Integrated Mapping of Skin-presenting Neglected Tropical Diseases in Liberia
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|ClinicalTrials.gov Identifier: NCT03683745|
Recruitment Status : Unknown
Verified September 2018 by Rachel Pullan, London School of Hygiene and Tropical Medicine.
Recruitment status was: Recruiting
First Posted : September 25, 2018
Last Update Posted : September 25, 2018
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|
|Study Type :||Observational|
|Estimated Enrollment :||48000 participants|
|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|
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.
- Population prevalence of Lymphatic Filariasis [ Time Frame: Over a four month period ]Clinical signs of lymphoedema and hydrocele associated with lymphatic filariasis
- Population prevalence of Yaws [ Time Frame: Over a four month period ]Clinical signs and PCR-confirmed yaws
- Population prevalence of Buruli Ulcer [ Time Frame: Over a four month period ]Clinical signs and PCR-confirmed Buruli ulcer
- Population prevalence of leprosy [ Time Frame: Over a four month period ]Clinical signs of disease and of Grade 2 disability for leprosy
- 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
- 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.
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
|Contact: Rachel L Pullan, PhDfirstname.lastname@example.org|
|Contact: Joseph Timothy, PhDemail@example.com|
|Harper, Maryland, Liberia|
|Contact: Emerson Rogers|
|Principal Investigator:||Rachel L Pullan, PhD||London School of Hygiene and Tropical Medicine|
|Principal Investigator:||Karsor Kollie, MSc||Ministry of Health, Liberia|