• 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

• Research priorities: Disability
• Country: Indonesia
• Budget: €84,118.21 | Project number: FP21.14
• Duration: July 2021 - September 2024
• Status: Ongoing

This study looks at how the management of leprosy reactions be improved by the implementation of peer-counselling, participatory video and teleconsultation in Indonesia.

Improving the management of leprosy reactions and the quality of life of persons affected: developing and testing three interventions in Indonesia

Project coordination

• Vrije Universiteit Amsterdam
• Dr Soetomo General Hospital
• London School of Hygiene & Tropical Medicine

Partners

• Forum Komunikasi Difabel Cirebon
• Mimi Institute

Project summary

Leprosy reactions are serious complications of leprosy which lead to nerve function impairment, disability and other long-term consequences such as pain. In 2018, this team conducted an LRI funded study in India and Indonesia that aimed to improve the management of leprosy reactions by identifying the experiences and perspectives of people with this condition. Based on the inputs of Indonesians with leprosy reactions, three promising hypotheses of interventions were identified: peer-counselling, participatory video and teleconsultation. This study aims to co-create, pilot, evaluate and adjust these interventions in two different settings in Indonesia, to manage leprosy reactions.

The interventions will be piloted separately and as a package in leprosy endemic area in Indonesia (Surabaya and Madura) to better understand the mechanism of each idea, the interactions between them, the role of context and the advantage and disadvantage of the proposed interventions in relation to different groups of people with leprosy reactions. The aim is to involve 8 persons affected by leprosy reactions as co-implementers. All will be involved as participants in a participatory video (makers of the video). On each study site, a team of 2 will become peer counsellors, and another 2 will co-organise the participatory video gatherings and facilitate the teleconsultation groups in parallel. All will receive the complete training package. The success of the pilot will be measured through surveys, interviews and focus groups discussion before and after the implementation. The survey measurements will allow to assess how much participants in the pilot are better able to deal with issues relating to the different measured domains, and the interviews and focus groups part will explore the participants’ experience and perceptions of the intervention, what is working and what is not, for what reason and how we can improve.

• Research priorities: Transmission
• Country: USA
• Budget: €54,187 | Project number: FP21.8
• Duration: January 2022 - December 2023
• Status: Completed

This study seeks to determine which rifampin-containing treatment modality is the most effective leprosy PEP regimen regardless of a) the immune status of the host and b) whether the leprosy infection is caused by M. leprae or M. lepromatosis.

The Use of Molecular Methods in Subclinical Murine Models of Leprosy to Examine the Efficacy of Proposed Post-Exposure Prophylaxis (PEP) Regimens

Project coordination

• IHRC, Inc,
• National Hansen’s Disease Program

Project summary

While multidrug therapy has considerably reduced the global impact of leprosy by lowering the overall prevalence of disease, it has not eliminated the incidence of new cases, particularly in areas of high endemicity. This indicates that transmission of leprosy is ongoing despite effective treatment. Persons with subclinical leprosy infections, possibly acquired from contact with confirmed leprosy cases, are believed to be one of the leading causes of this continuing transmission in areas with a high number of cases. Treatment of those known to have been exposed to leprosy, also known as post-exposure prophylaxis (PEP), could decrease the level of subclinical infections and, subsequently, transmission of the disease from person to person. This study will evaluate various PEP regimens and provide experimental evidence on their level of effectiveness. In order to achieve this, subclinical infections with leprosy bacteria will be established in three different mouse strains (Balb/c, Interferon-γ knockout (GKO), and athymic nude), which have distinct levels of immune competence. Upon infection, each of these strains exhibits features consistent with specific areas across the leprosy spectrum. Therefore, the team will model the interplay of the host immune status with the different PEP drug treatments. Drug efficacy will be evaluated using state-of the-art genetic tests with high specificity and sensitivity. The goal is to determine the most effective PEP regimen, regardless of the level of immune functionality in the host. Furthermore, the study will compare the efficacy of the different regimens against subclinical infections of both Mycobacterium leprae and Mycobacterium lepromatosis to ascertain if there is any difference in the treatment required between these two leprosy-causing bacterial species. In summary, this study is aimed at determining PEP regimens that are effective against both M. leprae and M. lepromatosis, regardless of the functioning of the host immune system or the lack there of. The study will provide useful experimental information to assist in the design of future PEP clinical trials.

Co-financer: Turing Foundation

• Research priorities: Operational research
• Country: Ghana
• Budget: €85,013.50 | Project number: FP21.17
• Duration: February 2021 - June 2024
• Status: Ongoing

This project looks at how electronic data collection tools could be used to support the collection of disease data, specifically illness, disability or conditions that result from having the disease.

Assessing Electronic Data Collection Tools, Pathways and HMIS Integration for Leprosy and LF MMDP Data to Improve Service Delivery

Project coordination

• American Leprosy Missions

Partners

• Damien Foundation Belgium
• Institute of Tropical Medicine Antwerp

Project summary

The primary research question asks how electronic data collection tools can be used to support the collection of morbidity management and disability prevention (MMDP) data and the implementation of a comprehensive and integrated morbidity management program for leprosy and lymphatic filariasis (LF) in various countries.

This study will look at the advantages and disadvantages of different data platforms currently being tested or used at the time of the study and makes recommendations about which features are crucial to functionality, usability, and sustainability.  The study will also examine the essential morbidity-related data required to manage a comprehensive and integrated MMDP program and advise on how it can be collected, shared, and utilized.  These findings address a critical gap related to information for MMDP interventions and could likely be adapted broadly to fit various country contexts.

Currently, very little reliable epidemiological data is available about disability in either leprosy or LF. Most data collected is concerned with only patient estimates so they can be identified for follow-up MMDP services, but little data is collected on the actual provision of those services at the patient-level.  For patients needing MMDP services, we often don’t know what degree of disability they have or information on treatment, reactions, or progress.  While some data may be available in small project areas, such data are rarely routinely collected, integrated into other data collection tools or databases, and available at the national level, resulting in limitations for national planning and decision making.

With the growth of cost-effective mobile, electronic data collection tools, there is an opportunity to apply these tools to support MMDP, improved care, and more positive patient outcomes.   Relevant data could be collected electronically, uploaded to a central database, made available to key stakeholders, and used to support national program planning, service provision and inform training and capacity building.   Developing a user-friendly system could allow for regular data collection and updating, and information sharing for all health system levels. Making information accessible to those providing care could be a critical factor for appropriate follow-up, treatment, and care, thus reducing and preventing disability.