Clinical trial NCT05888649: Community Preparedness for Outbreak Response and Readiness for Ebola Vaccination in Liberia
Official title: Community Preparedness for Outbreak Response and Readiness for ZEBOV Vaccination in Liberia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ebola Virus Disease
Keywords: Community Preparedness
Outbreak Response
Ebola Virus Disease (EVD)
Ebola Vaccine
Ebola Vaccine Acceptance
Community Leaders
Liberia
Lead sponsor: UL-PIRE Africa Center
Sponsor class: OTHER
Collaborators: name: West African Consortium for Clinical Research on Epidemic Pathogens (WAC-CREP)
First posted: 2023-06-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health adults (males and females)

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure #1
timeFrame: 2 Years
measure: Measure #2
timeFrame: 2 Years
Secondary outcomes:
measure: Measure #3
timeFrame: 2 Years
measure: Measure #4
timeFrame: 2 Years
Other outcomes:
Locations:
city: Monrovia
country: Liberia
facility: Montserrado, Margibi and Lofa Counties
state: Montserrado County
Study officials:
affiliation: UL-PIRE Africa Center, University of Liberia
name: Stephen B Kennedy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Wills C, Tyeku V. Community participation is essential in clinical trials. BMJ. 2000 Sep 30;321(7264):833. No abstract available.
citation: 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.
citation: 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.
citation: 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.