Projects
- 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
Partners
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
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
- Research priorities: Disability
- Country: Bangladesh, India
- Budget: € 197,213 | Project number: 707.19.21
- Duration: January 2020 – April 2026
- Status: Ongoing
This study aims to assess the effectiveness of additional doses of Clofazimine in reducing frequency and severity of ENL.
Does additional clofazimine for MB cases at high risk of ENL improve their prognosis/outcome over 2 years?
Project coordination
Project summary
Erythema nodosum leprosum (ENL) is an unpleasant complication of leprosy which can lead to considerable suffering, impaired quality of life, and long term disability. Clofazimine has long been used to reduce severity and recurrence of ENL, however, there is limited published evidence for its effectiveness.
This study intends to test the effectiveness of additional Clofazimine in reducing the incidence and severity of ENL. One group of patients who are suffering from ENL reactions will receive extra doses of Clofazimine for 6 to 12 months. The other group of patients suffering from ENL reactions will be given placebo vitamin tablets to compare the difference in well-being between the two groups. Both groups will also receive standard treatment with steroids, the same as given to people who are not in the trial.
Research question: Does 6- 12months additional administration of Clofazimine medicine to patients under the leprosy treatment or within 12 months of the completion of the treatment and once suffered from ENL reactions, reduce the frequency and severity of the reaction and its consequences in them and possibly have a beneficial effect on their nerve function during the observation period of 24 months.
The research group will assess the results in each group by using standard scales for ENL severity. This will also be done for quality of life as well as nerve damage, and the amount of steroid medication needed. The results will help doctors decide best treatments for ENL patients in future.
Co-financer: Turing Foundation
- Research priorities: Disability
- Country: Indonesia, Nepal
- Budget: € 153,321 | Project number: 707.19.20
- Duration: September 2020 – December 2024
- Status: Ongoing
This study aims to reduce the incidence of dapsone allergy on leprosy patients, by testing the patients’ blood for a genetic markerbefore they receive dapsone as part of their treatment.
Implementation of Dapsone Hypersensitivity Syndrome (DHS) Biomolecular Predictive Test to reduce the incidence of DHS among Leprosy Patients in Papua and Nepal
Project coordination
Partners
Project summary
Leprosy can cause permanent disability, especially if diagnosis and treatment is delayed. Leprosy patients are treated with multi-drug therapy (MDT) for 6-12 months consisting of: dapsone, rifampicin and clofazimine. Dapsone is taken daily. Unfortunately, for some people, dapsone may cause an allergy called dapsone hypersensitivity syndrome (DHS). Dapsone hypersensitivity may cause irreversible organ failure and may be life threatening. Many patients have to be hospitalized for weeks or months or receive intensive care due to DHS. DHS is very severe and traumatic and worsens the stigma of leprosy in the community.
Papua and Mollucas are islands with the largest leprosy population in Indonesia. In those regions, dapsone allergy has an incidence of 3%, with deaths reported in an estimated 10% of dapsone allergy cases. In Nepal, approximately 2% of Anandaban Hospital’s leprosy patients develop dapsone allergy after initiating MDT.
This study aims to reduce the incidence of dapsone allergy on leprosy patients in Papua, Mollucas and Nepal by testing the patients’ blood before they receive dapsone as part of their MDT. As previously shown by the research group, a special blood DNA test can be used to identify if the patient is at high risk for developing dapsone allergy. This test can predict up to 85% of cases that may develop dapsone allergy.
If the patient has the DNA marker, they are at risk for dapsone allergy, and they should not take dapsone for leprosy or any other sickness for the rest of their life. If the marker is absent in the DNA test, the patient is at low risk for dapsone allergy. However, they should still be careful to note any symptoms over the first 4-6 weeks of treatment and notify their doctor of any changes. They could still be in the 15% of cases who develop dapsone allergy without the DNA marker (< 0.5% of leprosy cases).
This study will also provide DNA test instructions in an online, open access publication so that leprosy care providers around the world can use it in clinical settings to better protect patients from dapsone allergy.
Co-funder: Turing Foundation