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Projects

COMBINE: Leprosy elimination by community screening and mass chemoprophylaxis in Kiribati

  • Research priorities: Transmission
  • Country: Kiribati
  • Budget: €202,024 | Project number: FP22.21
  • Duration: July 2022 - June 2026
  • Status: Ongoing

The study will determine the effect of community-wide screening and treatment for leprosy, combined with PEP for household contacts and once-off mass chemoprophylaxis of the whole population of South Tarawa/Betio on the leprosy new case detection rate.

The COMBINE study: Defining the impact of combined community-wide screening and mass chemoprophylaxis for leprosy in Kiribati: a prospective community implementation study

Project coordination

  • Pacific Leprosy Foundation

 Partners

  • Ministry of Health and Medical Services, Kiribati
  • The University of Otago
  • The University of Sydney
  • Centenary Institute

Project summary

Leprosy and tuberculosis are both spread by the respiratory route and transmission is greatly increased where there is crowding and poor economic conditions. In Kiribati the mean number of cases of leprosy reported annually over the period 2015-2019 was >1,500/1,000,000 people and for tuberculosis 4,680/1,000,000 people. The leprosy control programme in Kiribati currently includes examining the household contacts (HHC) of leprosy patients and giving them a single dose of rifampicin (SDR) as preventative therapy if they do not have leprosy. Mathematical modelling of leprosy transmission in Kiribati demonstrated that the most rapid control strategy would be to combine SDR for HHCs and mass SDR chemoprophylaxis to the community, but this has proved difficult to implement.

The COMBINE project provides a platform to screen a large population for both leprosy and tuberculosis and offer specific mass chemoprophylaxis as preventative measures for leprosy and latent tuberculosis. The tuberculosis component is building on previous studies on tuberculosis that have shown that active case finding in the community through screening and treatment substantially reduces the number of new cases of tuberculosis in succeeding years. Offering treatment for latent tuberculosis as well as screening may help reduce the incidence of tuberculosis. A combined leprosy and tuberculosis (TB) control programme will provide a model to improve delivery of treatment and preventative programmes for both conditions.

In this project, the research group aims to determine the effectiveness, operational constraints, interactions between the occurrence of leprosy and TB, and cost benefits of combined screening, treatment, and prophylaxis for leprosy and TB.

The project will be undertaken in the main population centres of Kiribati, South Tarawa and the adjacent islet of Betio, which are the epicentres of leprosy and tuberculous in Kiribati. Screening for leprosy will be by clinical examination done at the same time as chest x-rays, sputum sampling for PCR testing, and tuberculin skin tests to identify both active and latent tuberculosis. Those with suspicious skin lesions will be referred to the Skin clinic for diagnosis and treatment. Those with active tuberculosis will be treated for this according to WHO treatment guidelines and those with latent tuberculosis treated with 12 weeks of rifapentine and isoniazid. These treatments are also effective regimens to prevent the development of leprosy. All others will receive SDR as prophylaxis for leprosy.

At the end of the study the research group will be able to identify how effective the screening was been in detecting new cases, whether the number of cases has fallen compared with baseline, the acceptability of the rifampicin chemoprophylaxis, the steps needed to implement this effectively, and the costs involved. In addition, a detailed understanding of local spread of both leprosy and tuberculosis will be achieved through GPS mapping of the cases of leprosy, active tuberculosis and latent tuberculosis. This information will help other centres with high rates of leprosy and tuberculosis plan the best interventions for both conditions within their environments.

(The tuberculosis component is funded by a National Health and Medical Research Council grant from the Australian Government.)

Co-financer: Turing Foundation

Endgame strategy for leprosy in the Maldives

  • Research priorities: Transmission
  • Country: Maldives
  • Budget: €48,803 | Project number: FP22.8
  • Duration: July 2022 – December 2023
  • Status: Completed

The aim of this study is to develop an effective leprosy endgame strategy for low endemic settings.

Endgame strategy for leprosy in the Maldives: optimal targeting of post-exposure prophylaxis to interrupt transmission

Project coordination

Erasmus Medical Center

 Partners

  • The Maldives National University
  • WHO Regional Office for South-East Asia
  • Health Protection Agency, Ministry of Health (Maldives)

Project summary

The Maldives have reported 80 new leprosy cases in 32 of 189 inhabited islands during 2008-2018. Only four new child cases were detected indicating that transmission of M. leprae might be close to interruption. The Maldives is committed to make the country leprosy-free in the coming decade: to interrupt transmission (zero new child cases) and achieve zero new autochthonous leprosy cases. As part of this commitment an endgame strategy should be developed. No evidence is available yet on effective endgame strategies in a low endemic setting, such as the Maldives. It has been recommended to include contact screening and prophylactic treatment with a single-dose of rifampicin (SDR) of contacts of a patient. However, it remains unclear which strategy and what the optimal profile of the target population (e.g., close contacts or high endemic community) should be in a low-endemic island setting to ensure achievement of interruption of transmission. The group’s research question is: “What would be an optimal endgame strategy to ensure interruption of transmission of M. leprae in a low endemic setting?”

To answer this question, an in-depth descriptive analysis of the leprosy epidemiology in the Maldives will be conducted. Historic and recent cases will be analysed by age, sex, clinical type, disability grade, socio-economic status and geographic distribution to inform progress made thus far and the current state of the leprosy situation. At the same time, mathematical modelling will be applied to explore which implementation strategy of single-dose rifampicin PEP would be most effective to interrupt transmission while treating as few healthy individuals as possible. Various implementation strategies of contact tracing and screening (e.g. close contacts vs community), will be considered and prophylactic treatment with SDR of contacts. Based on these findings, a strategy will be advised to the National Leprosy Programme in collaboration with WHO and local stakeholders.

Co-financer: Turing Foundation

NTDs disabled people centered strategy to improving access to services

  • Research priorities: Disability
  • Country: Côte d’Ivoire
  • Budget: €123,970.00 | Project number: FP21.26
  • Duration: August 2021 – July 2023
  • Status: Completed

This project aims to develop an evidence-based intervention strategy to amplify the input and influence of people disabled by NTDs into programs and policies that impact their lives.

Exploring strategies and identifying effective mechanisms to mobilise persons disabled as a result of Neglected Tropical Diseases (NTD) to influence policy and programs to ensure person centered approach for affected persons in Cote d’Ivoire

Project coordination

  • effect: hope
  • National Leprosy Elimination Program Cote d'Ivoire

Partners

  • Federation Des Associations des Handicapes de Cote d'Ivoire
  • National Program NTD-MDA
  • Ministry of Health, Cote d'Ivoire

Project summary

A significant proportion of people affected by NTDs are living with permanent disabilities. The health system in Cote D’Ivoire is focused on curative services and cannot manage alone the longer term physical and socio-economic consequences on the person affected by the disease. This is likely in part due to the lack of a strong coordination mechanism involving several sectors of human development, but is also a result of competing priorities for resources and the lack of clear demand and influence of persons affected by NTDs on agenda setting and resource allocation at the policy level.

The aim of this study is to develop an evidence based intervention strategy to amplify the input and influence of people disabled by NTDs into programs and policies that impact their lives, improving their access to psychosocial, physical and economic rehabilitation services. It will be conducted in Cote d’Ivoire, an African sub-Saharan country co-endemic for 10 NTDs. It is a two phase study consisting of a formative and intervention phase.

The purpose of the formative stage is to build an understanding of the knowledge, attitudes and experience of people disabled by NTDs in relation. The formative phase will adopt a cross-sectional design using quantitative and qualitative methods, including baseline and endline surveys. Based on these findings, the project intends to develop and test interventions to mobilise NTD affected people to influence government policy and multisectoral programs towards improved access to psychosocial, economic and physical rehabilitation services. A steering committee composed of people disabled by NTDs supported by key stakeholders will develop the intervention strategy.

The intervention strategy will be piloted in the health region of Gbeke, a co-endemic region reporting a significant number of disabilities caused by NTDs. The intervention phase will facilitate the organisation of persons disabled by NTDs, reinforce their capacity, support them in the testing and validation of the intervention strategy, monitor and evaluate the implementation of the strategy and using the lessons learned and recommendations finalized the strategy and develop a toolkit and knowledge translation plan for scaling up of the strategy.

The outcomes and lessons learnt through the study will be used to develop and validate an intervention strategy and toolkit that can be used and adapted to mobilize underrepresented groups to influence the policies and programs that impact their lives. The highly transferable nature of the research output will enable scaling up and replication to other regions of Cote d’Ivoire and in other settings.

POC tests for leprosy in South America

  • Research priorities: Diagnostic tests
  • Country: Bolivia, Brazil
  • Budget: €305,484.00 | Project number: FP21.10
  • Duration: May 2021 – April 2025
  • Status: Ongoing

This project aims to identify means to

optimally implement POC diagnostic tests for leprosy and M. leprae infection in the South American Amazon.

Point-of-care immunodiagnostic tests for detection of leprosy and Mycobacterium leprae infection in high and low endemic areas in the South American Amazon

Project coordination

  • Leiden University Medical Center

Partners

  • Damien Foundation
  • Pontifícia Universidade Católica do Paraná
  • Instituto de investigaciones Biomedicas (IIBISMED)
  • Erasmus MC Medical Center

Project summary

Stable new case detection rates of leprosy are witnessed among endemic populations in many of the countries where leprosy occurs. Contact with M. leprae infected individuals is a risk factor for the development of leprosy. To facilitate timely treatment as well as reduce transmission, it is vital to both early diagnose leprosy and identify M. leprae infected individuals lacking clinical symptoms. Active case finding by screening for clinical symptoms amongst individuals at highest risk of developing disease such as contacts of (former) leprosy patients, is a proven method to early detect disease. However, this still represents a substantial hurdle in present-day leprosy health care.

The research team has previously developed low complexity diagnostics tests (similar to a glucose dipstick or a pregnancy test) that can be performed by first line health care workers in the field to detect whether and to which extent an individual is infected with M. leprae by using 1 drop of fingerprick blood. This type of test is referred to as point-of-care (POC) as it can be performed in the field by first line health care workers and requires no complicated laboratory techniques. In addition, a more extensive version of this test allows quantitative detection of multiple components (called biomarkers) that together allow identification of various forms of leprosy in venous blood of people living Bangladesh. In this study the team proposes to apply 1) POCDxv1 (for quantitative detection of anti-PGL-I antibodies as a measure of infection in large scale screening efforts) and 2) Multi Biomarker Tests (MBT; for detection of biomarker profiles associated with leprosy or M. leprae infection).

The study population will be two distinct South American populations: a hyper-endemic, former leprosy colony, located at the north western outskirts of the Brazilian Amazon, and a lesser endemic population on the south eastern side of the Amazon in Bolivia. The team aim is to 1) assess whether both tests can be used to detect infection and identify leprosy in South American populations located in Brazil and Bolivia where leprosy still occurs, 2) evaluate the feasibility to implement these low complexity tests in leprosy health care in these areas, and 3) simultaneously increase clinical expertise with regard to leprosy by training health care staff to detect leprosy.

Co-financer: Turing Foundation

Testing an App supported delivery system for Leprosy PEP services

  • Research priorities: Transmission
  • Country: India
  • Budget: €169,812 | Project number: FP21.20
  • Duration: August 2021 – February 2025
  • Status: Ongoing

This study aims to determine to what extent a mobile Application-supported SDR PEP delivery system is more effective and feasible than the present paper-based method.

Testing an App supported delivery system for Leprosy Post Exposure Prophylaxis (PEP) services

Project coordination

  • NLR India Foundation

Partners

  • NLR- until No Leprosy Remains - international office

Project summary

Leprosy still counts for around 200,000 new cases per year globally. India with around 60% of the annual new cases (120,000) remains the worst affected. Single dose rifampicin post-exposure prophylaxis (SDR PEP), a medicine is given after exposure to a leprosy case,  has been proven to be the only effective means for Leprosy prevention. It is proven to provide protection to around 60% of the contacts exposed to a Leprosy case. Though India decided to adopt SDR PEP nationally, implementation has so far been far less than optimum. A barrier may be the labour intensive and time-consuming process of SDR PEP implementation involving tracing the contacts based on new cases, listing of contacts, screening them on multiple criteria, and administration of SDR PEP to the eligible contacts. This study aims to provide evidence of efficiency of a digital PEP-delivery support system versus the traditional paper-based system for PEP activities – timely PEP administration to the eligible contacts (family, household, neighbour and social).

NLR India proposes to develop a mobile App to assist health care providers, primarily the field workers, for whom the App will be an easy to use tool for listing of contacts compared to paperwork. The App will provide a module for screening contacts based on multiple criteria instead of using their memory for using the criteria, and will readily provide the list of contacts eligible for SDR PEP and for referral for further examination and treatment for diseases like Leprosy and Tuberculosis. Before developing the App, NLR India will conduct a qualitative exploratory study, including key informant interviews and focus group discussions, to find out the reasons for the current low SDR PEP implementation. The study will be conducted in two districts of West Bengal. Participants will be the staff involved in delivery of SDR-PEP namely the Accredited Social Health Activist (ASHA), Auxiliary Nurse Midwife (ANM) and the Medical Officer of the local health facility/ primary health centre (PHC).

This information will be used for designing the App and assessing the effect of using the App for a year. If found effective, NLR India will assist the Government in scaling-up the implementation of the App supported SDR PEP program in other districts and states of India.

Co-financer: St. Francis’ Leprosy Guild
SFLG logo

  1. Pilot interventions for people with leprosy reactions in Indonesia (PIONEER)
  2. Molecular Methods in Subclinical Models of Leprosy to Test PEP
  3. Electronic Data Collection for Leprosy and LF MMDP
  4. LARS - Leprosy Antimicrobial Resistance Surveillance in PEP Setting in Tanzania

Subcategories

Diagnostic tests

Disability

Operational research

Stigma & discrimination

Transmission

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