Call for Proposals: In maternal and child health. Towards the elimination of congenital infection in Chagas Disease through better tools for diagnosis and treatment

In the context of maternal and child health, Unitaid has identified the opportunity to support the elimination target of congenital transmission of Chagas disease in endemic countries.

Context

Worldwide, 75 million people are at risk of Chagas disease, a neglected tropical disease (NTD) that infects 6-7 million people and results in over 10,000 annual deaths [1]. Chagas is endemic in 21 Latin American countries where it causes more deaths than any other parasite-borne disease including malaria. Most cases occur in Latin America, often in the poorest and most marginalized communities of endemic countries, but the disease is increasingly spreading to other geographies.

Chagas is transmitted most commonly through vectoral, congenital or transfusional routes. Vectoral Chagas infection occurs when Trypanosoma cruzi-infested faeces are rubbed into a bite from a vector (a triatomine bug) that defecates close to its bite. Chagas disease starts with an acute (often asymptomatic) phase followed by a longer chronic phase, during which the patients feel well, but can transmit the parasite to others, congenitally or via blood transfusions. The chronic phase can last for decades, during which 30-40% of people infected develop severe cardiac, gastrointestinal or neurological complications. Despite high morbidity and mortality, and a high associated economic burden, only 7% of people with Chagas disease have been diagnosed and only 1% receive appropriate treatment. [2] [3] With at least two million women of child-bearing age estimated to be chronically infected with Trypanosoma cruzi, mother-to-child transmission is a key infection route, with Chagas often undetected and untreated in both mothers and their newborns. Currently, vertical transmission of Chagas is considered the source of the highest number of new acute infection cases. [4] Given the success of therapy in newborns, early detection of infection in infants is critical. Evidence has further shown that active screening and optimal treatment women of child-bearing age can effectively prevent congenital transmission. [5] [6]

Current challenges in the access to testing and treatment for Chagas disease include the lack of availability of diagnostic tools and drugs in primary health care clinics, the lack of properly trained health care workers and poor awareness of Chagas disease, and limited options for effective and accessible diagnosis in newborns and infants. While the two available treatment options are highly effective in newborns and during the acute phase of Chagas infection, their efficacy decreases as the chronic phase progresses, becoming increasingly ineffective in treating the parasitic infection, making access to tools for early detection critical. Furthermore, both available drugs are contraindicated during pregnancy.

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[1] World Health Organization. Chagas Disease (American trypanosomiasis) – http://www.who.int/chagas/en

[2] World Health Organization. Chagas Disease in Latin America: an epidemiological update based on 2010 estimates. WHO 2005

[3] Pan American health Organization. Diagnosis and Treatment of Chagas disease in 21 endemic countries: the Americas, 2010-2016. 2018

[4] Sosa-Estani S (2005) Congenital transmissión of Tripanosoma cruzi in Argentina. Rev Soc Bras Med Trop 38(2): 29–32.

[5] Murcia L et al. (2013). Risk factors and primary prevention of congenital Chagas disease in a nonendemic country, Clin Infect Dis. 2013;56(4): 496-502

[6] Fabbro DL et al. (2014) Trypanocide treatment of women infected with Trypanosoma cruzi and its effect on preventing congenital Chagas. PLoS Neg Trop Dis 2014;8(11)

New opportunity

Recently, there has been significant progress in the innovation pipeline with tools such as rapid diagnostic tests, shorter treatment regimens for adults and early clinical trials for new chemical entities. These innovations promise to rapidly increase the rate of diagnosis, shorten treatment times, improve treatment efficacy, and reduce congenital transmission.

In addition to regional vector control efforts carried out by national governments, better diagnosis and treatment of women of childbearing age and newborns could impact the epidemiology of Chagas, limiting congenital transmission and substantially reducing new infections among these currently underserved populations.

New tools for timely diagnosis and better treatment could catalyse a paradigm shift in approaches to preventing transmission globally through the active and systematic screening of girls and women, inclusive of all pregnant women, to treat infected newborns (and their siblings) as soon as possible.

Access to affordable point-of-care diagnostics with immediate results will be key to providing an actionable diagnosis for vulnerable populations and particularly for newborns, and people in rural or endemic areas. Once a patient is diagnosed, effective, better tolerated and affordable treatments with reduced side effects, effective also during the chronic phase, could be available.

The scale up of innovative tools and approaches for case management of Chagas disease has the potential to increase the number of patients diagnosed and treated, reduce the number of new congenital infections, reduce chronic cases and severe complications, lead to potential health system savings and efficiencies, as well as support elimination strategies. This is an opportunity to catalyse elimination in line with the WHO Chagas Disease: Control and Elimination Report, PAHO eMTCT Plus Framework for Elimination of Mother-to-Child Transmission of HIV, Syphilis, Hepatitis B and Chagas and the WHO Accelerating Work to Overcome the Global Impact of Neglected Tropical Diseases: A Roadmap for implementation.

Call scope

Under this Call, Unitaid is soliciting proposals for the following interventions aimed at accelerating the availability, adoption and scale-up of improved tools to diagnose and treat Chagas Disease, including:

  • Pilot implementation of ‘test and treat’ approaches in a selection of endemic countries, in particular through active, systematic screening of girls and women at risk of infection, and their newborn infants

Pilots should aim to enable the adoption of existing and new innovative Chagas disease tools in endemic countries and provide a roadmap for the optimal scale up of rapid diagnostic tests and improved treatments more broadly. Activities could aim to increase awareness and demand of Chagas disease tools, improve their affordability and ensure better access to innovations, such as point of care tests, that shorten time to diagnosis. Projects could also include validation of rapid diagnostic testing algorithms in real-life settings, product registrations in target countries, healthcare worker training, and operational research to generate the necessary evidence for guideline change and scale up. In addition to diagnostics, pilots could demonstrate the effectiveness of shorter regimens of existing formulations.

Pilots should aim to generate evidence to support normative and operational guidance in country settings, with particular attention to ensuring the coordinated supply and distribution of quality-assured products needed for Chagas disease case management. With the increased adoption of new tools as part of pilot implementation, opportunities for volume-based price reductions or other market strategies should also be explored. Pilots should also establish best practices in terms of operational feasibility, safety, values and preferences of patients and healthcare workers, and cost-effectiveness. Target countries should cover a range of endemic settings and geographical diversity.

Demonstrated alignment with national programmes and other national and regional partners will be key to ensure scale up and sustainability beyond the life of the project. Emphasis should be placed on translating the outputs of the pilots into activities and tools that will support transition and broader scale up in project countries and beyond. Coordination with national programmes and firm country commitment to ensure a sustainable response will be required as a condition for implementation. As part of the broader sustainability objective, opportunities for co-funding of pilot implementation activities should be actively explored.

  • Develop and validate new products to expand access to Chagas disease diagnostics and treatments to key population groups

This component of the call should aim to develop and validate new diagnostics and treatments in populations which are most likely to be affected by Chagas but unable to access care. This could include, but is not limited to, innovative rapid diagnostic tests and other affordable, easy to use methods to detect T. cruzi biomarkers. These will need to be verified across geographies and tested against various strains of T. cruzi. Activities may include developing and/or validating tests to facilitate early detection in newborns and infants at point-of-care. Once proven effective, the tests must be registered in key countries, and inform best practices in global and national guidelines.

Separate targeted work may support late stage development for new drug regimens for improved treatment of Chagas disease, including treatment that is effective during the chronic stage and with fewer side effects. The late-stage development of new treatments safe for use during pregnancy and breastfeeding are particularly encouraged.

Applicants can submit proposals for one or both of the intervention areas outlined above. The call aims to cover diverse geographical settings within Chagas disease endemic countries. 

Topics which are out of scope for this Call include: basic and early-stage research, single-site interventions and small-scale research studies.

Proposals submitted should clearly demonstrate the fit with the objectives set out above, the expected impact and value for money, as well as the complementarity and added value to similar projects and how coordination will be ensured.

Under this Call for Proposals, Unitaid expects to award 1-2 grants for an approximate total level of support of up to US$ 15M. Co-funding of pilot implementation activities should be actively explored.

Process for proposal submission

When developing a proposal, please note the following resources:

  • Answers to frequently asked questions relevant to proposal development (this document is regularly updated) click here [PDF: 560 KB];

Unitaid works through market-based interventions to achieve global market and public health impact. Proposals should clearly demonstrate the use of innovative and sustainable approaches to accelerating access to better tools for Chagas Disease case management.

Applicants should be clear about the underlying assumptions made in their proposed approach and should highlight any major risks or other factors that may affect the delivery of results. Finally, proposals are expected to outline a lean, concrete and clear pathway to results and impact.

After assessment of the proposals and endorsement by the Unitaid Board all applicants will be officially notified as to whether they will be invited to develop a full grant agreement for Unitaid funding.

Successful applicants should plan to be available for a face-to-face kick-off meeting with Unitaid, in Geneva. In addition to this meeting, successful applicants should plan to have sufficient human resources available to advance a first draft of the project plan by Q2 2020.

Important dates

12 December 2019

Unitaid will be hosting a webinar to present the scope and content of the call for proposals and answer any process-related questions on Thursday 12 December 2019 at 14:00 Geneva (Switzerland) time.

To register for the webinar please complete the online form here. Please note that only registered participants will receive the WebEx call-in details. During registration you will have the option to send questions which Unitaid will aim to address during the webinar.

If you are unable to participate in the webinar, a recording of the session will be made available on this page shortly after in English and will also be translated to Spanish and Portuguese. Participation in the webinar is optional and you can respond to the call for proposals by sending your application at any point before the deadline indicated below.

27 February 2020

The closing date for receipt of full proposals is Thursday 27 February 2020 at 17:00 Geneva (Switzerland) time. Applications received past the indicated deadline will not be considered.

Please note, a proposal is considered submitted only once you receive an e-mail message of confirmation of receipt from Unitaid.

Please note that the confirmation of receipt is not an automated message and will be sent to you within one working day following the deadline. If for any reason you have not received the confirmation of receipt within one working day, please reach out to proposalsUnitaid@who.int

Please note that our email system accepts messages up to 8 MB in size. For submissions exceeding this size, please consider splitting your submission in several messages.

Submission and format of proposals

Proposals, including all annexes, should be submitted electronically to proposalsUnitaid@who.int. A full proposal consists of the following documents:

  • Proposal form with scanned version of signed Front page template, DOC: 160 KB]
  • Annex 1: Log frame template, [XLS: 50 KB]
  • Annex 2: Timeline GANTT chart template, [XLS: 35 KB]
  • Annex 3: Budget details template, [XLS: 23 KB]
  • Annex 4: Organizational details and CVs of key team members [no template]
  • Annex 5: Country engagement support Letters [no template]
  • Annex 6: Declaration of relevant interest template, [DOC: 21 KB]
  • Annex 7: Applicable ethics, anti-discrimination and environmental policies template, [DOC: 21 KB]
  • Annex 8: Declaration regarding tobacco entities template, [DOC: 25 KB]
  • Annex 9: Anti-Terrorism Declaration template, [DOC: 30 KB]
  • Guidance on Impact Assessment [PDF: 160 KB]
  • Financial Guidelines for Unitaid Grantees [PDF: 1,2 MB]

If you have any questions about the application processes throughout any stage of the application review process, please send your queries to the Grant Application Manager:  proposalsUnitaid@who.int

You will find further guidance in the Unitaid proposal process document [PDF: 530 KB].


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