• 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. 

• Research priorities: Stigma and discrimination
• Country: Nigeria
• Budget: €199,933 | Project number: 708.20.15
• Duration: July 2020 - June 2024
• Status: Ongoing

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

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

Project coordination

• German Leprosy and TB Relief Association (GLRA)

Partners

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

Project summary

Leprosy and Buruli ulcer (BU) co-exist in many States across Nigeria. Both are diseases of public health importance and are often associated with high levels of stigma and discrimination owing to their tendency to cause visible deformities. In 2018, Nigeria reported 2095 and 424 as number of persons suffering from leprosy and BU respectively. The number of persons disabled as a result of these diseases is unknown but it is estimated to be over thirty thousand.

Over time, stigma and discrimination negatively impact the well-being and mental health of persons with these diseases, resulting especially in depression or anxiety. Mental health services in Nigeria suffer from multiple gaps. It is estimated that there is only one mental health expert for hundreds of thousands of inhabitants. The few available professionals are disproportionately based in urban areas, leaving the millions of rural dwellers grossly underserved. This is especially so for the poor and marginalized like many leprosy and BU sufferers. This is compounded by poor funding of the health sector by the federal government. In 2017 and 2018, budgetary allocations to health were 4.16% and 3.9% respectively. There is need to explore sustainable ways to make mental health services accessible to those in dire need, especially persons affected by leprosy and BU.

Some studies show that a community-oriented approach run by trained lay persons (without specialist mental health background) with appropriate supervision, can improve access to effective, acceptable and cost-effective mental health services.

This project has a dual objective: 1) to determine the burden/extent of mental illness (especially depression) among persons affected by leprosy or BU 2) and ascertain whether a holistic (multi-layered) community-oriented approach involving patient self-help groups, lay community counsellors and non-specialist health workers improves the mental health and well-being of leprosy/BU patients in southern Nigeria.

It is believed that the use of self-help groups (SHG), lay community counsellors and trained health workers will reinforce and complement each other in a synergistic manner, resulting in outcomes superior to approaches based on health workers alone.

During the 4-year project period, ten local government areas with highest number of leprosy/BU patients in southern Nigeria were selected. Advocacy visits to relevant groups will precede training of lay community counsellors to provide counselling for patients identified to have depression or anxiety and promote social participation. Self-help groups will be established to provide enabling platform for peer-support through regular interactions/meetings, reduce self-stigma and promote self-esteem among patients. Trained health workers will ensure effective treatment and/or adequate referral services for patients. At the end of project, patients will be re-assessed to determine any difference in their mental health status and quality of life.

• Research priorities: Disability
• Country: Indonesia
• Project no.: 708.20.04
• Budget: €199,946
• Duration: December 2020 – November 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 University
University 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

• Research priorities: Transmission
• Country: India
• Budget: € 199,390 | Project number: 708.20.09
• Duration: July 2021 - June 2026
• Status: Ongoing

This study aims to investigate the effect of Mycobacterium indicus pranii (MIP) vaccine on appropriate cell lines as well as individual immune cell population.

Molecular Mechanisms of Immunomodulation Imparted by Mycobacterium indicus pranii (MIP) vaccine against multibacillary leprosy

Project coordination

• ICMR National Institute of Research in Tribal Health, Jabalpur, India

Partners

• The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat, India

Project summary

Multibacillary (MB) leprosy is a form of leprosy in which most patients have a high bacillary load, which can contribute to further transmission. Treating these patients with MDT can help in curing leprosy, but it doesn't protect them from re-infection.

It has been shown that when given in conjunction with MDT, the Mycobacterium indicus pranii (MIP) vaccine is able to modulate the immune response (immunomodulation) how to respond to M. leprae. It helps in containment of the leprosy bacilli by arranging immune cells around M. leprae, checking their multiplication, and eventually fighting them off in most of the cases.

While it is known that there is an improvement in treatment outcome in the patients when MIP is given along with MDT, the mechanisms behind it are not known. Previous studies in tuberculosis didn't show any significant differences between MIP vaccinated and a non-vaccinated group of people due to high level of heterogeneity. The heterogeneity is most likely coming from the heterogeneous mix of various cell types in whole blood or PBMC samples, as different types of cells perform different roles.

The research groups aims to address this inherent limitation by quantitative analysis of characteristic immune cell markers. They will do this by using Flow Cytometry and analyse the response to M. leprae antigen by stimulating with leprosy bacilli antigens. They intend to perform this investigation by separating different population of the immune cells using antibodies (immunoseparation), and perform RNA-Sequencing to know differential signature of gene expression in vaccinated and non-vaccinated group of patients in conjunction with MDT.

Co-financer: Turing Foundation