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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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COVID-19 Pandemic

Intervention / Treatment
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* Behavioral: Tri-City COVID Attitudes Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: currently enrolled in the Tri-City C.R.E.W. study (R01CA226838) Exclusion Criteria: Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: COVID-19 mHealth Intervention<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 testing, attitudes, practices | Qualitative prompts developed by investigators to assess attitudes and practices related to testing; difficulty accessing testing/vaccine or success stories; concerns heard from friends, family, news, social media, the streets; trust of government, health departments, pharmaceutical companies, corporations, doctors; perception of knowledge to make informed decision about testing and vaccine (acknowledging any regional differences). 10 questions were included, for example: What makes testing effective or not effective for stopping the spread of the virus? and Who has been the most persuasive in your decision on whether or not to get tested and/or vaccinated? Why? | Year 1 | 
| Acceptability and useability of COVID-19 testing and vaccine mHealth module | Acceptability of mHealth intervention adapted from Sekhon et al; usability scale adapted from Brooke, open-ended questions developed by study team to assess limitations, opinions about least/most favorite parts, any other participant feedback | Year 1 | 
| COVID-19 testing and vaccine knowledge | Nine questions developed by study team and corresponding to intervention content | Year 2 | 
| COVID-19 mistrust questions | Six items adapted from Bogart et al. COVID-19 medical mistrust, vaccine, and treatment hesitancy; one item with multiple trust response options from CDE Tier 2 (RadXUp) | Year 2 | 
| Vaccine acceptance | Seven items from Tier 1 and Tier 2 NIH- RADx-UP Common Data Elements (CDE) Vaccine Acceptance questions (RadXUp); 15 items from Hanna et al., COVID-19 vaccine acceptance scale | Year 2 | 
| COVID-19 testing | Items from Tier 1 CDE questions (RadXUp); ; two booster and three family testing and vaccine questions developed by study team | Year 2 | 
| COVID-19 testing access | Three items developed by study team on whether people know where to go and how to get tests | Year 2 |