Context

The TB burden reached an estimated 10.6 million cases in 2021, with an increase in incidence and mortality rates—the first increase after 20 years of progress. The burden of drug-resistant TB (DR-TB) is also estimated to have increased in 2021, reaching 450,000 new cases of rifampicin-resistant TB. Equitable access to the best available DR-TB treatments is still suboptimal – despite the introduction of bedaquiline in 2012 and delamanid in 2014, and an expectation of rapid adoption of shorter, less toxic and more effective treatments. Mortality has remained high with 191 000 deaths in 2021.

The pandemic has had a major impact on TB, decreasing case detection and reducing the number of people on treatment. TB continues to be one of the largest contributors to the crisis in antimicrobial resistance (AMR).  To reverse setbacks and to address the growing problem of drug resistance, it will be important and a high priority to improve detection tools and accelerate adoption of new drugs in the context of quality care.

Newly recommended and pipeline regimens could fundamentally change drug-resistant (DR) TB care. One regimen, BPaL/M^[1], was recommended by WHO at the end of 2022[2],  cutting treatment time by 50%. Additional pipeline regimens include those investigated in Unitaid’s endTB project[3] with anticipated evidence to be published at the end of 2023.  These regimens could provide better alternatives for persons ineligible for the BPaL/M regimen.  Key drugs in these new and pipeline regimens include bedaquiline, pretomanid, and delamanid.

To encourage rapid uptake, WHO issued a Call to Action to accelerate the implementation of the novel, 6-month all-oral regimen for the treatment of drug-resistant tuberculosis. ^[4]  Many high-burden country governments, with other stakeholders involved in the global response, are already advancing towards programmatic roll-out of at least BPaL/M.

Unitaid and other global health and development partners are actively engaging and coordinating on the best strategies for timely and broad access to the shorter and better regimens including leveraging the work of Unitaid’s current investments in TB.  Unitaid-funded work includes driving TB detection to primary and community levels, integrating digital technologies and adherence support into TB programs, enabling targeted next-generation sequencing for resistance surveillance and clinical decision-making, optimizing drug-resistant treatment for children, and market shaping to support affordable and timely supply.   Even with these efforts and the efforts of the global community to accelerate the programmatic scale-up of better, shorter regimens, several gaps and challenges remain.  The ultimate goal is to create conditions for the best health outcomes by enabling people-centred and community-driven approaches to find and get more people into quality care.  Unitaid recognizes civil society leadership and meaningful engagement with communities as critical for responsible demand creation, including understanding care-seeking (and barriers to access), increasing diagnostic and treatment literacy, and ensuring responsible use of new drugs and regimens.

Call scope

Under this call, Unitaid is soliciting proposals to accelerate and expand access to BPaL/M and – subject to available evidence and inclusion in WHO recommendations – other shorter regimens in the pipeline within a quality package of care (drug-susceptibility testing, digital technology and adherence support, and safety monitoring/pharmacovigilance) by supporting demand creation and generation activities and innovative strategies for case finding while combating AMR.

Areas of work

Multi-country and regional product introduction and implementation support for the shorter DR-TB regimens and supportive tools defined as part of a quality care package to drive demand and expand access to the maximum number of people with DR TB.  Geographical focus is LMICs with consideration of burden of TB, and specifically DR TB.

Proposals should include at least one of the areas [5] of work listed below.

• Area 1: interventions encompassing community-led strategies for stimulating demand while simultaneously advancing human rights, equity, and quality of services within the national TB programs and where feasible the broader health systems and private sector with a focus on:
  • Raising awareness and building capacity of communities to drive demand creation
  • Developing community-led monitoring, training, advocacy and communication tools and networks that ensure appropriate and tailored materials for different stakeholders (i.e., communities, health providers, local governments, etc.) including translation.
  • Conducting coordinated campaigns at global, regional, national, and subnational levels that promote uptake, access, and awareness of a comprehensive package of care
  • Establishing greater accountability nationally based on WHO’s Multisectoral Accountability Framework and the commitments set forth in the UN HLM on Tuberculosis in 2023.
  • Strengthening linkages and referral networks with other relevant programs and sectors to increase and maximize the reach of TB tools and services beyond national TB programs

AND/OR

• Area 2: Interventions to support countries in implementing innovative and targeted strategies for enhancing quality of TB services and care, case-finding and/or resistance monitoring considering:
  • Sub-national tailoring of implementation across the public and private sectors with consideration of faster, sustainable scale-up
  • Approaches for diverse country contexts determining feasibility, cost-effectiveness, and willingness
  • Measures and policies to broaden access to lifesaving medicines, while safeguarding long-term efficacy of key TB medicines that could have implications for AMR more broadly

In general, commodity costs related to programmatic introduction should be covered, where possible, through routine country grants of the Global Fund, USAID, PEPFAR or domestic expenditures. Proposals should therefore clearly indicate how the proposed activities will integrate with existing programs and planned efforts to support a holistic approach.

[1] Pretomanid, combined with  bedaquiline, linezolid, and/or moxifloxacin

[2] WHO consolidated guidelines on tuberculosis. Module 4: treatment – drug-resistant tuberculosis treatment, 2022 update, 15 December 2022. https://www.who.int/publications/i/item/9789240063129

[3] https://endtb.org/clinical-trial

[4] WHO CALL TO ACTION: Shorter and more effective treatment for all people suffering from drug-resistant TB, 21 March 2023.

[5] Proposals do not need to address all the examples (bullets) listed under a particular area, and may include work not listed (i.e. the bullets are examples, but are not intended to be mandatory or limiting).

Additional information

Unitaid considers working with communities a critical part of generating demand and strongly encourages adopting inclusive approaches, and the early and continued meaningful engagement of communities towards improving the lives and health of the most vulnerable people. The role of affected communities and planned collaborations with other relevant groups including grassroots community organizations and Civil Society Organizations at all stages of a project/programme including ideation is essential, with this engagement a key determinant for success. Community-led approaches are important to consider and adequately fund and resource when designing, planning, implementing, and evaluating activities and programmes.

Unitaid sees value in proposals from South-based lead implementers with experience in leading the implementation of large-scale multi-country projects that support access to health products in LMICs. We also support the meaningful inclusion of South-based sub-implementers, where feasible and relevant, in proposed project implementation consortia. To be clear, Unitaid’s objective of progressively engaging an increased number of lead implementing partners from the global South does not preclude proposals that also include partners from the global North, where their role is deemed complementary and important for the success of the proposal. In all cases, we encourage coordination and collaboration across implementors and seek proposals with regional impact across key LMIC markets and a clear path to global impact.

Unitaid is committed to climate and environmental action in its investments and expect its partners to make similar commitments. Proposals should clearly indicate: (i) Efforts that will be made to minimize carbon emissions from project activities (mandatory); (ii) Potential opportunities to contribute to broader climate and/or environmental co-benefits, in synergy with core project objectives (optional). More detailed guidance and definitions are provided in the proposal template.

Proposals should be carefully targeted, reflecting focused interventions to address key challenges regarding prevention, diagnosis, and treatment of drug-resistant TB in LMICs and access to health products. Proposals are expected to target one or both of the specified areas of work listed above. Proposals may, but do not have to, cover all activities described within the area of work. Proposals should clearly indicate the level of effort and budget for each activity.

Proposals should demonstrate value for money and measurable impact. Proposals should also include analysis of pathways to impact, scalability, and sustainability of key interventions.

Areas out of scope for this Call include: product development, full-scale implementation, and/or delivery of products.

Impact we are seeking

Through this Call for Proposals, Unitaid aims to reduce DR-TB cases and deaths by effectively treating DR-TB disease and breaking the chain of transmission and in particular:

• To contribute to facilitating the implementation of the better shorter regimens for DR-TB in the context of a more comprehensive and supportive approach that will support sustained effectiveness of current tools while creating the environment for new tools;
• To generate demand and increase the accelerated adoption and use of these tools for DR-TB in LMICs;
• Generating real-world experience regarding optimal strategies and delivery models for implementation, case-finding and resistance monitoring

The objectives outlined above will lead to: (1) better health outcomes due to additional people being treated, or due to people receiving effective treatments (2) financial savings/efficiencies due to the availability and use of a quality-of-care approach, and (3) improved and more equitable access by making products available and/or affordable in LMICs. The goal is to enable widespread access to a holistic care package for DR-TB through scale-up by governments and partners, to contribute to the global health response to diseases that predominantly affect people in LMICs.

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), please click here [PDF: 200 KB];
• Unitaid’s preliminary rationale for working in this area, please click here [PDF: 560 KB];

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

• Proposal form with scanned version of signed Front page template, [DOC: 300 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]

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]. Additional guidance can be found in the following documents:

• 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]

Webinar on this Call for Proposals: