Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03683745 |
Other study ID # |
14698-1 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 14, 2018 |
Est. completion date |
December 30, 2018 |
Study information
Verified date |
June 2024 |
Source |
London School of Hygiene and Tropical Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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. 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.
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.