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NCT05582746: COVID-19

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

Completed NA Results posted Last updated 30 January 2025
What this trial tests

NA trial testing Tri-City COVID Attitudes Study in COVID-19 Pandemic in 295 participants. Completed in 23 October 2024.

Timeline
15 September 2022
Primary endpoint
23 October 2024
23 October 2024

Quick facts

Lead sponsorUniversity of Kansas Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposescreening
Enrollment295
Start date15 September 2022
Primary completion23 October 2024
Estimated completion23 October 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Kansas Medical Center

Who can join

18 and older, female only, with COVID-19 Pandemic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

COVID-19 Testing and Vaccine Knowledge Primary · 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
GroupValue95% CI
COVID-19 mHealth Intervention3.58± 1.36
1-month assessment
GroupValue95% CI
COVID-19 mHealth Intervention3.98± 1.36
12-month assessment
GroupValue95% CI
COVID-19 mHealth Intervention3.85± 1.39
COVID-19 Mistrust Score Primary · 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
GroupValue95% CI
COVID-19 mHealth Intervention3.25± 1.21
1-month assessment
GroupValue95% CI
COVID-19 mHealth Intervention3.09± 1.16
12-month assessment
GroupValue95% CI
COVID-19 mHealth Intervention3.21± 1.08
COVID-19 Testing Accessibility - Ease of Access Primary · 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
GroupValue95% CI
COVID-19 mHealth Intervention4.36± 1.03
1-month
GroupValue95% CI
COVID-19 mHealth Intervention4.51± 0.89
12-month
GroupValue95% CI
COVID-19 mHealth Intervention4.49± 0.96
COVID-19 Testing Accessibility - Confidence to Locate Primary · 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
GroupValue95% CI
COVID-19 mHealth Intervention4.42± 1.05
1-month assessment
GroupValue95% CI
COVID-19 mHealth Intervention4.54± 0.95
12-month assessment
GroupValue95% CI
COVID-19 mHealth Intervention4.49± 0.96
COVID-19 Testing Accessibility - Free Access Primary · 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
GroupValue95% CI
COVID-19 mHealth Intervention209
1-month assessment
GroupValue95% CI
COVID-19 mHealth Intervention221
12-month assessment
GroupValue95% CI
COVID-19 mHealth Intervention195
Ever Had COVID-19 Testing Primary · 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
GroupValue95% CI
COVID-19 mHealth Intervention264
1-month assessment
GroupValue95% CI
COVID-19 mHealth Intervention253
12-month assessment
GroupValue95% CI
COVID-19 mHealth Intervention229
Ever Received COVID-19 Vaccine Primary · 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
GroupValue95% CI
COVID-19 mHealth Intervention191
1-month assessment
GroupValue95% CI
COVID-19 mHealth Intervention182
12-month assessment
GroupValue95% CI
COVID-19 mHealth Intervention165

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for COVID-19 Pandemic

Currently open trials in the same condition.

Other University of Kansas Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05582746.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing