• Grant: LRI Regular Grant
• Budget round: 2021
• Research priorities: Diagnostic tests
• Country: Bolivia, Brazil
• Project no.: FP21\10
• Budget: €305,484.00
• Duration: May 2021 – December 2025
• Status: Completed
• Co-funding partners: Turing Foundation

Project coordination
Leiden University Medical Center

Partners
Damien Foundation
Pontifícia Universidade Católica do Paraná
Instituto de investigaciones Biomedicas (IIBISMED)
Erasmus MC Medical Center

Aim: This project aims to identify means to optimally implement POC diagnostic tests for leprosy and M. leprae infection in the South American Amazon.

Full project title:
Point-of-care immunodiagnostic tests for detection of leprosy and Mycobacterium leprae infection in high and low endemic areas in the South American Amazon

Final project summary:

Stable new case detection rates of leprosy are witnessed among endemic populations in many of the countries where leprosy occurs. Contact with M. leprae infected individuals is a risk factor for the development of leprosy. To facilitate timely treatment as well as reduce transmission, it is vital to both early diagnose leprosy and identify M. leprae infected individuals lacking clinical symptoms. Active case finding by screening for clinical symptoms amongst individuals at highest risk of developing disease such as contacts of (former) leprosy patients, is a proven method to early detect disease. However, this still represents a substantial hurdle in present-day leprosy health care.

The research team has previously developed low complexity diagnostics tests (similar to a glucose dipstick or a pregnancy test) that can be performed by first line health care workers in the field to detect whether and to which extent an individual is infected with M. leprae by using 1 drop of fingerprick blood. This type of test is referred to as point-of-care (POC) as it can be performed in the field by first line health care workers and requires no complicated laboratory techniques. In addition, a more extensive version of this test allows quantitative detection of multiple components (called biomarkers) that together allow identification of various forms of leprosy in venous blood of people living Bangladesh. In this study the team proposes to apply 1) POCDxv1 (for quantitative detection of anti-PGL-I antibodies as a measure of infection in large scale screening efforts) and 2) Multi Biomarker Tests (MBT; for detection of biomarker profiles associated with leprosy or M. leprae infection).

The study population will be two distinct South American populations: a hyper-endemic, former leprosy colony, located at the north western outskirts of the Brazilian Amazon, and a lesser endemic population on the south eastern side of the Amazon in Bolivia. The team aim is to 1) assess whether both tests can be used to detect infection and identify leprosy in South American populations located in Brazil and Bolivia where leprosy still occurs, 2) evaluate the feasibility to implement these low complexity tests in leprosy health care in these areas, and 3) simultaneously increase clinical expertise with regard to leprosy by training health care staff to detect leprosy.

• Grant: LRI Regular Grant
• Budget round: 2021
• Research priorities: Transmission
• Country: India
• Project no.: FP21\20
• Budget: €169,812
• Duration: August 2021 – March 2026
• Status: Completed
• Co-funding partners: St. Francis’ Leprosy Guild

Project coordination
NLR India Foundation

Partners
NLR- until No Leprosy Remains

Aim: This study aimed to determine to what extent a mobile Application-supported SDR PEP delivery system is more effective and feasible than the present paper-based method.

Full project title:
Testing an App supported delivery system for Leprosy Post Exposure Prophylaxis (PEP) services

Final project summary:
One proven method of preventing leprosy is Single-Dose Rifampicin (SDR), a preventive treatment given to people who have been in close contact with someone diagnosed with leprosy. This approach, known as Leprosy Post-Exposure Prophylaxis (LPEP), helps reduce the risk of developing the disease.

Traditionally, LPEP delivery has relied on paper-based systems, which can be difficult to manage, prone to errors, and challenging for follow-up and reporting. To address these limitations, this project developed and evaluated a mobile phone application—the LPEP App—to support health workers in delivering LPEP more efficiently in the districts of Paschim Bardhaman and Howrah in West Bengal, India, between August 2021 and March 2026.

The project focused on generating evidence from a completed randomized controlled trial, sharing findings with key stakeholders, and preparing for future implementation. An exploratory study conducted at the start of the project informed the design and development of the LPEP App. The application was subsequently tested through a randomized controlled trial conducted between October 2023 and October 2024 across 27 clusters, including 14 intervention clusters and 13 control clusters.

The LPEP App digitized key programme activities, including contact listing, eligibility assessment, treatment recording, reporting, and follow-up. By replacing paper-based processes, the App improved data quality and strengthened programme monitoring.

Post-intervention findings showed that the App was both user-friendly and feasible for use in routine public health settings. Health workers reported that it helped them organise their work, record and manage contact information, monitor preventive treatment, and complete follow-up activities more efficiently. The App also supported improved data management and reporting compared with traditional paper-based approaches.

Importantly, the use of the App continued in intervention areas after the formal study period had ended, indicating acceptance and continued use by programme staff within routine service delivery.

Project findings and implementation experiences were shared through national and international scientific meetings, as well as a national dissemination workshop involving government representatives, public health experts, academic institutions, and development partners. Feedback from these stakeholders contributed to further refinement of the application and informed planning for future scale-up and integration.

A major achievement of the project was the development of a clear strategy for expanding the App to additional districts. Technical experts also designed an upgraded version that can be integrated with India's national leprosy information system, Nikusht 2.0, and aligned with the country's broader digital health framework.

Impact

Overall, the project demonstrated how digital tools can support the National Leprosy Eradication Programme (NLEP) by improving LPEP delivery, strengthening follow-up, and enhancing data quality without increasing the workload of frontline health workers. The project also resulted in the development of an upgraded, interoperable version of the application, known as Pratirodh. Plans are underway, in collaboration with the Indian Council of Medical Research (ICMR) and the Central Leprosy Division (CLD), to integrate Pratirodh into Nikusht 2.0, supporting wider adoption and strengthening digital approaches to leprosy prevention, monitoring, and transmission reduction.

• Grant: LRI Regular Grant
• Budget round: 2021
• Research priorities: Disability
• Country: Indonesia
• Project no.: FP21\14
• Budget: €84,118
• Duration: July 2021 - August 2024
• Status: Completed

Project coordination
Vrije Universiteit Amsterdam
Dr Soetomo General Hospital
London School of Hygiene & Tropical Medicine

Partners
Forum Komunikasi Difabel Cirebon
Mimi Institute

Aim: This study looked at how the management of leprosy reactions be improved by the implementation of peer-counselling, participatory video and teleconsultation in Indonesia.

Full project title:
Improving the management of leprosy reactions and the quality of life of persons affected: developing and testing three interventions in Indonesia

Final project summary:
Leprosy reactions (LR) are serious complications of leprosy that can cause nerve damage, disability, pain, and other long-term health problems. Beyond the physical effects, people experiencing LR often face emotional distress, anxiety, stigma, and financial hardship. In 2018, people affected by LR in Indonesia highlighted the need for better peer support and suggested creating a digital platform where patients could share experiences, access information, and support one another.

In response, this project developed and tested three complementary peer-support interventions: peer counselling, a telehealth forum, and a participatory video. People who had recovered from leprosy reactions played a central role in all three interventions. They served as peer counsellors, facilitated discussions in the telehealth forum, and helped create and act in the participatory video. The study explored how these approaches could improve the management of leprosy reactions in both an urban hospital setting in Surabaya and rural primary healthcare clinics in Bangkalan, Madura.

Using a participatory mixed-methods approach, the study was conducted between November 2022 and July 2023. It involved people undergoing treatment for leprosy reactions, their family members, peer co-implementers with lived experience, and healthcare workers. Surveys, interviews, and focus group discussions were used to assess changes in knowledge, self-care practices, treatment motivation, mental well-being, stigma, and the feasibility of the interventions.

A total of 127 participants took part in the study. People affected by leprosy who served as co-implementers showed strong commitment to supporting others and sharing accurate information about leprosy reactions. Following the pilot, several additional participants expressed interest in becoming peer supporters, highlighting the potential for a sustainable peer-support network.

All three interventions were found to be feasible and well accepted by participants, family members, healthcare workers, and peer facilitators. However, peer counselling had the greatest overall impact. Participants reported better understanding of leprosy reactions, increased motivation to continue treatment, reduced feelings of isolation, lower levels of internalized stigma, and improved mental well-being. Many explained that speaking with someone who had experienced similar challenges helped them feel understood, supported, and less alone.

The telehealth forum also produced positive results by improving access to information and enabling participants to connect with others experiencing LR. For many, the opportunity to communicate in real time reduced feelings of isolation and strengthened treatment engagement. However, its impact on stigma and mental well-being was less pronounced than that of peer counselling. While participants in Surabaya considered the telehealth forum a promising addition to routine care, those in rural Bangkalan reported barriers such as poor internet connectivity and limited digital literacy.

The participatory video provided a powerful platform for people affected by LR to share their experiences and encourage others. Video screenings increased knowledge among patients and family members and stimulated discussion in clinic waiting rooms. Although its impact on stigma and mental well-being was more limited, it helped raise awareness, promote understanding, and facilitate conversations about living with LR.

Overall, the interventions complemented one another. Peer counselling offered the most personalised support, telehealth expanded access to information and peer connections, and participatory video created opportunities for learning and discussion through shared experiences.

The study also identified several important considerations for future implementation. Sustained peer counselling would require reliable funding, transport support, and regular scheduling. The telehealth model may be more suitable in urban areas where internet access and digital skills are stronger, while greater involvement of healthcare workers would help address participants' clinical questions. For participatory videos, participants recommended covering a broader range of topics and producing shorter videos to maintain audience engagement.

The findings demonstrate that peer-support interventions can play an important role in improving the lives of people experiencing leprosy reactions. All three approaches increased knowledge and treatment motivation, while reducing isolation and internalized stigma. Of the interventions tested, peer counselling showed the strongest overall impact and should be considered a priority for future scale-up. Any expansion of these approaches should actively involve people with lived experience of leprosy reactions in both the design and implementation of the programme to ensure it remains relevant, effective, and responsive to patients' needs.

Impact

Putri, A. I., de Sabbata, K., Agusni, R. I., Alinda, M. D., Darlong, J., de Barros, B., ... & Peters, R. M. (2022). Understanding leprosy reactions and the impact on the lives of people affected: An exploration in two leprosy endemic countries. PLoS neglected tropical diseases, 16(6), e0010476.

Maulana, A. T., Putri, A. I., Mengistu, B. S., Walker, S. L., & Peters, R. M. (2025). Development, validation and reliability of knowledge, attitudes and practice questionnaire for people affected by leprosy reactions. Global public health, 20(1), 2501163.

Putri, A. I., Peters, R. M., De Sabbata, K., Mengistu, B. S., Agusni, R. I., Alinda, M. D., ... & Zweekhorst, M. B. (2025). A socio-ecological model of the management of leprosy reactions in Indonesia and India using the experiences of affected individuals, family members and healthcare providers. BMC health services research, 25(1), 196.

• Budget round: 2021
• Research priorities: Transmission
• Country: USA
• Project no.: FP21\8
• Budget: €54,187
• Duration: January 2022 - December 2023
• Status: Completed
• Co-funding partners: Turing Foundation

The Use of Molecular Methods in Subclinical Murine Models of Leprosy to Examine the Efficacy of Proposed Post-Exposure Prophylaxis (PEP) Regimens

Project coordination
IHRC, Inc,
National Hansen’s Disease Program

Aim: This study saught to determine which rifampin-containing treatment modality is the most effective leprosy PEP regimen regardless of a) the immune status of the host and b) whether the leprosy infection is caused by M. leprae or M. lepromatosis.

Final project summary:
Although multidrug therapy (MDT) has greatly reduced the global burden of leprosy, new cases continue to occur each year. This suggests that transmission of the disease is still ongoing despite the availability of effective treatment. People with early, symptom-free (subclinical) infections—often acquired through contact with someone who has leprosy—are thought to play an important role in sustaining transmission, particularly in high-burden areas.

One strategy to reduce transmission is post-exposure prophylaxis (PEP): preventive treatment given to people who have been exposed to leprosy. By reducing subclinical infections, PEP has the potential to lower the risk of disease development and limit further spread within communities.

This study evaluated different PEP regimens to determine which approaches are most effective. Researchers established low-level leprosy infections in three mouse strains with different levels of immune function (Balb/c, Interferon-γ knockout [IFNγ KO], and athymic nude mice). These models represent different points along the leprosy disease spectrum and provide a valuable platform for testing preventive treatments. The effectiveness of the drug regimens was assessed using highly sensitive and specific genetic testing methods.

The study had three main objectives:

1. To develop a robust pre-clinical model for evaluating PEP regimens.
2. To identify the most effective PEP regimen across different levels of host immune function.
3. To compare the effectiveness of PEP treatments against infections caused by Mycobacterium leprae and M. lepromatosis, the two bacterial species known to cause leprosy.

The results showed that RC-3X was the most effective of the regimens tested. This was expected, as it combines two drugs administered over three treatment rounds. However, multi-dose preventive regimens may be difficult to implement on a large scale and can place additional demands on both recipients and healthcare providers. Furthermore, some contacts may perceive repeated treatments as therapy rather than prevention, potentially increasing feelings of stigma.

Importantly, SHDR proved to be more effective than DDR, even though both regimens delivered the same total amount of rifampin. This finding suggests that optimizing the dosage within a single-treatment regimen may improve its effectiveness while maintaining the practical advantages of a simple preventive intervention.

The study also demonstrated that the athymic nude mouse model is a valuable tool for evaluating PEP regimens because of its high sensitivity, broad inoculation range, and ability to support long-term bacterial growth. Together, these findings provide important experimental evidence to guide the design and evaluation of future clinical trials aimed at improving leprosy prevention.

Impact

Lenz, S. M., Collins, J. H., Ray, N. A., Hagge, D. A., Lahiri, R., & Adams, L. B. (2020). Post-exposure prophylaxis (PEP) efficacy of rifampin, rifapentine, moxifloxacin, minocycline, and clarithromycin in a susceptible-subclinical model of leprosy. PLoS neglected tropical diseases, 14(9), e0008583.