Over the last four years, The Leprosy Mission has been part of a major project that aims to transform the treatment and prevention of leprosy and Buruli ulcers in low and middle-income countries.
This multi-year, three-country project is taking place alongside support from the University of Birmingham in the UK and uses funding awarded by the NIHR in the UK through its Research and Innovation for Global Health Transformation (RIGHT) call.
All arms of this large study are looking at treating and preventing ulcers. Some teams are considering this from a clinical level and others are looking at the community and socio-economic contributors to ulcer prevention and care.
Over the coming pages we will talk you through how The Leprosy Mission is contributing to this RIGHT project in India, Nigeria, and Nepal.
You can find out more about the RIGHT Call funding is being implemented on the University of Birmingham's website.
Cover photo credit: Sabrina Dangol
The RIGHT project in India is comprised of four studies, primarily in Chhattisgarh. Although India as a nation has a prevalence of leprosy that is less than 1 case per 10,000 population, Chhattisgarh is a highly endemic state and has an endemicity of more than 1 in 10,000 population. The higher prevalence of leprosy and the number of cases with leprosy-related disability made it an obvious choice for their four RIGHT studies.
The first study looks at the sustainability of self-help groups. The Leprosy Mission in India had been running self-help groups in Champa in Chhattisgarh for a number of years, offering support in areas like self-care and livelihoods. The groups were ready to operate on their own, and so The Leprosy Mission was removing its support and funding for the groups. This prompted the RIGHT team to evaluate the groups’ sustainability.
The RIGHT team wanted to understand what factors were crucial to either the success or the failure of the sustainability of the self-help groups; what were the barriers and what were the facilitators?
They also wanted to understand the key benefits that members received from the groups. If the groups encouraged members to maintain their self-care practices, this would be a victory in the battle against ulcers. Equally, if the self-help groups helped members to access livelihoods that would reduce their risk of ulcers, this would be another victory.
To conduct their analysis, the team chose five self-help groups in Champa and interviewed two groups of people related to the self-help groups. The first group of people are those who are directly involved in the running and maintenance of the self-help groups and the second group of people were those that were not directly involved, but were aware of what was happening, people like village leaders and local healthcare workers.
The RIGHT team conducted interviews with more than 40 participants and are now going through the process of reviewing thousands of pages of interview notes. They are hoping to publish their results in August 2023.
TLM’s team in India are working with the government health system in Chhattisgarh on health system strengthening measures. Study 2 is looking at the success of these efforts, but is also seeking to fill a significant gap in our efforts to tackle leprosy ulcers: data. There is no significant data on the prevalence of ulcers, which makes it hard for us to achieve and measure significant progress on ulcer care and prevention.
The first element of the project was the evaluation of health system strengthening in Chhattisgarh. The team in India are calling this the Replicable Model Project because they hope to understand how this model of system strengthening could be replicated elsewhere in India and around the world.
The first part of the evaluation of the Replicable Model is qualitative. They want to understand whether training local health workers was effective, whether the workers retained the information, whether leprosy screening practices have improved, and whether the pathways to further care have been strengthened.
To understand this they have been interviewing people within the government health system to ask what they have learnt and what could have improved the process and their understanding. The RIGHT team have also been observing the local health workers while they work, to see whether they are applying what they have learnt. They hope to understand from this which of the project’s activities were mission-critical (to facilitate early detection of new leprosy cases) and what needs to be included in any attempts to replicate the project elsewhere.
The evaluation also includes undertaking quantitative analysis, which saw the RIGHT team take five years of leprosy data from Champa district, Chhattisgarh before the project started and compare it data after the first two years of the Replicable Model Project implementation. Similar data is being collected concurrently in another district, where no such intervention was implemented; this will be used as a comparative group to help us see the actual effect of the intervention. They want to see if the project has led to an increase in case finding and if this will go on to an eventual decrease in the number of cases as transmission is interrupted. They will also evaluate whether this project has led to fewer visible disabilities at the time of diagnosis. They hope to have an analysis ready by June 2024.
The second element of Study 2 aimed to understand the prevalence of ulcers and disabilities due to leprosy in Champa district, Chhattisgarh. To do this, they took five years of patients’ data from Champa district so they could trace each of these patients to assess their ulcer situation and disability status. They now have a database of more than 670 ulcer patients, which is critical for Study 3.
The overarching plan for the RIGHT project was to develop self-care guidelines that could be contextualised within local contexts and evaluated.
To do this, the team first needed to understand the prevalence of ulcers, as well as the size and frequency of the ulcers. The database that the team created through Study 2 has become a landmark for ulcer studies and enabled them to embark on Study 3: an evaluation of the implementation of locally contextualised international self-care guidelines developed by RIGHT team.
These locally contextualised self-care guidelines were given to the Replicable Model Project team to implement; the RIGHT team wanted to see whether a crucial cog in the local health system could be utilised to implement the self-care guidelines: the Mitanins.
Mitanins (known as ASHA – Accredited Social Health Activist - workers in other parts of India), are healthcare workers who are the point of contact for many different disease control programmes. Their main focus was once maternal and child health, but their role has expanded and they are trusted by community members.
Study 3 will see the Replicable model project team train a group of healthcare workers (trainers of Mitanins) on how to follow the self-care guidelines. These healthcare workers will then train the Mitanins, and the Mitanins will go on to train the patients in a cascading manner.
The RIGHT team want to understand whether this process works, so they will observe the Mitanins at work and they will evaluate over time the prevalence of ulcers, as well as the number and size of the ulcers and overall disability due to leprosy. This will involve follow-ups with patients at 3, 6, and 12 month markers. They will use the WHO’s Eye-Hand-Foot as a crucial monitoring metric for overall disability.
The RIGHT team also want to understand the psychosocial impact of the intervention, whether this led to a better quality of life for ulcer patients. They want to understand, if we can reduce the ulcers and disability, will this lead to more participation in society?
The self-care guidelines provide for everything from self-care practices to access to assistive devices and referrals for secondary-level care (such as surgery). If the Mitanins can implement the guidelines effectively in Chhattisgarh, it would prove transformative for ulcer patients.
Ulcers are best able to heal when you are able to reduce the pressure on them. In a past edition of TLM’s Research Magazine we looked at a new design for an offloading device that would allow patients to more easily maintain their daily activities whilst keeping pressure off their wound.
Study 4 in India is looking at the efficacy of this LRI-funded offloading device project, with a particular focus on whether it can be implemented in the community in ulcers caused by leprosy and diabetes.
TLM’s physiotherapists will visit communities and set patients up with their own offloading devices. The RIGHT team will then monitor whether these devices, and their implementation in the community when compared to routine care provided in the community (micro-cellular rubber footwear), will lead to better ulcer outcomes. They want to understand whether feasibility of community implementation of these devices is acceptable and can still lead to faster healing of ulcer.
This study is also being run in Nepal, to expand the number of participants they can recruit to the study.
In Nigeria, RIGHT funding is being utilised by both The Leprosy Mission and the German Leprosy Mission (GLRA). TLM is using the funding for two key projects.
This Project is a qualitative study on the sustainability of self-help groups (SHGs) in two leprosy communities in Nigeria: the Alheri Village in Abuja and the Chanchaga Community in Niger State.
For over 3 decades, The Leprosy Mission had been supporting SHGs in these two communities with livelihood interventions, but funding for such interventions are being withdrawn gradually as they were meant to last only for a certain duration. The STARS project is aimed at evaluating the impact of past livelihood programmes, executed in integrated leprosy communities through the SHGs. This will set the scene for formal, long-term quantitative studies of the sustainability of these programme activities and of any short-term benefits they offer.
The study has the following objectives:
Retrieve any documents that describe or evaluate the self-help intervention funded by The Leprosy Mission in North Central Nigeria.
Interview people who might be able to describe interventions and provide any evidence on the short-term effects and sustainability of the programme activities or benefits.
Elicit their views on barriers to sustainability and on how these may be overcome.
To synthesise findings from the Alheri community in Yangoji Abuja, and the Chanchaga leprosy community in Niger State. The two communities provide an opportunity to compare and contrast across two different funding models for SHGs and hence sustainability in terms of wellbeing, health, social integration and economic development for marginalised people.
Some of the SHGs interventions being studied include, seed funding for businesses, self-care, support for subsistence and commercial agricultural activities, skills acquisition (such as tailoring, carpentry, and shoemaking), provision of water and toilet facilities, and the provision of shelter where it is needed.
In order to gauge the success of the SHGs, the STARS team have interviewed more than 40 people from two different categories: those who are directly involved in the SHGs and their family members (Insiders), and then those who have been involved in setting up or supporting the SHGs, such as TLM staff or local government staff (Outsiders).
Sustainability in the context of the STARS project is not only focused on whether those who acquired skills such as tailoring or those who were given seed capital to start businesses have continued with such vocations, but also that the groups which were set up through the past interventions have continued to exist and function despite the cessation of funding.
The study is currently at the stage of data analysis and the study team plans to publish the study outcome in peer-reviewed journals upon completion of the study. An abstract from the study was presented at the 21st International Leprosy Congress (ILC) in India in November 2022.
The HELP Project is one that was covered in the last issue of the Research Magazine and will see the Nigeria team look at whether honey can be used as an alternative to saline dressings for ulcer wounds in low resource settings.
In some remote parts of Nigeria, honey is far easier to access than saline and it could prove a useful tool for healthcare workers who need to dress wounds in a dressing that has healing properties. The HELP Project will look at whether honey dressings can promote healing in the same way as the standard practice of using saline dressings.
GLRA are using RIGHT funding to conduct two projects in South East Nigeria. The first project is looking at a health needs assessment for Buruli ulcer. The second is looking at the potential for utilising traditional healers in the prevention and management of leprosy and Buruli ulcers. They are also conducting a study onthe sustainability of SHGs in South East Nigeria.
As well as their support for the TLM India’s offloading device study, TLM Nepal are conducting four further studies under the RIGHT grant.
This study was covered in the first edition of TLM’s Research Magazine and has become well-known within the leprosy world over recent years.
The study is trialling a new method for treating ulcers known as LPRF (Leukocyte & Platelet-Rich Fibrin). This method sees ulcer wounds dressed with a gel generated made from their own blood, rather than the standard saline dressing.
For LPRF treatment, blood is drawn from the leprosy patient, and then spun in a centrifuge so that the white blood cells, stem cells and other healing factors are concentrated.
Afterwards, the healing mixture is like a gel that is then pressed into strips and applied like a matrix directly to the same patient’s ulcer.
The study has now completed enrolment of participants and the team are in the process of analysing the results from the trial. They’re hoping to have final results at the end of March and be ready to submit their results for publication in June or July 2023.
There has been a lot of excitement around the potential of using LPRF for healing ulcers and the study’s lead, Dr Indra Napit, is preparing to train people in Nepal and teams internationally in how to correctly use this new method.
At the end of February, the team in Nepal are submitting to the British Medical Journal a literature review of using the LPRF method to heal ulcers.
LPRF has been used to heal diabetes and pressure ulcers and the RIGHT team in Nepal have been looking at the literature surrounding this to see what they can learn and to make the case for the importance of their Randomised Control Trial on LPRF, the TABLE Project.
The SHERPA Project was also included in the first edition of TLM’s Research Magazine. The project has focused on preventing ulcers by tracking the success of self-help groups (SHGs) in helping patients to prevent ulcers through self-care and financial support for livelihood activities that put individuals at reduced risk of ulcers.
This project requires three years of data collection and the team are currently in the process of collecting data for year three (end-line data collection).
This Study is evaluating the success of two of TLM Nepal’s former self-help projects: CEDAR and PACED. They are looking to understand whether the projects were successful, whether participants are enjoying strong livelihoods, and whether the cooperatives that were set up through the projects are still running.
The Nepal team are working with researchers from the University of Kathmandu, who are interviewing participants in the CEDAR and PACED projects to learn whether the projects were a success and what it was that might have led to any success of failings of the projects.
The main aim is to understand whether the projects made life better for those who participated.
