Integrated Mapping of Skin-presenting Neglected Tropical Diseases in Liberia

NCT03683745 | Completed

• 1 other identifier: 14698-1
• Study Type: observational
• Target: 56,285
• Locations: 1 country
• Sites: 1

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.

Conditions

Leprosy; Buruli Ulcer; Yaws; Lymphatic Filariases

Keywords

disease burden

Outcome Measures

Primary Outcomes (3)

• Population prevalence of Lymphatic Filariasis

  Clinical signs of lymphoedema and hydrocele associated with lymphatic filariasis

  Over a four month period

• Population prevalence of Yaws

  Clinical signs and PCR-confirmed yaws

  Over a four month period

• Population prevalence of Buruli Ulcer

  Clinical signs and PCR-confirmed Buruli ulcer

  Over a four month period

Secondary Outcomes (3)

• Population prevalence of leprosy

  Over a four month period

• Population prevalence of BU and yaws in children

  Over a four month period

• Population prevalence of category 3 Buruli Ulcer

  Over a four month period

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All individuals resident in the study clusters, which were selected with probability proportional to size.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• AIM Initiative: collaborator
• Ministry of Health, Liberia: collaborator

Study Sites (1)

Maryland County

Harper, Maryland County, Liberia

Location

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.

MeSH Terms

Conditions

Leprosy; Buruli Ulcer; Yaws; Elephantiasis, Filarial

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Rachel L Pullan, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Karsor Kollie, MSc

  Ministry of Health, Liberia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 25, 2018
• Study Start: June 14, 2018
• Primary Completion: October 30, 2018
• Study Completion: December 30, 2018
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

LI (1)