Strengthening clinical research capacity and advancing the leishmaniasis elimination agenda across affected countries in Eastern Africa
Founded: 2003
The Leishmaniasis East Africa Platform (LEAP) was established to support the generation of scientific evidence for the development and distribution of new treatments for leishmaniasis in Eastern Africa. With more than 60 members from 20 institutions across Ethiopia, Kenya, Sudan, Uganda, and South Sudan, LEAP plays a pivotal role in strengthening local research capacity, facilitating cooperation between countries, and standardizing procedures and practices to diagnose, treat, control, and ultimately eliminate leishmaniasis in the region. The Platform is active in evaluating, validating, and registering new treatments that address local needs and conditions, strengthening research capacity and knowledge sharing, and setting regional priorities.
With an initial focus on visceral leishmaniasis (VL), LEAP has evolved to include all forms of leishmaniasis in its scope, including cutaneous leishmaniasis (CL) and post-kala-azar dermal leishmaniasis (PKDL).
The Platform supported clinical trials that resulted in an improved treatment for visceral leishmaniasis in Eastern Africa – sodium stibogluconate and paromomycin – in 2010, and in the delivery of a safer and more effective treatment for people living with both HIV and VL in 2022. Today, the Platform is actively involved in clinical trials testing new or improved treatments for leishmaniasis, including miltefosine + paromomycin for visceral leishmaniasis, miltefosine combination treatments for PKDL, and new compound, LXE408, for visceral leishmaniasis.
‘The Good Clinical Practice training presented me with a chance to not only expand my knowledge and skills but also handle study participants appropriately. It is a positive step towards becoming a globally certified clinical trial expert.’
Dr Eleni Ayele, Leishmaniasis Research and Treatment Centre at the Gondar University Hospital in Ethiopia
Publications
LEAP Newsletter, Issue 9
Previous LEAP Newsletters
Leap Newsletter, Issue 8, October 2023
English
Leap Newsletter, Issue 7, October 2021
English
LEAP Newsletter, Issue 6, November 2018
English
LEAP Newsletter, Issue 5, October 2016
English
LEAP Newsletter, Issue 4, November 2015
English
LEAP Newsletter, Issue 3, September 2014
English
LEAP Newsletter, Issue 2, April 2014
English
LEAP Newsletter, Issue 1, June 2013
English
DNDi Newsletters LEAP
Newsletter No. 18, June 2009
LEAP: A step into the right direction VL clinical studies in East Africa
Newsletter: No. 16, June 2008
English
Newsletter: No. 8, January-March 2004
English
Newsletter: No. 7, September-December 2003
English
Press releases
- Bahir Dar, Ethiopia and Geneva, Switzerland – 1 October 2014
Results of large-scale roll out of combination treatment for Kala-azar in Eastern Africa points to urgency to treat disease victims as outbreak surges in South Sudan. - Geneva – 22 November 2004
DNDi clinical trials for paromomycin begin in Sudan.
Platform updates
2023
- 7 active clinical sites.
- 34 people trained for clinical trials (25) and financial practices (19).
- 5 laboratories upgraded or improved.
- Renovated leishmaniasis ward at Kacheliba Sub-County Hospital and began construction of a new 32-bed leishmaniasis ward at Sigor Sub-County Hospital (Kenya).
- Improvements made to leishmaniasis facilities and construction of new laboratory block begun at Amudat Hospital (Uganda).
- Developed a draft framework for the elimination of VL in Eastern Africa at the WHO stakeholders meeting, co-organized by DNDi and the END Fund, with the participation of eight VL-endemic countries: Chad, Eritrea, Ethiopia, Kenya, Somalia, Sudan, South Sudan, and Uganda.
- Developed a draft neglected tropical disease (NTD) monitoring and evaluation master framework for Kenya to ensure alignment with the WHO NTD Roadmap.
- Held the 28th Leishmaniasis East Africa Platform (LEAP) Meeting in Naivasha, Kenya from 29 October to 1 November 2023, attended by 113 participants from 19 countries.
2022
- 5 active clinical sites.
- 27 people trained in new guidelines for the management of HIV-VL.
- 2 facilities upgraded at Sigor Sub-County Hospital, Kenya, and Amudat Hospital, Uganda, to support improved management of patients.
- Completed a comprehensive needs assessment of treatment guidelines uptake in Kenya, Uganda, and Ethiopia and developed country-level implementation plans to address gaps.
- Conducted joint supervision and assessment visits to leishmaniasis treatment facilities in Kenya and Uganda.
- Implemented a mentoring support programme between hospitals in Kacheliba and Sigor, Kenya.
- Participated in the 7th World Congress on Leishmaniasis (WorldLeish 7) held in Cartagena, Colombia in August 2022, and presented on access to treatments for leishmaniasis at the 2nd International Conference on Public Health in Africa held in Kigali, Rwanda in December 2022.
2021
- 11 people trained for clinical trials.
- 5 active clinical sites.
- Held the 2nd LEAP Scientific Conference, 26th LEAP Meeting, and 3rd LEAP Advisory Committee Meeting held in November 2021.
- Held a LeishAccess workshop in November 2021.
- Participated in the Kenya Leishmaniasis Technical Advisory Group meeting held in December 2021.
2020
- 6 active clinical sites.
- 138 people trained for clinical trials.
- Participated in the 5th AfriKADIA Project Management Committee (PMC) meeting in May 2020, and Project Advisory Committee (PAC) meeting in September 2020.
- Adopted new digital platform for remote monitoring and data management for clinical trials.
- Enrolled LEAP sites in external quality assessment programmes with the aim of developing interlaboratory comparability to allow standardization of diagnostic testing.
2019
- 7 active clinical trial sites (sites belonging to platform/network members and used for DNDi studies) in Ethiopia, Kenya, Sudan, and Uganda; 1 site constructed and equipped for clinical trials in Sudan
- 125 people trained, mainly on data management, good clinical and laboratory practice, and diagnostics
- 1st AfriKADIA symposium held in Nairobi with key stakeholders on ‘Translating research results into policy for control and elimination
of leishmaniasis in eastern Africa’ - Policy change: following revision of the VL guidelines in Uganda in 2018, the Ministry of Health released the 2019 Guidelines for the Diagnosis, Treatment, and Prevention of VL in Uganda
2018
- 5 clinical trial sites were active in Ethiopia, Kenya, Uganda, and Sudan.
- 163 people were trained, including investigators, lab technicians, nurses, and pharmacists, on Good Clinical Practice, Good Financial Practice, and DHIS2, an open-source data platform to manage health information.
- Supported the launch of the revised visceral leishmaniasis treatment guidelines in Kenya, with SSG&PM as first-line treatment, and supported the revision of visceral leishmaniasis guidelines in Uganda.
- Launched the 10-institution AfriKADIA Consortium in Ethiopia, whose main objective is to find improved treatments and diagnostic tools for visceral leishmaniasis in eastern Africa.
2017
- 5 clinical trial sites were active and 1 under construction in Ethiopia, Kenya, Uganda, and Sudan
- Outside of the clinical trials, 1,084 people were treated and 2,898 were screened
- Following the dissemination of the HIV/VL study results, support for the development of a new policy by WHO
- Results from the HIV VL LEAP 0511 clinical trial were presented during a meeting with the Ethiopian authorities and key stakeholders in Addis Ababa, Ethiopia.
Events
- Stakeholders meetings were held in Amudat in Uganda and Kacheliba, in West Pokot county in Kenya to disseminate the results of the LEAP 0208 and LEAP 0714 clinical trials. The results showed that miltefosine is safe in children and that treatment outcome is improved when allometric dosing is used. Community leaders including elders, political and religious leaders, and health workers attended the meetings.
- The LEAP members participated in the WorldLeish-6 congress held in Toledo, Spain, the “City of Three Cultures, from 16-20 May, 2017. The meeting is an international congress on leishmaniasis. It is is held every four years in a leishmaniasis-endemic country.
- LEAP presented a total of eight abstracts for both oral and poster presentations and participated in a parallel session on platforms for the research and control of leishmaniasis. The 24th LEAP meeting was hosted on 15 May, 2017, at the sidelines of the WorldLeish 6 congress. This year, the meeting was keen on discussing and reviewing current and planned activities. “KEEP MOVING FORWARD”, was the theme of this first meeting after the launch of LEAP 2.0, a restructuring of the platform to enable it adjust to the expanding clinical trial needs in the region.
- The meeting was attended by 56 participants including LEAP members, representatives from the World Health Organization (WHO), Infectious Diseases Data Observatory (IDDO) and GlaxoSmithKline (GSK), and members of the DNDi Rio team, who are members of the redeLEISH Platform, a network that brings together leishmaniasis experts in Latin America.
- Dr Jose Postigo, the WHO Head of the Leishmaniasis Control Programme gave the key note address on ‘Leishmaniasis in Africa: Is elimination possible? The WHO approach‘, concluding that there was still a lot more to be done in controlling leishmaniasis before embarking on elimination in eastern Africa.
New platform & training
- The Infectious Disease Data Observatory (IDDO) visceral leishmaniasis (VL) data sharing platform was officially launched during the 24th LEAP meeting. IDDO, a pioneering VL data repository, is an initiative of a team from Oxford University in partnership with DNDi.
- 120 people were trained, including investigators, lab technicians, nurses, and pharmacists on Good Clinical Practice and Others received training on how to better communicate on their projects. Financial support for seven long-term trainings (Master’s degrees or diplomas) was also provided.
2016
- The LEAP Platform handled 6 clinical trial sites in Ethiopia, Kenya, Uganda, and Sudan, as well as maintaining clinical trial sites even though they were not involved in R&D activities. Outside of the trials, 1,156 people were treated, and 3,069 screened.
- Launch of LEAP 2.0: the platform was restructured to adjust to expanding clinical trial needs in the region; with expansion of disease areas – from VL only to CL and PKDL – extension of member countries (Eritrea, South Sudan, Somalia), and for a focus on new areas of activities (access, Phase I studies, data sharing)
2015
- The 22nd LEAP meeting took place in Khartoum, Sudan in October 2015, with 68 participants, alongside the 22nd LEAP Principal Investigators (PIs) Meeting and the first Project Advisory Committee (PAC) of the AfriCoLeish Project ‘new combination treatments for VL in Africa’ and fexinidazole studies were completed.
