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Integrated Mapping of Skin-presenting Neglected Tropical Diseases in Liberia

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ClinicalTrials.gov Identifier: NCT03683745
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborators:
AIM Initiative
Ministry of Health, Liberia
Information provided by (Responsible Party):
Rachel Pullan, London School of Hygiene and Tropical Medicine

Brief Summary:

Appropriate targeting of interventions for neglected tropical diseases (NTDs) that require innovative and intensified disease management (IDM) requires accurate data on the distribution of these diseases within endemic countries. In most instances however, existing case register data generated through national health management information systems or during programmatic activities do not provide an accurate representation of the true burden of IDM NTDs. This study will pilot a cluster randomized screening and confirmation survey to estimate the burden of IDM NTDs characterised by skin conditions associated with long-term disfigurement and disability. These include: leprosy, Buruli ulcer, yaws and lymphoedema and hydrocele resulting from lymphatic filariasis. The survey is being conducted in one county in Liberia.

The protocol involves community-level screening by community health volunteers trained to use photo-based visual aids to recognise changes in the skin that broadly indicates patent infection. All suspected cases will be verified in their homes by local and national experts trained in the diagnosis of skin-presenting NTDs. The survey will generate accurate district-level prevalence estimates of leprosy, yaws, Buruli ulcer and lymphatic filariasis-associated lymphoedema and hydrocele and quantify the total costs and cost per case detected. In addition, results from this protocol will be compared with routinely collected case register data, to better understand how health system records reflect the true disease situation on the ground and quantify unmet need.


Condition or disease
Leprosy Buruli Ulcer Yaws Lymphatic Filariases

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 48000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Prevalence Survey for Innovative and Intensified Disease Management (IDM) Neglected Tropical Diseases (NTDs): A Cluster Randomised Two-stage Active Case Search for IDM-NTDs in Liberia
Actual Study Start Date : June 14, 2018
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : December 30, 2018


Group/Cohort
Maryland
Maryland is a county in southeast Liberia. Survey clusters based on catchment populations served by community health volunteers (CHVs) around 24 district health facilities (primary sampling unit). Clusters will constitute ~600 people (~100 households) with population-weighted cluster selection applied. In total, 80 clusters will be required. CHVs would conduct house-to-house visits to develop a full census and listing of all possible cases using broad case definitions. Full details of all potential cases will then be passed to an expert verification team based at the closest health facility. Suspected cases will arrive at the health facility over a 10-day verification period to receive a diagnosis using clinical examination and/or laboratory confirmation.



Primary Outcome Measures :
  1. Population prevalence of Lymphatic Filariasis [ Time Frame: Over a four month period ]
    Clinical signs of lymphoedema and hydrocele associated with lymphatic filariasis

  2. Population prevalence of Yaws [ Time Frame: Over a four month period ]
    Clinical signs and PCR-confirmed yaws

  3. Population prevalence of Buruli Ulcer [ Time Frame: Over a four month period ]
    Clinical signs and PCR-confirmed Buruli ulcer


Secondary Outcome Measures :
  1. Population prevalence of leprosy [ Time Frame: Over a four month period ]
    Clinical signs of disease and of Grade 2 disability for leprosy

  2. Population prevalence of BU and yaws in children [ Time Frame: Over a four month period ]
    Clinical signs of Buruli ulcer and yaws in children <15years

  3. Population prevalence of category 3 Buruli Ulcer [ Time Frame: Over a four month period ]
    Category 3 lesions for Buruli ulcer


Biospecimen Retention:   Samples With DNA

Specimens will be obtained from all clinically suspected cases, for confirmatory diagnosis. These include:

  • skin swabs of suspected yaws lesions
  • nasal swabs of suspected leprosy cases
  • skin swabs of Buruli ulcer lesions

Samples will be tested using molecular analysis including PCR and sequencing for detection of T. pallidum, M. Ulcerans, M. leprae and other pathogens which can cause similar manifestations.

Samples are to be stored (in Liberia, and in London) at -20 degrees in appropriately secured laboratory freezers (CL2 and CL3) for future research projects. This is explained in the information sheet, with a statement included in the consent forms.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All individuals resident in the study clusters, which were selected with probability proportional to size.
Criteria

Inclusion Criteria:

  • Adults over 18 must be willing and able to give informed consent for examination, and children over 13 years must be willing and able to give informed assent
  • An adult (>18 year of age) parent or guardian must be present at the time of the examination who can give informed consent for children <18 years to be examined.

Exclusion Criteria:

  • Individuals for whom no adult parent/guardian is available to provide consent and/or who are unwilling to provide assent/consent for themselves.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683745


Contacts
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Contact: Rachel L Pullan, PhD 02079272702 rachel.pullan@lshtm.ac.uk
Contact: Joseph Timothy, PhD 02079272702 joseph.timothy@lshtm.ac.uk

Locations
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Liberia
Maryland County Recruiting
Harper, Maryland, Liberia
Contact: Emerson Rogers         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
AIM Initiative
Ministry of Health, Liberia
Investigators
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Principal Investigator: Rachel L Pullan, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Karsor Kollie, MSc Ministry of Health, Liberia

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Responsible Party: Rachel Pullan, Associate Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03683745     History of Changes
Other Study ID Numbers: 14698-1
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rachel Pullan, London School of Hygiene and Tropical Medicine:
disease burden
Additional relevant MeSH terms:
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Leprosy
Buruli Ulcer
Filariasis
Elephantiasis, Filarial
Elephantiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Skin Ulcer
Skin Diseases