• 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.

• Research priorities: Transmission
• Country: Tanzania
• Budget: €140,337.00 | Project number: 708.20.14
• Duration: June 2021 – May 2024
• Status: Ongoing

This study proposes to build a reference laboratory for AMR surveillance in Tanzania which will be used in the frame of the PEP-SDR project and beyond.

Leprosy Antimicrobial Resistance Surveillance in Post Exposure Prophylaxis Setting in Tanzania (LARS)

Project Coordination

• National Institute of Medical Research Mwanza

Partners

• National program for TB and Leprosy MoH
• Universite de Paris
• German Leprosy and TB Relief Association (GLRA)
• Swiss Tropical and Public Health Institute
• Colorado State University

Project summary

In Tanzania, the prevalence of leprosy has declined over the past three decades, but the annual case detection rate remains high in over twenty high-endemic districts that show evidence of continued transmission of leprosy despite extensive leprosy elimination campaigns. Post-exposure prophylaxis (PEP) with single dose rifampicin (SDR) for close contacts of leprosy patients is among the most promising new tools to control leprosy transmission. Two post-exposure prophylaxis (PEP) with single dose rifampicin (SDR) studies are ongoing or will soon be initiated in Tanzania: one in the framework of leprosy post-exposure prophylaxis program (LPEP, 2015) and the other (PEP4LEP - EDCTP). The risk of rifampicin resistance selection by PEP-SDR is one of the key concern in the field. This fear is reinforced in Tanzania by the restriction of the rifampicin to tuberculosis patients. Beside drug resistance, another concern of PEP-SDR is its impact on strain selection. These aspects has never been investigated in leprosy neither the rapidity of positive selection under such environmental pressure. Currently, there is no local laboratory reference for drug-resistance observation of M. leprae (Mycobacterium), and no information is available regarding the current level of drug resistance in Tanzania.

Herein, this project aims to:

1)           Determine the level of Anti-Microbial Resistance (AMR) in M.leprae in Tanzanian districts where Single Dose Rifampicin-Post exposure Prevention (SDR-PEP) is implemented compared to non-Single Dose Rifampicin-Post exposure Prevention (SDR-PEP) districts with identification of mutations in the drug-resistance-determining region (DRDR) in 750 newly identified leprosy patients.

2)           Develop/Build local capacities for conducting Anti-Microbial Resistance (AMR) observation in M.leprae in Tanzania

This will be achieved by sequencing skin samples from 750 new diagnosed leprosy patients in three years in different districts with different PEP implementation status.

Capacity building will be done during this project in implementing a national leprosy drug resistances laboratory.

Additional 150 samples will be stored to study at a later timepoint the genetic diversity of M.leprae strain in districts with and without Single Dose Rifampicin-Post Exposure Prevention (SDR-PEP) using M.leprae whole genome (genetic makeup) sequencing.

Co-financer: German Leprosy and TB Relief Association (GLRA)

• Research priorities: Stigma and discrimination
• Country: Ethiopia
• Project no.: 708.20.17
• Budget: € 203,209
• Duration: October 2020 – September 2023
• Status: Ongoing

Full project tilte:
Assessing the effectiveness of family-based approaches aimed at prevention and sustainable self-management of disabilities, impacting the quality of life, mental wellbeing and participation of people with leprosy, podoconiosis and lymphatic filariasis and their families in the Amhara region, Ethiopia

Project coordination
Ethiopian National Association of People Affected by Leprosy (ENAPAL)

Partners
Debre Markos University
Disability Studies Nederland

Aim: This study aims to assess the effectiveness, longer-term outcomes and sustainability of the family-based approach aimed at prevention and sustainable self-management of disabilities due to leprosy, LF and podoconiosis, impacting the quality of life, mental wellbeing and participation of affected persons and their families in Ethiopia. 

Project summary
People with leprosy, lymphatic filariasis (LF) and podoconiosis often experience restrictions in their daily lives, due to their impairments. Most impairments can be prevented when self-management is practised. There have been efforts to formulate self-care groups, in which people meet and support each other on a regular basis. However, the involvement of families in preventing disabilities has received little attention, while this is a much more practical and sustainable approach. In another LRI-funded project, a family-based approach has successfully been piloted among persons affected by leprosy, LF and podoconiosis and their family members in the Awi zone, Ethiopia. This family-based approach consists of awareness raising, disability management and socio-economic empowerment.

In the previous project only the short term outputs and impact of the approaches have been studied in a small sample. Effectiveness of the family-based approach cannot be studied in such a small sample and with a relatively short follow-up time. To date most prevention of disability effectiveness studies have been flawed by failing to use a randomised controlled design. This has resulted in a lack of evidence about the effectiveness of these interventions. To collect credible evidence for this new, previously piloted family-based approach, the current study will use a randomised controlled design. A randomised controlled design is the most rigorous way of determining whether a cause-effect relation exists between intervention and outcomes.

In this three-year study, researchers aim to assess the effectiveness, longer-term outcomes and sustainability of the family-based approach aimed at prevention and sustainable self-management of disabilities due to leprosy, LF and podoconiosis, impacting the quality of life, mental wellbeing and participation of affected persons and their families in Ethiopia. The research question of this project is "how effective is the family-based approach aimed at prevention and sustainable self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis compared to usual practice and care?"

Impact

The cross-cultural validation of the Beach Center Family Quality of Life Scale among persons affected by leprosy or podoconiosis in Northwest Ethiopia. Aycheh M, Noordende A, Moges N, et al. PLoS neglected tropical diseases. 2023; 17 (10) : 1-15.