Amendment 2_7200AA23R00002_REACH Solicitation.pdf

Solicitation Issuance Date: February 28, 2023 Solicitation Amendment #1 Issuance Date: March 7, 2023 Solicitation Amendment #2 Issuance Date: March 20, 2023 Closing Date/Time for Questions: March 8, 2023 at 12:00pm Closing Date/Time for Receipt of Proposals: April 3, 2023 at 5:00pm March 31, 2023 at 12:00pm

Subject: Request for Proposal (RFP) Number: 7200AA23R00002 U.S. President’s Malaria Initiative (PMI) Reaching Every At-Risk Community and Household with Malaria Services (REACH Malaria)

Dear Prospective Offerors, The United States Agency for International Development (USAID) is seeking proposals to provide implementation support and technical assistance to Ministries of Health (MoHs), local partners, and the global malaria community to support the delivery of facility and community-based malaria services, including malaria case management, prevention of malaria in pregnancy (MiP), seasonal malaria chemoprevention (SMC), and non-vector control prevention and control interventions as described in the attached Request for Proposals (RFP).

This procurement will be conducted under full and open competition procedures pursuant to Part 15 of the Federal Acquisition Regulations (FAR), under which any type of organization is eligible to compete.

USAID anticipates a single award of a Cost-Plus-Fixed-Fee, term-type contract for a five-year period of performance as a result of this RFP. In order to understand the magnitude of USAID’s requirement, the Government estimates 135,330 professional technical staff person days level of effort. The NAICS code for this procurement is 541990. The authorized geographic code for this procurement is 935. Offerors are encouraged to read the entire solicitation, which includes all pertinent technical sections and the terms, conditions, and instructions required for submitting proposals. Offerors are responsible for ensuring proposals are received at USAID by the due date and time as specified above. Failure to comply with the submission date will deem any submission unacceptable and it will not be reviewed or evaluated. Section L of the RFP sets forth all instructions for the preparation and submission of required proposal contents. Prospective offerors must submit questions and proposal submissions by email to REACH@usaid.gov, by the time and dates indicated above.

This RFP in no way obligates USAID to award a contract nor does it commit USAID to pay any cost incurred in the preparation and submission of a proposal. Award of a Contract under this RFP is subject to availability of funds and other internal USAID approvals. This RFP can be viewed and downloaded from https://sam.gov. USAID bears no responsibility for data errors resulting from transmission or conversion processes. USAID reserves the right to amend or rescind this solicitation at any time. If substantive questions are received which affect the response to the solicitation, or if changes are made to the closing date and time, as well as other aspects of the RFP, this solicitation may be amended and amendments to this solicitation will be issued and posted on the same website from which you downloaded the solicitation. USAID advises to regularly check the above website for amendments.

Sincerely, Patricia Bradley, Contracting Officer

7200AA23R00002

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

2 150

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

H

G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE

FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 253 (c) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

REQ-GH-23-00000702/28/2023

X

7200GH

USAID M/OAA

Office of Acquisition & Assistance 1300 Pennsylvania Avenue, NW Washington, DC 20523-1000

1700 ET 04/03/2023

Natalia Kornilova reach@usaid.gov

X

X

X

X

X

X

X

X

X

X

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PAGE(S)

Patricia Bradley

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____0_________ calendar days (60 calendar days unless a different period is inserted

Amendment #2

Table of Contents

SECTION B - SUPPLIES OR SERVICES AND PRICE/COSTS 8

B.1 PURPOSE 8

B.2 CONTRACT TYPE 8

B.3 ESTIMATED COST, FIXED FEE, AND OBLIGATED AMOUNT 8

B.4 BUDGET 8

B.5 INDIRECT RATES 8

B.6 COST REIMBURSABLE 9

B.7 PAYMENT OF FIXED FEE 9

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK 10

C.1 PURPOSE 10

C.2 BACKGROUND 10

C.3 OBJECTIVE 20

C.4 STATEMENT OF WORK 22

C.5 RESULTS 29

SECTION D - PACKAGING AND MARKING 30

D.1 AIDAR 752.7009 MARKING (JANUARY 1993) 30

D.2 BRANDING STRATEGY, IMPLEMENTATION PLAN AND MARKING PLAN 30

SECTION E - INSPECTION AND ACCEPTANCE 33

E.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE 33

E.2 INSPECTION AND ACCEPTANCE 33

SECTION F - DELIVERIES OR PERFORMANCE 34

F.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE 34

F.2 PERFORMANCE PERIOD 34

F.3 PLACE OF PERFORMANCE 34

F.4 AUTHORIZED WORK DAY/WEEK 34

F.5 PERFORMANCE STANDARDS 34

F.6 KEY PERSONNEL 35

F.7 REPORTS AND DELIVERABLES OR OUTPUTS 36

F.8 LEVEL OF EFFORT 43

SECTION G - CONTRACT ADMINISTRATION DATA 45

G.1 AIDAR 752.7003 DOCUMENTATION FOR PAYMENT (NOV 1998) 45

G.2 CONTRACTING OFFICER 46

G.3 CONTRACTING OFFICER’S REPRESENTATIVE (COR) 46

G.4 CONTRACTOR’S PRIMARY POINT OF CONTACT 46

G.5 PAYING OFFICE 47

G.6 ACCOUNTING AND APPROPRIATION DATA 47

G.7 CONTRACTOR'S PAYMENT ADDRESS 47

G.8 TECHNICAL DIRECTION/RELATIONSHIP WITH USAID 47

SECTION H - SPECIAL CONTRACT REQUIREMENTS 49

H.1 AUTHORIZED GEOGRAPHIC CODE 49

H.2 EXECUTIVE ORDER ON TERRORISM FINANCING 49

H.3 FOREIGN GOVERNMENT DELEGATIONS TO INTERNATIONAL CONFERENCES

(JAN 2002) 49

H.4 LOGISTIC SUPPORT 49

H.5 CONSENT TO SUBCONTRACT 49

H.6 INFORMATION TECHNOLOGY APPROVAL (APRIL 2018) (DEVIATION NO. M-OAA-

DEV-FAR-22-03c) (APRIL 2020) 50

H.7 NONEXPENDABLE PROPERTY AND INFORMATION TECHNOLOGY RESOURCES 51

H.8 LANGUAGE REQUIREMENTS 51

H.9 ENVIRONMENTAL COMPLIANCE AND MANAGEMENT 51

H.10 302.3.5.19 USAID-FINANCED THIRD-PARTY WEB SITES (NOVEMBER 2017) 52

H.11 302.3.5.21 SUBMISSION OF DATASETS TO THE DEVELOPMENT DATA LIBRARY

(DDL) (OCTOBER 2014) 53

H.12 PROHIBITION OF ASSISTANCE TO DRUG TRAFFICKERS 55

H.13 SECURITY 55

H.14 INHERENTLY GOVERNMENTAL AND CLOSELY ASSOCIATED FUNCTIONS 55

H.15 PRESS RELATIONS 55

H.16 ELECTRONIC PAYMENTS SYSTEM 55

H.17 RESTRICTIONS AGAINST DISCLOSURE (MAY 2016) (DEVIATION NO. M-OAA-DEV-

AIDAR-22-06c) 56

H.18 SOFTWARE LICENSE ADDENDUM (MAY 2016) (DEVIATION NO. M-OAA-DEV-

AIDAR-22-06c) 56

H.19 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY (APRIL

2018) (DEVIATION NO. M-OAA-DEV-AIDAR-22-06c) 57

H.20 MEDIA AND INFORMATION HANDLING AND PROTECTION (APRIL 2018)

(DEVIATION NO. M-OAA-DEV-AIDAR-22-06c) 58

H.21 PRIVACY AND SECURITY INFORMATION TECHNOLOGY SYSTEMS INCIDENT

REPORTING (APRIL 2018) (DEVIATION NO. M-OAA-DEV-AIDAR-22-06c) 59

H.22 SKILLS AND CERTIFICATION REQUIREMENTS FOR PRIVACY AND SECURITY

STAFF (APRIL 2018) (DEVIATION NO. M-OAA-DEV-AIDAR-22-06c) 62

H.23 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY

RESOURCES (APRIL 2018) (DEVIATION NO. M-OAA-DEV-AIDAR-22-06c) 63

H.24 CLOUD COMPUTING (APRIL 2018) (DEVIATION NO. M-OAA-DEV-AIDAR-22-06c) 67

H.25 GRANTS UNDER CONTRACTS (GUC) 71

H.26 LETTER OF CREDIT ADVANCE PAYMENT 72

SECTION I - CONTRACT CLAUSES 74

I.1 FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) 74

I.2 AIDAR 752.252-1 AIDAR SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE (MAR 2015) 76

I.3 FAR 52.203-13 CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT (NOV

2021) 77

I.4 FAR 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (NOV 2021) 81

I.5 FAR 52.204-25 PROHIBITION ON CONTRACTING FOR CERTAIN TELE-

COMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

I.6 FAR 52.222-35 EQUAL OPPORTUNITY FOR VETERANS (JUN 2020) 85

I.7 FAR 52.222-36 EQUAL OPPORTUNITY FOR WORKERS WITH DISABILITIES (JUN

2020) 86

I.8 FAR 52.222-50 COMBATING TRAFFICKING IN PERSONS (NOV 2021) 86

I.9 FAR 52.223-99 ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR

FEDERAL CONTRACTORS (OCT 2021) (DEVIATION #M/OAA-DEV-FAR-22-01c) 91

I.10 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS

SUBCONTRACTORS (DEC 2013)(DEVIATION JUN 2022) 92

I.11 FAR 52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (NOV 2020) 93

I.12 AIDAR 752.222-70 USAID DISABILITY POLICY (DECEMBER 2004) 93

I.13 AIDAR 752.229-71 REPORTING OF FOREIGN TAXES (JUL 2007) 93

I. 14 AIDAR 752.231-72 CONFERENCE PLANNING AND REQUIRED APPROVALS (AUG

2013) (DEVIATION) APR 2022 94

I.15 AIDAR 752.245-70 GOVERNMENT PROPERTY—USAID REPORTING

REQUIREMENTS (OCT 2017) 96

I.16 AIDAR 752.228-3 WORKER’S COMPENSATION INSURANCE (DEFENCE BASE ACT)

(DEC 1991) [(DEVIATION JUN 2022)] 98

SECTION J - LIST OF ATTACHMENTS 99

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF

THE OFFEROR 100

K.1 NOTICE LISTING SOLICITATION PROVISIONS INCORPORATED BY REFERENCE100

K.2 FAR 52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (DEC 2022) 100

K.3 FAR 52.204-20 PREDECESSOR OF OFFEROR (AUG 2020) 104

K.4 FAR 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021) 105

K.5 FAR 52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES-

REPRESENTATION (OCT 2020) 107

K.6 FAR 52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS (AUG 2020)

K.7 FAR 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

K.8 FAR 52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT

TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016) 111

K.9 FAR 52.209-13 VIOLATION OF ARMS CONTROL TREATIES OR AGREEMENTS-

CERTIFICATION (NOV 2021) 111

K.10 FAR 52.219-1 SMALL BUSINESS PROGRAM REPRESENTATIONS (SEPT 2021) 113

K.12 FAR 52.222-22 PREVIOUS CONTRACTS AND COMPLIANCE REPORTS (FEB 1999) 116

K.13 FAR 52.222-25 AFFIRMATIVE ACTION COMPLIANCE (APR 1984) 117

K.14 FAR 52.225-20 PROHIBITION ON CONDUCTING RESTRICTED BUSINESS

OPERATIONS IN SUDAN--CERTIFICATION (AUG 2009) 117

K.15 FAR 52.227-15 REPRESENTATION OF LIMITED RIGHTS DATA AND RESTRICTED

COMPUTER SOFTWARE (DEC 2007) 118

K.16 FAR 52.230-1 COST ACCOUNTING STANDARDS NOTICES AND CERTIFICATION

(JUN 2020) 118

K.17 FAR 52.230-7 PROPOSAL DISCLOSURE—COST ACCOUNTING PRACTICE CHANGES

(APR 2005) 120

K.18 AGREEMENT ON, OR EXCEPTIONS TO, TERMS AND CONDITIONS 121

K.19 AUTHORIZED NEGOTIATORS 121

K.20 SIGNATURE 121

K.21 KEY INDIVIDUAL CERTIFICATION CONCERNING NARCOTICS OFFENSES AND

DRUG TRAFFICKING 121

KEY INDIVIDUAL CERTIFICATION 121

SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS OR

RESPONDENTS 123

L.1 FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998) 123

L.2 FAR 52.215-1 INSTRUCTIONS TO OFFERORS-COMPETITIVE ACQUISITION (NOV

2021)- ALTERNATE 1 (OCT 1997) 123

L.3 FAR 52.216-1 TYPE OF CONTRACT (APR 1984) 127

L.4 FAR 52.233-2 SERVICE OF PROTEST (SEP 2006) 127

L.5 GENERAL INSTRUCTIONS 128

L.6 DELIVERY INSTRUCTIONS 129

L.7 INSTRUCTIONS FOR THE PREPARATION OF THE TECHNICAL PROPOSAL 130

L.8 INSTRUCTIONS FOR THE PREPARATION OF THE COST PROPOSAL 135

L.9 INSTRUCTIONS FOR THE PREPARATION OF THE BRANDING STRATEGY 143

L.10 WAIVERS UNDER FAR PART 4.2101 PROHIBITION ON COVERED

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES AND EQUIPMENT

(DECEMBER 2021) 143

SECTION M - EVALUATION FACTORS FOR AWARD 146

M.1 GENERAL INFORMATION 146

M.2 TECHNICAL EVALUATION CRITERIA 146

M.3 COST PROPOSAL EVALUATION 149

M.4 DETERMINATION OF THE COMPETITIVE RANGE 149

M.5 SOURCE SELECTION 150

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICE/COSTS

B.1 PURPOSE

The purpose of this contract is to provide technical services that fall within the Scope of Work (SOW) specified in Section C for the Reaching Every At-Risk Community and Household with Malaria Services (REACH Malaria).

B.2 CONTRACT TYPE

This is a Cost-Plus-Fixed-Fee (CPFF) term type contract. For the consideration set forth in the contract, the Contractor must provide the level of effort described in Section F.8 to accomplish the deliverables and outputs as described in Section C and Section F.

B.3 ESTIMATED COST, FIXED FEE, AND OBLIGATED AMOUNT

(a) The estimated cost for the performance of the work required, exclusive of fixed fee is [TBD].

The fixed fee, if any, is [TBD]. The total estimated cost-plus-fixed-fee for this contract is [TBD].

(b) Within the estimated cost-plus-fixed-fee amount, if any, specified in paragraph (a) above, the amount currently obligated and available for reimbursement of allowable costs incurred by the contractor (and payment of fee, if any) for performance is [TBD].

(c) The Contractor must not exceed the aforesaid obligated amount, nor will the U.S. Government be responsible for costs incurred should the Contractor do so. Funding for his contract will be on an incremental basis, subject to the availability of funds.

B.4 BUDGET

Line Item # Description Total 0001 Direct Costs 0002 Indirect Costs Total Estimated Cost

0003 Fixed Fee Total Estimated Cost-Plus-Fixed-Fee

B.5 INDIRECT RATES

Pending establishment of revised provisional or final indirect cost rates, allowable indirect costs must be reimbursed on the basis of the following negotiated provisional or predetermined rates and the appropriate bases for prime contractors and their major subcontractors.

Description Rate Base Type Period

TBD TBD% 1/ 1/ 1/

1/ Base of Application:

Type of Rate:

Period:

*Special Note: The indirect cost table above is the current approved indirect cost rates for the prime and major subcontractor(s).

The Contractor will make no change in its established method of classifying or allocating indirect costs that impacts this contract without the prior written approval of the Contracting Officer.

Note: Contractors are allowed to recoup indirect costs (OH, G&A, etc.) as other direct costs if it is part of the contractor’s usual accounting procedures, consistent with FAR Part 31 and the contractor's

NICRA.

B.6 ADVANCE UNDERSTANDING ON CEILING INDIRECT COST RATES AND FINAL

REIMBURSEMENT FOR INDIRECT COSTS

(a) Reimbursement for indirect costs shall be at the lower of the negotiated final (or predetermined) rates, but not in excess of the following ceiling rates:

Description 2022 2023 2024 2025 2026

TBD TBD% TBD% TBD% TBD% TBD%

(b) The Government will not be obligated to pay any additional amount should the final indirect cost rates exceed the negotiated ceiling rates. If the final indirect cost rates are less than the negotiated ceiling rates, the negotiated rates will be reduced to conform to the lower rates.

(c) This advance understanding shall not change any monetary ceiling, cost limitation, or obligation established in the contract. Any changes in classifying or allocating indirect costs require the prior written approval of the Contracting Officer.

B.6 B.7 COST REIMBURSABLE

Allowable costs shall be limited to reasonable, allocable, and necessary costs determined in accordance with FAR 52.216-7 “Allowable Cost and Payment,” FAR 52.216-8 “Payment of Fixed Fee,” if applicable, FAR 52.232-22 “Limitation of Funds,” and AIDAR 752.7003 “Documentation for Payment.”

B.7 B.8 PAYMENT OF FIXED FEE

Payment of fixed fee will be made upon the proportion of the level of effort specified in Section F.8 that was provided by the contractor in the period covered by the submitted invoice. In the event that the Contractor does not provide the total LOE stipulated in Section F.8 the total amount of the fixed fee will be reduced in similar proportion. In accordance with FAR 52.216-8 Fixed Fee the Contracting Officer will withhold 15% of the total fee or $100,000, whichever is less, until the required award conditions under the referenced clause have been met.

[END OF SECTION B]

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

U.S. President’s Malaria Initiative (PMI) Reaching Every At-Risk Community and Household with Malaria Services (REACH Malaria)

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 WHO-approved, non-vector control prevention and control interventions 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 Report1 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 U.S. 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 alone2. 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.3 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, care was sought for only 69% of children with fever in SSA, of whom only 76% received an artemisinin-based 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).4

U.S. President’s Malaria Initiative

1WHO World Malaria Report, 2021 accessed at: https://www.who.int/publications/i/item/9789240040496 2 Ibid.

3 Ibid.

4 WHO World Malaria Report, 2021

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% 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, there has been evolution in the tools available to prevent and treat malaria and in epidemiological, entomological and political contexts, 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 2025.5 The Strategy accounts for the progress over the past fifteen years and new and emerging challenges. Malaria prevention and control remain 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.

The Strategy maintains the broader orienting goal to work with PMI partner countries (see https://www.pmi.gov/where-we-work/) and global partners to further reduce malaria deaths and substantially decrease malaria morbidity, towards the long-term goal of elimination and includes 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, the Reaching Every At-Risk Community and Household with Malaria Services (REACH Malaria) award will be instrumental in advancing progress in each of these five focus areas.

In addition to the aforementioned five focus areas, PMI’s strategy describes key principles that are foundational for PMI and its partners, including REACH Malaria:

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

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.

5 Available at https://www.pmi.gov/home/pmis-strategy/#

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 15 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. It takes into account learning across countries and the current evidence base for these interventions and approaches. Beginning from 2005, 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 its predecessor project PMI 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, social and behavior change (SBC), operations research (OR), and surveillance, monitoring, and evaluation (SM&E).

Funding Allocation Process

PMI’s approach to programming resources and defining support at the country level is to work within the framework of the NMCP’s strategic plan. PMI supports investments that respond to opportunities and gaps prioritized by the NMCP, taking into account investments by partner countries and other donors and partners active in malaria control. PMI annually updates technical guidance which provides the technical parameters and direction for the use of PMI resources (see:

https://d1u4sg1s9ptc4z.cloudfront.net/uploads/2022/03/PUBLIC_PMI-FY2023-Technical- Guidance_508_031722.pdf).

Each year, PMI undertakes a planning process, working closely with partner country MoH counterparts and key stakeholders, to develop a country Malaria Operational Plan (MOP). These plans summarize the current policies and status of malaria prevention and control intervention scale-up in the country;

describe the SM&E strategies to be supported; identify challenges and programmatic and resource gaps;

and provide a description of planned USG investments by activity, budget amount, and implementing partner. Annual MOPs thus serve as the guide for implementing partners on PMI’s expectations across technical areas and for each specific activity, informing the basis for partner annual work plan development. The specific activities that REACH will support in each country will be determined during MOP planning and discussed with the MoH and partners during initial work plan development. It is during this work plan development with the in-country PMI team and MoH that the specific activities will be defined. PMI MOPs undergo rigorous interagency technical review at the headquarters level and are ultimately approved by the U.S. Global Malaria Coordinator and made publicly available at www.pmi.gov in advance of the availability of fiscal year new funding. Prioritization of country-level activities will be guided by the approved country MOPs.

Technical Implementation

The work to be carried out under this contract includes several interventions promoted by the WHO as crucial for the diagnosis, treatment, and control of malaria.6 The contractor shall implement and provide technical assistance related to: malaria case management, community health services, malaria in pregnancy, seasonal malaria chemoprevention, malaria elimination, and other prevention interventions / new tools. Additionally, the contractor shall support actions to monitor and respond to threats to malaria diagnostics and therapeutics, threats to malaria prevention and control, and will strengthen local capacity. Given the important global progress and complex context for each of these interventions, a brief overview of these topics is provided below.

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 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 15 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 PMI partner 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

World Health Organization, WHO Guidelines for Malaria. 3 June 2022. https://www.who.int/publications/i/item/guidelines-for-malaria support is development of national case management policies and guidelines, including those for community health programs and the private sector, that are updated, financially supported, and rolled out as indicated.

PMI has worked alongside partner countries to promote and expand quality assurance of case management. This has included support for strengthening expert diagnostic capacity at reference laboratories and for effective external quality assessment systems, training and supervision activities at health facilities, including on-site training, mentoring, continuous quality improvement processes. PMI has also supported development and deployment of 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 MoH at all levels in all PMI-supported countries.

However, despite these advances, progress in access to appropriate 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. These actions also affect patient practices as 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 system challenges include distance and perceived or actual cost to access health services, stock outs of essential drugs and commodities (including laboratory supplies, ACTs, RDTs, and SP); human resources for health constraints, including poor retention, 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 are relevant for meeting MoH and 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 long supported the implementation of community case management of malaria to increase 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. As such, CHWs are increasingly being tasked with a broad array of malaria activities which underscores the importance of enabling systems and work environments for CHWs.

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 antenatal care (ANC) attendance. Coordination and planning between the National Malaria Control Programs (NMCP) and Reproductive, Maternal, Newborn, and Child Health (RMNCH) units and other infectious disease programs are essential to increasing coverage of MiP interventions and ANC contacts.

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.

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.9

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.

Reaching sustained high uptake of SMC in targeted geographic areas can be challenging for several reasons. 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 for 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, as defined by seasonality of malaria transmission, means increased costs for drugs, tools and workforce, and increasingly large and sometimes unwieldy campaigns. High acceptance, 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 SMC Alliance, a group which provides important global leadership.

Surveillance, Monitoring and Evaluation (SM&E)

9 PMI 15th Annual Report to Congress, April 2021: https://d1u4sg1s9ptc4z.cloudfront.net/uploads/2021/07/PMI-15th- Annual-Report-1.pdf

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 partner specializing in surveillance, monitoring, and evaluation, work at the service delivery point by a service delivery partner remains an essential component of planning and implementing service delivery activities. Recording and reporting of accurate data and subsequently using that data for decision making is essential.

Assessing the success of programmatic efforts to improve malaria service delivery also requires high quality data. While the Contractor may 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.

The Contractor may consider other data sources for project evaluation such as health facility surveys, iCCM assessments, programmatic monitoring data and creative evaluation approaches. The Contractor shall use existing, validated evaluation tools 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 10 PMI countries toward national or subnational elimination from their 2015 status, with at least one country achieving elimination.10 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 appropriate targeting 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

10 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.

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 case/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 SBC, as well as promotion of health care seeking behaviors, should be reinforced. While some of these aspects are implemented during the malaria burden reduction phase, during the elimination 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 national 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.

Other Prevention Interventions/New Tools

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 perennial malaria chemoprevention (PMC) Although PMC 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 PMC 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.