RFI-7200AA-22-REACH_signed.pdf

To: Sources Sought (Attachment B)– Small Business Only; RFI (Attachment C) - All Interested Organizations.

Reference Number: RFI-7200AA-22-REACH Release Date: 7/22/2022 Response Date: 8/11/2022, 12 PM EDT

Subject: Request for Information/Sources Sought- Reaching Every At-Risk Community and Household with Malaria Services (REACH) Malaria Activity

PURPOSE:

Referring to FAR Part 10, FAR 15.201(e) the United States Government, represented by the United States Agency for International Development (USAID), is publishing the subject Request for Information (RFI)/Sources Sought for the Reaching Every At-Risk Community and Household with Malaria Services (REACH) Malaria Activity. The estimated range for this activity is 190-213 million dollars over 5-year period.

As permitted by FAR Part 10, this is a market research tool being utilized for informational and planning purposes. Your responses will assist the Government in the development of its acquisition strategy for a possible Request for Proposal (RFP), to be issued at a later date, and in determining whether any type of small business set-aside is possible for this procurement or whether full and open or other competitive procedures should be utilized. If full and open or other competition is ultimately pursued, responses to this synopsis will be used to aid in establishing small business subcontracting goals.

The purpose of this RFI/Sources Sought is twofold:

1) Sources Sought

USAID is conducting this Sources Sought to identify small business contractors who possess the capabilities to provide services as specified in the Attachment A: DRAFT SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK and to determine their availability, capability, and adequacy. If your firm may be interested in this requirement, is a qualified small business for the NAICS code 541990 (Size Standard in Millions of Dollars is $17.0 according to SBA Table of Small Business Size), and has performed similar projects, we request the information specified in the Attachment B: Sources Sought Information. An organization that is not considered a small business under the applicable NAICS code should not submit a response to the Attachment B of this notice.

2) RFI

USAID is soliciting feedback on the technical design of a new Activity and notify the industry that USAID is interested in identifying organizations that may have the institutional capacity to implement the conceptual program or components of the program described in the Attachment A:

DRAFT SECTION C – DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK. The solicited information is found in the Attachment C titled RFI Questions.

https://www.sba.gov/sites/default/files/2022-07/Table%20of%20Size%20Standards_Effective%20July%2014%202022_Final-508.pdf

SUBMISSION INFORMATION:

Please submit your response to requested information in the Attachment B electronically to Ms. Natalia Kornilova, at nkornilova@usaid.gov and Ms. Carmen Grizzard at magrizzard@usaid.gov with a copy to Ms. Patricia Bradley at pbradley@usaid.gov no later than August 11th, 12 PM EDT. Please indicate RFI/Sources Sought reference number provided above in the subject of the email. You will receive only an electronic confirmation acknowledging receipt of your response. No individualized feedback or suggestions will be sent to responders. Your responses may contribute to upcoming activity design(s).

However, this RFI/Sources Sought will not be construed as a commitment by the U.S. Government (USG) to issue any solicitation or pay for any information submitted in response to this request.

Responders are responsible for adequately marking proprietary or restricted information contained in their responses. No basis for claims against the U.S. Government shall arise because of a response to this RFI/Sources Sought or from the USG’s use of such information. Specific questions about this RFI/Sources Sought should be directed only to the email addresses identified above. This office will not respond to any telephonic or other inquiries regarding this notice.

Please note USAID is not seeking technical or cost proposals currently. Do not submit any proposal in response to this RFI/Sources Sought. Only the information as requested in Attachment B and C as applicable will be considered.

CONTENT:

Attachment A – DRAFT SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK Attachment B – Sources Sought Information Attachment C – RFI Questions

Sincerely, Patricia Bradley, Contracting Officer, M/OAA/GH mailto:nkornilova@usaid.gov mailto:magrizzard@usaid.gov

Attachment A

DRAFT SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C.1 PURPOSE

The purpose of this contract is to provide implementation support and technical assistance to Ministries of Health (MoHs), local partners, and the global malaria community to accelerate progress in planning, delivery and monitoring of facility and community-based malaria services, including malaria case management, prevention of malaria in pregnancy (MiP), seasonal malaria chemoprevention (SMC), tailored deployment of existing and new prevention and control interventions1 and data collection and use for service delivery.

C.2 BACKGROUND

The past two decades have seen extraordinary progress in malaria control efforts. The scale-up of proven, cost-effective malaria interventions – such as effective case management and prevention of MiP – has contributed to this progress. The World Health Organization’s (WHO) 2021 World Malaria Report2 estimates that more than 10.6 million malaria deaths and 1.7 billion malaria cases were averted worldwide between 2000 and 2020. During that same time period, many countries made notable progress towards subnational or national malaria elimination. The risk of malaria has declined as a result of cumulative efforts and funding by the United States Government (USG) through the President’s Malaria Initiative (PMI), the USG and other governments through the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), national governments in endemic countries, the Bill and Melinda Gates Foundation, and many other donors and foundations.

Incredible achievements have been reached in the fight to end malaria, yet progress has been uneven and has fallen short of global goals. The COVID-19 pandemic has further threatened this progress, resulting in excess malaria cases and deaths due to COVID-19 service disruptions. WHO reported that there were an estimated 241 million new cases of malaria and approximately 627,000 malaria-attributed deaths worldwide in 2020 alone3. The vast majority of these cases and deaths occurred among young children in sub-Saharan Africa (SSA) where malaria infection during pregnancy also contributes to maternal and newborn morbidity and mortality.4 Additionally, factors such as climate change, genetic mutations that compromise test and treatment effectiveness and conflict in malaria-affected communities further complicate global malaria efforts.

Gaps in intervention quality and coverage contribute to continued malaria related mortality and morbidity.

Millions of people do not receive the malaria prevention and treatment services that they need. In 2020, only 69% of children with fever in SSA sought care, of whom only 76% received an artemisinin-based

1 The new prevention and control interventions that may be supported by this award include WHO-approved, non-vector control interventions such as the malaria vaccine and perennial malaria chemoprevention

2WHO World Malaria Report, 2021 accessed at: https://www.who.int/publications/i/item/9789240040496

3 Ibid.

4 Ibid.

combination therapy (ACT). Additionally, 43% of pregnant women in SSA did not receive a single dose of intermittent preventive treatment for malaria during pregnancy (IPTp).5

U.S. President’s Malaria Initiative

PMI, led by USAID and implemented together with the U.S. Centers for Disease Control and Prevention, is the USG’s primary vehicle for assisting malaria-affected countries to scale up proven malaria control and elimination interventions. When it was launched in 2005, the goal of PMI was to reduce malaria-related mortality by 50 percent across 15 high-burden countries in SSA through a rapid scale-up of four proven and highly effective malaria prevention and treatment measures: insecticide-treated mosquito nets (ITNs); indoor residual spraying; accurate diagnosis and prompt treatment with ACTs; and IPTp.

Since the start of PMI, the tools available to prevent and treat malaria and epidemiological, entomological and political context have evolved, influencing the ways in which PMI strategically engages. The U.S.

President’s Malaria Initiative 2021-2026 Strategy: End Malaria Faster articulates a vision for how PMI will contribute to the global goals of saving more than four million lives and averting over 1 billion cases by 2025. 6 The Strategy accounts for the progress over the past fifteen years and new and emerging challenges. Malaria prevention and control remains a major U.S. foreign assistance objective and PMI’s strategy fully aligns with the USG’s vision of ending preventable child and maternal deaths and protecting communities from infectious diseases.

While maintaining the broader orienting goal to work with PMI-supported countries (see https://www.pmi.gov/where-we-work/) and partners to further reduce malaria deaths and substantially decrease malaria morbidity, towards the long-term goal of elimination, the Strategy defines five core focus areas:

1. Reach the unreached: Achieve, sustain, and tailor deployment and uptake of high-quality, proven interventions with a focus on hard-to-reach populations.

2. Strengthen community health systems: Transform and extend community and frontline health systems to end malaria.

3. Keep malaria services resilient: Adapt malaria services to increase resilience against shocks, including COVID-19 and emerging biological threats, conflict, and climate change.

4. Invest locally: Partner with countries and communities to lead, implement, and fund malaria programs.

5. Innovate and lead: Leverage new tools, optimize existing tools, and shape global priorities to end malaria faster

As PMI’s flagship service delivery partner, it is expected that the REACH Malaria award will be instrumental in advancing progress in each of the five focus areas.

In addition to the aforementioned focus areas, PMI’s strategy describes key principles that serve as the foundation for PMI and its partners such as REACH Malaria:

1. Country ownership: Work within and support national malaria strategies; promote country ownership and leadership of the malaria program to ensure sustainability.

5 WHO World Malaria Report, 2021

6 Available at https://www.pmi.gov/home/pmis-strategy/# https://www.pmi.gov/where-we-work/

2. Equity: Achieve equity by prioritizing those with the greatest need and at highest risk, including gender, racial, socioeconomic and geographic equity; incorporate gender responsiveness in provision of services.

3. Local leadership: Invest in people closest to those whom we serve by leveraging community structures and supporting local partners to lead and sustain the fight against malaria.

4. Strategic partnerships: Partner with host country governments, multilateral and regional organizations, implementers, foundations and other funders, financing institutions, private sector, and community organizations to avoid duplication, promote sharing of information, mobilize communities, leverage resources to fight malaria, align on global priorities, and reach a shared vision towards a malaria-free future.

5. Efficiency: Seek to make the greatest impact against malaria with every dollar.

6. Flexibility, responsiveness, adaptability: Maintain flexibility and remain responsive to the ever-changing nature of malaria, adapting to new challenges and situations in partner countries.

7. Multisectoral approach: Engage with stakeholders in other sectors, including education, agriculture, and commerce, to achieve malaria control and elimination objectives.

8. Integration with USG global health investments: Where beneficial, integrate malaria activities with maternal and child health, HIV/AIDS, tuberculosis, neglected tropical diseases, and Global Health Security activities.

Alignment of REACH Malaria with these principles will be instrumental to achieving the expected program impact.

The work to be carried out under this contract builds on more than fifteen years of PMI and USAID investments at the country level in strengthening community and facility malaria case management, MiP, SMC, and related service delivery efforts, and takes into account learning across countries and the current evidence base for these interventions and approaches. During the first five years of the Initiative, PMI invested in the Improving Malaria Diagnostics project, which was designed to expand, improve, and build capacity for laboratory-based diagnosis of malaria in PMI partner countries. This project was followed by the MalariaCare project, which was designed with an expanded scope to support the scale-up of and build country capacity for malaria case management through the strengthening of prompt malaria diagnosis and appropriate treatment, including through the use of a standardized toolkit to maintain high quality case management services. MalariaCare was followed by the PMI Impact Malaria project which further expanded the scope to include MiP service strengthening and SMC. Resources developed by PMI Impact Malaria are available online. In addition to the malaria service deliveries covered under the scope of Impact Malaria, REACH Malaria will emphasize support to local entities and to community health systems, increase service delivery resilience to withstand shocks and adapt to emerging threats; strengthen quality and use of data for decision-making; and support tailored deployment of existing and new non-vector control prevention interventions.

The work to be carried out under this contract will be done in close coordination with global, national, and local partners, including PMI and USAID implementing partners supporting activities in the areas of supply chain, SBC, operations research (OR), and surveillance, monitoring, and evaluation (SM&E).

Malaria Case Management

Prompt, effective case management is a crucial component of reducing malaria morbidity and mortality and a cornerstone of malaria control. In 2010, WHO revised its treatment guidelines, calling for all patients with suspected malaria to undergo quality-assured diagnostic testing with either microscopy or rapid diagnostic tests (RDTs) and for treatment decisions to be based on test results. Consistent with these guidelines, PMI supports partner countries to promote early care-seeking, implement universal diagnostic testing, and when a test is positive, to provide immediate treatment with appropriate antimalarial drugs at https://malariacare.wordpress.com/resources/toolkit/ https://impactmalaria.org/resources public health facility and community levels, and in the private sector where relevant. The goal is for all patients with suspected malaria to rapidly seek care, all patients with suspected malaria to be quickly identified and tested, and all patients with confirmed malaria to receive effective treatment without delay.

Over the last fifteen years, PMI has invested significant resources to support the scale-up of appropriate malaria case management at different levels of health facilities and at community levels across the 27 different PMI countries. PMI has worked closely with MoHs to invest in efforts aimed at developing capacity for effective implementation of malaria case management, providing support for all elements of a comprehensive quality program to diagnose and treat patients appropriately. A cornerstone of this support is development of country-level case management policies and guidelines, including those for community health programs and the private sector, that are updated and rolled out as indicated. PMI has worked alongside partner countries to promote and expand quality assurance of case management by providing support for strengthening expert diagnostic capacity at reference laboratories and through support for training and supervision activities at health facilities, including on-site training, mentoring, continuous quality improvement processes, and troubleshooting with routine supervision that assesses and documents health worker performance through direct observation, facility and record review, and re-checking of blood slides. These programs are implemented with leadership and planning from the Ministry of Health at all levels in all PMI-supported countries.

However, despite these advances, progress in case management continues to lag behind expectations for several reasons. Among health care provider actions, poor recognition of symptoms of suspected malaria and of danger signs for severe disease and inadequate knowledge and practice in diagnosing and/or treating patients with malaria (e.g., continued presumptive treatment, provision of treatment despite a negative diagnostic test results, failure to follow injectable artesunate treatment with a full course of ACT) reduce the effectiveness of patient management across the malaria case management continuum and increases patient morbidity and mortality. Negative care-seeking and provision experiences also diminish trust in the health system and negatively impacts norms, attitudes and practices related to care-seeking. In addition, disconnected patient referral systems across levels of care further contribute to preventable malaria morbidity and mortality. Broader service delivery challenges include stock outs of essential drugs and commodities (including laboratory supplies, ACTs, RDTs, and SP); human resources for health constraints, lack of access to laboratory services; and poor quality supervision.

The healthcare landscape is varied and diverse across partner countries and communities, but many of the challenges described above are encountered and even magnified in the private sector. Given the high utilization of private sector services and the important role of the private sector in reaching the unreached in some PMI partner countries, private sector services in these settings must be improved and supported in order to meet PMI strategic country goals. Key needs may include policy changes and harmonized regulations to facilitate appropriate diagnosis and treatment, reporting of private outlet data into national health management information systems (HMIS), appropriate oversight and quality assurance of service provision, and overall coordination and integration of private service provision within the larger health system.

Community Health

Achieving PMI’s objectives requires accessibility of malaria case management, including the extension of malaria services into communities, especially those that are hard to reach. In collaboration with partner countries, PMI has also long supported the implementation of community case management of malaria to expand access to prompt and effective treatment and health information. Nearly all PMI partner countries have received PMI financial and technical support for community case management of malaria, which is often implemented through integrated community case management (iCCM) for malaria, pneumonia, and diarrhea. Models for the use of community health workers (CHWs) in malaria case management vary widely across and within PMI partner countries. In some countries, CHWs are also authorized to provide malaria case management at the community level for all ages (mCCM). Additionally, a growing number of countries are implementing proactive community case management models that involve CHWs actively seeking out cases of fever on a regular basis. Building off of the iCCM platform, CHWs in many PMI partner countries play an important role in referral and provision of pre-referral services to manage severe malaria in children.

However, many communities remain unreached with malaria services and challenges persist even in countries where community-based malaria service delivery is implemented at scale. In many settings, CHW programs are fragmented within countries rather than fully institutionalized within the broader primary health care system. This brings about challenges related to linkages with health facilities (supply chain, supervision, referrals), human resources (selection, supervision, payment, retention), and data collection and HMIS integration. These in turn affect CHW retention, quality of care, and demand for services.

These challenges must be addressed collaboratively between partners and MoHs, starting at the policy level and flowing into strengthened implementation of community health policies, with technical assistance that addresses not just services but systems.

Malaria in Pregnancy

Malaria infection during pregnancy contributes to maternal and newborn morbidity and mortality.

Approximately 125 million women living in malaria-endemic countries throughout the world become pregnant every year, more than 30 million of whom live in tropical areas of Africa where there is intense transmission of Plasmodium falciparum7. In these areas, malaria infection directly contributes to adverse outcomes in maternal and newborn health. Pregnant women, especially those in their first or second pregnancies, are particularly vulnerable to malaria as pregnancy reduces a woman’s immunity to malaria, making her more susceptible to malaria infection and increasing the risk of illness, severe anemia, and death. For the unborn child, maternal malaria increases the risk of miscarriage, stillbirth, premature delivery, and low birth weight - a leading cause of child mortality. Preventive interventions, including IPTp, promotion of long lasting ITN usage, and promoting prompt health care seeking for fever during pregnancy have been shown to significantly reduce the risk of maternal anemia, low birth weight, and perinatal deaths.

In line with WHO guidelines8, PMI works with partner countries to support a three-pronged approach to reducing malaria in pregnancy in areas with moderate to high levels of malaria transmission: (1) provision and promotion of ITNs to pregnant women; (2) administration of IPTp with sulfadoxine/pyrimethamine, where indicated; and (3) prompt diagnosis and effective treatment of malaria and anemia among pregnant women. A cornerstone of this approach is early and frequent ANC attendance. The 2016 WHO Antenatal Care (ANC) Guidelines9 which called for a minimum of eight contacts (plus an additional contact recommended at 13-16 weeks to allow for early provision of IPTp) with a health provider has implications for MiP programming as countries adopt and adapt the ANC recommendations.

Coordination and planning between national malaria control program (NMCP) and Reproductive, 7 Dellicour S, Tatem AJ, Guerra CA, Snow RW, ter Kuile FO. Quantifying the Number of Pregnancies at Risk of Malaria in 2007: a Demographic Study. PLOS Med. 2010;7:1, e1000221.

8 World Health Organization. Protecting malaria high-risk groups. Retrieved November 20, 2021, from https://www.who.int/activities/protecting-malaria-high-risk-groups.

9 World Health Organization. 2016. WHO recommendations on antenatal care for a positive pregnancy experience.

Maternal, Newborn, and Child Health (RMNCH) units and other infectious disease programs are essential to increasing coverage of MiP interventions and ANC contacts.

PMI supports the delivery of these activities through ANC platforms in partner countries and promotes collaboration between NMCPs and RMNCH programs at the country level. PMI may work with more than one PMI implementing partner at country level to support this three-pronged approach. With support from PMI, the proportion of women receiving at least three doses of IPTp has more than doubled from 12% to 33% in PMI partner countries. More than half of women now receive at least two doses. 10

Despite this progress, PMI recognizes the need for continued efforts and creative approaches to address remaining barriers hindering IPTp uptake and increase coverage. In addition to the service delivery challenges listed above, some of the key challenges and barriers to progress in uptake of malaria in pregnancy interventions include inadequate provider adherence to national IPTp and malaria in pregnancy diagnosis and treatment guidelines; slow country adoption and implementing practices of the 2016 WHO ANC guidelines; lack of effective communication between and inconsistency across NMCP and RMNCH program policies and guidelines; delays in pregnant women initiating their first ANC visit and failure to return regularly; and consumer perceptions of ANC services. Global partners, including PMI, are working with countries to develop and evaluate new strategies and approaches for prevention and control of MiP in service delivery settings, including alternative approaches and/or drugs for IPTp, and implementation of community-delivered IPTp by trained CHWs to improve uptake.

Seasonal Malaria Chemoprevention

SMC has grown in prominence and coverage over the past decade and has become a core malaria prevention intervention in many PMI-supported countries. PMI currently supports NMCPs to implement SMC in nine countries (Benin, Burkina Faso, Cameroon, Ghana, Guinea, Mali, Niger, Nigeria, Senegal), and is open to supporting SMC implementation in additional PMI partner countries where the intervention is recommended and where PMI, together with the NMCP, has prioritized this support.

However, reaching sustained high uptake of SMC in targeted geographic areas can be challenging for several reasons. First, implementation requires monthly household visits over a period of three-five months during peak malaria transmission season, which can mean difficult traveling conditions with rainy weather conditions. Some SMC-eligible areas are also in insecure zones posing additional safety and logistical challenges for implementation. Coordination between donors and implementers is essential to successful SMC implementation: most SMC countries have multiple donors and multiple partners working with the NMCP to implement campaigns. In addition to these illustrative logistical challenges, growing populations in SMC-eligible zones means increased costs for drugs, tools and workforce, and increasingly large and sometimes unwieldy campaigns. High coverage and adherence to the full treatment course at each round of delivery also requires strong community sensitization and buy-in.

Similar to other service delivery interventions, achieving this buy-in requires coordination with SBC partners. Measurement of success in SMC implementation requires some investments in monitoring and evaluation of the intervention. PMI is an active member of the Roll Back Malaria SMC Alliance, a group which provides important global leadership.

Surveillance, Monitoring and Evaluation (SM&E)

High quality data are essential for tracking progress and making evidence-driven decisions on how to target limited resources. Strengthening of SM&E requires a multi-pronged approach, including work at the national level on HMIS. While national-level activities should be addressed by an implementing

10 PMI 15th Annual Report to Congress, April 2021: https://d1u4sg1s9ptc4z.cloudfront.net/uploads/2021/07/PMI- 15th-Annual-Report-1.pdf https://d1u4sg1s9ptc4z.cloudfront.net/uploads/2021/07/PMI-15th-Annual-Report-1.pdf https://d1u4sg1s9ptc4z.cloudfront.net/uploads/2021/07/PMI-15th-Annual-Report-1.pdf partner specializing in surveillance, monitoring, and evaluation, work at the service delivery point remains an essential component of planning and implementing service delivery activities. High quality data at the national level flows from strengthened data collection and input at the community and facility levels. Recording and reporting of accurate data and subsequently using that data for decision making is an essential component of service delivery.

Assessing the success of programmatic efforts to improve malaria service delivery also requires high quality data. While it may be possible to use country HMIS data to track project achievements towards key outcomes, interpretation of trends can sometimes be challenging due to HMIS data access issues, changes in data quality over time and the need to align data with the geographic scope of the project.

Consideration of other data sources such as health facility surveys, iCCM assessments, programmatic monitoring data and possible evaluation approaches is essential. However, USAID prefers that the contractor use existing, validated tools for purposes of evaluation instead of spending time and effort on new tool development.

Malaria Elimination

A key objective of the PMI Strategy 2021–2026 is to accelerate towards elimination and bring ten PMI countries toward national or subnational elimination from their 2015 status, with at least one country achieving elimination. 11 Countries will require support in order to achieve their elimination objectives.

This support may range from coordinating elimination activities at the national and subnational levels amongst various stakeholders, assisting countries with identifying and targeting elimination activities at the subnational level, conducting elimination readiness assessments to determine existing capacities and areas for improvement, identifying new strategies and approaches to strengthen key aspects of the surveillance system to ensure accurate and timely notification and response.

Malaria elimination builds on the foundation laid by intensive malaria control, with universal coverage of efficacious interventions for vector control among populations at risk, effective case management for all ages, and robust HMIS. As countries progress towards elimination, activities must increasingly be tailored based on malaria risk stratification to address the specific needs of areas and/or populations with differing epidemiologic and socioeconomic profiles. This can only be accomplished if countries have the capacity to collect, analyze, and interpret real-time, high-quality HMIS /malaria surveillance information.

As countries move toward national or subnational elimination, rapidly identifying and treating all malaria patients and individuals carrying parasites is critical. As in any other setting, in the elimination setting, all malaria cases should be confirmed with a diagnostic test and treated with effective antimalarials. This means having trained staff, supplies and systems in place in areas at risk of malaria transmission, including hard-to-reach locations. As such, in addition to strong surveillance and reporting systems, robust laboratory capacities and supply chain management systems are needed. CHWs often become the foundation for malaria case management as the need for rapid diagnosis, treatment, and response necessitates quick and easy access to care.

Elimination-specific system adaptations are also essential. Once a case is detected, a thorough foci investigation needs to be conducted to determine the potential for malaria transmission and to detect and manage cases surrounding the index case. Additionally, prevention activities such as personal protection means and messages, as well as promotion of positive health seeking behavior, should be reinforced.

While some of these aspects are implemented during the malaria control phase, during the elimination

11 The criteria for PMI considering elimination support in a given country is: 1) national (or subnational) parasite prevalence <5%, and 2) the national malaria strategy contains specific goals and objectives related to malaria elimination. Within the PMI portfolio, the countries in the Greater Mekong Sub-region (Burma, Cambodia, Laos, Thailand) are pursuing national elimination efforts, whereas the following countries are working at subnational levels: Ethiopia, Kenya, Madagascar, Senegal, Tanzania/Zanzibar, Zambia, and Zimbabwe.

phase, there is a need for rapid response that is adapted to the context in order to swiftly break the chain of transmission, and maintain gains achieved.

Finally, as countries aim for elimination certification by the WHO, there are requirements for documentation related to the availability of key systems as well as the detection and recording of cases.

As these systems are strengthened, it is critical that they be integrated into broader health systems. This will facilitate, for example, detection of malaria cases in areas which have not had cases for some time.

While this is often overlooked, these efforts for documentation and integration need to start years in advance of applying for elimination certification. PMI will assist countries in building these capacities and meeting these requirements.

Threats to malaria diagnostics and therapeutics

Antimalarial drug resistance and hrp2/3 gene deletions threaten the utility of our current treatments and diagnostic tools. PMI supports high quality implementation of routine Therapeutic Efficacy Studies (TES) as recommended by WHO to monitor antimalarial efficacy, along with molecular monitoring of drug resistance markers. Development of protocols to assess efficacy of SMC and other chemoprevention interventions is underway and implementation may be supported by PMI in the future. PMI also supports testing for deletions in the hrp2/3 genes that render the most commonly used RDTs ineffective. Timely and reliable results from these monitoring activities are critical for informing NMCP decisions on drug and RDT choice. While significant progress has been made in generating and reporting high quality data, challenges in timely execution and adherence to standard protocols for data collection and analysis remain. With the detection of partial artemisinin resistance in Rwanda12 and the high prevalence of hrp2/3 deletions found in the Horn of Africa13, it is more important than ever to ensure that accurate information is available on which to base commodity procurement on policy decisions.

In line with PMI’s strategy to invest locally and make malaria services more resilient, an important component of these activities is partnering with local institutions and strengthening local capacity to lead and implement timely, responsive surveillance. The CDC Malaria Laboratory offers training, quality assurance (QA) and control (QC), and troubleshooting for molecular testing in PMI partner countries, and efforts are underway to support African laboratory hubs for regional support and capacity strengthening.

Threats to malaria prevention and control

Over the past decade Ebola, Zika, and COVID-19 have threatened progress in malaria control and prevention. With each epidemic, PMI and its partners have worked alongside host country governments, MoHs, and NMCPs to adapt programming to ensure continuation of malaria activities as well as respond to the epidemic itself. For instance, during the COVID-19 pandemic SMC campaigns had to be modified in order to increase the safety of the SMC providers and staff as well as safety of the communities being served. In addition, PMI partners assisted MoHs to respond to the epidemic itself by adapting trainings for health care providers to include proper case management for COVID-19, training laboratory staff on testing techniques, sample collection, and transportation of COVID-19 samples based on global best practices on management of COVID-19, supporting infection prevention and control practices in health facilities, and integrating messaging related to prevention and detection of COVID-19 into training and supervision provided to CHWs, and promoting appropriate access to malaria services. PMI will continue to support host country governments, MoH and NMCPs to adapt malaria programming as necessary for

12 Uwimana A, Umulisa N, Venkatesan M, et al. Association of Plasmodium falciparum kelch13 R561H genotypes with delayed parasite clearance in Rwanda: an open-label, single-arm, multicentre, therapeutic efficacy study.

Lancet Infect Dis. 2021;21(8):1120-1128.

13 Golassa L, Messele A, Amambua-Ngwa A, Swedberg G. High prevalence and extended deletions in Plasmodium falciparum hrp2/3 genomic loci in Ethiopia. PLoS One. 2020 Nov 5;15(11):e0241807.

future epidemics/pandemics and PMI contractors may be asked to respond to the epidemic/pandemic directly with specific response funds, if technically appropriate.

Other Prevention Interventions/New Tools

Over the past several years, WHO has recommended new drug-based interventions for prevention and reduction of malaria that are targeted at areas of high transmission for specific high risk groups such as Intermittent Preventive Treatment for infants (IPTi). Although IPTi has not been taken up by most countries, there are numerous ongoing studies in diverse settings to determine the feasibility and impact of the intervention. A number of countries have also included IPTi within subnational stratification and tailoring exercises so it is possible that this intervention may become more broadly deployed.

Additionally, WHO recommended the first-ever malaria vaccine in October 2021 and Gavi approved funding for a malaria vaccine program in December 2021. While initial supply will be highly constrained, the malaria vaccine has potential to be a critical new tool within the set of malaria prevention interventions. Data on the synergistic, combined effect of SMC and the RTS,S / AS01 vaccine14 also demonstrate the importance of strategic packaging and deployment of limited resources.

While introduction, procurement and delivery will be supported with Gavi resources, complementary support such as inclusion of malaria vaccine into health facility malaria supervision models and vaccine demand generation will be supported by malaria partners.

Local Capacity Strengthening

While USAID has long recognized the importance of investment in local organizations and partners in the countries in which it operates, the PMI Strategy for 2021-2026 includes a renewed emphasis on investing locally. This strategic focus area includes three aims: (1) support host country governments to execute malaria programs successfully; (2) invest in people and partners closest to those we serve; and (3) encourage country commitment to end malaria.

To this end, PMI strives to provide increased investment and programmatic support to local partners, implementers, research organizations, and host country government programs, as appropriate. PMI will work alongside government authorities at both the national and local levels to provide technical and operational (e.g. coordination, communication, and supervision) assistance to government health officers as they conduct quality health campaigns and routine malaria interventions. PMI will also seek to build new relationships and strengthen existing relationships with local civil society organizations, religious groups, and private actors. At the same time, PMI will work to strengthen private sector and partner-country commitments against malaria and will advocate for the inclusion of critical malaria services in national health strategies.

PMI’s malaria service delivery efforts will focus on greater investment through local entities to implement critical service delivery activities such as TES. Projects will seek to foster the involvement of local entities with existing malaria technical expertise and / or award management experience in partner countries. Additionally, service delivery projects will leverage the resources of PMI in order to provide technical and administrative assistance to local entities that may not yet have experience implementing malaria activities or managing USAID awards. The goal of this process is to promote greater country ownership of malaria service delivery interventions and to support the development of malaria technical expertise wherever possible.

14 Chandramohan D, Zongo I, Sagara I, et al. Seasonal Malaria Vaccination with or without Seasonal Malaria Chemoprevention. N Engl J Med. 2021;385(11):1005-1017.

C.3 OBJECTIVE

The purpose of this contract, as stated in Section C.1, reflects the intent of PMI and USAID missions to continue investments in ongoing and new areas of emphasis related to malaria case management, control of malaria in pregnancy, and other malaria prevention service delivery interventions (both existing and those that may be identified and proven effective in the future). The three immediate results (IR) to be obtained through this contract are:

IR 1: Strengthened implementation of quality malaria service delivery with a focus on unreached populations

IR 2: Strengthened and more resilient health systems from national to community level

IR 3: Effective global leadership in malaria service delivery approaches provided

In achieving these results, the contract will contribute to PMI’s three overall objectives (reducing malaria mortality, reducing malaria morbidity, and moving countries towards pre-elimination) and will work across all five of PMI’s core areas of strategic focus. In the event of the ongoing COVID-19 pandemic or a new epidemic/pandemic of a febrile illness, the Contractor will be expected to adapt malaria programming accordingly and may be asked to support epidemic/pandemic related service delivery activities that fall within the objectives and scope of work of this award.

Figure 1. REACH Malaria Results Framework

The three IRs will be achieved through strategic interventions and contributions that comprise the twelve sub-IRs shown in Figure 1. More information about how these sub-IRs will be achieved are described within the Statement of Work.

C.4 STATEMENT OF WORK

In order to achieve the aforementioned results, REACH Malaria will provide technical assistance and implementation support for improved access, uptake, and quality of malaria case management; strengthen quality of community health systems (from the clinic to community level) that support the delivery of community case management; improve quality and uptake of MiP services; support high coverage of and adherence to SMC; and implement tailored deployment of existent and new prevention and control interventions for maximal impact, as agreed to with partner countries and PMI.

To complement these technical interventions, the scope also includes technical and implementation support for increasing the quality and use of data for decision-making and monitoring of progress and impact; developing of high quality Ministry of Health policies and malaria programs, documents and activities; strengthening in-country capacity to plan and execute malaria activities; increasing service delivery resilience to withstand shocks and adapt to emerging threats; and increasing financial, management and technical support to local partners supporting malaria services. This critical in-country work will be complemented by global leadership to increase the contribution of PMI lessons, knowledge, and learning to global policy, resources and implementation guidance and increased the generation and dissemination of malaria service delivery implementation knowledge and evidence.

The IRs below are listed in descending order in terms of both anticipated funding levels as well as in total level of effort that will be requested to achieve each objective (e.g., work requested under IR 1 will require more time and resources to achieve than IR 2). While implementing requested services and technical support, the contractor will build capacity and skills of MoH and other in-country staff at all levels of the health system (i.e., provincial, district, health facility, community level and private sector where appropriate) without creating parallel structures. This applies to all aspects of the contract, but is particularly emphasized within IR 2. Technical and material assistance is to be delivered in support of the national malaria control and related health policies and strategies. The intent is to build the capacity of the government, local entities, and other key stakeholders to lead planning and implementation of all malaria control service delivery strengthening program activities. By the end of the contract, it is expected that these entities would be competitive should the USAID Mission choose to compete a local bilateral award.

In the event of the ongoing COVID-19 pandemic or a new epidemic/pandemic of a febrile illness, the Contractor will be expected to adapt malaria programming accordingly and may be asked to support epidemic/pandemic related service delivery activities that fall within the objectives and scope of work of this award (e.g.adaptation of and continued utilization of health care services).

Intermediate Result (IR) 1: Strengthened implementation of quality malaria service delivery with an equity-based focus on unreached populations.

The Contractor will provide technical assistance and/or direct implementation support for delivering malaria services for all populations at risk, especially the hardest to reach, through targeted and equity-based delivery approaches that leverage opportunities from other health sectors and in turn strengthen the health system. This will include malaria case management at different levels of public health facilities and at the community level through iCCM or other community-based platforms, and the private sector, as appropriate; for implementation of malaria in pregnancy services; for SMC delivery and uptake; and for tailored deployment of existing and new prevention and control interventions.

Activities must be informed by routine HMIS data, supervision data, and other information collected through monitoring and evaluation efforts to strategically identify quality of care and existing needs and to target interventions/activities based on these data and gender and equity considerations. In addition, activities must be carried out in coordination with PMI and USAID central and bilateral partners working in the areas of supply chain, SBC, OR, and SM&E, and other USAID partners working in RMNCH and infectious diseases.

Illustrative tasks included within the scope of IR1:

● Provide technical and material assistance for training and supervision of health care providers, including CHWs, in the diagnosis and treatment of uncomplicated malaria, treatment and/or referral of severe malaria, and provision of malaria in pregnancy services.

● Provide technical assistance to support the introduction and/or expansion of diagnostic and clinical malaria services at the community level and in the private sector, where appropriate, with a particular focus on strengthening access for unreached populations.

● Provide technical and implementation support for strengthening facility and community level case reporting.

● Facilitate linkages between CHWs and the broader health system to ensure that CHWs are well supported to provide quality services to the hardest to reach and that the referral system is strengthened to ensure that facility based care is reachable when needed

● Provide technical assistance to support implementation of quality assurance/quality control systems on diagnostic testing (RDTs and microscopy) for malaria, including competency assessments, external quality assurance programs, and slide banks for malaria microscopy.

● Support data driven targeting of CHW expansion to reach the unreached.

● Direct payment of CHWs , when appropriate and consistent with national guidelines.

● Identify and prioritize key technical and programmatic bottlenecks at the national and subnational level that require an evidence‐based response for malaria case management, malaria in pregnancy, SMC and new non-vector control prevention interventions.

● Identify approaches to improve coverage, quality, and efficiency of interventions by addressing national and subnational country-specific bottlenecks.

● Provide comprehensive technical assistance and/or implementation support for SMC in countries that meet the criteria for its implementation, including support for SMC acceptance and adherence. 15

● Provide assistance to determine elimination readiness and to pilot and/or scale up case management and surveillance approaches (e.g., primaquine and reactive case detection) in pre-elimination/elimination areas16, and other drug-based approaches as appropriate given the malaria transmission setting and national policies.

● Work with NMCPs and PMI to provide evidence for identifying the most effective drug-based and vaccine approaches for areas, including pre-elimination and elimination areas.

● Provide technical assistance to support provider/health facility linkages to the supply chain management systems and collaborate with MoH supply chain and pharmacy management departments and relevant implementing partners.

● Provide technical and material assistance to support the development and implementation of SBC to increase provider adherence to diagnostic testing, appropriate malaria treatment, and uptake of MiP SMC and new non-vector control interventions, and to support provider counseling and promotion of malaria service delivery interventions for clients.

● Provide technical and material assistance for training and supervision of health providers and data managers in the accurate recording and reporting of case management and malaria in pregnancy data through the routine health information system, and the analysis and use of data by supervisors and program managers.

● Facilitate greater linkages in malaria service delivery programming between NMCPs, immunization programs, RMNCH, HIV/infectious disease units, health promotion units, and other relevant MoH entities.

IR 2: Strengthened and more resilient health systems from national to community level

15 The following PMI-supported countries currently have districts/regions that meet the WHO criteria for implementing SMC: Burkina Faso, Mali, Niger, Senegal, Benin, Cameroon, Guinea, Ghana, and Nigeria.

16 The following PMI-supported countries that…