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.

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.

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.

[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.

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.

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.

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.