Attachment J.13.pdf

Global Health (GH) Project Appraisal Document (PAD)

Project Title: Prevention of Malaria through Vector Control

Project Number: ______

Basic Data

A. Management unit: GH/ID/MAL

B. Choice of instrument(s): Contract: Integrated Malaria Vector Control

Cooperative Agreement: Innovative Vector Control

Consortium (IVCC)

C. Whether to be competed: Integrated Malaria Vector Control - Yes

IVCC Cooperative Agreement - No

D. Project end date: September 30, 2027

E. Final year of obligation: FY 2026

F. Estimated total core funding: $50 million

G. Core funding planned for first FY: $10 million

H. Estimated total field support: $810 million

I. Division: Malaria

J. Design team: Lilia Gerberg, Allison Belemvire, Kristen George, Jennifer Armistead, Jenny Carlson, Melissa

Yoshimizu, Seth Irish (CDC)

K. Non-design team reviewers: Julie Wallace, Susan Youll, Natalia Machuca, Naomi Serbantez, Peter Troell

L. Geographic focus: Angola, Benin, Burkina Faso, Burma, Burundi, Cambodia, Cameroon, Côte d'Ivoire, D.R. Congo, Ethiopia, Ghana, Guinea, Kenya, Liberia, Madagascar, Malawi, Mali, Mozambique, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Tanzania, Thailand, Uganda, Zambia, Zimbabwe, Thailand-based Regional Development Mission for Asia

(RDMA), and Latin America and the Caribbean

(LAC) region

Project Description

Summary Statement

Despite significant progress over the past decade, malaria remains a major global public health problem – with an estimated 241 million cases and 627,000 deaths in 2020. While this represents a decline from 2000 levels, there has been a plateau in progress in recent years due to insecticide resistance, funding stagnation, and other factors. To address this plateau, highly efficacious and long-lasting vector control measures, including new tools, are necessary to maintain progress in malaria control and eliminate malaria. Furthermore, strengthening health systems and local capacity is critical to ensure locally-owned programs and sustainable results.

Purpose of the Project

The purpose of this project is to support malaria-endemic countries to implement entomological monitoring, indoor residual spraying (IRS) and insecticide-treated mosquito net

(ITN) distribution, and other malaria vector control interventions in order to end malaria faster.

Inputs include: upstream development support for novel insecticides and insecticide-based tools, direct implementation and/or technical assistance for malaria vector control, support for data-based decision making, training and capacity strengthening, operational research, and global leadership.

Results include: strengthened enabling environment to implement integrated vector control interventions; enhanced community acceptance of and engagement with malaria vector control; improved and/or sustained access to malaria vector control interventions; strengthened national malaria programs’ and local partners’ capacity to conduct entomological monitoring and analyze and use data, as well as to implement and/or manage vector control implementation activities; and advancement in the development of improved and/or new tools for malaria vector control.

The activities will contribute to the achievement of the Bureau for Global Health (GH) and President’s Malaria Initiative (PMI) priorities of: combating infectious disease through malaria prevention and control, preventing child and maternal deaths, health system and local capacity strengthening, and research and innovation. Additionally, the project will contribute to

PMI’s strategic objectives (2021-2026) for reducing malaria mortality and malaria morbidity and striving toward elimination.

Critical assumptions are: 1) Stable and/or increased funding for malaria prevention; 2)

Stable security situation in countries; 3) Ministries of Health continue to remain committed to malaria control and prevention; and 4) Manufacturers and researchers continue to invest in developing new malaria vector control tools.

Prevention of Malaria through Vector Control

The Malaria Division within the GH’s Office of Infectious Diseases (GH/ID/MAL) will recommend to award a contract and a cooperative agreement under this project. The contract will support integrated malaria vector control activities and the cooperative agreement will support the Innovative Vector Control Consortium (IVCC).

Integrated Malaria Vector Control Contract

Building on progress to date, the contract will continue to scale up and sustain key project outputs of ownership and appropriate use of insecticide-treated mosquito nets (ITNs), targeted and cost-effective use of indoor residual spraying (IRS), and entomological monitoring to collect data to inform the selection, implementation, and assessment of vector control interventions.

Research, piloting, and introduction of new vector control products and tools will be another key input into the long-term efficacy of ITNs, IRS, and other potential vector control measures. Fostering public-private partnerships to support malaria vector control activities could entail engaging global and local private companies (e.g., telecommunications, agriculture, extraction, and oil and gas industries) to increase the quality and coverage of activities as part of corporate social responsibility commitments.

The vector control activities envisioned in this contract will be carried out in the current

24 PMI partner countries in sub-Saharan Africa, one additional country where USAID currently supports malaria control efforts (Burundi), and three countries in the Greater Mekong Subregion

(Burma, Cambodia and the Thailand-based Regional Development Mission for Asia (RDMA)).

Vector control activities will also be carried out in Latin America and the Caribbean. Additional countries may be added if additional funding becomes available to support a PMI expansion.

Innovative Vector Control Consortium Cooperative Agreement

GH/ID/MAL will recommend to restrict eligibility to award a cooperative agreement to

IVCC. IVCC is an international product development partnership whose aim is to foster research and development of new vector control products and tools for public health, including new insecticides and insecticide formulations. It is the only organization of its kind in the world.

GH/ID/MAL proposes to support IVCC’s upstream research and development portfolio for new insecticides and tools that can be used for malaria control. The objective is to contribute to their efforts to mitigate insecticide resistance by registering at least one new active ingredient or insecticide formulation for malaria vector control every three to four years.

Other Leveraged Resources

To end malaria, vector control must be part of a suite of technical interventions including diagnosis and treatment, prevention of malaria in pregnancy, and seasonal malaria chemoprevention, as well as the cross-cutting activities of social and behavior change;

surveillance, monitoring and evaluation; and pharmaceutical and supply chain strengthening.

Thus, through malaria operational planning countries can leverage other resources to ensure that activities under the Prevention of Malaria through Vector Control Project help achieve desired malaria outcomes. Furthermore, some Missions may use local bilateral mechanisms to implement portions of their portfolio (e.g., surveillance and monitoring, research, health system strengthening and training, digital health and data management), which are other potential leveraged resources.

Estimated Budget

The Prevention of Malaria through Vector Control Project intends to award a contract and a cooperative agreement. The estimated budget for the Integrative Malaria Vector Control contract over five year is $850 million, of which $810 million will be field support funds and $40 million will be core funds. The estimated budget for the IVCC cooperative agreement over five years is $10 million of core funds.

Year 1

FY 2022

Year 2

FY 2023

Year 3

FY 2024

Year 4

FY 2025

Year 5

FY 2026

Total

Integrative

Malaria

Vector

Control

Contract

Field

Support

$162 million

$162 million

$162 million

$162 million

$162 million

$810 million

Core $8 million $8 million $8 million $8 million $8 million $40 million

IVCC

Cooperative

Agreement

Core $2 million $2 million $2 million $2 million $2 million $10 million

Total $860 million

Contract: Integrated Malaria Vector Control - $850 million (field support 95 percent or $810 million; core: 5 percent or $40 million)

Cooperative Agreement: Innovative Vector Control Consortium - $10 million (core: 100 percent or $10 million)

These estimates are based on experiences over the last 15 years in PMI partner countries with the

IRS IQC Task Orders (2006-2013), IDIQs (2013-present), and the Netmark (1999-2009), Networks (2009-2014), and VectorWorks (2014-2019) ITN Projects. An independent government cost-estimate (IGCE) was prepared based on assumptions of various levels of country buy-in scenarios. The estimate for the proposed IVCC Cooperative Agreement is based on a review of the IVCC research and development portfolio, and experiences with a similar public-private partnership for antimalarial drug development, the Medicines for Malaria Venture.

I. Background

In spite of impressive successes in malaria control in Sub-Saharan Africa since 2000, malaria remains a major public health problem on the continent, with an estimated 229 million cases and 409,000 deaths in 2019. While this represents a decline from 2000 levels, there has been a plateau in progress in recent years.

USAID has been involved in malaria control since the malaria eradication era (mid-1950s to late 1960s), initially focusing primarily on IRS in Latin America and the Caribbean as part of the malaria eradication era. Beginning in the 1990s, USAID’s emphasis shifted to Sub-Saharan

Africa, with capacity building within ministries of health and distribution of subsidized ITNs through social marketing programs. Experiences from the malaria eradication era demonstrated that national malaria control programs cannot rely solely on just one malaria prevention or treatment measure, if malaria control successes are to be sustained and ultimately result in elimination. Thus, when the President’s Malaria Initiative was launched in June 2005, its goal was to scale up a package of four proven and highly effective malaria prevention and treatment measures including both IRS and ITNs in 15 high-burden Sub-Saharan African countries and reduce malaria-related deaths by 50 percent. With increased funding, PMI’s geographic scope has expanded and the Initiative now works in 24 partner countries in Africa and supports three programs in the Greater Mekong Subregion in Asia.

II. Relationship to Other Donor Programs

Although both the Global Fund and World Bank have supported IRS in selected African countries, PMI has been the major donor supporting the scale up of national IRS programs.

Relatively few African Ministries of Health invest significant portions of their budgets in IRS, and those that do (e.g., Ethiopia and Zimbabwe) are mostly countries with seasonal malaria, lower levels of transmission, and long traditions of IRS. Since the launch of PMI in 2005, PMI has protected more than 310 million people with IRS. In FY 2020, PMI supported IRS in 16 of the 24 PMI focus countries, resulting in more than 5 million structures sprayed and almost 20 million people protected. During the past 15 years, PMI and its IRS implementing partners have gained extensive experience in implementing large-scale IRS programs in diverse political and epidemiologic settings across Africa. Over this period, increasing emphasis has been placed on transferring capacity and responsibility for spray operations to national malaria control programs through technical assistance and government-to-government funding.

Following its launch in 2005, PMI has become the second largest donor for ITN procurement and distribution, after the Global Fund. Since PMI began, it has supported the distribution of 500 million ITNs (375 million of which were procured by PMI; 130 million had been procured by others). In FY 2020, PMI delivered more than 40 million ITNs, protecting approximately 80 million people. Since other donors (e.g., the Against Malaria Foundation

(AMF)) procure ITNs but do not pay shipment or distribution costs, in some countries PMI supports distribution to the end user. Furthermore, PMI’s ability to make emergency procurements has also been important in filling gaps in ITN needs for nationwide or large sub-national campaigns in several countries and PMI has played a critical role in donor coordination around large campaigns.

III. Analytic Considerations

Technical Analysis

Supported Interventions

ITNs: To reduce malaria transmission, the World Health Organization (WHO) recommends that both large-scale ITN mass distribution campaigns and continuous distribution occur as part of a multi-channel strategy to achieve and maintain access to ITNs. PMI supports procurement of long-lasting ITNs, and is committed to supporting the transition from standard pyrethroid-only ITNs to new types of nets, where supported by entomological data and funding allows. Furthermore, PMI supports technical assistance and support for distribution through a variety of distribution channels, namely mass campaigns (nationwide or sub-national); antenatal, child health, and immunization clinics; school-based and community programs; social marketing; and partnerships with the private sector. Achieving high ITN ownership and access alone is not sufficient; correct and consistent use of ITNs is necessary to prevent malaria infections. For this reason, support for social and behavior change activities are critical to the success of the project.

Based on durability monitoring data, we are seeing that long-lasting ITNs are not lasting the average anticipated ITN lifespan of three years in a number of settings, due primarily to loss of physical integrity, though insecticidal effectiveness is shorter than expected in a number of sites as well. Continued and enhanced efforts are needed to extend the useful life of nets by promoting proper care. Further research is needed to improve the physical and insecticidal integrity of the nets, and ongoing post-market surveillance is important to help ensure the quality of nets being distributed. A combination of continuous distribution approaches, including school-based and community channels, as well as facility-based distribution via antenatal care (ANC) http://www.who.int/malaria/publications/atoz/who_recommendation_coverage_llin/en/ http://www.who.int/malaria/publications/atoz/who_recommendation_coverage_llin/en/ and expanded program on immunizations (EPI), should be maximized to maintain high coverage achieved via mass campaigns.

IRS: Indoor residual spraying, a proven and highly effective malaria control measure, involves the spraying of residual insecticide on the interior walls of homes to kill mosquitoes, thereby interrupting malaria transmission. Unlike ITNs, IRS is a “passive intervention” whose effectiveness does not depend on modification of human behavior (except for removing household belongings during spraying). There are currently five classes of insecticide recommended for IRS by WHO, allowing for insecticide rotation strategies to mitigate insecticide resistance in many countries. However, IRS requires significant human and financial resources, thus PMI prioritizes spraying primarily to areas where malaria transmission can be interrupted or reduced by a single round of spraying each year. Also, environmental compliance and monitoring and evaluation are critical components to IRS. Indoor residual spraying is a powerful tool for combating malaria in areas of insecticide resistance, as a complement to ITNs to further reduce malaria burden, and in locations where the primary mosquito vectors rest indoors. Targeted use of IRS also may be an important tool to reduce malaria burden in areas moving toward elimination or in areas where other control measures are not effective.

PMI’s IRS activities will be evaluated principally by determining the proportion of targeted houses that are sprayed and by monthly monitoring of the insecticide content on sprayed walls to assess if it persists for the duration of the malaria transmission season.

Entomological Monitoring: PMI supports entomological monitoring, the backbone of an integrated vector control strategy, to evaluate entomological parameters and answer specific questions to inform programmatic decision making. Given increasing insecticide selection pressure on vector mosquito populations and changes in vector susceptibility to insecticides, species composition and/or behavior, entomological monitoring is imperative. Entomological monitoring should include insecticide susceptibility testing, quality and performance assessments of IRS and ITNs and other vector control tools, and maintenance of well-characterized mosquito colonies. Vector bionomics monitoring should be question-driven and based on the needs of a particular country.

PMI’s entomological activities will be reported based on standard USAID/PMI entomological indicators and evaluated based on the accuracy, and completeness of quarterly monitoring trackers and annual entomological reports.

Insecticide and novel vector control tool development: The effectiveness of both ITNs and IRS for malaria prevention in many African countries is being jeopardized by the spread and intensification of insecticide resistance. For that reason, research and development of new insecticides and new vector control tools for public health use continues to be a high priority for the global malaria community and for PMI.

Between 2000 and 2015, malaria infection prevalence in endemic Africa halved and the incidence of clinical disease fell by 40 percent. Insecticide-treated nets were the largest contributor to averted cases (accounting for 68 percent).1 Our challenge is to sustain and/or increase access to vector control interventions while maintaining their effectiveness in the face of insecticide resistance. Donor support to ITN procurement and distribution peaked in 2010 with the international drive to reach universal coverage by the end of that year. While most countries in Africa have achieved higher levels of net ownership, there has been a plateauing of support to malaria prevention and control in recent years, threatening the global community’s ability to sustain gains and drive toward elimination.

The spread and intensification of pyrethroid resistance has posed a major threat to the effectiveness of standard ITNs. Data shows evidence of insecticide resistance to one or more classes of insecticides in all PMI-supported countries in Africa. The availability of new types of nets (i.e., piperonyl butoxide (PBO) synergist and dual active ingredient nets) will help to mitigate this risk, however these new types of nets come at a higher cost and some countries are struggling to maintain their coverage target while ensuring they are deploying the optimal type of net, considering the entomological monitoring data.

While the majority of PMI partner countries relied on pyrethroids for IRS in the early years of PMI, because of documented pyrethroid resistance, no PMI-implemented IRS programs have used pyrethroids since 2015. The choice of which insecticide class to use in a particular setting takes into account the following factors: insecticide resistance and subsequent insecticide resistance mitigation plans, duration of efficacy, ITNs deployed in the targeted IRS area, and cost. The choice of insecticides that can be used for IRS has increased, with two new clothianidin-based products WHO PQ-approved and available for PMI procurement, and additional new products are expected to be available in the coming years. Furthermore, potentially cost-saving implementation approaches (e.g., partial spraying) are being explored.

Data from control programs in both public health and agriculture demonstrate that deploying carefully chosen rotations of insecticides, or mixtures of insecticides can be effective in slowing down the rate at which operationally significant levels of insecticide resistance will be selected.

Thus, insecticides used for IRS should be preemptively rotated between classes about every two years; PMI supports subnational rotation between insecticides with susceptibility, to the greatest extent possible.

National malaria control programs, which are often supported by local research institutions, need well-functioning entomologic and insecticide resistance monitoring systems as well as the capacity to collect, analyze and use entomological data for decision making. These components will allow for selection of the most appropriate combination of vector control tools and monitoring their effectiveness in reducing the mosquito vector and reducing malaria cases.

Bhatt 2015. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4820050/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4820050/

Thus this project, in alignment with PMI and Agency priorities of localization, will strengthen the capacity of local governments, partners and research institutions to lead, manage, and monitor proven, life-saving vector control interventions for malaria in order to increase sustainability and locally driven approaches. The project will create partnerships with local institutions to implement activities to the greatest extent possible, linking them with NMCPs and other national and regional partners to strengthen collaboration among community stakeholders and ensure that effective interventions are implemented by those closest to the people served.

Gender Analysis

Gender equality and women’s empowerment are essential for achieving USAID’s development goals. The Women's Entrepreneurship and Economic Empowerment (WEEE) Act requires all USAID strategies, projects, and activities be shaped by Gender Analyses, that gender equality and women’s empowerment be integrated across the program cycle, and that standard indicators are used to assess progress. ADS Chapter 2052 and the USAID Gender Equality and

Female Empowerment Policy3 also promote equality between women and men, boys and girls, and empower women and girls to participate fully in and benefit from development activities, through the integration of gender in the entire project cycle from project design and implementation to monitoring and evaluation. GH/ID/MAL completed the mandatory gender analysis described in Chapter 205 of the Automated Directives System (ADS) as part of the design process for the Prevention of Malaria through Vector Control Project.

“Gender analysis” is defined in the WEEE Act as “a socioeconomic analysis of available or gathered quantitative and qualitative information to identify, understand, and explain gaps between men and women.” Other, non-binary identities may also be included in an analysis. An analysis examines differences in status, differential access to education, opportunities, and services, the influence of gender roles, structural barriers, and norms, and the potential impacts of development policies and programs on men and women, including unintended or negative consequences. An analysis also includes recommendations for development policies and programs that narrow gender gaps and improve the lives of women and girls.

This integrated approach focuses on achieving three overarching outcomes: 1) Reducing gender disparities in access to, control over and benefit from resources, wealth, opportunities, and services – economic, social, political, and cultural; 2) Reducing gender-based violence and mitigating its harmful effects on individuals and communities, so that all people can live healthy and productive lives; and 3) Increasing the capability of women and girls to realize their rights, determine their life outcomes, and influence decision making in households, communities, and societies. Activities under the Prevention of Malaria through Vector Control project will

ADS Chapter 205: “Integrating Gender Equality and Female Empowerment in USAID’s Program

Cycle)https://www.usaid.gov/ads/policy/200/205 USAID Gender Equality and Women’s Empowerment Policy, 2020. https://www.usaid.gov/GenderEqualityandWomensEmpowermentPolicy https://www.usaid.gov/ads/policy/200/205 https://www.usaid.gov/ads/policy/200/205 https://www.usaid.gov/ads/policy/200/205 https://www.usaid.gov/ads/policy/200/205 https://www.usaid.gov/ads/policy/200/205 https://www.usaid.gov/ads/policy/200/205 https://www.usaid.gov/ads/policy/200/205 https://www.usaid.gov/GenderEqualityandWomensEmpowermentPolicy contribute to the first and third listed outcomes by reducing gender disparities in access to and benefit from malaria vector control services, and increasing women’s empowerment to determine their life outcomes and influence decision making. The project can institute operational policies to address barriers, such as ensuring privacy at the work place; having a zero toleration sexual harassment and developing guidelines and training; and identifying women with potential for supervisory positions, for whom mentorship and training are provided. By incorporating women in the delivery of vector control interventions (including social behavior communications and community mobilization), this project can increase acceptance and compliance, and thus impact.

By employing women in various cadres of vector control campaigns, including community engagement, management and data collection positions, the project can enable women to participate in skill-building and economic opportunities which can influence their agency through economic independence. Furthermore, the project can use routine programmatic data, the project actively monitors and reports against gender-related goals, both in terms of operational and results-based outcomes.

Summary of Findings from Existing Gender Analyses and Assessments

Although anyone can get malaria, women and adolescent girls often bear the health, societal, and economic brunt of malaria, which can exacerbate poverty and deepen inequalities.

Millions of pregnant women and children under five are particularly vulnerable to malaria, making prevention critical. Others—especially adolescent girls—fall through the many gendered gaps in the provision of malaria services.4

Therefore, while PMI fully supports the Roll Back Malaria (RBM) Partnership to End

Malaria’s goal of ensuring universal access to malaria prevention and treatment measures, PMI specifically targets pregnant women through free ITN distribution in antenatal clinics (ANC) and with intermittent preventive treatment (IPTp) with the drug, sulfadoxine-pyrimethamine.

Furthermore, when resources for malaria control in a particular country are limited and universal coverage with ITNs is unattainable, pregnant women and children less than five years of age are often given preference in terms of access to nets. PMI’s social behavior change (SBC) activities target women and their partners with messages to make them aware of the increased risks of malaria during pregnancy and the means to prevent the severe consequences of malaria infections. In areas where religious or cultural beliefs and barriers may impede women from accessing malaria prevention measures or seeking treatment for malaria infections when they occur, PMI works with religious leaders to educate women and their partners about the importance of comprehensive antenatal care.

Bill & Melinda Gates Foundation (2020). Gender and Malaria Evidence Review. www.Gatesgenderequalitytoolbox.org

Gunn et al (2018). Current strategies and successes in engaging women in vector control: a systematic review.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838394/

Malaria No More (2021). Achieving a double dividend: the case for investing in a gendered approach to the fight against malaria.

https://35zcec34w0tj3wi5x24cndw1-wpengine.netdna-ssl.com/wp-content/uploads/2021/06/Malaria-and-Gender-Report_FINAL.pdf http://www.gatesgenderequalitytoolbox.org/ http://www.gatesgenderequalitytoolbox.org/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838394/ https://35zcec34w0tj3wi5x24cndw1-wpengine.netdna-ssl.com/wp-content/uploads/2021/06/Malaria-and-Gender-Report_FINAL.pdf

Analysis of Key Gender Issues

Although both men and women are equally susceptible to malaria infections, pregnant women and their fetuses are disproportionally affected by malaria and its consequences – maternal anemia, miscarriage, stillbirth, and low birth weight, which is associated with an increased risk of infant death. An estimated 10,000 women and 100,000 infants die annually as a consequence of malaria infection during pregnancy.

Gender and Access to Malaria Services

As patients, caregivers and healthcare providers, the adverse effects that women and adolescent girls experience due to malaria result in significant, long-term health and economic costs for themselves, their families and their communities. Women in malaria-endemic countries also are the leading investors in the fight against malaria. They make up 70 percent of the community health workforce and, together with adolescent girls, are the greatest contributors in the informal “care economy.” Adolescent girls who stay home to care for family members recovering from malaria are more likely to discontinue their education earlier than adolescent boys, who often do not have to play the care-giving role. Social factors may account for gender differences in use of malaria services. For example, women in some contexts have difficulty accessing ANC services where ITNs are provided because male family members are unwilling to pay for these services or women’s health may not be considered as important as that of male family members.

Laws, Policies, Regulations, and Institutional Practices

Laws, policies and regulations should uphold the right of all genders, including transgendered individuals, to have access to malaria prevention measures, and to get tested and treated for malaria free of charge. Institutional practices should be examined to ensure that all genders feel welcome and receive access to malaria prevention measures and quality, respectful care.

Gender Roles, Responsibilities and Time Use

Gender roles, responsibilities and time use can impact risk factors for malaria and health seeking behavior. For example, men may be exposed to malaria more frequently than women due to time spent in workplaces (such as fields or forests) and night time in outdoor bars and sports viewing venues. Women may be exposed in pre-dawn activities such as fetching water, by caring for sick individuals or attending outdoor funerals more often than men. Responsibilities and time use can also impact the ability of individuals to seek care. Responsibilities such as work, household chores, and caring for children can make getting to a clinic difficult, especially if the hours are limited.

Patterns of Power and Decision Making

Household level power dynamics can impact women’s and men’s ability to access financial resources, and, ultimately, their ability to take advantage of services available. These power dynamics may also impact who makes decisions about household members seeking healthcare and what type of healthcare is sought. Additionally, in order to make effective decisions about their health, both men and women need to be knowledgeable about signs and symptoms of malaria, aware of available services, and confident that their needs will be met.

Specific Gender Requirements

The value of gender studies in malaria prevention through vector control can be enhanced by 1) the ongoing collection of accurate, disaggregated data and 2) a balance in the collection and analysis of gender-based studies to capture not only the experiences of men and women but also the dynamism of the social relationships and interactions of other critical social, cultural and environmental determinants of health. For these to be achieved, multidisciplinary and interdisciplinary approaches are required that do not privilege some forms of knowledge over others.

Gender Related Implementation Practices

The hiring practices of PMI’s implementing partners for IRS and ITN campaigns promote the use of women as spray personnel and supervisors (when safety issues related to their contact with the insecticide do not preclude their participation), for community mobilization during IRS, for promotion before and during net distribution, and for follow-up after ITN campaigns. Additionally, gender equitable approaches are encouraged for entomological monitoring, and by providing training and professional development opportunities among implementing partners and national stakeholders. These gender-specific considerations will be incorporated into the specific activity designs of the mechanisms proposed and will continue to promote appropriately balanced activities that lead to positive vector control outcomes.

Gender and Evaluation Criteria

RFPs related to this project will include integration of gender, equity, and social inclusion considerations as an evaluation criterion, where appropriate.

Environmental Analysis

PMI has more than 15 year’s experience with environmental issues related to IRS and

ITNs and has a Program Environmental Assessment (PEA) in place covering IRS, ITN and insecticide based activities and has prepared detailed written guidance on environmental compliance and monitoring for PMI staff at headquarters and in the field.

In 2006, USAID issued its first Programmatic Environmental Assessment (PEA) as an umbrella assessment for integrated vector control activities in Sub-Saharan Africa. This PEA was updated in 2012 and was expanded to cover ITN and other public health insecticide based tools beyond IRS. The PEA has most recently been updated in 2017; further updates are in process (2021). The purpose of the PEA is to provide malaria control managers and PMI staff with technical, policy, and procedural guidance for the preparation of environmental assessments of individual projects, thereby expediting country-level assessments.

All PMI partner countries have completed supplemental environmental assessments

(SEAs) that fall under the umbrella of the PEA for IRS in consultation with Mission and

Regional Environmental Officers and national ministries of health, environment, and agriculture.

In brief, these consist of an evaluation of which pesticide(s) may be procured or used (including ones procured by U.S. Government partners) based on scientific selection of the safest and most efficacious pesticide(s) according to U.S. Environmental Protection Agency registration data.

The assessment, which expires after five years and requires amendment if there are any programmatic changes, includes a plan for safe use to minimize any risks to humans or the environment, as well as a fully-funded mechanism for ongoing monitoring and compliance throughout the life of the project. The supplemental environmental assessments must be approved by the Mission Environmental Officer, Regional Environmental Officer, PHN Officer, Mission Director, and USAID Bureau Environmental Officers before any USAID funds can be obligated for the activity. An annual update to the assessment occurs prior to spraying in each country to ensure that the original assessment plan is still applicable. If PMI-supported IRS or

ITN activities are expanded to additional countries over the next five years, similar SEA procedures will be followed.

GH/ID/MAL completed the mandatory Initial Environmental Examination (IEE) for this project and received concurrence from the Bureau Environmental Officer. The determinations were: Categorical Exclusion for provision of monitoring and evaluation support; Positive

Determination for implementation of IRS and ITN distribution, and Negative Determination for the remainder of the activities/sub-activities that will be implemented under this project. In addition, once awards are made, the BEO shall approve a Plan for Environmental Mitigation and

Monitoring (EMMP) before major programmatic implementation begins. Refer to Tab 3 for the approved Initial Environmental Examination and Climate Risk Screening.

Climate Risk Screening

GH/ID/MAL completed the mandatory climate-risk screening (CRS) as part of the process of designing the Prevention of Malaria through Vector Control Project. The assessment identified moderate (9) and high (4) climate-related risks associated with this project. This assessment was part of the approved Initial Environmental Examination for this project, and

GH/ID/MAL will integrate measures to manage climate risk into the Environmental-Mitigation and Monitoring Plan and Activity Monitoring, Evaluation, and Learning Plan. The designated

Agreement/Contract Officer’s Representatives (A/CORs) will ensure that mitigation measures https://www.pmi.gov/2017-programmatic-environmental-assessment-for-integrated-vector-control-now-available/ are implemented and reporting requirements are met. Refer to Tab 3 for the approved IEE and

CRS.

Construction Risk Management

In accordance with the ADS 201 mandatory reference for Construction Risk Management

(201maw), a risk screening of each identified and discrete construction activity (at any level) must be performed and documented prior to construction implementation. USAID defines

‘construction’ as the “construction, alteration, or repair (including dredging and excavation) of buildings, structures, or other real property and includes, without limitation, improvements, renovation, alteration and refurbishment. The term includes, without limitation, roads, power plants, buildings, bridges, water treatment facilities, and vertical structures.” The policy defines

“improvements, renovation, alteration and refurbishment” to include “any betterment or change to an existing property to allow its continued or more efficient use within its designed purpose

(renovation), or for the use of a different purpose or function (alteration).” The definition further includes items such as improvements to or upgrading of primary mechanical systems, and excludes others such as non-structural, cosmetic work, such as painting. This definition only includes construction activities and does not include ancillary or other related activities such as architectural and engineering design or construction oversight.

The Prevention of Malaria through Vector Control Project may support small-scale construction, including minor facility renovation or cosmetic improvements, where necessary to accommodate structures for project activities (e.g., insectaries). These construction activities would be funded with field funds. Each Mission will be responsible for the construction risk assessment once specific activities are identified. Once a risk assessment has been completed, the A/COR will provide the required information to GH/PPP/PIBM for entry into the A&A plan.

IV. Implementation Plan

Choice of Mechanism

Integrated Vector Control Contract: The purpose of this contract is to support IRS, ITNs, entomological monitoring and related vector control prevention services that will assist USAID in reducing the burden of malaria worldwide. The direct beneficiary is USAID and each country where activities are being implemented. There are specific activities and deliverables that will be associated with this program which requires substantial technical direction and oversight, including implementation of highly technical entomological monitoring and environmental compliance activities based on the latest international standards and PMI best practices. The purpose of this activity clearly falls in the acquisition of services for the direct benefit or use of

USAID and therefore this should be an acquisition instrument rather than an assistance one, per

ADS 304.3.3.1.

Additionally, USAID will be actively directing the awardee’s performance. USAID needs day-to-day administrative management of the contract in order to ensure that logistically-complex

IRS, ITN and vector control activities are implemented to the highest environmental and human safety standards possible in order to meet USAID's health objectives. Furthermore, there are specific deliverables associated with this activity with a specific set of specifications that the organization must meet prior to USAID accepting and approving such deliverables.

The recommended procurement contract will play a vital role in supporting the U.S. Government and Agency’s goal of ending malaria faster. Successful implementation of malaria vector control activities in partner countries is dependent in part on a time-sensitive and uninterrupted supply of quality-assured commodities and the provision of malaria vector control technical assistance.

The use of a procurement contract will ensure the availability of approved insecticide and other vector control commodities using a global procurement strategy. The Agency will benefit directly from the purchase of the supplies and services described because the uninterrupted supply of these commodities and technical assistance services to specified destinations and stakeholders in accordance with the Agency’s specific requirements will satisfy Agency needs and requirements supportive of PMI’s vector control mandate and program funding authorizations.

IVCC Cooperative Agreement: GH/ID/MAL will recommend restricting eligibility to award a cooperative agreement to IVCC. The recommendation to restrict eligibility is based on the fact that IVCC is the only organization in the world dedicated to the development of new public health insecticides and insecticide formulations, a non-competitive cooperative agreement is proposed.

The discovery and development of new active ingredients for vector control is a high-risk endeavor, and many promising products never reach the stage of registration and use in disease control programs. For that reason, USAID will not earmark its contribution to any single candidate product in the IVCC portfolio, but will support the full range of insecticide products for malaria vector control that are being developed by the IVCC. In addition to efficacy data, the

IVCC project proposal process for new vector control products includes a requirement to declare toxicology and eco-toxicology risk assessments at each development stage. This data is reviewed by an external scientific advisory committee in order to provide go, no-go decisions. USAID could become involved with the decision making on products at this level. OHA has been consulted regarding their experience with research and the following lessons learned have been incorporated into the design of this project:

● By investing early in new products, negotiations with manufacturers can be undertaken to keep prices low enough for a developing country market;

● In addition to product development, it is important to invest in policy, advocacy, costing, and marketing; and

● Leveraging resources from other donors is important when investing in a pipeline of products for which the success of each product is unknown.

Pursuant to ADS 304.3.1 b, and ADS 304.3.3, a cooperative agreement is proposed because

IVCC has been and will continue to perform the project and work for its own purpose and mission. A cooperative agreement will further enable USAID to support the awardee’s project endeavors with financial assistance and thereby leverage other existing funding from other donors. The funded activities complement USAID’s mission but the awardee will not implement the program as agents of the U.S. Government. This is important because it will enable IVCC to maintain independence as a research organization and attract funding from multiple sources to promote the development of new malaria vector control projects. A cooperative agreement is proposed rather than a grant because USAID requires substantial involvement in the selection of key personnel and work plan approval. In addition, involvement with project leadership will enable USAID to shape the research consistent with USAID objectives for the funding and play a role in research progress. Furthermore, USAID will explore using multiple channels and partners, including direct USAID technical engagement, for expertise on promoting market incentives, when products are ready for market introduction. Examples include collaboration with other RBM partners to generate market demand forecasts, remove regulatory hurdles, and direct price negotiations. These efforts would complement but not impact the design of the

IVCC mechanism.

Project Management

Three members of the GH/ID/MAL team will serve as A/CORs for the Malaria Vector Control

Contract and the IVCC Cooperative Agreement. They will be supported by the broader

GH/ID/MAL Vector Monitoring and Control Team (VMCT), of which they are members, as well as leverage technical expertise from the interagency PMI/CDC entomologists, and PMI in-country activity managers assigned to each of the PMI partner countries. In addition, a vector control Program Assistant is under recruitment to assist with the management for this project.

Mission Concurrence

In accordance with ADS 201.3.3.6, Mission Director (or designee) concurrence for core-funded activities is required. The A/COR will contact the Mission's health and program office during the development of the Malaria Operational Plan (MOP) if core-funded activities are included to obtain Mission Director concurrence.

V. Monitoring and Evaluation Plan and Learning Approach

PMI follows the RBM Partnership to End Malaria guidance in evaluating malaria control efforts in the countries where PMI contributes to malaria control efforts. PMI does not attempt to attribute impact in malaria control to its contributions as distinct from those of national malaria control programs or other donors.

Outcomes for standardized ITN indicators are monitored through nationwide household surveys (e.g., Demographic and Health Surveys [DHS], Malaria Indicator Surveys (MIS), and

Multiple Indicator Cluster Surveys [MICS]) conducted every two to five years in each focus country. The outputs and outcomes of IRS activities are monitored through spray team records and reports. To measure the impact of malaria control interventions, PMI uses declines in all-cause child mortality (ACCM) and parasitemia and, where possible, examines incidence and malaria mortality through national routine health information systems (e.g., Health Management

Information Systems [HMIS]) data and/or modeling. Furthermore, PMI collects vector control-related data via ITN durability monitoring, routine entomological monitoring, Malaria

Behavioral Surveys, and other targeted activities. If all-cause, under-five deaths and malaria morbidity decline, together with an increase in malaria intervention coverage, and no other cause can be identified for the changes in mortality and morbidity, then it is considered plausible that the health improvements were due to the malaria control efforts. As reflected in the 2021-2026

PMI Strategy, malaria burden in PMI-supported countries has notably changed since PMI’s inception in 2005. While some countries have greatly reduced malaria mortality and morbidity, progress in other countries has been slower, resulting in a PMI Strategy that reflects tailored strategies and implementation approaches based on each country’s specific malaria epidemiology. These changes in malaria burden require indicators and tools that can measure progress in countries with high prevalence and those moving towards elimination.

PMI commissioned an external evaluation in 2011 to review its overall performance, including its substantial investments in malaria prevention. The evaluation included extensive consultations with both PMI field staff as well as headquarters staff (in Atlanta and Washington).

The evaluation encouraged continued investment in malaria prevention activities through ITN and IRS programs, while recognizing the threat that insecticide resistance poses to the overall insecticide-based vector control approach. PMI endorsed the overall findings and agreed that the main recommendations were both relevant and useful for program improvement.

In 2021, PMI released its 2021-2026 Strategy, “End Malaria Faster,” which aims to greatly reduce malaria deaths and cases in countries that account for 80 percent of the world’s malaria burden. According to this strategy, PMI aims to save lives, reduce health inequities, and improve disease surveillance and global health security. With partners, PMI will maximize program efficiency by addressing five focus areas: reach the unreached, strengthen community health systems, keep malaria services resilient, invest locally, and innovate and lead.The two mechanisms included in this project are being designed in line with this strategy and these priorities. They will continue to strengthen PMI’s ability to prevent malaria and save lives through ITN and IRS programs which protect the unreached, while improving surveillance through investments in entomological and insecticide resistance monitoring, including those at the community level. Furthermore, they will emphasize local institutions and continue to strengthen their capacity to lead and innovate. USAID will conduct internal reviews of instruments within this project in accordance with the USAID evaluation policy.

The Prevention of Malaria through Vector Control Project will adhere to ADS

201.3.4.10, “Monitoring, Evaluation, and CLA During the Design and Implementation of

Activities.” Upon award of the contract and cooperative agreement A/CORs will work with the recipient to develop an Activity Monitoring, Evaluation, and Learning (MEL) Plan. The MEL plan will describe the process for timely and recurring monitoring, evaluating, and learning from implementation to adapt and achieve the award objectives.

Additionally, GH/ID/MAL will work with award recipients to identify learning questions.

The learning plan will indicate how activities will address learning questions, knowledge gaps, and will identify ways to allow for adjustment as…