - Confidence to Locate
Time Frame: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.

Self-reported confidence level of locating the place to get COVID-19 testing. A 5-point Likert scale item ranges from 1 (strongly disagree) to 5 (strongly agree).

A higher score represent participants' higher level of confidence (i.e., a better outcome).
Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
COVID-19 Testing Accessibility - Free Access
Time Frame: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
Percentage of participants' aware the government program that offers free tests through the mail.
Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
Ever Had COVID-19 Testing
Time Frame: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
Count number of participants who indicated they ever had COVID-19 testing.
Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
Ever Received COVID-19 Vaccine
Time Frame: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
Count number of participants who indicated they ever had COVID-19 vaccine.
Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Jason Glenn, PHD, University of Kansas School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Actual)

October 23, 2024

Study Completion (Actual)

October 23, 2024

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00148911
  • 5U01MD017415-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data generated through this application will be presented at scientific meetings annually, and in a timely manner, the final dataset will be published in peer-reviewed journals in the form of research articles. Efforts will be made to publish in journals open online to the public. De-identified data generated from this project, as well as data collection instruments will be shared publicly on the Coordination and Data Collection Center (CDCC) and the NIH RADx Data Hub, as well as on the Open Science Framework, a free, open-source research management and collaboration tool designed to help researchers document their project's lifecycle and archive materials. It is built and maintained by the nonprofit Center for Open Science. The final peer-reviewed journal manuscripts that arise from this NIH support will be submitted to the digital archive PubMed Central, per the NIH Public Access policy.

IPD Sharing Time Frame

on-going

IPD Sharing Access Criteria

access to the RAD-x DATA HUB via eRA account

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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