ClinicalTrials.gg
CompletedNCT03683745Updated Jun 10, 2024

Integrated Mapping of Skin-presenting Neglected Tropical Diseases in Liberia

An observational study in Leprosy, Buruli Ulcer and Yaws, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Liberia. Per ClinicalTrials.gov, last updated 2024-06-10.

Sponsored by London School of Hygiene and Tropical Medicine · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
56,285
Sex
All
01

Study 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.

Read the detailed description

Innovative and intensified disease management (IDM) includes a range of different interventions - ranging from medicine to surgery - to relieve the symptoms and consequences of a group of neglected tropical diseases (NTDs) for which effective tools are scarce or where the widespread use of existing tools is limited. The World Health Organisation (WHO) has developed a series of strategies to achieve the control, elimination and eventual eradication of these NTDs, comprising universal access to early diagnosis and prompt treatment, improving active surveillance, integrating passive surveillance into health-service provision, and accelerating efforts towards elimination and eradication by intensifying core interventions. Appropriate targeting of IDM interventions requires accurate epidemiological data on the distribution of these NTDs 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.

A number of IDM NTDs are characterised by cutaneous manifestations that are associated with long-term disfigurement and disability. These include Buruli ulcer, cutaneous leishmaniasis, leprosy, mycetoma, yaws, onchocerciasis and lymphoedema and hydrocele (resulting from lymphatic filariasis and podoconiosis). These diseases require similar case-detection approaches, presenting opportunities for the development of novel, integrated mapping approaches. Population-based prevalence surveys (PBPS) are the gold standard methodology for obtaining accurate disease estimates when case detection and reporting through the health system is incomplete, and these have been used to provide sub-national estimates of disease distributions for yaws and podoconiosis. For less common outcomes (fewer than 1 case in 1000 individuals) however, standard PBPS rapidly become unfeasible. Given that the expected prevalence range for many of these IDM NTDs in endemic regions lies between as low as 1 in 10,000 for Buruli ulcer and 1-5% for yaws, it is clear that the PBPS approach requires adaptation to achieve the samples sizes needed to generate sufficiently precise prevalence estimates.

One alternative to randomly sampling individuals or households is to screen all residents within sampling clusters. House-to-house screening by mobile expert teams would likely yield the highest number of cases, but such a strategy would be expensive and difficult to sustain. As an alternative, trained village volunteers have been used during programmatic activities to effectively detect and refer diseases such as Buruli ulcer and leprosy in a number of countries. Given how difficult it is to diagnose many IDM-NTDs accurately, using community volunteers to perform an exhaustive house-to-house case search would require follow up expert case validation. The success of such an approach would thus rely on high levels of community awareness, coupled with well-trained village volunteers being able to recognise possible conditions, and a highly skilled, mobile case-validation team to confirm all potential cases. Effectively incorporating skill development in IDM-NTD screening among village volunteers could however represent a long-term and sustainable solution to the complex issue of managing these conditions at the community and primary health care level.

This study aims to establish the prevalence and distribution of case-management NTDs in the county of Maryland, Liberia using an integrated two-stage cluster-randomised sampling approach, including assessment of the proportion of cases not currently known to the health system.

The specific objectives include:

  1. To generate regional prevalence estimates of (i) lymphatic filariasis-associated lymphoedema and hydrocele, (ii) yaws, (iii) Buruli ulcer and (iv) leprosy in Maryland, Liberia, including the proportion of cases not currently known to the health system
  2. To model the endemicity status of (i) lymphoedema and hydrocele, (ii) yaws, (iii) Buruli ulcer and (iv) leprosy to support the development of targeted, integrated control strategies.
  3. To compare case detection rates from active community-based screening and validation with passive case detection reported through routine health system reports and health management information systems.

This protocol represents a novel tool for integrated mapping of IDM-NTDs. These conditions are difficult to diagnose and lack effective tools for both case finding and disease management purposes. This strategy may provide a template for cost-effective case identification and management that can be integrated within routine health systems in similar epidemiological settings.

02

Conditions studied

  • Leprosy
  • Buruli Ulcer
  • Yaws
  • Lymphatic Filariases

Keywords

  • disease burden
03

In context

Leprosy

52 studies on the registry are indexed under Leprosy; 13 are open to participants now.

Browse Leprosy studies →

Lead sponsor

London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Probability sample

Study population

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

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 over 18 must be willing and able to give 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
56,285 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Population prevalence of Lymphatic Filariasis

    Clinical signs of lymphoedema and hydrocele associated with lymphatic filariasis

    Time frame: Over a four month period

  2. Population prevalence of Yaws

    Clinical signs and PCR-confirmed yaws

    Time frame: Over a four month period

  3. Population prevalence of Buruli Ulcer

    Clinical signs and PCR-confirmed Buruli ulcer

    Time frame: Over a four month period

Secondary outcomes

  1. Population prevalence of leprosy

    Clinical signs of disease and of Grade 2 disability for leprosy

    Time frame: Over a four month period

  2. Population prevalence of BU and yaws in children

    Clinical signs of Buruli ulcer and yaws in children \<15years

    Time frame: Over a four month period

  3. Population prevalence of category 3 Buruli Ulcer

    Category 3 lesions for Buruli ulcer

    Time frame: Over a four month period

07

Study locations

1 site
  • Maryland County
    Harper, Maryland, Liberia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in Oct 2018, 4 months.

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

Registered
Sep 19, 2018
First posted
Sep 25, 2018
StartActual
Jun 14, 2018
Primary completionActual
Oct 30, 2018
CompletionActual
Dec 30, 2018
Last update
Jun 10, 2024
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 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03683745
Collaborators
AIM Initiative, Ministry of Health, Liberia
Responsible party
Rachel Pullan (Associate Professor, London School of Hygiene and Tropical Medicine) — Principal investigator
First posted
Sep 25, 2018
Start date
Jun 14, 2018
Primary completion
Oct 30, 2018
Completion
Dec 30, 2018
Last update
Jun 10, 2024

Study contacts

Rachel L Pullan, PhD
principal investigator · London School of Hygiene and Tropical Medicine
Karsor Kollie, MSc
principal investigator · Ministry of Health, Liberia

Oversight

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

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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