Context

Vector control tools are critical to the control and elimination of malaria. Of the 663 million malaria cases averted in sub-Saharan Africa between 2001 and 2015, it has been estimated that nearly 80 percent were due to the use of Insecticide Treated Nets (ITNs) and Indoor Residual Spraying (IRS).[1] Despite the gains achieved by cost-effective vector control interventions, multiple factors threaten future progress. Chief among these are insecticide resistance, residual transmission, invasive vector species, and challenges in malaria prevention in specific populations and contexts (e.g. mobile and migrant populations, climate-related crises, conflict settings). Since 2010, resistance to at least one class of insecticide has been reported in sixty-one countries. Detecting and monitoring levels of resistance, and understanding the added value that different tools can offer in these settings, is critical as national malaria programs consider what intervention mixes may be the most impactful in their country. Interventions recommended by WHO for large-scale deployment also face constraints when it comes to reducing outdoor malaria transmission, as ITNs and IRS are more effective against indoor biting and resting mosquitoes. Another emerging threat is the spread of Anopheles stephensi, a highly adaptable mosquito species and malaria vector that readily breeds in a range of habitats, including in urban environments. Generally, malaria is most common in rural areas in Africa, but as powerful forces like rural poverty and climate change increasingly drive urban migration, the spread of An. stephensi could lead to unprecedented increases in malaria transmission. Recent modelling drawing on data from the expansion of An. stephensi in Djibouti and Ethiopia suggests that P. falciparum malaria cases could increase by 50% (95%CI 14-90) if no additional interventions are implemented.[2] Emerging tools and refined delivery strategies could address some these challenges, but support is needed to facilitate rapid adoption and healthy market conditions for sustainable use alongside the mainstays of vector control.

With more vector control tools, of varying costs and effectiveness to choose from, evidence to guide country-led prioritization has become increasingly important, particularly given resource constraints and the need to achieve and maintain optimal intervention coverage amidst likely trade-offs. Epidemiological trials are ongoing for several new vector control products, which are under review by the WHO Vector Control Advisory Group (VCAG). Based on the trial results, VCAG will determine whether these new interventions have public health value. If confirmed, the WHO guideline development process is initiated. However, a WHO recommendation alone will not be sufficient to enable early adoption and scale-up, particularly as evidence to guide practical implementation of new interventions is often very limited. Further evidence generation to inform how best to deploy and integrate these new tools within existing malaria control strategies to maximize their impact and cost-effectiveness is needed. Research to refine priority use cases and effective delivery strategies, including integrated or combination approaches, will help define the added value of these tools in different settings. Operational and cost-effectiveness data will also inform WHO programmatic guidance on their use and help national malaria programs make evidence-based decisions on how to target and tailor deployment to different sub-national transmission settings.

In addition, efforts are needed to build a healthy market for these new tools. Market entry support to ensure an adequate supply base and sustainable pricing for newly recommended products is critical. Activities like demand forecasting, product acceptability studies, and price sensitivity studies will help inform supply needs and decision-making around market interventions and other strategies to ensure equitable access. Evaluation support for fast-follower products may also be needed to demonstrate non-inferiority and help strengthen the market.

Recognizing these evidence generation and market entry support needs, Unitaid is launching this Call for Proposals to build and catalyze uptake of an expanded vector control toolbox to fight malaria. The main objectives of this Call for Proposals are the following:

• To build the epidemiological and operational evidence needed to inform deployment and integration of new vector control tools within the wider malaria control toolbox, focusing on cost-effectiveness, and operational deployment strategies in specific settings.
• To establish healthy market conditions for new vector control tools, including supply security and sustainable pricing, through activities such as demand forecasting, cost-of-goods analyses, product evaluations and regulatory support.

[1] Bhatt S, et al. The effect of malaria control on Plasmodium falciparum in Africa between 2000 and 2015. Nature. (2015); 526:207–11.

^[2] Hamlet, A, et al. The potential impact of Anopheles stephensi establishment on the transmission of Plasmodium falciparum in Ethiopia and prospective control measures. BMC medicine 20.1 (2022): 1-10.

Call scope

Tools

Unitaid will consider proposals that support introduction of new vector control tools that expand the existing toolbox and meet the following criteria:

• New tools must be intended for use against malaria, and should aim to address one or more of the key challenges described above (e.g. insecticide resistance, residual transmission, invasive vectors)

• New tools must belong to the intervention classes and prototype/products under WHO Vector Control Advisory Group (VCAG) review for assessment of public health value[1]

• New tools must be on track to be considered for a WHO recommendation by 2025/2026.

Areas of work

Proposals are solicited for the following interventions.

Operational research on new vector control tools and delivery strategies to accelerate uptake in the event of a positive WHO recommendation

Operational research should be designed to guide country decision-making around future procurement and deployment of new tools in the event that they are recommended by WHO. To ensure a country-led research agenda, all proposed research should leverage direct engagement with national malaria control programs on priority research objectives.[2] These studies could include a range of different methodological approaches (e.g. pragmatic trials, quasi-experimental designs, implementation research) and should include cost-effectiveness studies, examining both direct and indirect costs and benefits. The studies should evaluate new tools as they are currently envisaged to be deployed (i.e. either alone or in combination with other tools), leveraging and building on the existing evidence base either from ongoing or completed studies. Studies should aim to assess the incremental or relative cost-effectiveness of new tools compared to or in addition to existing interventions and aim to generate generalizable findings that are transferable to similar settings. It is assumed that epidemiological, entomological and anthropological data collection would be required and modelling or key informant consultations would inform the feasibility and selection of different combination approaches and deployment strategies to yield maximum potential impact and efficiencies. Strong stakeholder engagement will be critical throughout research design and implementation, including with national policymakers and implementers, civil society and communities. Social and behavioral research can provide valuable insights into the acceptability of new tools, barriers, and motivators to use, and should be considered.  Efforts to test and refine modelling approaches and technologies that inform subnational tailoring and programmatic decision-making on intervention targeting may also be included. Given the rapid progression of climate change, data and technology platforms may incorporate or consider the addition of climate or weather data to inform intervention selection or delivery in different settings, particularly in areas where An. stephensi is a growing concern.  The overall operational research strategy should be outlined in the proposal, with clear objectives and activities prioritized based on expected impact. This will be further developed during grant development in close consultation with project partners.

In order to lay the groundwork for rapid uptake of new vector control interventions targeted under this Call for Proposals, these research grants will begin prior to the release of new WHO recommendations and will be conducted in parallel to epidemiological trials assessing their public health value. As part of project planning, it should be noted that any operational research activities would cease if it is found that the product(s) do not demonstrate public health value, following assessment by VCAG.

Market readiness to support a sustainable market for an expanding vector control toolbox

Proposals should include activities to prime the market for future scale-up, should the new interventions be recommended. While accurate demand forecasting is challenging for newer vector control tools with many unknowns around country decision-making, efforts to conduct this forecasting should be included as it is critical to understanding supply needs and informing the selection of market interventions and other strategies to ensure equitable access. Forecasting efforts should take into account changes in at-risk populations as a result of climate change. Scenario planning for predicting long-term volumes should consider scale-up in different settings, as well as the influence of factors like extreme weather. This work may be complemented by activities at the country-level to assess the financing landscape for new vector control products and inform cost-benefit decisions around product adoption, given resource constraints.  Market readiness activities may also include efforts to expand the supplier base, including technical assistance to manufacturers for market entry, including potential local manufacturers. Manufacturer support may include product evaluations to meet WHO PQ requirements for non-inferiority of second-in-class products.  Other activities could include cost-of-goods analyses or price sensitivity studies to support manufacturer negotiations. The overall market shaping strategy should be outlined in the proposal and will be further developed during grant development in close consultation with project partners.

Settings of interest

Evidence generation should be aimed at identifying and refining effective delivery strategies for new vector control tools in comparison or in combination with existing ones in the following target settings:

1. Countries with a high malaria burden
   Evidence generation should include different subnational transmission settings and aim to produce transferrable findings to inform country-led prioritization of malaria prevention interventions.
2. Countries where Anopheles stephensi is an emerging threat
   Evidence generation should focus on identifying optimal approaches to address the invasion of An. stephensi, particularly in urban and peri-urban settings, with the goal of informing evidence-based guidance for national malaria control programs on effective response strategies. Piloted strategies should build on recommendations in the recent WHO Vector Alert[3] and RBM Consensus Statement,[4] such as for integrated vector control in coordination with Aedes programs, One Health approaches, and community-based control activities.

Project Oversight

Technical input and oversight of the initiative will be shared across key partners, and to this end an expert advisory group or steering committee should be formed to oversee project activities. The steering committee will be the strategic support structure for the grant, providing the lead grantee with thought partnership, a forum for problem-solving, relationship support, and evaluating strategic and/or operational shifts over the course of the project. The structure and design of this oversight body can be best defined during grant development to ensure it is fit-for-purpose.

[1] WHO. (‎2018)‎. Overview of product classes and prototype/products under Vector Control Advisory Group (‎VCAG)‎ review for assessment of public health value. World Health Organization. License: CC BY-NC-SA 3.0 IGO.

[2] One available resource is a recent review of national malaria program research priorities, though applicants are invited to seek additional inputs on priority research questions from national decision makers.  PMI Insights (2022). Malaria operational research and program evaluation priorities for the sub-Saharan Africa region: Full report. Available at: https://www.pmi.gov/operational-research-prioritization-protocol

[3] World Health Organization (2023). Vector Alert: Anopheles stephensi invasion and spread in Africa and Sri Lanka.

[4] RBM Partnership to End Malaria – Vector Control and Multi-sectoral Action Work Group (2023). Global Vector Control Response to invasive Anopheles stephensi Consensus Statement.

Proposal requirements

Proponents should clearly describe their overall project design with a Theory of Change, showing how it meets the objectives of the initiative and how the proposed activities form part of a coherent whole. Proposals should explicitly state what impact will be achieved within the project life-time, as well as what, and how, lasting impact will be achieved.

Proponents should include a clear roadmap of how introduced tools can be incorporated into national vector control programs, and scaled up, with the necessary WHO recommendation. Proponents should provide detailed scenario analyses on price, demand, and associated market factors, and articulate a coherent market-shaping strategy to support sustainable impact.

It is expected that a consortium of partners will be required to undertake the full complement of activities described (Areas of work, as above). Applicants may choose to focus their proposals on one or both settings of interest. The consortium should clearly demonstrate strong expertise in the different technical and market intervention areas needed to undertake the project, including the implementation of large-scale multi-country projects of this nature as well as research activities that cover both pragmatic trials and economic evaluations in LMICs. This should include evidence of strong skills in design and analysis of quasi-experimental studies, a specialized approach likely to be needed in this project. Of the two areas of work described above, the operational research component is the main focus, and this should be reflected in the consortium leadership structure and budget. Proponents are expected to outline an evaluation framework as part of their proposal, which will be further defined in collaboration with project partners as part of the grant agreement development process.

Beyond the consortium, broad collaboration with relevant stakeholders will be vital to achieving the project objectives. Proponents should clarify the key stakeholders with whom they will engage, and how this will be achieved. It is important to include a country engagement model that outlines how countries will be supported in decision making and tailoring of the introduced tools, how they will be monitored and accessed for impact. Demonstrated articulation with national programs and other scale-up partners will be key.

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.

Additional information

Unitaid considers working with communities to be a critical part of generating demand and strongly encourages adopting inclusive approaches, towards improving the lives and health of the most vulnerable people. The engagement of affected communities and collaborations with other relevant groups including grassroots community organizations and civil society organizations at all stages of a project is essential.  Community-led approaches are important to consider when designing, planning, implementing, and evaluating activities and programs.

Unitaid sees value in proposals from South-based implementors with experience in leading the implementation of large-scale multi-country projects that support access to health products in countries. We encourage coordination and collaboration across implementors and are interested in proposals that have a regional impact and logical pathway to global impact

Unitaid is committed to climate and environmental action in its investments and expect its partners to make similar commitments. Proposals should indicate: (i) Efforts that will be made to minimize carbon emissions from project activities (e.g., greener procurement practices, reduced travel through more reliance on in-country based teams and service providers); (ii) Potential opportunities to contribute to broader climate and/or environmental co-benefits, in service of core project objectives. Unitaid is open to consider limited funding when necessary to support such discrete activities, subject to Unitaid’s current and future guidelines and financial prioritization. Estimated budget requirements should be explicitly mentioned in the relevant section of the proposal form. Applicants are also encouraged to pursue opportunities to access climate change-related funding, especially in the context of building resilience and adapting to extreme weather (e.g. heavy flooding) conditions with targeted malaria control strategies.

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

Impact we are seeking

Through this Call for Proposals, Unitaid aims to improve access to health products of public health importance in low- and middle-income countries, and in particular:

• To introduce new vector controls with the potential to address key challenges facing the malaria response, including insecticide resistance, residual transmission, invasive vectors, and difficulty reaching vulnerable populations in specific contexts (e.g. mobile and migrant populations, climate-related crises, conflict settings);
• To generate evidence on refined delivery strategies for the new tools in comparison or in combination with existing ones in specific target settings;
• To generate demand and increase their adoption and use in LMICs;
• To increase their affordability and supply security in LMICs.

The objectives outlined above will lead to: (1) reductions in malaria cases and deaths due to optimized deployment of new and existing vector control tools, (2) financial savings/efficiencies due to refined delivery strategies and combination approaches defined by country programs in line with national priorities, and (3) improved and more equitable access to vector control products for vulnerable and hard to reach populations. The goal is to enable widespread access to affordable health products 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: 400 KB] Updated on 15.08.2023;
• Unitaid’s preliminary rationale for working in this area, please click here [PDF: 900 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

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: 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: