LeprosyNCT03683745
Integrated Mapping of Skin-presenting Neglected Tropical Diseases in Liberia
An observational study of Leprosy and Buruli Ulcer, run by London School of Hygiene and Tropical Medicine at 1 site in Liberia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leprosy, Buruli Ulcer, Yaws
- How many people
- 56,285 participants
- Where
- 1 siteLiberia
- Study dates
- 14 Jun 2018to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All individuals resident in the study clusters, which were selected with probability proportional to size.
Who may be able to join
- 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.
Who cannot join
- Individuals for whom no adult parent/guardian is available to provide consent and/or who are unwilling to provide assent/consent for themselves.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- 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
- 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.
- 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.
- Conditions
- Leprosy, Buruli Ulcer, Yaws, Lymphatic Filariases
- Keywords
- disease burden
- Medical subject headings
- Leprosy, Buruli Ulcer, Yaws, Elephantiasis, Filarial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population prevalence of Lymphatic Filariasis
Clinical signs of lymphoedema and hydrocele associated with lymphatic filariasis
Measured: Over a four month period
Population prevalence of Yaws
Clinical signs and PCR-confirmed yaws
Measured: Over a four month period
Population prevalence of Buruli Ulcer
Clinical signs and PCR-confirmed Buruli ulcer
Measured: Over a four month period
Secondary outcomes (3)
Population prevalence of leprosy
Clinical signs of disease and of Grade 2 disability for leprosy
Measured: Over a four month period
Population prevalence of BU and yaws in children
Clinical signs of Buruli ulcer and yaws in children <15years
Measured: Over a four month period
Population prevalence of category 3 Buruli Ulcer
Category 3 lesions for Buruli ulcer
Measured: Over a four month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start14 Jun 2018
- Primary completion30 Oct 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 56,285 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- AIM Initiative, Ministry of Health, Liberia
- Responsible party
- Principal investigator, Rachel Pullan, London School of Hygiene and Tropical Medicine
- Investigators
- Rachel L Pullan, PhD, Principal investigator, London School of Hygiene and Tropical MedicineKarsor Kollie, MSc, Principal investigator, Ministry of Health, Liberia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683745
- Sponsor's protocol ID
- 14698-1
- Status last verified
- Jun 2024
- First submitted
- 19 Sep 2018
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03683745
- Acronym / sponsor ID
- 14698-1
- Conditions
- Leprosy, Buruli Ulcer, Yaws, Lymphatic Filariases
- Keywords
- disease burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56,285 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- AIM Initiative, Ministry of Health, Liberia
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- 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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals resident in the study clusters, which were selected with probability proportional to size.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals for whom no adult parent/guardian is available to provide consent and/or who are unwilling to provide assent/consent for themselves.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Population prevalence of leprosy
Time frame: Over a four month period
Population prevalence of BU and yaws in children
Time frame: Over a four month period
Population prevalence of category 3 Buruli Ulcer
Time frame: Over a four month period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel L Pullan, PhD principal investigator
London School of Hygiene and Tropical Medicine
Karsor Kollie, MSc principal investigator
Ministry of Health, Liberia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leprosy and Buruli Ulcer, run by London School of Hygiene and Tropical Medicine at 1 site in Liberia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Liberia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population prevalence of Lymphatic Filariasis (time frame: Over a four month period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.