- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05888649
Community Preparedness for Outbreak Response and Readiness for Ebola Vaccination in Liberia
May 24, 2023 updated by: UL-PIRE Africa Center
Community Preparedness for Outbreak Response and Readiness for ZEBOV Vaccination in Liberia
This community-based mixed methods study intends to identify, explore, and assess the determinants of community preparedness for outbreak situations, including acceptance for Ebola vaccines.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This community-based study intends to identify, explore, and assess the determinants of community preparedness for outbreak situations and acceptance for the administration of Ebola vaccination.
The investigators will conduct an anthropologically driven mixed methods study design that comprises both qualitative and quantitative research methods for the successful implementation of this community-based study.
The investigators will conduct structured interviews with community members and local responders to broadly assess and understand the perspectives regarding appropriate strategies previously employed to effectively support community preparedness during outbreak response and also to broadly access and understand appropriate strategies previously employed to effectively support community acceptance for Ebola vaccines, respectively.
Learning from the experiences of local voices produces globally emergent systems that are trusted, reliable and sustainable.
Study Type
Observational
Enrollment (Estimated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephen B Kennedy, MD, MPH
- Phone Number: +231770645830
- Email: sbkennedy4@gmail.com
Study Contact Backup
- Name: Hannah Berrian, MPH
- Phone Number: +231777938203
- Email: hannahberrian@gmail.com
Study Locations
-
-
Montserrado County
-
Monrovia, Montserrado County, Liberia, 1000
- Montserrado, Margibi and Lofa Counties
-
Contact:
- Stephen B Kennedy, MD, MPH
- Phone Number: +231770645830
- Email: sbkennedy4@gmail.com
-
Contact:
- Hannah Berrian, MPH
- Phone Number: +231777938203
- Email: hannahberrian@gmail.com
-
Principal Investigator:
- Stephen B Kennedy, MD, MPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Health adults (males and females)
Description
Inclusion Criteria:
- Adults
- Community Leaders
- Community Members
- Reside in 1 of 3 highly prevalent counties
- Participated actively in EVD outbreaks related activities
- Documented roles recognized by the Incident Management System
Exclusion Criteria:
- Not Adults
- Does not reside in any of the 3 highly prevalent counties
- Did not actively participate in the EVD outbreak response related activities
- Roles not documented by the Incident Management System
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cluster 1
Communities highly affected and impacted by EVD
|
Assessment of the determinants for community preparedness to EVD outbreaks and acceptance of EVD vaccines.
Other Names:
|
|
Cluster 2
Communities not highly affected and impacted by EVD
|
Assessment of the determinants for community preparedness to EVD outbreaks and acceptance of EVD vaccines.
Other Names:
|
|
Cluster 3
Communities receptive to EVD vaccination
|
Assessment of the determinants for community preparedness to EVD outbreaks and acceptance of EVD vaccines.
Other Names:
|
|
Cluster 4
Communities resistance to EVD vaccination
|
Assessment of the determinants for community preparedness to EVD outbreaks and acceptance of EVD vaccines.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure #1
Time Frame: 2 Years
|
Assess Community Preparedness with the Resiliency Scale
|
2 Years
|
|
Measure #2
Time Frame: 2 Years
|
Assess Community Acceptance of EVD Vaccine with the Resiliency Scale
|
2 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure #3
Time Frame: 2 Years
|
Assess Roles of Community Leaders with the Resiliency Scale
|
2 Years
|
|
Measure #4
Time Frame: 2 Years
|
Assess Roles of Formal and Informal Community Structures with the Resiliency Scale
|
2 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen B Kennedy, MD, MPH, UL-PIRE Africa Center, University of Liberia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kennedy SB, Neaton JD, Lane HC, Kieh MW, Massaquoi MB, Touchette NA, Nason MC, Follmann DA, Boley FK, Johnson MP, Larson G, Kateh FN, Nyenswah TG. Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges. Clin Trials. 2016 Feb;13(1):49-56. doi: 10.1177/1740774515621037. Epub 2016 Jan 14.
- Nyenswah T, Fallah M, Sieh S, Kollie K, Badio M, Gray A, Dilah P, Shannon M, Duwor S, Ihekweazu C, Cordier-Lassalle T, Shinde SA, Hamblion E, Davies-Wayne G, Ratnesh M, Dye C, Yoder JS, McElroy P, Hoots B, Christie A, Vertefeuille J, Olsen SJ, Laney AS, Neal JJ, Yaemsiri S, Navin TR, Coulter S, Pordell P, Lo T, Kinkade C, Mahoney F; Centers for Disease Control and Prevention (CDC). Controlling the last known cluster of Ebola virus disease - Liberia, January-February 2015. MMWR Morb Mortal Wkly Rep. 2015 May 15;64(18):500-4. Erratum In: MMWR Morb Mortal Wkly Rep. 2015 Jul 31;64(18):806. Yaemsiri, Sirin [Added]. MMWR Morb Mortal Wkly Rep. 2015 Oct 23;64(41):1180. Cordier-Lasalle, Thierry [Corrected to Cordier-Lassalle, Thierry].
- O'Dowd A. Infectious diseases are spreading more rapidly than ever before, WHO warns. BMJ. 2007 Sep 1;335(7617):418. doi: 10.1136/bmj.39318.516968.DB. No abstract available.
- Kennedy SB, Nisbett RA. The Ebola epidemic: a transformative moment for global health. Bull World Health Organ. 2015 Jan 1;93(1):2. doi: 10.2471/BLT.14.151068. No abstract available.
- Fregonese F. Community involvement in biomedical research conducted in the global health context; what can be done to make it really matter? BMC Med Ethics. 2018 Jun 15;19(Suppl 1):44. doi: 10.1186/s12910-018-0283-4.
- Dickert N, Sugarman J. Ethical goals of community consultation in research. Am J Public Health. 2005 Jul;95(7):1123-7. doi: 10.2105/AJPH.2004.058933. Epub 2005 Jun 16.
- Wills C, Tyeku V. Community participation is essential in clinical trials. BMJ. 2000 Sep 30;321(7264):833. No abstract available.
- Esangbedo DO, Ughasoro MD, Tagbo BN, Olowu A, Anikene C, Iwegbulam CC. Health-Care Workers' Perspectives on Ebola Virus Vaccine: A Focus Group and In-Depth Interview Interventional Study. Am J Trop Med Hyg. 2016 Sep 7;95(3):654-62. doi: 10.4269/ajtmh.16-0206. Epub 2016 Jul 5.
- Chiam AL, Cheng NWI, Larson H. Community engagement for outbreak preparedness and response in high-income settings: A systematic review. Glob Public Health. 2022 Jul;17(7):1113-1135. doi: 10.1080/17441692.2021.1919734. Epub 2021 May 2.
- PREVAIL III Study Group; Sneller MC, Reilly C, Badio M, Bishop RJ, Eghrari AO, Moses SJ, Johnson KL, Gayedyu-Dennis D, Hensley LE, Higgs ES, Nath A, Tuznik K, Varughese J, Jensen KS, Dighero-Kemp B, Neaton JD, Lane HC, Fallah MP. A Longitudinal Study of Ebola Sequelae in Liberia. N Engl J Med. 2019 Mar 7;380(10):924-934. doi: 10.1056/NEJMoa1805435.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2023
Primary Completion (Estimated)
April 30, 2025
Study Completion (Estimated)
April 30, 2025
Study Registration Dates
First Submitted
April 27, 2023
First Submitted That Met QC Criteria
May 24, 2023
First Posted (Actual)
June 5, 2023
Study Record Updates
Last Update Posted (Actual)
June 5, 2023
Last Update Submitted That Met QC Criteria
May 24, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MISP 101054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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