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Ebola Virus DiseaseNCT05888649

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

An observational study of Ebola Virus Disease, run by UL-PIRE Africa Center at 1 site in Liberia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Ebola Virus Disease
What is being tested?
Community Clusters
How many people
1,500 participants
Where
1 siteLiberia
Study dates
Jun 2023to 30 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Health adults (males and females)

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Stephen B Kennedy, MD, MPH contact

+231770645830

sbkennedy4@gmail.com

Hannah Berrian, MPH contact

+231777938203

hannahberrian@gmail.com

Liberia1 site

  • Montserrado, Margibi and Lofa Counties

    Monrovia, Montserrado County, 1000

    Stephen B Kennedy, MD, MPH, +231770645830, sbkennedy4@gmail.com

    Hannah Berrian, MPH, +231777938203, hannahberrian@gmail.com

Other trials in Liberia

About this study

Official title: 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.

Read the 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.

Being tested
Community Clusters
Keywords
Community Preparedness, Outbreak Response, Ebola Virus Disease (EVD), Ebola Vaccine, Ebola Vaccine Acceptance, Community Leaders, Liberia
Medical subject headings
Hemorrhagic Fever, Ebola

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community ClustersBehavioural

    Also called Community Cohorts

    Assessment of the determinants for community preparedness to EVD outbreaks and acceptance of EVD vaccines.

Study groups in NCT05888649
Study groupRoleWhat they receive
Cluster 1Communities highly affected and impacted by EVD
Receives: Behavioral: Community Clusters
Cluster 2Communities not highly affected and impacted by EVD
Receives: Behavioral: Community Clusters
Cluster 3Communities receptive to EVD vaccination
Receives: Behavioral: Community Clusters
Cluster 4Communities resistance to EVD vaccination
Receives: Behavioral: Community Clusters

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure #1

    Assess Community Preparedness with the Resiliency Scale

    Measured: 2 Years

  2. Measure #2

    Assess Community Acceptance of EVD Vaccine with the Resiliency Scale

    Measured: 2 Years

Secondary outcomes (2)

  1. Measure #3

    Assess Roles of Community Leaders with the Resiliency Scale

    Measured: 2 Years

  2. Measure #4

    Assess Roles of Formal and Informal Community Structures with the Resiliency Scale

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study startJun 2023 (estimated)
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05888649
Sponsor's protocol ID
MISP 101054
Status last verified
May 2023
First submitted
27 Apr 2023
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 26768572

  • 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.

    PubMed 25974635

  • 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.

    PubMed 17762021

  • 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.

    PubMed 25558097

  • 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.

    PubMed 29945597

  • 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.

    PubMed 15983268

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

    PubMed 11009541

  • 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.

    PubMed 27382077

  • 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.

    PubMed 33938368

  • 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.

    PubMed 30855742

Questions about this trial

What is this clinical trial studying?

An observational study of Ebola Virus Disease, run by UL-PIRE Africa Center at 1 site in Liberia.

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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Jun 2023. 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 Liberia. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Stephen B Kennedy, MD, MPH (+231770645830, sbkennedy4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure #1 (time frame: 2 Years). The study lists 2 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 NCT05888649, which also lists 10 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 5 Jun 2023.

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