Diagnostic tools for poverty-related diseases – 2018

Description

Background
Disease diagnosis in sub-Saharan Africa is highly challenging, as the population has limited access to health care systems. Early and rapid diagnosis of poverty-related diseases (PRDs) offers the best opportunity for patients to receive timely and appropriate treatment, but adequate diagnostic tools are not readily available because of a lack of drive to develop and deploy them in disease-endemic countries. In addition, co-infections with several pathogens are frequent in many populations and represent further challenges in the diagnosis of many PRDs. There is therefore a clear need for the development and uptake of rapid, accurate, cost-effective, scalable and field-friendly diagnostic tools.

Scope
Projects should focus on validation of the clinical performance and/or implementation of new or improved diagnostic tools and technologies for the detection of any of the PRDs*, including co-infections. The proposed tools and technologies should improve the performance of diagnosis, prediction, monitoring, intervention or assessment of therapeutic response, with a significant impact on clinical decision and health outcomes. Proposals should focus on late stage development (e.g. evaluation and/or demonstration phase trials) or implementation studies in sub-Saharan Africa. Diagnostic algorithms to detect multiple infections are also welcome. Additionally, proposals should provide detailed plans for the uptake of the diagnostic tools and technologies upon successful completion of the project, including engagement with WHO or other relevant policy makers as well as plans for product registration (i.e. CE mark).

Proposals focused entirely on early-stage, laboratory-based studies using biobanked samples are outside the scope of this call. Priority will be given to point-of-care diagnostics for use in resource-limited settings.

EDCTP considers that proposals requesting a contribution from the EDCTP2 of between EUR 1 and 3 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

EDCTP considers that proposals of between 24 and 48 months duration would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals for activities of a different duration.

Expected impact
Projects funded under this Call for Proposals should:

• contribute to the achievement of SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’
• lead to improvements in patient care through early detection and treatment of disease and/or enhanced monitoring and tracking of disease progression and therapeutic response
• contribute towards the implementation of innovative, rapid and simple diagnostics that can be deployed at low cost in health systems in resource-poor settings
• contribute to reduce infections by key antimicrobial resistant microorganisms in humans as recommended by the Global Action Plan Against Antimicrobial Resistance (PDF) and by the European Action Plan Against Antimicrobial Resistance (AMR) 2017
• be in line with EDCTP2’s strategic research agenda (PDF) to be considered as having a higher impact.

Eligibility
A proposal/application will only be considered eligible if:

1. its content corresponds, wholly or in part, to the topic/contest description for which it is submitted
2. it complies with the eligibility conditions set out below, depending on the type of action:
   • Consortia comprising a minimum of three independent legal entities are eligible to apply. Two of the legal entities shall be established in two different Participating States (European Partner States)** and one of the legal entities must be established in a sub-Saharan African country***. All three legal entities shall be independent of each other.
   • ‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.

Note

* In the EDCTP2 programme, “poverty-related diseases (PRDs)” include HIV/AIDS, malaria, tuberculosis and the following neglected infectious diseases (NIDs): dengue/severe dengue; rabies; human African trypanosomiasis (sleeping sickness); leishmaniases; cysticercosis/taeniasis; dracunculiasis (guinea-worm disease); echinococcosis; foodborne trematodiases; lymphatic filariasis; mycetoma; onchocerciasis (river blindness); schistosomiasis; soil-transmitted helminthiases; Buruli ulcer; leprosy (Hansen disease); trachoma; yaws; diarrhoeal infections; lower respiratory infections; as well as emerging infectious diseases of particular relevance for Africa, such as Ebola or yellow fever.

** The following European countries are EDCTP Participating States: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden and United Kingdom.

*** The following African countries are eligible: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo (Democratic Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé and Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia, Zimbabwe.

Procedure and application process

Two-stage application procedure. For the first stage, a letter of intent must be submitted by the first deadline. Successful applicants in the first stage will be invited to submit a full proposal for the second stage.

• Proposals for Stage 1 must be submitted by 11 October 2018 at 17:00:00 CET via EDCTPgrants. Evaluation results for Stage 1 are expected to be made available by 21 December 2018.
• Proposals for Stage 2 must be submitted by 21 March 2019 at 17:00:00 CET via EDCTPgrants. Evaluation results for Stage 2 are expected to be made available by 25 July 2019.

Evaluation, scoring and thresholds
Following an admissibility and eligibility check, letters of intent and full proposals are evaluated by external, independent experts. Proposals are evaluated according to the criteria Excellence, Impact and Implementation. Each criterion is scored between 0 and 5.

For the evaluation of first-stage proposals under a two-stage submission procedure, only the criteria ‘excellence’ and ‘impact’ will be evaluated. Within these criteria, only the aspects in bold will be considered.

The threshold for both individual criteria will be 4. The overall threshold, applying to the sum of the two individual scores, will be set at the level such that the total requested budget of proposals admitted to stage 2 is as close as possible to three times the available budget, and in any case, not less than two and a half times the available budget. The actual level will therefore depend on the volume of proposals and funding request per proposal received. The threshold is expected to normally be set at 8 or 8.5.

For the evaluation of first-stage proposals under a two-stage submission procedure, an arithmetic average (mean value) or median of the individual scores may be taken as the consensus score. The consensus report may consist of a collation of the individual evaluation reports or extracts from them.  As part of the evaluation, a review committee may be convened to reach consensus on the applications proceeding to the second stage.

The Coordinator has a ‘right to reply’ to the expert assessments (rebuttal procedure) at the second-stage evaluation.

The following aspects are considered under the evaluation criteria:

1. Excellence
The following aspects will be taken into account, to the extent that the proposed work corresponds to the topic description in the work plan:

• Fit with the scope and objectives of the EDCTP2 Programme, the EDCTP strategic research agenda and the call topic description
• Importance, relevance/pertinence and clarity of the objectives
• Soundness of the concept and credibility of the proposed approach/methodology
• Importance of the question being addressed and the rationale/need for the proposed clinical trial(s) or research study now
• Excellence and appropriateness of the clinical trial design, including the proposed location(s) of the trial
• Extent that the proposed trial will advance the field. In particular, how it differs from or complements any relevant planned, ongoing or recently completed trials internationally
• Appropriate consideration of interdisciplinary approaches, and where relevant, use of stakeholder knowledge.

2. Impact
The following aspects will be taken into account:

• Call specific aspects as listed under ‘expected impact’ in each individual call
• The extent to which the outputs of the proposed work would contribute, at the European, African and/or International level, to each of the expected impacts listed in the work plan under the relevant topic
• Likelihood to result in major advances in the field
• Advancing the clinical development of new and improved products.
• Generalisability of the trial/study results beyond the immediate research setting in a way that will maximise the impact of the results
• Contribution to improved disease management and prevention through changes in policy, with the ultimate goal of improving public health
• Contribution to strengthening the capacity in sub-Saharan Africa to conduct clinical trials
• Effectiveness and quality of the proposed measures to exploit and disseminate the project results (including management of IPR) to communicate the project activities to different target audiences, and to manage research data.

3. Quality and efficiency of the implementation
The following aspects will be taken into account:

• Quality and effectiveness of the work plan, including extent to which the resources assigned to work packages are in line with their objectives and deliverables
• Appropriateness of the management structures and procedures, including risk and innovation management, and how responsibilities for research data quality and sharing, and security will be met
• Complementarity of the participants within the consortium, and the extent to which the consortium as whole brings together the necessary expertise
• Appropriateness of the allocation of tasks and resources, ensuring that all participants have a valid role and adequate resources in the project to fulfil that role
• Feasibility and appropriateness of the methods and project management to achieve the objectives within the time frame of the grant
• Compliance with national and international standards of research, Good Clinical Practice, ethics and safety related issues
• Participants have the operational capacity, to carry out the proposed work, based on the competence and experience of the individual participant(s)
• Competence of the participants and their investigators in conducting trials according to international standards of Good Clinical Practice (ICH-GCP)
• Involvement of sub-Saharan African researchers in the scientific leadership of the clinical trial
• Arrangements and plans to take forward clinical development of the products under evaluation (where applicable).

The Coordinator has a ‘right to reply’ to the expert assessments (rebuttal procedure).

Financial provisions
The call budget is €18 million.

The EDCTP considers that proposals requesting a contribution from the EDCTP2 of between EUR 1 and 3 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts. The funding level is 100% of eligible costs.

Grant agreement
EDCTP2 multi-beneficiary grant agreement.

Application process

• The application must be submitted online via EDCTPgrants
• Only registered users of EDCTPgrants system can apply for grants and therefore you are advised to register on the system as soon as possible.

Documents and other information

Documents

• Template of Proposal for stage 1 – Letter of Intent (Word)
• Template for Proposal for stage 2 – Full Application (Word)
• Guidance for applicants on preparing full proposals and annex 1 of the grant agreement (PDF)
• Template for essential information to be provided for proposals including clinical studies (Word)

More information

• For questions related to this call for proposals, please contact: edctpgrants@edctp.org
• For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via edctpgrants@edctp.org
• For guidance on online application procedure, please refer to the Guidance for applicants
• For more information about EDCTP2 procedures, please refer to the EDCTP2 Grants Manual and EDCTP2 FAQs
• EDCTP2 policy on clinical trials registration, publication and data sharing (PDF)
• Global Code of Conduct for Research in Resource-Poor Settings (PDF)

Projects awarded under this call

DIAGMAL
Phase III evaluation of an innovative simple molecular test for the diagnosis of malaria in different endemic and health settings in sub-Saharan Africa

Academisch Medisch Centrum bij de Universiteit van Amsterdam (Amsterdam UMC), Amsterdam, the Netherlands, with partners in Burkina Faso, Ethiopia, Kenya, Namibia, Sudan, and the United Kingdom
Project coordinator: Dr Henk Schallig (Amsterdam UMC)
Starting date: 01 December 2019
Duration: 48 months
EDCTP grant amount: EUR 2,999,499
Grant agreement: RIA2018D-2496
Project website

ERASE-TB
Early risk assessment in TB contacts by new diagnostic tests

Ludwig Maximilians Universitaet Muenchen (LMU), Munich, Germany, with partners in Mozambique, Sweden, Tanzania, the United Kingdom, and Zimbabwe
Project coordinator: Dr Norbert Heinrich (LMU)
Starting date: 01 May 2020
Duration: 48 months
EDCTP grant amount: EUR 3,324,698
Grant agreement: RIA2018D-2508

LAMP4Yaws
Clinical evaluation of a loop-mediated isothermal amplification test for Treponema pallidum pertenue: A diagnostic tool to support yaws eradication

London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom, with partners in Cameroon, Côte d’Ivoire, Germany, Ghana, and Spain
Project coordinator: Dr Michael Marks (LSHTM)
Starting date: 01 January 2020
Duration: 36 months
EDCTP grant amount: EUR 2,907,871
Grant agreement: RIA2018D-2495
Project website

PreFIT
Predicting the future: incipient tuberculosis

Stichting Amsterdam Institute for Global Health and Development (AIGHD), Amsterdam, the Netherlands, with partners in Mozambique, South Africa, Spain, Switzerland, and Uganda
Project coordinator: Prof. Frank Cobelens (AIGHD)
Starting date: 01 February 2020
Duration: 48 months
EDCTP grant amount: EUR 3,299,454
Grant agreement: RIA2018D-2509

SeroSelectTB
Evaluation of the feasibility, accuracy, and effect of a rapid point-of-care serological triage test for active TB (SeroSelectTB) in high burden, HIV-endemic African settings: a multi-centre, parallel-group, randomised, controlled trial

Norwegian Institute of Public Health (NIPH), Oslo, Norway, with partners in Austria, Ethiopia, France, Germany, the Netherlands, South Africa, and Tanzania
Project coordinator: Prof. Carol Holm-Hansen (NIPH)
Starting date: 01 January 2020
Duration: 48 months
EDCTP grant amount: EUR 2,998,559
Grant agreement: RIA2018D-2493
Project website

STooL4TB
Evaluating a new stool-based qPCR for diagnosis of tuberculosis in children and people living with HIV

Fundación Privada Instituto de Salud Global Barcelona (ISGlobal), Barcelona, Spain, with partners in Eswatini, Germany, Mozambique, the Netherlands, and Uganda
Project coordinator: Dr Alberto Garcia Basteiro (ISGlobal)
Starting date: 01 October 2020
Duration: 48 months
EDCTP grant amount: EUR 2,999,989
Grant agreement: RIA2018D-2511

TB Triage+
Community-based tuberculosis triage testing after symptom screening in hard-to-reach African populations: CAD4TB versus C-reactive protein

Swiss Tropical and Public Health Institute (SwissTPH), Basel, Switzerland, with partners in Belgium, Germany, Lesotho, the Netherlands, South Africa, and Switzerland
Project coordinator: Dr Klaus Reither (SwissTPH)
Starting date: 01 January 2020
Duration: 48 months
EDCTP grant amount: EUR 3,191,622
Grant agreement: RIA2018D-2498

TriageTB
Field evaluation of a point-of-care triage test for active tuberculosis

Stellenbosch University (SUN), Stellenbosch, South Africa, with partners in Germany, the Netherlands, Switzerland, Uganda, and the United Kingdom
Project coordinator: Prof. Gerhard Walzl (SUN)
Starting date: 01 October 2019
Duration: 54 months
EDCTP grant amount: EUR 3,291,740
Grant agreement: RIA2018D-2499
Project website

XACT-III
A randomised control trial to evaluate a scalable active case-finding intervention for tuberculosis using a point-of-care molecular tool (Xpert Omni)

The University of Cape Town Lung Institute (Pty) Ltd., Cape Town, South Africa, with partners in Italy, the United Kingdom and Zimbabwe
Project coordinator: Prof. Keertan Dheda (UCT)
Starting date: 01 April 2020
Duration: 48 months
EDCTP grant amount: EUR 754,774
Grant agreement: RIA2018D-2505

XACT-IIIB
A randomised control trial to evaluate a scalable active case-finding intervention for tuberculosis using a point-of-care molecular tool (Xpert Omni)

The University of Cape Town Lung Institute (Pty) Ltd., Cape Town, South Africa, with partners in Mozambique, the Netherlands, The United Kingdom, and Zambia
Project coordinator: Prof. Keertan Dheda (UCT)
Starting date: 01 April 2020
Duration: 48 months
EDCTP grant amount: EUR 2,920,284
Grant agreement: RIA2018D-2505