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

COVID-19 Pandemic Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05582746
• Other study ID #: STUDY00148911
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 508
• Est. completion date: November 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to provide informed consent

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Intervention

Behavioral:
• Tri-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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	COVID-19 testing and vaccine knowledge	Nine questions developed by study team and corresponding to intervention content	Year 2
Primary	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
Primary	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
Primary	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
Primary	COVID-19 testing access	Three items developed by study team on whether people know where to go and how to get tests	Year 2