COVID-19 PandemicCOVID-19NCT05582746
COVID-19 Testing and Vaccine Literacy for Women With Criminal Legal System Involvement
A study testing Tri-City COVID Attitudes Study in people with COVID-19 Pandemic, run by University of Kansas Medical Center at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Tri-City COVID Attitudes Study
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to 23 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- currently enrolled in the Tri-City C.R.E.W. study (R01CA226838)
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Localized mHealth Approach to Boosting COVID-19 Testing and Vaccine Literacy, Access, and Uptake Among Women With Criminal Legal System Involvement
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
Read the 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
- Conditions
- COVID-19 Pandemic
- Being tested
- Tri-City COVID Attitudes Study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-City COVID Attitudes StudyBehavioural
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 group | Role | What they receive |
|---|---|---|
| COVID-19 mHealth Intervention | Other | We are using a pre-post study design, given the low risk of the educational intervention and expected benefit. Receives: Behavioral: Tri-City COVID Attitudes Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Testing and Vaccine Knowledge
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).
Measured: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
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).
Measured: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
COVID-19 Testing Accessibility - Ease of Access
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).
Measured: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
COVID-19 Testing Accessibility - Confidence to Locate
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).
Measured: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
COVID-19 Testing Accessibility - Free Access
Percentage of participants' aware the government program that offers free tests through the mail.
Measured: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
Ever Had COVID-19 Testing
Count number of participants who indicated they ever had COVID-19 testing.
Measured: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
Ever Received COVID-19 Vaccine
Count number of participants who indicated they ever had COVID-19 vaccine.
Measured: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start15 Sep 2022
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Jason E Glenn, PhD, University of Kansas Medical Center
- Investigators
- Jason Glenn, PHD, Principal investigator, University of Kansas School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582746
- Sponsor's protocol ID
- STUDY00148911
- Other IDs
- 5U01MD017415-02
- Acronym
- COVID-19
- Status last verified
- Jan 2025
- First submitted
- 5 Oct 2022
- Last updated
- 30 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32639537Khorasani 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.
PubMed 34041670Wickliffe 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.
PubMed 31242801Volpp 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.
PubMed 34038633Geana 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.
PubMed 33973268Ramaswamy 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.
PubMed 32380869Biasio 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.
PubMed 33118868Bogart 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.
PubMed 33196555Lipnicky 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.
PubMed 33634650Zhang 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.
PubMed 33585053LaVeist 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.
PubMed 11092161
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localized mHealth Approach to Boosting COVID-19 Testing and Vaccine Literacy, Access, and Uptake Among Women With Criminal Legal System Involvement
- ClinicalTrials.gov ID
- NCT05582746
- Acronym / sponsor ID
- COVID-19 / STUDY00148911
- Conditions
- COVID-19 Pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Posted 30 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 mHealth Intervention | Other | Behavioral: Tri-City COVID Attitudes StudyWe are using a pre-post study design, given the low risk of the educational intervention and expected benefit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- currently enrolled in the Tri-City C.R.E.W. study (R01CA226838)
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tri-City COVID Attitudes StudyWe 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 | Behavioural | COVID-19 mHealth Intervention |
Primary outcome
COVID-19 Testing and Vaccine Knowledge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32639537Saloner 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.
- Background: PubMed 34041670Khorasani 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.
- Background: PubMed 31242801Wickliffe 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.
- Background: PubMed 34038633Volpp 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.
- Background: PubMed 33973268Geana 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.
- Background: PubMed 32380869Ramaswamy 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.
- Background: PubMed 33118868Biasio 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.
- Background: PubMed 33196555Bogart 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.
- Background: PubMed 33634650Lipnicky 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.
- Background: PubMed 33585053Zhang 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.
- Background: PubMed 11092161LaVeist 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Glenn, PHD principal investigator
University of Kansas School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tri-City COVID Attitudes Study in people with COVID-19 Pandemic, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Testing and Vaccine Knowledge (time frame: Pre-Intervention assessment measured at baseline, Post-intervention assessment measured at 1-month and 12-month follow-ups.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05582746, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.