Trial Outcomes & Findings for COVID-19 Testing and Vaccine Literacy for Women With Criminal Legal System Involvement (NCT NCT05582746)
NCT ID: NCT05582746
Last Updated: 2025-01-30
Results Overview
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).
COMPLETED
NA
295 participants
Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
2025-01-30
Participant Flow
Participant milestones
| Measure |
COVID-19 mHealth Intervention
We are using a pre-post study design, given the low risk of the educational intervention and expected benefit. All participants received an mHealth intervention to boost COVID-19 testing and vaccine literacy, access, and uptake among women with CLSI in three cities.
|
|---|---|
|
Baseline
STARTED
|
295
|
|
Baseline
COMPLETED
|
295
|
|
Baseline
NOT COMPLETED
|
0
|
|
1-month Follow-up
STARTED
|
295
|
|
1-month Follow-up
COMPLETED
|
265
|
|
1-month Follow-up
NOT COMPLETED
|
30
|
|
12-month Follow-up
STARTED
|
265
|
|
12-month Follow-up
COMPLETED
|
235
|
|
12-month Follow-up
NOT COMPLETED
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There were n=10 (3.4%) missing for age.
Baseline characteristics by cohort
| Measure |
COVID-19 mHealth Intervention
n=295 Participants
We are using a pre-post study design, given the low risk of the educational intervention and expected benefit. All participants received an mHealth intervention to boost COVID-19 testing and vaccine literacy, access, and uptake among women with CLSI in three cities.
|
|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 11.5 • n=285 Participants • There were n=10 (3.4%) missing for age.
|
|
Sex: Female, Male
Female
|
295 Participants
n=295 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=295 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=295 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
256 Participants
n=295 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=295 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
172 Participants
n=295 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
94 Participants
n=295 Participants
|
|
Race/Ethnicity, Customized
Race · Other People of Color
|
24 Participants
n=295 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or not reported
|
5 Participants
n=295 Participants
|
|
Region of Enrollment
United States
|
295 participants
n=295 Participants
|
|
Education
Less than High School
|
59 Participants
n=295 Participants
|
|
Education
High School or higher
|
227 Participants
n=295 Participants
|
|
Education
unknown or not reported
|
9 Participants
n=295 Participants
|
|
Insurance
Yes
|
244 Participants
n=295 Participants
|
|
Insurance
No
|
36 Participants
n=295 Participants
|
|
Insurance
unknow or not reported
|
15 Participants
n=295 Participants
|
|
Employment
Yes
|
111 Participants
n=295 Participants
|
|
Employment
No
|
168 Participants
n=295 Participants
|
|
Employment
Unknown or not reported
|
16 Participants
n=295 Participants
|
|
City
Kansas City
|
51 Participants
n=295 Participants
|
|
City
Birmingham
|
88 Participants
n=295 Participants
|
|
City
Oakland
|
156 Participants
n=295 Participants
|
PRIMARY outcome
Timeframe: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.Population: There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).
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).
Outcome measures
| Measure |
COVID-19 mHealth Intervention
n=295 Participants
We are using a pre-post study design, given the low risk of the educational intervention and expected benefit. All participants received an mHealth intervention to boost COVID-19 testing and vaccine literacy, access, and uptake among women with CLSI in three cities.
|
|---|---|
|
COVID-19 Testing and Vaccine Knowledge
Pre-intervention assessment
|
3.58 score on a scale
Standard Deviation 1.36
|
|
COVID-19 Testing and Vaccine Knowledge
1-month assessment
|
3.98 score on a scale
Standard Deviation 1.36
|
|
COVID-19 Testing and Vaccine Knowledge
12-month assessment
|
3.85 score on a scale
Standard Deviation 1.39
|
PRIMARY outcome
Timeframe: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.Population: There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).
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).
Outcome measures
| Measure |
COVID-19 mHealth Intervention
n=295 Participants
We are using a pre-post study design, given the low risk of the educational intervention and expected benefit. All participants received an mHealth intervention to boost COVID-19 testing and vaccine literacy, access, and uptake among women with CLSI in three cities.
|
|---|---|
|
COVID-19 Mistrust Score
Pre-intervention assessment
|
3.25 score on a scale
Standard Deviation 1.21
|
|
COVID-19 Mistrust Score
1-month assessment
|
3.09 score on a scale
Standard Deviation 1.16
|
|
COVID-19 Mistrust Score
12-month assessment
|
3.21 score on a scale
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.Population: 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).
Outcome measures
| Measure |
COVID-19 mHealth Intervention
n=295 Participants
We are using a pre-post study design, given the low risk of the educational intervention and expected benefit. All participants received an mHealth intervention to boost COVID-19 testing and vaccine literacy, access, and uptake among women with CLSI in three cities.
|
|---|---|
|
COVID-19 Testing Accessibility - Ease of Access
Pre-Intervention assessment
|
4.36 score on a scale
Standard Deviation 1.03
|
|
COVID-19 Testing Accessibility - Ease of Access
1-month
|
4.51 score on a scale
Standard Deviation 0.89
|
|
COVID-19 Testing Accessibility - Ease of Access
12-month
|
4.49 score on a scale
Standard Deviation 0.96
|
PRIMARY outcome
Timeframe: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.Population: There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).
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).
Outcome measures
| Measure |
COVID-19 mHealth Intervention
n=295 Participants
We are using a pre-post study design, given the low risk of the educational intervention and expected benefit. All participants received an mHealth intervention to boost COVID-19 testing and vaccine literacy, access, and uptake among women with CLSI in three cities.
|
|---|---|
|
COVID-19 Testing Accessibility - Confidence to Locate
Pre-Intervention assessment
|
4.42 score on a scale
Standard Deviation 1.05
|
|
COVID-19 Testing Accessibility - Confidence to Locate
1-month assessment
|
4.54 score on a scale
Standard Deviation 0.95
|
|
COVID-19 Testing Accessibility - Confidence to Locate
12-month assessment
|
4.49 score on a scale
Standard Deviation 0.96
|
PRIMARY outcome
Timeframe: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.Population: There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).
Percentage of participants' aware the government program that offers free tests through the mail.
Outcome measures
| Measure |
COVID-19 mHealth Intervention
n=295 Participants
We are using a pre-post study design, given the low risk of the educational intervention and expected benefit. All participants received an mHealth intervention to boost COVID-19 testing and vaccine literacy, access, and uptake among women with CLSI in three cities.
|
|---|---|
|
COVID-19 Testing Accessibility - Free Access
1-month assessment
|
221 Participants
|
|
COVID-19 Testing Accessibility - Free Access
12-month assessment
|
195 Participants
|
|
COVID-19 Testing Accessibility - Free Access
Pre-Intervention assessment
|
209 Participants
|
PRIMARY outcome
Timeframe: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.Population: There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).
Count number of participants who indicated they ever had COVID-19 testing.
Outcome measures
| Measure |
COVID-19 mHealth Intervention
n=295 Participants
We are using a pre-post study design, given the low risk of the educational intervention and expected benefit. All participants received an mHealth intervention to boost COVID-19 testing and vaccine literacy, access, and uptake among women with CLSI in three cities.
|
|---|---|
|
Ever Had COVID-19 Testing
Pre-Intervention assessment
|
264 Participants
|
|
Ever Had COVID-19 Testing
1-month assessment
|
253 Participants
|
|
Ever Had COVID-19 Testing
12-month assessment
|
229 Participants
|
PRIMARY outcome
Timeframe: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.Population: There is missing data due to no response, measures reported are reported before multiple imputation for missingness (i.e., only complete cases).
Count number of participants who indicated they ever had COVID-19 vaccine.
Outcome measures
| Measure |
COVID-19 mHealth Intervention
n=295 Participants
We are using a pre-post study design, given the low risk of the educational intervention and expected benefit. All participants received an mHealth intervention to boost COVID-19 testing and vaccine literacy, access, and uptake among women with CLSI in three cities.
|
|---|---|
|
Ever Received COVID-19 Vaccine
Pre-Intervention assessment
|
191 Participants
|
|
Ever Received COVID-19 Vaccine
1-month assessment
|
182 Participants
|
|
Ever Received COVID-19 Vaccine
12-month assessment
|
165 Participants
|
Adverse Events
COVID-19 mHealth Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place