Community Preparedness for Outbreak Response and Readiness for Ebola Vaccination in Liberia

Ebola Virus Disease Clinical Trial

Official title:

Community Preparedness for Outbreak Response and Readiness for ZEBOV Vaccination in Liberia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05888649
• Other study ID #: MISP 101054
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2023
• Source: UL-PIRE Africa Center
• Contact: Stephen B Kennedy, MD, MPH
• Phone: +231770645830
• Email: sbkennedy4[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ebola Virus Disease
• Hemorrhagic Fever, Ebola
• Virus Diseases

Intervention

Behavioral:
• Community Clusters
Assessment of the determinants for community preparedness to EVD outbreaks and acceptance of EVD vaccines.

Locations

Country	Name	City	State
Liberia	Montserrado, Margibi and Lofa Counties	Monrovia	Montserrado County

Sponsors (2)

Lead Sponsor	Collaborator
UL-PIRE Africa Center	West African Consortium for Clinical Research on Epidemic Pathogens (WAC-CREP)

Country where clinical trial is conducted

Liberia, 

References & Publications (10)

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. — View 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. — View 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.16-0 — View 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. — View 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 — View 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. — View 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, N — View 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. — View 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 E — View Citation

Wills C, Tyeku V. Community participation is essential in clinical trials. BMJ. 2000 Sep 30;321(7264):833. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure #1	Assess Community Preparedness with the Resiliency Scale	2 Years
Primary	Measure #2	Assess Community Acceptance of EVD Vaccine with the Resiliency Scale	2 Years
Secondary	Measure #3	Assess Roles of Community Leaders with the Resiliency Scale	2 Years
Secondary	Measure #4	Assess Roles of Formal and Informal Community Structures with the Resiliency Scale	2 Years