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Unitaid, together with the Global Fund to fight AIDS, Tuberculosis and Malaria, are pleased to announce this call under the area for intervention “accelerating the adoption of innovative vector control tools”.

Vector control has been a key contributor to the progress made against malaria. It is estimated that the use of Long Lasting Insecticidal Nets (LLINs) accounts for 69 percent of the malaria cases averted since 2001. However, the effectiveness of this core malaria intervention is threatened by increases in the distribution and strength of insecticide resistance in Anopheles mosquitoes, the vector of malaria. The World Health Organization (WHO) has identified widespread insecticide resistance as a key threat to sustaining the gains made against malaria. Resistance to pyrethroids – the only insecticide class that can currently be used in LLINs – is a particular risk. A key priority for malaria-endemic countries is to have access to a range of affordable vector control tools so as to be able to effectively implement a comprehensive strategy to manage insecticide resistance. A specific priority within malaria vector control is the expansion of the current LLIN market to include new LLINs that have increased efficacy against pyrethroid-resistant mosquitoes (“next-generation LLINs”), in particular those with active ingredients other than, or in addition to, pyrethroids.

To be considered for a WHO policy recommendation, new vector control tools, including next-generation LLINs, require an evidence base to support their public health value. But a policy recommendation alone may not be sufficient to enable early adoption and scale-up. In particular, the additional benefit of next-generation LLINs over existing LLINs or other potential vector control interventions, and the potential variation in benefit between settings, may not be clear. Additional evidence generation during early deployment is often needed to provide country programmes and implementation partners with an understanding of the added value of new tools in different settings. Without this evidence, there may be reluctance to purchase new products, particularly if these are more costly and their purchase results in a net reduction of volumes of LLINs and reduced coverage of at-risk populations. As a result, purchase volumes remain low and manufacturers are unable to reach the economies of scale needed for price reductions.

Promising new LLINs that may have increased efficacy against insecticide-resistant mosquitoes are entering the market. Unless the issues above are addressed, there is a risk that the market for these LLINs will be left in an indefinite nascent state. Recognizing this, Unitaid and the Global Fund intend to establish a joint initiative: the Catalytic LLIN Partnership Initiative. The initiative will be carried out in partnership with the President’s Malaria Initiative (PMI).

Current Call for proposals and examples of specific opportunities

The objective of the Catalytic LLIN Partnership Initiative is to catalyze the market introduction of next-generation LLINs. This will be achieved through the following work areas:

Generating epidemiological evidence

Pilot implementation

 

This initiative will align with the WHO revised evaluation process for vector control tools, technologies and approaches. LLINs with claims of improved efficacy against insecticide-resistant mosquitoes which have been submitted to or evaluated by the WHO Vector Control Advisory Group (VCAG), will be considered for inclusion. Not all project activities (generation of epidemiological evidence, research on pilot implementation, market shaping, co-payment) will be appropriate or required for all products, and proponents should provide a clear rationale for the suggested products of focus and the suite of activities in each case.

Call scope

Under this Call, Unitaid is soliciting proposals with a view to engage partners with sound expertise to meet the objective of the Catalytic LLIN Partnership Initiative through its management and implementation.

Work areas to be executed, include:

1. Generation of the epidemiological data required to support assessment of public health value by VCAG, as a prerequisite for a WHO policy recommendation.

This must specifically respond to the VCAG supported approach to trial design for the products in question. Study protocols must be endorsed by VCAG before studies begin, and regular updates to VCAG will need to be provided during study implementation.

Cluster randomized trials should be conducted with concurrent experimental hut trials and bioassays to collect data on key entomological indicators, with the secondary objective of investigating potential correlations between epidemiological and entomological study endpoints. These data will contribute towards broader discussions on the evaluation of the potential public health impact of new classes of LLINs, or variations with LLIN classes, in the future.

It is expected that the grantee will work with manufacturers to make the data generated available for their use in any appropriate changes to the product label for WHO Prequalification.

2. Pilot implementation of next-generation LLINs to set the stage for accelerated uptake if and when a positive WHO policy recommendation is made

Pilot implementation should include the generation of additional evidence that would guide country decision-making around future procurement and deployment in the event that this is recommended in a WHO policy. These studies could include a range of different methodological approaches (e.g. pragmatic trials, quasi-experimental designs) and should include cost-effectiveness studies, examining both direct and indirect costs and benefits, looking specifically at the incremental cost-effectiveness of next-generation LLINs compared to existing LLINs in a range of operational settings. The economic evaluation should be pragmatic and aimed at answering key questions for decision-makers, such as: At what product price and level of insecticide resistance is it advantageous to switch from a standard pyrethroid-only LLIN to a LLIN containing a combination of insecticides? The proponent may also propose questions that could be considered in the area of operational guidance for use of new LLINs in the area of resistance management.

Implementation should also include activities to prime the market for future scale-up, should this be recommended. In particular, the project should aim to mitigate the higher cost of new products at market entry through increased volumes and potentially other market introduction/shaping activities that could facilitate price reductions. This may include, for example, cost-of-goods analysis and price elasticity studies to support price negotiations as well as alternative procurement methods to consolidate volumes and/or support price reduction The overall market shaping strategy should be outlined in the proposal, the rationale explained (i.e. why this intervention is better for this marketplace vs other options) and will be further developed during grant development in close consultation with project partners.

To allow countries to deploy next-generation LLINs without compromising overall LLIN coverage, a time-limited co-payment will be applied while evidence is generated. The co-payment will be made available to selected countries which already have funding in place for LLINs, and will allow them to access eligible next-generation LLINs within their existing budgets. Countries interested in participating in the Initiative will be made aware of the status of individual products in the WHO evaluation process, such as those which have only been formally assessed against WHO testing criteria for pyrethroid nets and for which evidence on improved efficacy against insecticide resistant mosquito populations is in progress. While proponents are expected to propose country eligibility criteria and an initial set of target countries, selection of countries will be finalized during grant development in collaboration with project partners.

The procurement and delivery of co-paid LLINs will be undertaken by the Global Fund and PMI according to established procedures. The implementing partner will be responsible for the management and application of co-payment funds; the mechanics of a co-payment mechanism which is flexible to involvement of different donor funds yet still draws on and leverages the strengths of the current procurement approaches should be proposed. Specific activities around implementation of the co-payment are likely to include: supporting country registration if appropriate; managing new LLIN orders for included countries; administration of co-payment funding to eligible suppliers; engagement with country programmes, the Global Fund and PMI for demand forecasting activities; and conducting price negotiations with suppliers together with procurement agents. The relative roles of the donors and the grantee in these activities will be defined during grant development.

For products for which evidence is being generated to support assessment by VCAG under activity 1 above, it should be noted that any pilot implementation activities would cease if it is found that the product does not have public health value.

Project Oversight

Grant development and implementation will be managed by the Unitaid Secretariat, with close involvement of other funders.

Technical input and oversight of the initiative will be shared across key partners, and to this end an expert advisory group or steering committee will 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.

Proposal requirements

Unitaid’s preference is for proposals that encompass the full complement of activities to be undertaken under the Catalytic LLIN Partnership Initiative.

Proponents should clearly describe their overall project design, 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.

It is expected that a consortium of partners will be required to undertake the full complement of activities for the initiative. Proponents should clearly demonstrate strong expertise in the different technical 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 epidemiological trials and economic evaluations in low- and middle-income countries. 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. 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. Demonstrated articulation with national programmes and other scale-up partners will be key.

Where activities under the Catalytic LLIN Partnership Initiative dove-tail with activities undertaken through Global Fund country grants or PMI funding, the latter will continue as planned. Specifically, Global Fund country grants and PMI funding will continue to cover commodity costs at the rate of standard LLINs, LLIN delivery costs such as campaigns, and routine monitoring and evaluation; with activities under the Catalytic LLIN Partnership Initiative undertaken alongside. Specific and pro-active efforts to work complementarily, in harmony and avoiding duplication are therefore critical. Delineation of responsibilities between Global Fund/PMI and the lead grantee, as well as methods of coordination, will be defined following proposal selection as part of the Grant Agreement Development process.

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.

This Initiative is a time-limited opportunity. Proposed approaches should work to achieve changes that will have lasting effects on the market.

Process for proposal submission

When developing a proposal, please note the following resources:

• Answers to frequently asked questions about proposal development

Important dates

Please note: A proposal is considered submitted only once you receive an e-mail message of confirmation of receipt from Unitaid (Please note that this is not an automated message and confirmation will be sent after verification of your submission not earlier than 8 January 2018 and typically within one working day from receipt of a proposal).

Submission and format of proposals

Proposals, including all annexes, should be submitted electronically to [email protected].

A full proposal consists of the following documents:

• Proposal form with scanned version of signed Front page [template DOC, 130 KB]
• Annex 1: Log frame [template XLS, 50 KB]
• Annex 2: Timeline GANTT chart [template XLS, 113 KB]
• Annex 3: Budget details [template XLS, 70 KB]
• Annex 4: Organizational details and CVs of key team members [no template]
• Annex 5: Support Letters (not mandatory) [no template]
• Annex 6: Declaration of relevant interest  [no template]
• Annex 7: Applicable ethics, anti-discrimination and environmental policies [no template]
• Annex 8: Declaration regarding tobacco entities [no template]
• Guidance on Impact Assessment

Please note that our email system accepts messages up to 7 MB in size. For submissions exceeding this size, please consider splitting attachments in several messages.

Queries

Your proposal and potential queries receive personal attention: submitting your application at least a day before the deadline allows providing feedback on its completeness. You will receive answers to your queries at any one stage of the application review process. Please send your queries to Grant Application Manager at [email protected].

Assessment and notification

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.

You will find further guidance in the Unitaid proposal process document.