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

Primary Purpose

COVID-19 Pandemic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tri-City COVID Attitudes Study
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for COVID-19 Pandemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to provide informed consent

Sites / Locations

  • University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

COVID-19 mHealth Intervention

Arm Description

We are using a pre-post study design, given the low risk of the educational intervention and expected benefit.

Outcomes

Primary Outcome Measures

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?
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
COVID-19 testing and vaccine knowledge
Nine questions developed by study team and corresponding to intervention content
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)
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
COVID-19 testing
Items from Tier 1 CDE questions (RadXUp); ; two booster and three family testing and vaccine questions developed by study team
COVID-19 testing access
Three items developed by study team on whether people know where to go and how to get tests

Secondary Outcome Measures

Full Information

First Posted
October 5, 2022
Last Updated
December 5, 2022
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05582746
Brief Title
COVID-19 Testing and Vaccine Literacy for Women With Criminal Legal System Involvement
Acronym
COVID-19
Official Title
Localized mHealth Approach to Boosting COVID-19 Testing and Vaccine Literacy, Access, and Uptake Among Women With Criminal Legal System Involvement
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
508 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 mHealth Intervention
Arm Type
Other
Arm Description
We are using a pre-post study design, given the low risk of the educational intervention and expected benefit.
Intervention Type
Behavioral
Intervention Name(s)
Tri-City COVID Attitudes Study
Intervention Description
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
Primary Outcome Measure Information:
Title
COVID-19 testing, attitudes, practices
Description
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?
Time Frame
Year 1
Title
Acceptability and useability of COVID-19 testing and vaccine mHealth module
Description
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
Time Frame
Year 1
Title
COVID-19 testing and vaccine knowledge
Description
Nine questions developed by study team and corresponding to intervention content
Time Frame
Year 2
Title
COVID-19 mistrust questions
Description
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)
Time Frame
Year 2
Title
Vaccine acceptance
Description
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
Time Frame
Year 2
Title
COVID-19 testing
Description
Items from Tier 1 CDE questions (RadXUp); ; two booster and three family testing and vaccine questions developed by study team
Time Frame
Year 2
Title
COVID-19 testing access
Description
Three items developed by study team on whether people know where to go and how to get tests
Time Frame
Year 2

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: currently enrolled in the Tri-City C.R.E.W. study (R01CA226838) Exclusion Criteria: Unable to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megha Ramaswamy, PhD
Phone
913-588-1053
Email
mramaswamy@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joi Wickliffe, MPH
Phone
913-588-2646
Email
jwickliffe@kumc.edu
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megha Ramaswamy, phd

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.
Citations:
PubMed Identifier
32639537
Citation
Saloner B, Parish K, Ward JA, DiLaura G, Dolovich S. COVID-19 Cases and Deaths in Federal and State Prisons. JAMA. 2020 Aug 11;324(6):602-603. doi: 10.1001/jama.2020.12528.
Results Reference
background
PubMed Identifier
34041670
Citation
Khorasani SB, Koutoujian PJ, Zubiago J, Guardado R, Siddiqi K, Wurcel AG. COVID-19 Vaccine Interest among Corrections Officers and People Who Are Incarcerated at Middlesex County Jail, Massachusetts. J Urban Health. 2021 Aug;98(4):459-463. doi: 10.1007/s11524-021-00545-y. Epub 2021 May 26. No abstract available.
Results Reference
background
PubMed Identifier
31242801
Citation
Wickliffe J, Kelly PJ, Allison M, Emerson A, Ramaswamy M. Retention Strategies in Working With Justice-Involved Women. J Correct Health Care. 2019 Jul;25(3):231-237. doi: 10.1177/1078345819853310. Epub 2019 Jun 26.
Results Reference
background
PubMed Identifier
34038633
Citation
Volpp KG, Cannuscio CC. Incentives for Immunity - Strategies for Increasing Covid-19 Vaccine Uptake. N Engl J Med. 2021 Jul 1;385(1):e1. doi: 10.1056/NEJMp2107719. Epub 2021 May 26. No abstract available.
Results Reference
background
PubMed Identifier
33973268
Citation
Geana MV, Anderson S, Ramaswamy M. COVID-19 vaccine hesitancy among women leaving jails: A qualitative study. Public Health Nurs. 2021 Sep;38(5):892-896. doi: 10.1111/phn.12922. Epub 2021 May 11.
Results Reference
background
PubMed Identifier
32380869
Citation
Ramaswamy M, Hemberg J, Faust A, Wickliffe J, Comfort M, Lorvick J, Cropsey K. Criminal Justice-Involved Women Navigate COVID-19: Notes From the Field. Health Educ Behav. 2020 Aug;47(4):544-548. doi: 10.1177/1090198120927304. Epub 2020 May 8.
Results Reference
background
PubMed Identifier
33118868
Citation
Biasio LR, Bonaccorsi G, Lorini C, Pecorelli S. Assessing COVID-19 vaccine literacy: a preliminary online survey. Hum Vaccin Immunother. 2021 May 4;17(5):1304-1312. doi: 10.1080/21645515.2020.1829315. Epub 2020 Oct 29.
Results Reference
background
PubMed Identifier
33196555
Citation
Bogart LM, Ojikutu BO, Tyagi K, Klein DJ, Mutchler MG, Dong L, Lawrence SJ, Thomas DR, Kellman S. COVID-19 Related Medical Mistrust, Health Impacts, and Potential Vaccine Hesitancy Among Black Americans Living With HIV. J Acquir Immune Defic Syndr. 2021 Feb 1;86(2):200-207. doi: 10.1097/QAI.0000000000002570.
Results Reference
background
PubMed Identifier
33634650
Citation
Lipnicky A, Kelly PJ, Ramaswamy M. Facebook as a follow-up tool for women with criminal justice histories. Int J Prison Health. 2020 Apr 10;16(2):117-122. doi: 10.1108/IJPH-08-2019-0042.
Results Reference
background
PubMed Identifier
33585053
Citation
Zhang Y, Fisk RJ. Barriers to vaccination for coronavirus disease 2019 (COVID-19) control: experience from the United States. Glob Health J. 2021 Mar;5(1):51-55. doi: 10.1016/j.glohj.2021.02.005. Epub 2021 Feb 9.
Results Reference
background
PubMed Identifier
11092161
Citation
LaVeist TA, Nickerson KJ, Bowie JV. Attitudes about racism, medical mistrust, and satisfaction with care among African American and white cardiac patients. Med Care Res Rev. 2000;57 Suppl 1:146-61. doi: 10.1177/1077558700057001S07.
Results Reference
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COVID-19 Testing and Vaccine Literacy for Women With Criminal Legal System Involvement

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