• Grant: LRI Regular Grant
• Budget round: 2020
• Research priorities: Transmission
• Country: Tanzania
• Project no.: 708.20.14
• Budget: €140,337
• Duration: June 2021 – December 2026
• Status: Ongoing
• Co-funding partners: German Leprosy and TB Relief Association (GLRA)

Full project title:
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

Aim: 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.

 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.

• Grant: LRI Regular Grant
• Budget round: 2020
• Research priorities: Stigma and discrimination
• Country: Ethiopia
• Project no.: 708.20.17
• Budget: € 203,209
• Duration: October 2020 – September 2025
• Status: Completed

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 UniversityDisability Studies Nederland

Aim: This study assessed 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. 

Final project summary:
Leprosy, podoconiosis, and lymphatic filariasis (LF) are neglected tropical diseases (NTDs) that can lead to long-term disability when diagnosis and treatment are delayed. While leprosy can affect the eyes, hands, and feet, podoconiosis and LF primarily cause swelling of the lower limbs and recurrent episodes of painful inflammation. The consequences of these conditions extend beyond physical health, often affecting mental well-being, family life, social participation, and economic opportunities.

Recognising the important role that families play in supporting people affected by these diseases, this study evaluated a family-based intervention designed to improve disability management, enhance quality of life, and reduce stigma. Unlike earlier studies, the project used a rigorous cluster randomized controlled trial to assess both the effectiveness and the long-term sustainability of the intervention compared with routine care.

The study was conducted in the East and West Gojjam Zones of Ethiopia and involved 832 people affected by leprosy, podoconiosis, or lymphatic filariasis, together with their family members. Before implementing the intervention, the research team adapted and validated several tools in Amharic to ensure they could reliably measure family quality of life, stigma, and participation restrictions within the local context.

The intervention combined health education, disability management, socioeconomic support, psychosocial support, and community strengthening activities. Participants received information about their condition to improve understanding and reduce stigma, while practical training focused on self-care and disability management, including proper care of affected eyes, hands, feet, and legs. Families received essential materials such as shoes, socks, soap, and buckets to support self-care practices. The programme also promoted mental well-being, encouraged family involvement, and strengthened existing disability associations while supporting the development of new community support groups.

Data were collected before the intervention, immediately after completion of the programme, and again one year later. The findings demonstrated substantial and lasting benefits for participants and their families.

The intervention led to significant improvements in physical health. Among people affected by leprosy, problems involving the eyes, hands, and feet decreased considerably. Participants living with podoconiosis or lymphatic filariasis experienced meaningful reductions in swelling, with foot circumference decreasing by up to three centimetres and leg circumference by an average of two centimetres. The study also found fewer wounds, infections, and other complications associated with these diseases.

Participants who had previously experienced frequent acute attacks reported a marked reduction in these episodes following the intervention. As a result, they experienced greater comfort, improved mobility, and were better able to work, care for their families, and participate in everyday community life.

The programme also had a significant positive impact on family well-being. Measures of family quality of life improved steadily throughout the intervention and remained high one year later, suggesting that the benefits were sustained over time. This highlights the value of involving family members in care and support, rather than focusing solely on the individual affected by the disease.

Beyond the physical improvements, participants reported important social and psychological benefits. Experiences of stigma decreased, people felt less isolated, and symptoms of depression were reduced. Many participants reported greater confidence and increased participation in community activities. Families also gained a better understanding of the diseases and developed more positive attitudes towards disability, helping to create a more supportive home environment.

Overall, this study demonstrates that a family-based approach can significantly improve the lives of people affected by leprosy, podoconiosis, and lymphatic filariasis. By integrating medical care, self-care education, psychosocial support, and practical assistance, the intervention delivered lasting improvements in health, well-being, and social inclusion. The findings provide strong evidence that family-centred approaches can play a vital role in reducing disability and stigma and should be considered in future NTD programmes and policies in Ethiopia and other similar settings around the world.

Impact

van't Noordende, A. T., Aycheh, M. W., Moges, N. A., Tadesse, T., & Schippers, A. P. (2022). Family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis versus usual care in Ethiopia: study protocol for a cluster-randomised controlled trial. BMJ open, 12(3), e056620.

Aycheh, M. W., van’t Noordende, A. T., Moges, N. A., & Schippers, A. P. (2023). The cross-cultural validation of the Beach Center Family Quality of Life Scale among persons affected by leprosy or podoconiosis in Northwest Ethiopia. PLoS Neglected Tropical Diseases, 17(10), e0011235.

Aycheh, M. W., van’t Noordende, A. T., Moges, N. A., & Schippers, A. P. (2026). Family quality of life and associated factors among people with leprosy or podoconiosis/lymphatic filariasis with visible disabilities and their family members in Ethiopia: a baseline study for a randomized controlled trial. Transactions of the Royal Society of Tropical Medicine and Hygiene, 120(3), 199-210.

• Grant: LRI Regular Grant
• Budget round: 2020
• Research priorities: Stigma and discrimination
• Country: Nigeria
• Project no.: 708.20.15
• Budget: €199,933
• Duration: July 2020 - June 2024
• Status: Completed

Project coordination
German Leprosy and TB Relief Association 

Partners
National TB, Leprosy and Buruli ulcer Control Programme
Ebonyi State University
CBM International

Aim: This study aimed to determine the burden of mental illness (especially depression) among persons affected by leprosy or Buruli ulcer,  and whether community-oriented approach improves their mental health and well-being.

Full project title:
Improving mental health and quality of life of persons affected by leprosy or Buruli ulcer in Southern Nigeria

Final project summary:
For many people affected by leprosy and Buruli ulcer (BU), the challenges extend far beyond the physical symptoms of disease. Visible deformities and disabilities often lead to stigma, discrimination, social exclusion, and loss of self-esteem. Over time, these experiences can have a devastating impact on mental health, contributing to depression, anxiety, and a diminished quality of life. Yet in Nigeria, access to mental health services remains limited, particularly for people living with neglected tropical diseases.

To address this critical gap, a pioneering research project was implemented in southern Nigeria to explore sustainable ways of making mental health support accessible to people affected by leprosy and Buruli ulcer. The project sought to determine the extent of mental health challenges within this population and evaluate whether a holistic, community-based approach could improve their well-being.

The intervention was built around a coordinated three-tier support system involving patient self-help groups, trained community lay counsellors, and frontline healthcare workers. The idea was simple but powerful: by combining peer support, psychosocial counselling, and improved access to mental health care, patients would receive comprehensive support that addressed both their emotional and social needs.

The study was conducted across ten Local Government Areas with the highest burden of leprosy and Buruli ulcer cases in southern Nigeria. Prior to implementation, advocacy visits were carried out to engage key stakeholders and build community support. Twenty-five community lay counsellors were trained to provide psychosocial counselling, identify symptoms of depression and anxiety, and encourage social participation among affected individuals. In addition, twenty-five frontline healthcare workers received training to strengthen mental health service delivery, including treatment and referral pathways. Thirty-three self-help groups were also established, creating safe spaces where people affected by leprosy and BU could support one another, share experiences, rebuild confidence, and combat self-stigma.

The study enrolled 635 participants at baseline and followed 543 participants through to the end of the project. During implementation, the team delivered 650 counselling sessions and facilitated 392 self-help group meetings, providing sustained support to participants throughout the intervention period.

Among participants in the intervention areas, the proportion experiencing symptoms of depression dropped dramatically from 94.5% at baseline to just 2.4% after the intervention. Similarly, anxiety levels declined from 84.5% to 2.4%. At the same time, positive mental well-being increased from 22.7% to 100%, while the proportion reporting a good quality of life rose from 23.5% to 96.5%.

In contrast, participants in the control areas—where the intervention was not implemented—experienced worsening outcomes. Rates of depression increased from 83.5% to 98.8%, and anxiety rose from 72.5% to 96.5%. Measures of mental well-being and quality of life declined significantly over the same period.

Beyond the impressive findings, the project demonstrated the transformative power of community-based mental health care. By empowering affected persons to support each other, equipping community members with counselling skills, and strengthening health systems to respond to mental health needs, the intervention restored hope, dignity, and social inclusion for hundreds of individuals.

The impact of this work extended beyond the communities involved in the study. The evidence generated has influenced national policy, with the Federal Ministry of Health of Nigeria adopting the model for nationwide implementation. This represents a major step forward in integrating mental health services into programmes for neglected tropical diseases and ensuring that people affected by leprosy and Buruli ulcer receive the holistic care they deserve.

This project demonstrates that even in settings with limited mental health resources, innovative community-driven approaches can achieve extraordinary improvements in mental well-being, quality of life, and social inclusion—offering a scalable model for addressing mental health needs among vulnerable populations across Nigeria and beyond.

Impact

Ossai, E. N., Ekeke, N., Esmai-Onyima, A., Eze, C., Chinawa, F., Iteke, O., ... & Anyaike, C. (2024). Understanding the burden of poor mental health and wellbeing among persons affected by leprosy or Buruli ulcer in Nigeria: A community based cross-sectional study. Plos one, 19(6), e0304786.

Ekeke, N., Ossai, E. N., Kreibich, S., Onyima, A., Chukwu, J., Nwafor, C., ... & Eze, C. (2022). A cluster randomized trial for improving mental health and well-being of persons affected by leprosy or Buruli ulcer in Nigeria: A study protocol. The International Journal of Mycobacteriology, 11(2), 133-138.

Ekeke, N., Ukwaja, K. N., Onyima-Esmai, A., Ossai, E., Chinawa, F., Chukwu, J., ... & Murphy-Okpala, N. (2026). Translation and validation of the Igbo version of the Warwick–Edinburgh Mental Well-being Scale in Nigeria. International Health, ihaf150.

• Grant: LRI Regular Grant
• Budget round: 2020
• Research priorities: Disability
• Country: Indonesia
• Project no.: 708.20.04
• Budget: €199,946
• Duration: December 2020 – December 2025
• Status: Ongoing
• Co-funding partners: Turing Foundation

Full project title:
Efficacy and Tolerability of Adjunct Metformin in Combination with Standard Multidrug Treatment for Multibacillary Leprosy: A Randomized Double-blind, Controlled Proof-of-Concept Trial in Indonesia

Project coordination
Oxford University

Partners
Gadjah Mada UniversityUniversity of Diponegoro

Aim:  This study aims to investigate a new treatment strategy to limit or prevent the development of leprosy reactions and its consequences.

Project summary
Presently, the standard treatment of leprosy is with a combination of three antibiotics, also referred to as multidrug therapy (MDT), often given for one year. One of the main challenges of MDT is the occurrence of so-called leprosy reactions, which is a strong inflammatory response of the body’s immune system to the leprosy infection. This can happen in about 30 to 50% of all patients and can cause nerve injuries leading to disabilities and deformities. Leprosy reactions are very difficult to treat as they are often chronic and recurrent. This means that many people who have a leprosy reaction need to use medicines that suppress the inflammation, called corticosteroids, for long periods of time. However, corticosteroids have many serious side-effects, such as diabetes, osteoporosis, psychological and eye problems, and susceptibility to (severe) infections.

Therefore, this study aims to investigate a new treatment strategy to limit or prevent the development of leprosy reactions and its consequences. The researchers want to find out whether a medicine called metformin, if given in combination with standard MDT, can kill the leprosy bacteria faster, prevent or limit leprosy reactions, and thus reduce the need for corticosteroids. Metformin is a cheap and safe drug that has been used for over decades in the treatment of people with diabetes, and is now receiving renewed interest as a promising drug that can have a positive effect on how the body’s immune system reacts to infections.

A team of researchers from Indonesia and abroad proposes to conduct a clinical trial involving 110 people who have been newly diagnosed with multibacillary leprosy in Indonesia. The study participants will be randomly divided into two groups: one will receive metformin and the other will receive a placebo (an inert drug) for a period of half a year. Both groups will, at the same time, start with the standard MDT, given for a full year.

Through this clinical trial, researchers hope to find out whether the use of metformin is safe and well-tolerated by the volunteers. They also hope to see that metformin could protect against the occurrence of leprosy reactions. Hopefully, the information provided by the research will help to improve the treatment of patients with leprosy in the future, by preventing disabilities and deformations, both in Indonesia and worldwide.

Impact

Picturing health: the burden of leprosy in eastern Indonesia Pieter Y, Grijsen ML. The Lancet. Elsevier BV. 2022; 399 (10335) : 1588-1599. 

Metformin as adjunctive therapy in combination with multidrug treatment for multibacillary leprosy: A protocol for a randomized double-blind, controlled Phase 2 trial in Indonesia (MetLep Trial) https://wellcomeopenresearch.org/articles/8-289/v1