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Not yet recruitingNCT05888649Updated Jun 5, 2023

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

An observational study in Ebola Virus Disease, sponsored by UL-PIRE Africa Center. Not yet recruiting at 1 site in Liberia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.

Sponsored by UL-PIRE Africa Center · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ebola Virus Disease

Keywords

  • Community Preparedness
  • Outbreak Response
  • Ebola Virus Disease (EVD)
  • Ebola Vaccine
  • Ebola Vaccine Acceptance
  • Community Leaders
  • Liberia
03

In context

Hemorrhagic Fever, Ebola

104 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 266 across 16 observational studies indexed under Hemorrhagic Fever, Ebola.

Browse Hemorrhagic Fever, Ebola studies →

Lead sponsor

This is the only study on the registry with UL-PIRE Africa Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Health adults (males and females)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cluster 1

    Communities highly affected and impacted by EVD

    Behavioral: Community Clusters

  • Cluster 2

    Communities not highly affected and impacted by EVD

    Behavioral: Community Clusters

  • Cluster 3

    Communities receptive to EVD vaccination

    Behavioral: Community Clusters

  • Cluster 4

    Communities resistance to EVD vaccination

    Behavioral: Community Clusters

Interventions

  • BehavioralCommunity Clusters

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

    Also known as: Community Cohorts

06

What researchers measure

Primary outcomes

  1. Measure #1

    Assess Community Preparedness with the Resiliency Scale

    Time frame: 2 Years

  2. Measure #2

    Assess Community Acceptance of EVD Vaccine with the Resiliency Scale

    Time frame: 2 Years

Secondary outcomes

  1. Measure #3

    Assess Roles of Community Leaders with the Resiliency Scale

    Time frame: 2 Years

  2. Measure #4

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

    Time frame: 2 Years

07

Study locations

1 site
  • Montserrado, Margibi and Lofa Counties
    Monrovia, Montserrado County 1000, Liberia
08

References and documents

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. 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. doi: 10.15585/mmwr.mm6441a9.. Cordier-Lasalle, Thierry [Corrected to Cordier-Lassalle, Thierry]. 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2023; primary completion for Apr 2025, 22 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2023
First posted
Jun 5, 2023
StartEst.
Jun 2023
Primary completionEst.
Apr 30, 2025
CompletionEst.
Apr 30, 2025
Last update
Jun 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05888649
Lead sponsor
UL-PIRE Africa Center
Collaborators
West African Consortium for Clinical Research on Epidemic Pathogens (WAC-CREP)
Responsible party
Sponsor
First posted
Jun 5, 2023
Start date
Jun 2023 (estimated)
Primary completion
Apr 30, 2025 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Jun 5, 2023

Study contacts

Stephen B Kennedy, MD, MPH
Contact
sbkennedy4@gmail.com
+231770645830
Hannah Berrian, MPH
Contact
hannahberrian@gmail.com
+231777938203
Stephen B Kennedy, MD, MPH
principal investigator · UL-PIRE Africa Center, University of Liberia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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