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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05582746

Acronym

COVID-19

Enrollment

295

Registered

2022-10-17

Start date

2022-09-15

Completion date

2024-10-23

Last updated

2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pandemic

Brief summary

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

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

Interventions

BEHAVIORALTri-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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Unable to provide informed consent

Design outcomes

Primary

Measure	Time frame	Description
COVID-19 Testing and Vaccine Knowledge	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).
COVID-19 Mistrust Score	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).
COVID-19 Testing Accessibility - Ease of Access	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).
COVID-19 Testing Accessibility - Confidence to Locate	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).
COVID-19 Testing Accessibility - Free Access	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.
Ever Had COVID-19 Testing	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.
Ever Received COVID-19 Vaccine	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	295
Total	295

Baseline characteristics

Characteristic	COVID-19 mHealth Intervention
Age, Continuous	45.8 years STANDARD_DEVIATION 11.5
City Birmingham	88 Participants
City Kansas City	51 Participants
City Oakland	156 Participants
Education High School or higher	227 Participants
Education Less than High School	59 Participants
Education unknown or not reported	9 Participants
Employment No	168 Participants
Employment Unknown or not reported	16 Participants
Employment Yes	111 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	256 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants
Insurance No	36 Participants
Insurance unknow or not reported	15 Participants
Insurance Yes	244 Participants
Race/Ethnicity, Customized Race Black or African American	172 Participants
Race/Ethnicity, Customized Race Other People of Color	24 Participants
Race/Ethnicity, Customized Race Unknown or not reported	5 Participants
Race/Ethnicity, Customized Race White	94 Participants
Region of Enrollment United States	295 participants
Sex: Female, Male Female	295 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	3 / 295
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

Primary

COVID-19 Mistrust Score

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).