Projects
- Grant: LRI Regular Grant
- Research priorities: Operational research
- Country: India
- Project no.: FP22\17
- Budget: €44,568
- Duration: June 2022 - February 2025
- Status: Completed
- Co-funding partners: St. Francis’ Leprosy Guild
Project coordination
The Leprosy Mission Trust India
Aim: The study aimed to investigate whether removable off-loading devices are as effective as total contact cast to promote healing of non-complicated plantar ulcers.
Full project title:
Removable off-loading devices versus total contact cast to promote healing of plantar ulcer in Leprosy: a non-inferiority, randomized control trial
Final project summary:
One of the most common complications of leprosy is damage to the nerves in the feet, which can cause a loss of sensation. Without the ability to feel pain or pressure, people may unknowingly develop wounds on the soles of their feet, known as plantar ulcers. Because these wounds are often painless, individuals may continue walking on the affected area, causing further damage and making healing difficult.
A critical component of treating plantar ulcers is offloading—reducing the pressure placed on the wound to allow healing to occur. Alongside regular wound care and dressing, effective offloading is essential for preventing complications and promoting recovery.
For many years, the Total Contact Cast (TCC) has been considered the standard method for offloading plantar ulcers. While highly effective, the application of a TCC requires specialized training and expertise. However, the number of healthcare professionals skilled in applying the cast has declined, even within specialized leprosy hospitals. In addition, many patients find that wearing a cast limits their mobility and makes everyday activities more challenging.
To address these challenges, researchers explored the use of a Removable Walker Boot (RWB) as a simpler and more accessible alternative. Unlike the traditional cast, the walker boot is easier to apply, requires less specialized training, and may offer greater comfort and convenience for patients.
A randomized controlled study was conducted across three hospitals operated by The Leprosy Mission Trust India to compare the effectiveness of the two approaches. The study enrolled 151 people affected by leprosy who had simple plantar ulcers, assigning them randomly to receive treatment with either a removable walker boot or a total contact cast.
Of the participants enrolled, 128 completed the study, including 65 individuals in the walker boot group and 63 in the total contact cast group. Researchers assessed the proportion of ulcers that healed within six weeks, while also evaluating patient satisfaction and quality of life.
The findings showed encouraging results. Within six weeks, approximately 65% of ulcers in the walker boot group healed, compared with 73% in the total contact cast group. Although the cast group showed a slightly higher healing rate, the difference was small and did not clearly demonstrate that one treatment was superior to the other.
Importantly, participants using the removable walker boot reported higher levels of satisfaction with their treatment experience. Patients found the device easier to manage and more compatible with daily life. Furthermore, both groups experienced comparable improvements in quality of life over a six-month period, indicating that the walker boot was able to deliver similar longer-term benefits to the traditional cast.
The study provides important evidence that the removable walker boot can serve as an effective alternative to the total contact cast for the treatment of simple plantar ulcers in people affected by leprosy. By offering comparable healing outcomes while improving patient satisfaction and reducing dependence on highly specialized healthcare workers, the walker boot represents a practical and patient-friendly solution.
These findings are particularly significant for resource-limited settings, where access to trained staff may be limited. The removable walker boot has the potential to expand access to effective ulcer care, improve patient experiences, and contribute to better long-term outcomes for people living with the consequences of leprosy.
- Grant: LRI Regular Grant
- Budget round: 2022
- Research priorities: Transmission
- Country: Nepal
- Project no.: FP22\19
- Budget: €143,803
- Duration: March 2022 – August 2025
- Status: Completed
Full project title:
How effective is ongoing SDR-PEP implementation under routine programme conditions – a retrospective cohort study in Nepal
Project coordination
NLR Nepal
Partners
FAIRMED Foundation Nepal
Rehabilitation Empowerment and Development Nepal (READ)
Aim: The study provided scientific evidence on the effectiveness of single-dose rifampicin post-exposure prophylaxis (SDR-PEP) in preventing leprosy among contacts under routine programme conditions. It also generated valuable insights into the impact of ongoing SDR-PEP implementation on new case detection rates at the district level.
Final project summary:
Leprosy remains an important public health challenge in several low- and middle-income countries. Beyond its physical effects, the disease can contribute to poverty through the stigma, discrimination, and social exclusion experienced by affected individuals and their families. Nepal continues to be among the countries with the highest burden of leprosy worldwide.
Since the introduction of multidrug therapy (MDT) in 1982, leprosy control efforts have focused primarily on early case detection and treatment. While MDT is highly effective in curing the disease, it does not fully prevent ongoing transmission. This has led to increased interest in preventive interventions that can reduce the risk of developing leprosy among people who have been in contact with newly diagnosed patients.
Evidence from studies in Indonesia, Bangladesh, and other countries has shown that combining contact tracing with single-dose rifampicin post-exposure prophylaxis (SDR-PEP) can significantly reduce the risk of developing leprosy among contacts. The Leprosy Post-Exposure Prophylaxis (LPEP) programme, implemented in several countries including Nepal, demonstrated that SDR-PEP is both feasible and effective within routine health services. These findings contributed to the World Health Organization's recommendation to use SDR-PEP as part of leprosy prevention strategies.
Despite the successful implementation of SDR-PEP, questions remained about its longer-term effectiveness and the continued detection of new leprosy cases in some districts. This study was therefore conducted to assess the incidence of leprosy among contacts who had received SDR-PEP and to better understand why new cases continued to occur despite preventive treatment.
The study evaluated approximately 28,200 contacts who received SDR-PEP between 2015 and 2019, alongside an equal number of contacts who did not receive preventive treatment in comparison districts. In addition, all newly diagnosed leprosy cases detected among contacts during the study period were assessed.
The findings demonstrated that SDR-PEP provided substantial protection against the development of leprosy. Contacts who received SDR-PEP had a 72% lower risk of developing leprosy compared with those who did not receive preventive treatment. This protective effect was equally evident among blood relatives and household contacts, who are considered to be at highest risk of infection and are therefore the main target group for post-exposure prophylaxis programmes.
The study also found that the proportions of multibacillary (MB) and paucibacillary (PB) leprosy among newly diagnosed cases were similar in both groups. This suggests that SDR-PEP does not selectively prevent one type of leprosy over another but instead provides broad protection against disease development.
While the study design did not allow definitive conclusions about the impact of SDR-PEP on leprosy transmission at the population level, the results clearly demonstrated its strong protective effect for individuals at risk. The findings suggest that sustained implementation of SDR-PEP over several years could reduce the number of contacts progressing to disease and, over time, contribute to lower transmission within communities.
Impact
Banstola, N. L., Hasker, E., Mieras, L., Gurung, D., Baral, B., Mehata, S., Prasai, S., Ghimire, Y., Das, B. K., Napit, P., & van Brakel, W. H. (2024). Effectiveness of ongoing single dose rifampicin post-exposure prophylaxis (SDR-PEP) implementation under routine programme conditions—An observational study in Nepal. PLOS Neglected Tropical Diseases, 18(12), e0012446.
- Grant: LRI Regular Grant
- Budget round: 2022
- Research priorities: Stigma and discrimination
- Country: Niger
- Project no.: FP22\6
- Budget: €199,835
- Duration: April 2022 - June 2026
- Status: Ongoing
Project coordination
The Leprosy Mission Niger
Université Abdou Moumouni, Niamey, Niger
Partners
University of Rochester
The Leprosy Mission England & Wales
Ministry of Health, Niger
Aim: The study aims to develop and test the effectiveness of a replicable stigma-reduction intervention to improve leprosy knowledge and to reduce negative perceptions and stigmatising behaviours towards Leprosy patients among HCWs in endemic communities in Niger.
Full project title:
Understanding & Reducing Leprosy-Related Stigma Among Healthcare Workers in Niger
Project summary
Neglected Tropical Diseases (NTDs) are endemic in Niger Republic. These diseases and their consequences are especially common among rural populations. Leprosy is a NTD that persists in Niger, despite efforts to increase access to care. In 2019, 333 new cases of leprosy were diagnosed nationally, of which 23% had advanced disability, an indicator of late case detection. This is partly due to the stigma associated with the infection and its physical sequalae even after the disease has been treated successfully. Stigma caused by leprosy is deeply rooted in history and permeates every aspect of society, including the healthcare system. Preliminary evidence of stigma directed at patients by healthcare workers (HCWs) and lack of knowledge of leprosy among HCWs indicate the need to identify leprosy-stigma reduction activities if the disease is to be eradicated through access to early screening, treatment and rehabilitation.
The goal of this study is to utilize a community-based participatory approach to develop and test a leprosy-stigma training programme among health workers in 16 regional health centres in Niger. The study has two phases. First, using the WHO stigma framework, it aims to identify the local and contextual reasons behind stigma directed at patients by HCWs, and the resulting impact on people affected by leprosy. An understanding of these elements is necessary to develop and invest in effective leprosy stigma-reduction strategies and will contribute to the Zero Transmission / Zero Disability agenda.
A second phase of the study aims to develop and test the feasibility, acceptability and effectiveness of a training programme to reduce stigmatizing attitudes and behaviours among HCWs. Results will provide a contextual, yet replicable model for Leprosy stigma-reduction programme.
This study will be conducted collaboratively with active involvement of all stakeholders, including the national and international study team, healthcare providers, leaders and members of communities of persons affected by leprosy. The study will use a mixed method design to identify the elements of leprosy-related stigma perpetrated by HCWs, the impact on people affected by leprosy, and the development and testing of a leprosy stigma-reduction program targeting HCWs.
- Research priorities: Transmission
- Country: Kiribati
- Budget: €202,024 | Project number: FP22.21
- Duration: July 2022 - June 2026
- Status: Ongoing
The study will determine the effect of community-wide screening and treatment for leprosy, combined with PEP for household contacts and once-off mass chemoprophylaxis of the whole population of South Tarawa/Betio on the leprosy new case detection rate.
The COMBINE study: Defining the impact of combined community-wide screening and mass chemoprophylaxis for leprosy in Kiribati: a prospective community implementation study
Project coordination
Partners
- Ministry of Health and Medical Services, Kiribati
- The University of Otago
- The University of Sydney
- Centenary Institute
Project summary
Leprosy and tuberculosis are both spread by the respiratory route and transmission is greatly increased where there is crowding and poor economic conditions. In Kiribati the mean number of cases of leprosy reported annually over the period 2015-2019 was >1,500/1,000,000 people and for tuberculosis 4,680/1,000,000 people. The leprosy control programme in Kiribati currently includes examining the household contacts (HHC) of leprosy patients and giving them a single dose of rifampicin (SDR) as preventative therapy if they do not have leprosy. Mathematical modelling of leprosy transmission in Kiribati demonstrated that the most rapid control strategy would be to combine SDR for HHCs and mass SDR chemoprophylaxis to the community, but this has proved difficult to implement.
The COMBINE project provides a platform to screen a large population for both leprosy and tuberculosis and offer specific mass chemoprophylaxis as preventative measures for leprosy and latent tuberculosis. The tuberculosis component is building on previous studies on tuberculosis that have shown that active case finding in the community through screening and treatment substantially reduces the number of new cases of tuberculosis in succeeding years. Offering treatment for latent tuberculosis as well as screening may help reduce the incidence of tuberculosis. A combined leprosy and tuberculosis (TB) control programme will provide a model to improve delivery of treatment and preventative programmes for both conditions.
In this project, the research group aims to determine the effectiveness, operational constraints, interactions between the occurrence of leprosy and TB, and cost benefits of combined screening, treatment, and prophylaxis for leprosy and TB.
The project will be undertaken in the main population centres of Kiribati, South Tarawa and the adjacent islet of Betio, which are the epicentres of leprosy and tuberculous in Kiribati. Screening for leprosy will be by clinical examination done at the same time as chest x-rays, sputum sampling for PCR testing, and tuberculin skin tests to identify both active and latent tuberculosis. Those with suspicious skin lesions will be referred to the Skin clinic for diagnosis and treatment. Those with active tuberculosis will be treated for this according to WHO treatment guidelines and those with latent tuberculosis treated with 12 weeks of rifapentine and isoniazid. These treatments are also effective regimens to prevent the development of leprosy. All others will receive SDR as prophylaxis for leprosy.
At the end of the study the research group will be able to identify how effective the screening was been in detecting new cases, whether the number of cases has fallen compared with baseline, the acceptability of the rifampicin chemoprophylaxis, the steps needed to implement this effectively, and the costs involved. In addition, a detailed understanding of local spread of both leprosy and tuberculosis will be achieved through GPS mapping of the cases of leprosy, active tuberculosis and latent tuberculosis. This information will help other centres with high rates of leprosy and tuberculosis plan the best interventions for both conditions within their environments.
(The tuberculosis component is funded by a National Health and Medical Research Council grant from the Australian Government.)
Co-financer: Turing Foundation
- Research priorities: Transmission
- Country: Maldives
- Budget: €48,803 | Project number: FP22.8
- Duration: July 2022 – December 2023
- Status: Completed
The aim of this study is to develop an effective leprosy endgame strategy for low endemic settings.
Endgame strategy for leprosy in the Maldives: optimal targeting of post-exposure prophylaxis to interrupt transmission
Project coordination
Partners
- The Maldives National University
- WHO Regional Office for South-East Asia
- Health Protection Agency, Ministry of Health (Maldives)
Project summary
The Maldives have reported 80 new leprosy cases in 32 of 189 inhabited islands during 2008-2018. Only four new child cases were detected indicating that transmission of M. leprae might be close to interruption. The Maldives is committed to make the country leprosy-free in the coming decade: to interrupt transmission (zero new child cases) and achieve zero new autochthonous leprosy cases. As part of this commitment an endgame strategy should be developed. No evidence is available yet on effective endgame strategies in a low endemic setting, such as the Maldives. It has been recommended to include contact screening and prophylactic treatment with a single-dose of rifampicin (SDR) of contacts of a patient. However, it remains unclear which strategy and what the optimal profile of the target population (e.g., close contacts or high endemic community) should be in a low-endemic island setting to ensure achievement of interruption of transmission. The group’s research question is: “What would be an optimal endgame strategy to ensure interruption of transmission of M. leprae in a low endemic setting?”
To answer this question, an in-depth descriptive analysis of the leprosy epidemiology in the Maldives will be conducted. Historic and recent cases will be analysed by age, sex, clinical type, disability grade, socio-economic status and geographic distribution to inform progress made thus far and the current state of the leprosy situation. At the same time, mathematical modelling will be applied to explore which implementation strategy of single-dose rifampicin PEP would be most effective to interrupt transmission while treating as few healthy individuals as possible. Various implementation strategies of contact tracing and screening (e.g. close contacts vs community), will be considered and prophylactic treatment with SDR of contacts. Based on these findings, a strategy will be advised to the National Leprosy Programme in collaboration with WHO and local stakeholders.
Co-financer: Turing Foundation