Context

Progress in the fight against TB is not sufficient to reach global goals. The 2020 WHO Global TB Report shows little change since the previous year. Nearly 1.4 million people died from TB in 2019. Of the estimated 10 million people who developed TB that year, approximately 3 million were either not diagnosed, or were not officially reported to national authorities.[1] TB continues to be one of the greatest infectious disease killers in the world, especially of the most vulnerable.   Despite recent advancements in treatment and diagnosis, existing tools are inadequate and/or underutilized to close the gap in identifying missing cases.

In addition, the COVID-19 pandemic has started to undo progress made to date. There are major disruptions to TB programs and supply chains and substantial reductions in numbers of individuals being diagnosed and seeking care.[2],[3] COVID-19-related lockdowns have limited the mobility of people and access to healthcare, highlighting the need to bring care closer to those in need.  In this context, there is a need for rapid diagnostic tools that can test for many pathogens and be implemented in primary healthcare settings including local health clinics, medical offices, health posts, or by community health workers during home visits.  Advances in contact tracing and diagnosis for COVID-19 provide opportunities for adaptation and leveraging of such tools for TB.

Recent research and evidence on the patient pathway for TB highlight gaps in care often at the first point of contact with the health system, where affected individuals are not served adequately or are lost to follow-up. This leads to delays and misdiagnoses which translate to wasted resources, high costs for both the individual and the system, poor health outcomes, drug resistance, and onward transmission. [4],[5] TB diagnosis remains the weakest link in the TB cascade of care. Often, those affected by TB must interact with the health system many times before receiving accurate diagnosis and appropriate care.

Without substantial intervention to address the gap in finding missing TB cases, TB transmission will remain out of control, perpetuating the TB epidemic, leading to continued morbidity and mortality.  This gap in case detection is in part due to inadequate uptake and national scale-up of existing WHO recommended TB diagnostic tools. Furthermore, many of these existing diagnostic tools fail to sufficiently meet the needs of people at risk of TB or of health systems in terms of accuracy, time to results, affordability, and appropriateness for use at the lowest health care levels.^[6],[7] Existing tests with their complexity and cost are centralized mostly at secondary and tertiary levels of the health system. Some of this complexity is the heavy reliance on sputum samples, often difficult to obtain especially from children, to obtain bacteriological confirmation.  There is a need to address the key barriers to providing true point-of-care solution for TB detection, including lack of infrastructure (e.g. unreliable power supply in remote settings), need for sputum samples, need for specialized laboratories and technicians, high testing and maintenance costs, and lack of robustness in rural and tropical settings.

Through this call for proposals, Unitaid aims to catalyse access and optimal introduction and placement of effective tools for the timely and accurate detection of TB.

[1] WHO Global TB Report 2020,

[2] http://www.stoptb.org/news/stories/2020/ns20_014.html

[3] https://www.theglobalfight.org/covid-aids-tb-malaria

[4] Conducting Patient-Pathway Analysis to Inform Programming of Tuberculosis Services, JID 2017:216 (Suppl 7). http://stoptb-strategicinitiative.org/wp-content/uploads/2018/07/Conducting-PPA-to-inform-TB-Services.pdf

[5] TB patients endure tortuous pathways and broken care cascades by Madhukar Pai. https://naturemicrobiologycommunity.nature.com/posts/22350-tb-patients-endure-tortuous-pathways-broken-care-cascades

[6] Treatment Action Group TB Diagnostic Pipeline Report 2020

[7] TAG’s an Activist’s Guide to Tuberculosis Diagnostic Tools

Call scope

Unitaid is soliciting proposals that aim to bring innovative diagnostic solutions into the care cascade for TB to ensure that a person with TB receives timely, reliable diagnosis that links with referral to appropriate care, thereby saving lives and contributing to achieving the global targets for ending the TB epidemic. Proposals’ scope should address the following objectives:

• Optimizing diagnostic testing devices and platforms, particularly for non-sputum samples, which include detection of TB for use at primary and community health settings including:
  • Point of care integrated molecular testing devices which can process various samples (i.e., urine, stool, blood) and have platforms which sequentially or simultaneously test for multiple infectious agents, pathogen variations and Antimicrobial Resistance (AMR). Improvements in these tests should generate evidence in appropriateness of usage in rural and low resource settings and allow for more integrated or bidirectional case detection and policies for TB and other disease management.  Rapid testing using alternative samples (i.e., urine, blood, and stool) without the need for consistent electrical-sourced equipment.
  • Optimization of tools to ensure improvement of concentration of samples, amplification of the signal in a particular assay, and/or detection sensitivity for TB.
  • Diagnostic tools with CAD-aided design could also be in scope of this call if improvements are made in portability and can demonstrate direct impact for TB.

• Demonstrating the effectiveness, appropriateness and optimal placement of an innovative diagnostic solution to enable TB detection in primary and community health settings. This must include a clear plan of action for how the intervention fits into an end-to-end implementation strategy that involves close working relationships with national health programs, affected communities and other key stakeholders. Consideration should be taken to ensuring appropriate, coordinated, and sustainable procurement, supply chains, and maintenance.
  • Please note any device, application, sample collection method proposed for implementation to improve TB detection must be inclusive of the diverse and broad population of those at risk of TB including children. Furthermore, the considerations for sustainability of the solution should be addressed and includes building evidence for placement of the proposed solution within the TB care cascade, plans for introducing it through international and national policy and ensuring affordable access to all those living in high-burden TB contexts.

Proposals should be carefully targeted, reflecting focused interventions to address key challenges with TB diagnosis in lower levels of the health system, and demonstrate value for money and measurable impact within the time frame of the grant.  Proposals should also include analysis of the complementarity as well as added advantages of the proposed solutions over the standard of care and current practices. 

Proposals that address TB as well as other related infectious diseases, leverage investments across different product categories, and those that reflect collaborative partnerships between communities, civil society, and industry are welcomed. Meaningful engagement with civil society and affected communities should be included across proposed activities for example integration of community and civil society into project governance such as steering committees and advisory boards. 

Proponents are encouraged to consider products that are available on the market or can be introduced in the market by no later than December 2022. (i.e. products that could be eligible for procurement through international funders and procurers including the governments of high burden TB countries and that have sufficient supply capacity created to address anticipated demand by the end of this timeframe).

Areas out of scope for this Call include proposals: a) with products in early stage development and/or that still require feasibility and proof of concept studies; b) aiming for full-scale implementation and/or delivery of products; c) aiming to deliver services without introducing a commodity based diagnostic solution.

Impact we are seeking

Through this Call for Proposals, Unitaid aims to catalyze global improvements in TB detection in the following ways:

• Support the availability and increased coverage of innovative screening and diagnostic technologies and approaches to significantly increase global detection rates for TB,
• Facilitate new or revised normative guidance to enable global adoption of these innovations,
• Reduce the time required for TB diagnosis and treatment initiation to improve treatment outcomes and reduce the duration of infectious periods,
• Increase the proportion of notified TB cases with a bacteriological confirmation and reduce the risk of the incorrect diagnoses and treatment of non-TB cases.

The objectives outlined above to improve TB detection will lead to (1) a reduction in TB-related mortality and morbidity by reducing the number of undetected cases and increasing speed of treatment initiation, (2) a reduction in onward transmission from undetected cases or those with delayed diagnoses, and (3) a reduction in toxicity or complications resulting from the unnecessary  treatment of non-TB cases. The ultimate goal is to significantly contribute to progress against the WHO’s End TB Strategy interim milestones and targets for 2035, which includes a goal of >90% global treatment coverage. Additional information on the impact that Unitaid is seeking can be found in the accompanying area for intervention document found here [PDF : 814 KB].

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’s preliminary rationale for working in this area for intervention, please click here [PDF: 560 KB]

Proposals should clearly demonstrate the use of innovative and sustainable approaches to accelerating uptake of drugs for PPH. 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.

Important dates

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: 170 KB]
• Annex 1: Log frame and GANTT chart template, [XLS: 278 KB]
• Annex 2: Budget details template, [XLS: 24 KB]
• Annex 3: Organizational details and CVs of key team members [no template]
• Annex 4: Country engagement support Letters [no template]
• Annex 5: Declaration of relevant interest template, [DOC: 21 KB]
• Annex 6: Applicable ethics, anti-discrimination and environmental policies template, [DOC: 21 KB]
• Annex 7: Declaration regarding tobacco entities template, [DOC: 24 KB]
• Annex 8: Anti-Terrorism Declaration template, [DOC: 30 KB]
• Annex 9: Audited financial statements for the past 3 years [no template]
• Guidance on Impact Assessment [PDF: 160 KB]
• Financial Guidelines for Unitaid Grantees [PDF: 1,2 MB]
• Unitaid Results Framework [PDF: 1.3 MB]
• Unitaid Scalability Framework [PDF: 466 KB]

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].

Webinar on this Call for Proposals: