Implementation of newly available diagnostic tools by national control programmes is ongoing in several HAT-endemic countries, with the help of FIND and other partners. Case detection and confirmation strategies include:
- Passive screening using RDT, microscopy & LAMP for T.b. gambiense
- Active screening by motorcycles with RDT b. gambiense
- Sustained control by passive screening using microscopy & LAMP T.b. rhodesiense
A major part of implementation includes capacity building projects designed to strengthen health facilities through installation of solar energy, procurement of laboratory equipment and consumables, training of personnel, quality assurance, advocacy and sensitization of communities. Collectively, this work is accelerating elimination of HAT by facilitating early detection of cases and preventing transmission of the disease.
New diagnostic tools
Three diagnostic tests for sleeping sickness have been developed in collaborations between FIND and academic, manufacturing and endemic country partners:
1. The SD HAT rapid diagnostic test (RDT):
– Simple to use and store
– Inexpensive (50 US cents)
– Very sensitive (92%)
– Imperfect specificity: 3 in 100 people who do not have HAT test positive for the disease, so positives must be confirmed by other tests
– Requires minimal expertise and training, and can be performed by staff at the smallest health-care facilities as well as by mobile teams
2. Primo Star iLED fluorescence microscope (iLED FM)
– Low power requirements and long-lasting light sources
– Slides are quick and easy to stain
– Versatile – can also be used for malaria and TB
– Does not require a dark room
– Low sensitivity – LED FM misses many cases
– LED FM can be used to perform all parasitological confirmation tests for HAT and can be powered from solar panels
3. Loop-mediated isothermal amplification (LAMP) of DNA
– Highly sensitive
– Identifies HAT suspects missed by microscopy
– Also works on blood samples dried on filter paper
– Requires reliable power and a reasonably well equipped lab
– Can be performed by technicians with no training in molecular biology and can be deployed at district- or microscopy level laboratories
One of the challenges in HAT elimination is the fact that the disease emerges in rural locations. HAT diagnostic tools capable of case confirmation and test-of-cure can only be deployed at district or microscopy level laboratories.
To overcome this, FIND and partners designed a new screening process that makes new diagnostic technologies more accessible to potential patients.
After implementation of new diagnostic tools in targeted endemic regions–strategically dispersed to minimize patient travel–symptomatic patients are screened as follows:
1. Patients with symptoms suggestive of HAT are tested with a malaria RDT because symptoms can be similar
2. If a patient is negative for malaria (or positive but still symptomatic after malaria treatment) a HAT RDT is performed
3. If the HAT RDT is positive, the patient is referred to the nearest facility for parasitological confirmation, including with LED fluorescent microscopy
4. If found positive by microscopy, the patient is staged and treated for HAT. When a patient is negative by microscopy, further testing is required at a facility equipped to perform LAMP. If the patient is at a facility that does not have LAMP, a blood sample is dried on filter paper and transported to the nearest LAMP facility by a motorcycle belonging to the project.
5. Patients found positive by LAMP are considered strong HAT suspects and undergo further tests by microscopy to demonstrate parasites, in line with WHO guidelines
*Screening process is adapted based on the particular resources, needs, geography and demography of different locations
The Chad Ministry of Health national sleeping sickness control programme signed an agreement with FIND in 2014 to collaborate on a 3 year project to intensify control of sleeping sickness. The aim of the project is to determine the feasibility and cost-effectiveness of implementing new diagnostic tools and strategies to improve surveillance and control of sleeping sickness in the country.
Human African trypanosomiasis (HAT), is endemic in 4 foci in southern Chad (Mandoul, Moissala, Tapol and Goré). In recent years, the disease has consistently been reported in both the Mandoul and Moissala foci, where almost two thirds of the cases have been detected through active screening activities.
RDTs have been introduced in 10 health facilities in the Mandoul focus. HAT suspects identified with a positive RDT result are referred to either the Bodo district hospital or Bodo Mission health centre, where capacity has been strengthened and staff trained to perform confirmatory diagnosis using methods such as LED fluorescence microscopy and LAMP. Health centres have been equipped with solar panels to power all the equipment that are needed. The project is also exploring the feasibility of supporting the opening of new health centres in villages that are currently under-served, including supporting them to carry out confirmatory diagnosis using LED fluorescence microscopy.
The national sleeping sickness control programme of Chad used to have only one mobile team, which used a four-wheel drive vehicle to visit villages and perform screening using the card agglutination test for trypanosomiasis (CATT), with the support of the World Health Organization. An additional mobile team using motorcycles has been established. It screens at-risk communities with the RDT and collects blood samples on filter papers from suspects who are found positive. The blood sample dried on filter paper are transported to the Bodo district hospital for LAMP analysis. Suspects found positive with LAMP are referred to a microscopy centre for further investigation, and treatment if disease is confirmed. The cost-effectiveness of this alternative screening strategy is being compared to the classical mobile team approach. Through this project, a sustainable strategy for accelerated control of HAT in Chad, to cover all endemic regions in the country, is being put in place.
Partners: This project is supported by the government of Chad and FIND, and through FIND, by the Bill and Melinda Gates Foundation, the German Federal Ministry of Education and Research, the Department for International Development (DFID) of the United Kingdom and the Swiss Agency for Development and Cooperation (SDC).
The Democratic Republic of the Congo (DRC), Republic of Congo and Angola are partnering with FIND to implement a trans-boundary project aimed at accelerating elimination of human African trypanosomiasis (HAT) or sleeping sickness.
Due to environmental, biological, demographic and other poorly understood factors, infections with HAT tend to aggregate in spatially limited areas referred to as foci. While such foci are often located within individual countries and can be controlled by single national disease control programmes, others traverse neighboring countries and necessitate concerted, international control efforts. In a large endemic region known as Kongo Central (formerly the Bas-Congo province of DRC, the north of Angola and the south of the Republic of Congo), the prevalence of HAT is low.
Since this region is isolated from other endemic areas, intensified and sustained management of the disease could lead to its elimination. This transboundary project introduces new diagnostic tools and methods in health facilities across the entire area.
In the DRC, 600 health facilities have been equipped with the SD BIOLINE HAT RDT, 23 facilities have been upgraded to perform state-of-the-art parasitological methods, including LED fluorescence microscopy, while LAMP (loop-mediated isothermal amplification) has been introduced in 5 facilities. Such a network of health facilities can support the implementation of FIND’s game-changing diagnostic screening strategy.
Mapping health facilities
In the Republic of the Congo, characterization of health facilities is being carried out in eight HAT-endemic communes that border Kongo Central. Similarly, in Angola, characterization of health facilities is being carried out in endemic areas of the Zaire and Cabinda provinces, located next Kongo Central. The data from the characterization will be used to select health facilities to be strengthened for the implementation of new diagnostic solutions, thus enhancing control of HAT. The activities in the two countries will ensure full coverage of the endemic focus, complementing the efforts that are going on in Kongo Central. Strengthening diagnostic capacity in these three neighboring countries will have a significant impact on control of the disease, prevent its resurgence in the region and accelerate HAT elimination.
- Mapping health facilities
In 2013, the Ministry of Health (MoH) of Malawi signed an agreement with FIND for strengthening the diagnostic capacity of health centres adjacent to the Vwaza Marsh Game Reserve to intensify control of sleeping sickness in Malawi by increasing the chances for early diagnosis of the disease.
Malawi is endemic for Trypanosoma brucei rhodesiense sleeping sickness or human African trypanosomiasis (HAT), which presents as a more chronic form in this region compared to eastern African countries.
The Ministry of Health, with support from FIND, has been strengthening the capacity of health centres around the Vwaza Marsh Game Reserve to detect cases of HAT by providing novel diagnostic tests and appropriate training. The collaboration includes refurbishing health facilities and equipping them with iLED FM and LAMP to diagnose HAT and other diseases prevalent in the area, as well as training laboratory personelle.
Patients who are suspected of HAT in health centres are tested using the micro-haematocrit centrifugation test (MHCT) and LED fluorescence microscopy. If they are negative, a blood sample is dried on a filter paper and transported by motorcycle to a diagnostic centre where the LAMP test is performed, and if this is positive, the patient is referred to the district hospital for parasitological confirmation, staging and treatment.
This has reduced the time taken between infection and confirmatory diagnosis of the disease, thereby increasing the chances of detecting cases in the early stage, when treatment is safer and more effective. It also reduces the burden on patients in time and costs of travelling to distant diagnostic services, which until recently, had to be done at the Rumphi District Hospital, more than 50 km from the game reserve.
The project is designed to improve general healthcare, surveillance and early detection of HAT patients, and interrupt transmission of the disease. It is complementary to other projects planned by the government of Malawi, which are focusing on the livestock reservoir and the tsetse fly vector. If it is successful, it will be replicated in other HAT-endemic countries.
Partners: This initiative is supported by the government of Malawi and FIND, and through FIND, by the Bill and Melinda Gates Foundation, the German Federal Ministry of Education, the Research and the Department for International Development (DFID) of the United Kingdom, and the Swiss Agency for Development and Cooperation (SDC).
In 2014, the Nigerian government, through the Nigerian Institute for Trypanosomiasis Research (NITR), a national agency under the supervision of the Federal Ministry of Science and Technology, signed an agreement with FIND to collaborate in implementation of a 3 year strategy for intensified surveillance of sleeping sickness in the country.
Nationwide active surveillance of sleeping sickness has not been undertaken in the last four decades. Consequently, the distribution of the disease in the country, including that in the established endemic foci, remains unknown. However, recent investigations have confirmed presence of sleeping sickness in Abraka (and its environs) in Delta State. It is apparent that active and passive screening of the population at risk by the government of Nigeria has caused a dramatic fall in prevalence of the disease, such that between 2008 and 2012 only 7 cases were reported to WHO. This low number means that active screening for HAT is no longer cost-effective, and there is thus a need to implement alternative strategies.
FIND and NITR characterized all the health facilities in the Delta State by determining their geographic location, the number of cases reported during the past five years, presence of a laboratory, availability of equipment for diagnosis, capacity of health personnel, availability of water and electricity, accessibility and coverage by mobile phone. This information was used to select facilities for implementation of the new strategy. In total, 57 health centres have been upgraded to perform RDTs, five centres to perform parasitology and one centre to perform LAMP. This has included renovations, supply of equipment and consumables, and training of laboratory technicians and health personnel in the use of the new technologies. These activities contribute significantly to strengthening the health system in the region.
In order to raise the awareness of communities about HAT and about the possibility to be tested with new diagnostic tools, radio spots are being broadcasted on local FM channels and advocacy materials distributed at health facilities and in villages. FIND supports NITR who implements the project in collaboration with the Ministry of Health. It is anticipated that by the end of the three year project, HAT will have been eliminated and a sustainable surveillance system established.
Partners: This project is supported by the government of Nigeria and FIND, and through FIND, by the Bill and Melinda Gates Foundation, the German Federal Ministry of Education and Research, the Department for International Development (DFID) of the United Kingdom and the Swiss Agency for Development and Cooperation (SDC).
Republic of Guinea
In 2014 the Ministry of Health of the Republic of Guinea signed a collaborative agreement with FIND to strengthen HAT diagnostic capacity by introducing new tools in health centres located in the most endemic areas of the country.
Guinea has the largest sleeping sickness burden in West Africa with more than 800 cases reported between 2000 and 2009. Despite significant efforts over the last years that resulted in improved disease control, HAT remains endemic in the coastal region of the country. Until recently, most HAT cases were being diagnosed through mass screening of the population. However, due to limited funding and manpower, annual active screening campaigns could only cover a fraction of endemic areas, and passive screening was possible in only three health centres. Thus most sleeping sickness patients remained undiagnosed until they were in the late stage of the disease.
With support from FIND the Ministry of Health has strengthened the capacity of health centres in the districts of Forécariah, Dubréka and Boffa in the littoral part of the country where the most active disease foci are located.
The Ministry of Health and FIND have equipped four main laboratories facilities with iLED FM and 2 for confirmatory diagnosis of HAT with LAMP. In addition, all health facilities in the three coastal HAT foci have been geo-referenced and characterized. Based on this information, 95 facilities have been selected for introduction of the RDT in order to maximize accessibility of this screening test to the population at risk. HAT suspects identified by a positive RDT result at the peripheral level will be referred to the nearest of the four main laboratories for confirmatory diagnosis and receive treatment according to national guidelines. Communities are informed of the possibility of being tested with the RDT at the level of health centres using various advocacy tools, such as national TV and local radio broadcasting.
The project also includes research activities to evaluate the performance and cost of using the new tests developed by FIND and its partners, in comparison with the methods currently used in Guinea, in order to establish the optimal conditions under which these tests should be implemented, both in passive and in active surveillance.
This three-year project is complementary to other efforts by the Guinean Ministry of Health and its partners (including the World Health Organization, the Bill and Melinda Gates Foundation and the Institut de Recherche pour le Développement) to strengthen HAT case detection and vector control.
Partners: This initiative is supported by the government of the Republic of Guinea and FIND, and through FIND, by the Bill and Melinda Gates Foundation, the German Federal Ministry of Education and Research, the Department for International Development (DFID) of the United Kingdom and the Swiss Agency for Development and Cooperation (SDC).
In 2014, Malteser International signed an agreement with FIND to collaborate on a project to introduce an integrated strategy to control sleeping sickness in South Sudan. In 2015, the Ministry of Health of the Republic of South Sudan also signed an agreement with FIND to expand this collaboration with the goal of intensifying surveillance and control of human African trypanosomiasis (HAT) in a sustainable manner by integrating new screening and diagnostic tools as well as strategies into the primary health care system.
The southern and southwestern regions of South Sudan, near the borders of Uganda, the Democratic Republic of the Congo (DRC) and the Central African Republic (CAR), are endemic for Trypanosoma brucei gambiense HAT. In 2013 and 2014, the number of cases reported in South Sudan was 117 and 63 respectively, which was the fourth highest behind the DRC, CAR and Chad (WHO, 2015).
Active screening for HAT in South Sudan was not previously carried out because of lack of resources. Control of the disease had been supported by various NGOs during the times of conflict, but most of them have recently stopped their activities. As a result, it is suspected that a large number of HAT cases were not being diagnosed and treated, thereby preventing sustained progress towards elimination of the disease.
Implementation of this three-year project is starting in the States of Central (Yei River County) and Western Equatoria (Maridi County) with the intention of expanding to other counties depending on progress and availability of funding. The activities of the project include: mapping and characterization of all health facilities in the Yei River and Maridi Counties; up-grading and equipping selected health facilities; training of technicians and health workers; implementing control activities using the three technologies described above; and advocacy and communication. Mapping of health facilities guides the upgrading of facilities to ensure reasonable coverage of the endemic region by health services, while characterization aids in defining the capacity strengthening needs of each facility. Advocacy and communication at the levels of the community, healthcare workers and government are critical to ensure not only adequate coverage by screening activities but also sustainability.
FIND and the government of Uganda have been implementing a similar project to eliminate T.b. gambiense HAT in the northwestern part of the country, the region bordering South Sudan. An extension of these activities to South Sudan is a great opportunity to sustain and accelerate control and eventually eliminate HAT in the region.
Partners: Malteser International, the relief agency of the Sovereign Order of Malta for humanitarian aid, and the Ministry of Health are the lead implementing partners, with support from the WHO and Jhpiego, an international NGO dedicated to saving the lives of women and families worldwide.
The government of Uganda, in a partnership with FIND, is intensifying surveillance and control of HAT in the West Nile region and Amuru district. This follows the signing of a three year collaborative agreement between the Coordinating Office for Control of Trypanosomiasis in Uganda (COCTU) of the Uganda Trypanosomiasis Control Council (UTCC) and FIND. The project includes the use of new tests developed with the support of FIND, and a new approach that is intended to shorten the distance that a sick person has to travel to seek diagnosis. Experts from the Ministry of Health (MOH), the Ministry of Agriculture, Animal Industry and Fisheries (MAAIF) and Makerere University are leading this initiative, which if successful could lead to elimination of T.b. gambiense HAT in the country.
In the first year of the project (2013-14), the strategy was implemented in 212 health facilities spread across the T.b. gambiense sleeping sickness belt of Uganda. In the second year of the project (2015), the facilities that had not reported any cases for several years were dropped from the project in order to be more cost-effective. These facilities had been initially included to ensure that the reported absence of cases was real, and not because of missed cases due to poor surveillance strategies. The number of participating facilities during the second year of the project is now 125, compared to 212 in the first year.
All participating health facilities were stocked with the rapid tests after appropriate training was carried out, while microscopy and molecular tests were located at strategic centres in all the districts. All the data on individuals tested and on stocks of kits available at each health facility are communicated to the coordinating office at the MOH, which is responsible for the day-to-day running of the project.
Various departments in Uganda have been collaborating with FIND to develop the tests that are being implemented in this project. Most of the work on LED fluorescence microscopy was carried out in partnership with Makerere University, Lwala Hospital and the National Livestock Resources Research Institute (NALIRRI), while Makerere University and Lwala Hospital have been at the forefront in research on LAMP for both T.b. rhodesiense and T.b. gambiense in Uganda and the DRC. The project is an extension of the long-term relationship between FIND and the government of Uganda and their collaboration on other diseases such as tuberculosis and malaria.
Partners: Funding for this project comes from the government of Uganda, as well as through FIND, the Bill and Melinda Gates Foundation (BMGF), Department for International Development (DfID) of the UK, the German Federal Ministry of Education and Research, the Republic and Canton of Geneva, Switzerland, and the Swiss Agency for Development and Cooperation (SDC).
Mapping health facilities
All the health facilities in the project area were geo-referenced and characterized by the government of Uganda in an earlier project with support from FIND. This made it easier to identify the facilities in which to install different diagnostics for HAT.
- Mapping health facilities