Leprosy Clinical Trial
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
NCT number | NCT03683745 |
Other study ID # | 14698-1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 14, 2018 |
Est. completion date | December 30, 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.
Status | Recruiting |
Enrollment | 48000 |
Est. completion date | December 30, 2018 |
Est. primary completion date | October 30, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Liberia | Maryland County | Harper | Maryland |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | AIM Initiative, Liberia Ministry of Health |
Liberia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Population prevalence of Lymphatic Filariasis | Clinical signs of lymphoedema and hydrocele associated with lymphatic filariasis | Over a four month period | |
Primary | Population prevalence of Yaws | Clinical signs and PCR-confirmed yaws | Over a four month period | |
Primary | Population prevalence of Buruli Ulcer | Clinical signs and PCR-confirmed Buruli ulcer | Over a four month period | |
Secondary | Population prevalence of leprosy | Clinical signs of disease and of Grade 2 disability for leprosy | Over a four month period | |
Secondary | Population prevalence of BU and yaws in children | Clinical signs of Buruli ulcer and yaws in children <15years | Over a four month period | |
Secondary | Population prevalence of category 3 Buruli Ulcer | Category 3 lesions for Buruli ulcer | Over a four month period |
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