HARMONIZE NOFO 01_16_2025 1655.pdf

Issue Date: January 17, 2025

Deadline for Questions: January 31, 2025

Closing Date and Time for CONCEPT NOTE: February 28, 2025, 5:00PM Eastern Standard Time (i.e., local time in Washington, D.C.)

Closing Date and Time for FULL APPLICATION: To be determined

Subject: Notice of Funding Opportunity Number (NOFO), Number: 7200AA25RFA00003

Program Title: Harmonization of systems and services to embed HIV service delivery into primary health care (HARMONIZE)

Federal Assistance Listing Number: 98.001

Greetings, The United States Agency for International Development (USAID) is seeking applications for a cooperative agreement from qualified entities to implement the Harmonization of systems and services to embed HIV service delivery into primary health care (HARMONIZE) programs.

Eligibility for this award is not restricted.

USAID intends to make an award to the applicant(s) who best meets the objectives of this funding opportunity based on the merit review criteria described in this NOFO, subject to a risk assessment. Eligible parties interested in submitting an application are encouraged to read this NOFO thoroughly to understand the type of program sought, application submission requirements, and selection process.

To be eligible for award, the applicant must provide all information as required in this NOFO and meet eligibility standards in Section B of this NOFO. This funding opportunity is posted on www.grants.gov and may be amended. It is the responsibility of the applicant to regularly check the website to ensure they have the latest information pertaining to this NOFO and to ensure that it has been downloaded from the internet in its entirety. USAID bears no responsibility for data errors resulting from transmission or conversion processes. If you have difficulty registering on www.grants.gov or accessing the NOFO, please contact the Grants.gov Support Center by phone at 1-800-518-4726 or by email at support@grants.gov for technical assistance or if you need assistive technology and are unable to access any material on this site.

Unless an exception in 2 CFR 25.110 applies, applicants must comply with 2 CFR 25 requirements to obtain a Unique Entity Identifier (UEI) and register in the System for Award Management (SAM.gov), as applicable. See Section E, Submission Requirements and Deadlines, for more information. The registration process may take many weeks to complete. Therefore, applicants are encouraged to begin registration early.

Please send any questions to the point(s) of contact identified in Section A.4. The deadline for questions is shown above. Responses to questions received prior to the deadline will be available to all potential applicants through an amendment to this notice posted to www.grants.gov.

Issuance of this NOFO does not constitute an award commitment on the part of the Government nor does it commit the Government to pay for any costs incurred in preparation or submission of comments/suggestions or an application. Applications are submitted at the risk of the applicant. All preparation and submission costs are at the applicant’s expense.

Thank you for your interest in USAID programs.

Sincerely, /s/

Elton E. Fortson

Agreement Officer

Table of Contents

SECTION A: BASIC INFORMATION 5

SECTION B: ELIGIBILITY 7

SECTION C: PROGRAM DESCRIPTION 9

SECTION D: APPLICATION CONTENT AND FORMAT 44

SECTION E: SUBMISSION REQUIREMENTS AND DEADLINES 74

SECTION F: APPLICATION REVIEW INFORMATION 77

SECTION G: AWARD NOTICES 89

SECTION H: POST-AWARD REQUIREMENTS AND ADMINISTRATION 90

SECTION I: OTHER INFORMATION 97

ANNEX 1 - SUMMARY BUDGET TEMPLATE 99

ANNEX 2 - STANDARD PROVISIONS 100

ANNEX 3 - ABBREVIATIONS AND ACRONYMS 103

NOFO TABLE OF CONTENTS

Section A – Basic Information

Section B – Eligibility

Section C – Program Description

Section D – Application Content and Format

Section E – Submission Requirements and Deadlines

Section F – Application Review Information

Section G – Award Notices

Section H – Post-Award Requirements and Administration

Section I – Other Information

Annex 1 - Summary Budget Template

Annex 2 - Standard Provisions

Annex 3 - Abbreviations and Acronyms

SECTION A: BASIC INFORMATION

1. Executive Summary

At the beginning of the President’s Emergency Plan for AIDS Relief (PEPFAR) HIV response, an intensive vertical approach to HIV care and treatment was necessary to help countries rapidly scale up services and curb the exploding epidemic. Siloed services are disease-centered (rather than person-centered, which support more comprehensive health needs across a continuum), increase opportunity costs for clients, and present additional challenges for partner countries in financing and managing a health system that meets all health needs for its population. For partner countries to sustain these services, it is necessary to embed them into existing health systems, particularly at the level of primary health care (PHC). This can also result in more tremendous success in closing gaps in 95-95-95 targets and ending

AIDS.

Furthermore, the COVID-19 pandemic demonstrated the fragility of countries’ health systems and health workforce with the disruption of key HIV treatment and prevention services. It is essential to strengthen the systems needed to prevent and mitigate the increasing occurrence and severity of health threats from emerging infectious disease outbreaks, climate change, or political instability. PEPFAR investments in health systems have contributed to global health security by strengthening the health workforce, laboratory systems, supply chain, infection prevention and control, risk communication, and community engagement. Expanding the reach of HIV health services and systems investments can support the prevention, detection, and response to other health threats.

2. Estimate of Funds Available and Number of Awards Contemplated

USAID intends to award 7200AA25RFA00003 pursuant to this NOFO.

Subject to the availability of funding and at the discretion of the Agency, USAID intends to provide $3 million of seed funding for each year of implementation of this activity. Field support buy-in is anticipated every year for five years for a total of $780 million.

3. Start Date and Period of Performance for Federal Awards

The anticipated period of performance is five years. The estimated start date will be upon signature of the Award and is anticipated to be July 17, 2025.

4. Agency Points of Contact

Name: Elton Fortson Title: Agreement Officer Email: nofo_harmonize@usaid.gov mailto:efortson@usaid.gov

Name: Roxane Wiser Title: Agreement Specialist Email: nofo_harmonize@usaid.gov

5. Acquisition and Assistance Ombudsman

The A&A Ombudsman helps ensure equitable treatment of all parties who participate in USAID’s acquisition and assistance process. The A&A Ombudsman serves as a resource for all organizations who are doing or wish to do business with USAID. Please visit this page for additional information: https://www.usaid.gov/work-usaid/acquisition-assistance-ombudsman.

The A&A Ombudsman may be contacted via: Ombudsman@usaid.gov

6. Authorized Geographic Code

The geographic code for the procurement of commodities and services under this program is 935, which authorizes grantees to purchase goods and services from any country except prohibited source countries. Except as may be specifically approved in advance by the Agreement Officer, all commodities and services that will be reimbursed by USAID under this award must be from the authorized geographic code specified in this NOFO, and must meet the source and nationality requirements set forth in 22 CFR 228.

https://www.usaid.gov/work-usaid/acquisition-assistance-ombudsman

SECTION B: ELIGIBILITY

1. Eligible Applicants

Eligibility for this NOFO is not restricted and all potential applicants are eligible. USAID intends to award one cooperative agreement to the applicant(s) who best meets the objectives of this funding opportunity based on the merit review criteria described in this document, subject to a risk assessment. The applicant must meet eligibility standards in Section C of this NOFO. Instructions for responding to this NOFO are included in Section D and E. This NOFO is posted on www.grants.gov and may be amended. Eligible parties interested in submitting an application are encouraged to read this document thoroughly to understand the type of program sought, application submission requirements, and selection process.

USAID welcomes applications from organizations that have not previously received financial assistance from USAID. USAID welcomes applications from local organizations and/or consortiums that include local organizations. USAID defines a “local entity” as an individual, a corporation, a nonprofit organization, or another body of persons that:

1. Is legally organized under the laws of; and

2. Has as its principal place of business or operations in; and

3. Is

a. majority owned by individuals who are citizens or lawful permanent residents of; and

b. managed by a governing body the majority of who are citizens or lawful permanent residents of a country receiving assistance.

For purposes of this definition, “majority owned” and “managed by” include, without limitation, beneficiary interests, and the power, either directly or indirectly, whether exercised or exercisable, to control the election, appointment, or tenure of the organization’s managers or a majority of the organization’s managers or a majority of the organization’s governing body by any means.

Faith-based organizations are eligible to apply for federal financial assistance on the same basis as any other organization and are subject to the protections and requirements of Federal law.

Interested and eligible applicants may submit no more than one application under this

NOFO.

If Partners are included in the application, then for the purposes of the technical and cost application for this NOFO, partners should be grouped into two categories:

Principal consortia partners, which have an intended or proposed role across multiple scopes of work. The intended roles of principal consortia partners should be reflected as appropriate in the technical approach, the management and staffing approaches, and the cost narrative and budget. Signed letters of intent to collaborate shall be provided in a Technical Application Annex for partners in this category. All principal consortia partners included in the cost application will be considered sub-awardees and may be approved at the time of award if they meet all pre-award requirements AND have a budget tab and narrative included in the cost application.

Resource partners, often regional or country-level organizations, which may have a role in one specific context or specific area of work as required, and do not have a proposed budget in the application. Signed letters of intent to collaborate are NOT required for partners in this category and these partners are not approved as sub-awardees at the time of award.

However, the technical and management narratives should still describe how these partners will be selected and utilized as required to successfully achieve the program purpose. Formal consortiums should submit official consortium documentation as described in Section D of this NOFO.

2. Cost Sharing

Cost Sharing is not required for this activity. Though there is not a cost share requirement under this NOFO, if the applicant is including voluntary cost share the applicant should include in the Budget and Budget Narrative: 1) an estimate of the amount of cost-sharing 2) the type of resources committed (e.g., funds, in-kind, etc.) 3) the sources of cost share contributions (e.g., third party contributions from non-Federal entity, applicant organization funds, direct procurement, etc.), and 4) the basis of calculation (e.g., detailed explanation of costs). To complete the SF-424A, components of cost share should be broken down into the same major cost categories described above. Applicants must also submit third-party information such as references, letters of support, or letters of commitment to contribute to cost sharing. Please note that if cost share is included in the application, it will not be evaluated because it is not required or specifically encouraged.

SECTION C: PROGRAM DESCRIPTION

This funding opportunity is authorized under the Foreign Assistance Act (FAA) of 1961, as amended. The resulting award will be subject to 2 CFR 200 – Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, and USAID’s supplement, 2 CFR 700, as well as the additional requirements found in Section H.

I. Introduction Over the past 20 years, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) has made tremendous progress in accelerating the HIV response by expanding treatment coverage and closing the gap in life expectancy for people living with HIV (PLHIV). Through the efforts of PEPFAR, 25 million lives have been saved, 20.1 million men, women, and children are on life-saving treatment, and 5.5 million babies have been born HIV-free. Eight countries (Botswana, Burundi, Eswatini, Lesotho, Malawi, Namibia, Rwanda, Zimbabwe) have reached the UNAIDS 95- 95-95 goals (95% of all people living with HIV know their HIV status; 95% of all people with diagnosed HIV infection receive sustained antiretroviral therapy (ART); and 95% of all people receiving ART will have viral suppression) as of 2023, and another nine countries (Cameroon, Ethiopia, Haiti, Kenya, Nigeria, Tanzania, Uganda, Vietnam, Zambia) have reached or are close to reaching the 95-95-95 goals. As a result of COVID-19, global HIV progress has slowed; the latest data collected by UNAIDS show that while new HIV infections fell globally from 2020 to 2021, the drop was only 3.6% —a minor annual reduction since 2016.1 Preventing new infections, reducing mortality, and improving quality of life are critical to sustaining the gains of the HIV response. Renewed efforts to strengthen countries’ health systems will also maintain advances in the HIV response and contribute to global health security goals to prevent, detect, and respond to health threats.

At the beginning of PEPFAR’s HIV response, an intensive vertical approach to HIV care and treatment was necessary to help countries rapidly scale up services and curb the exploding epidemic. These vertical approaches are now less critical due to the scale-up and institutionalization of “test and treat”; simplified and effective antiretroviral therapy (ART) regimens; multi-month dispensing and other differentiated service delivery modalities;

biomedical prevention approaches (e.g. voluntary medical male circumcision (VMMC), pre-exposure prophylaxis (PrEP), PEP, condoms, and lubricants); and other comprehensive structural programs for adolescent girls and young women and orphans and vulnerable children. Siloed services are disease-centered (rather than person-centered, which support more comprehensive health needs across a continuum), increase opportunity costs for clients, and present additional challenges for partner countries in financing and managing a health system that meets all health needs for its population. For partner countries to sustain these services, it is necessary to embed

1 In Danger: UNAIDS Global AIDS Update 2022. https://www.unaids.org/sites/default/files/media_asset/2022-global-aids-update_en.pdf. Accessed Oct 30, 2023.

https://www.unaids.org/sites/default/files/media_asset/2022-global-aids-update_en.pdf https://www.unaids.org/sites/default/files/media_asset/2022-global-aids-update_en.pdf them into existing health systems, particularly at the primary health care (PHC) level. This can also result in more tremendous success in closing gaps in 95-95-95 targets and ending AIDS.2

PLHIV face health needs that are becoming more prominent, including those related to sexual and reproductive health, mental health, and noncommunicable diseases (NCDs). Aging PLHIV have an increased prevalence of NCDs, and as the aging population has expanded, providing care for NCDs has become critical to prolonging health span and reducing mortality. Delivering HIV services as part of primary health care can provide non-stigmatizing entry opportunities to reach people at risk for HIV infection with prevention and testing services and support linkage to and continuity of treatment. Transforming PHC to enable the management and delivery of HIV services, encourages greater national ownership and more substantial local capacity for service delivery.

Transforming primary health care to deliver comprehensive HIV services will support delivery of “whole person” care across individuals’ life stages and optimize resources for cross-cutting systems investments that address systems bottlenecks, including a strengthened health workforce. PHC is often the first point of contact between PLHIV and the health system, helping ensure people have access to quality health services without financial hardship. It also provides education and support to individuals and communities to help improve their health and prevent illness. PHC systems are the first defense against infectious disease outbreaks and other public health threats. Harmonization of health services can, therefore, bolster the capacity to prevent, detect, and respond to HIV and other health threats.

Global health security (GHS) is the presence of developed and resilient public health systems that can prevent, detect, and respond to health threats wherever they occur. Unfortunately, the COVID-19 pandemic demonstrated the fragility of countries’ health systems and health workforce with the disruption of key HIV treatment and prevention services. It is essential to strengthen the systems needed to prevent and mitigate the increasing occurrence and severity of health threats from emerging infectious disease outbreaks, climate change, or political instability. PEPFAR investments in health systems have contributed to global health security by strengthening the health workforce, laboratory systems, supply chain, infection prevention and control, risk communication, and community engagement. Expanding the reach of HIV health services and systems investments can support preventing, detecting, and responding to other health threats.

The goal of the HARMONIZE (Harmonization of systems and services to embed HIV service delivery into primary health care) award is to contribute to sustaining the gains in the HIV response, accelerate the response to close remaining gaps, and enable pandemic preparedness and resilience in the face of other health threats by supporting existing country health systems and primary health care programs to manage and provide HIV prevention, care, and treatment services with other health services.

2 The path that ends AIDS: UNAIDS Global AIDS Update 2023. https://www.unaids.org/sites/default/files/media_asset/2023-unaids-global-aids-update_en.pdf. Access Oct 30, 2023 https://www.unaids.org/sites/default/files/media_asset/2023-unaids-global-aids-update_en.pdf https://www.unaids.org/sites/default/files/media_asset/2023-unaids-global-aids-update_en.pdf

Three broad strategic objectives will help achieve this goal, which focuses on assisting countries to design, adapt, and deliver high-quality, person-centered routine HIV services as part of general health services offered within the health system, including services delivered both within facilities and in communities.

Strategic Objective 1: Support health facilities and community sites to achieve and maintain sustained epidemic control by embedding HIV and other related services into the existing health system while strengthening PHC systems and services.

Strategic Objective 2: Build local system and governance structure capacity necessary for the design, administration, management, and implementation of essential HIV prevention, care, and treatment services delivered as part of primary health care.

Strategic Objective 3: Strengthen the investment in health services, service delivery programs, and health and surveillance systems to rapidly prevent, detect, and respond to emerging new HIV infections to sustain the HIV response and strengthen the prevention, detection, and response for other health threats.

Section 4 describes these three objectives in greater detail, along with related results and illustrative activities and indicators.

II. PEPFAR and USAID Strategic Alignment

A. Program Background: The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)

Working in over 50 countries for the past 20 years, PEPFAR has saved and improved millions of lives, prevented millions of HIV infections, and changed the course of the global HIV/AIDS epidemic. Today, PEPFAR supports more than 20 million men, women, youth, and children with ART and has provided HIV testing services for 85.5 million people. PEPFAR has enabled more than 5.5 million babies to be born HIV-free to HIV+ women and has provided assistance to more than seven million orphans and vulnerable children and their caregivers. PEPFAR funds the clinical cascade of services, which includes finding people at risk for HIV infection, testing them, referring HIV-negative individuals for HIV prevention services, initiating HIV-infected individuals onto ART, and retaining them on treatment so that they will remain virally suppressed. Delivering the clinical cascade of services at scale provides the basis for attaining and maintaining epidemic control. Epidemic control is the point at which new HIV infections have decreased and fall below the number of all-cause deaths among PLHIV.

PEPFAR supports partner countries’ efforts to achieve epidemic control while also promoting the long-term sustainability of partner countries’ HIV/AIDS responses as they assume greater responsibility for controlling the HIV/AIDS epidemic and ensuring epidemic maintenance thereafter. Epidemic maintenance is defined as a state after epidemic control is achieved, when achievements made along the HIV/AIDS prevention and treatment cascades can be fully controlled, financed, and led by local health systems (inclusive of public, private, and civil society sectors) with little to no involvement by PEPFAR. In alignment with the United Nations Sustainable Development Goals, PEPFAR collaborates with partner countries, multilateral institutions, the private sector, faith groups, and community and civic society organizations to end AIDS as a public health threat. The potential for sustainability, innovation, and scalability is much more significant with the support and collaboration of a broad array of partners, especially capable local partners, including community-based organizations (CBOs) and faith-based organizations (FBOs), academic institutions, private sector, and most importantly, partner governments.

B. PEPFAR’s Technical and Strategic Areas of Emphasis

In its five-year strategy, Reimagining PEPFAR’s Strategic Direction, PEPFAR plans to accelerate the response to end the HIV/AIDS pandemic as a public health threat by 2030 and ensure equitable access while sustainably strengthening public health systems. To accomplish this, PEPFAR focuses on five strategic pillars supporting health equity, sustainability, public health systems, security, partnerships, and science. HARMONIZE will support Strategic Pillar 2, Sustaining the Response, and Strategic Pillar 3, Public Health Systems and Security.

Figure 1: Reimaging PEPFAR’s Strategic Direction: Strategic Pillars and Enablers

As part of Strategic Pillar 2, Sustaining the Response, PEPFAR highlights the need to work with governments to embed vertical HIV/AIDS programming more efficiently and effectively into the local health service delivery infrastructure. Where possible, PEPFAR will embed HIV programming into strengthened public health systems to manage tuberculosis, high-burden non-communicable diseases, sexual reproductive health, rights, and services, as well as other local health priorities that impact PLHIV – to protect HIV/AIDS gains and strengthen health and economic outcomes. In addition, it will be https://www.state.gov/wp-content/uploads/2022/09/PEPFAR-Strategic-Direction_FINAL.pdf https://www.state.gov/wp-content/uploads/2022/09/PEPFAR-Strategic-Direction_FINAL.pdf critical to design and sustain service delivery models, including differentiated service delivery approaches, that effectively meet the needs of HIV prevention and PLHIV for adult men and women, youth3, children, and key populations (KP).

In Strategic Pillar 3, Public Health Systems and Security, PEPFAR will continue to strengthen partner country public health systems, pandemic preparedness, and community-led efforts necessary to sustain long-term HIV impact. These efforts can also support epidemic surveillance and deliver effective, efficient, and sustainable health care for PLHIV and program participants. Aligned with the U.S. government and global and regional priorities, these investments will further enhance global health security by not only equipping countries to sustain the impact of HIV but also efficiently strengthening local capacity for preparedness and response to other diseases and outbreaks. As an area of focus, PEPFAR will enhance the capacity of regional and national public health institutions in PEPFAR-supported partner countries by improving their leadership and management in disease surveillance, data collection and management, and laboratory systems to sustain reductions in HIV incidence and strengthen local capacity to protect the HIV/AIDS response gains and for preparedness and response to other diseases and outbreaks.

C. USAID’s Policy Framework

USAID’s Policy Framework establishes three overarching priorities to drive progress: 1) Confront the greatest challenges of our time; 2) Embrace new partnerships; and 3) Invest in USAID’s enduring effectiveness. To confront the greatest challenge of our time, USAID will bolster health security, improve PHC, and reverse the decline in global life expectancy. USAID will work on the ground with countries to help them strengthen global health security and be better prepared for the next pandemic or health emergency. To respond to future disease outbreaks and pandemics, we will continue to reorient our commitment to address emerging global health issues. USAID will go beyond disease programs to expand its impact and investments in PHC systems, such as digital health and primary health workforce which includes community health workers. We will improve coordination across global health programming, including in digital health, and investment in a stronger primary health workforce and community health workers capable of adapting to shifting needs, delivering more comprehensive services that work toward universal health coverage, and ultimately saving more lives. It is with this focus on global health security and strengthening primary health care that ongoing efforts in service delivery in the core HIV programs will end HIV/AIDS as an epidemic threat.

D. USAID/GH Primary Impact

PHC is a whole-of-society approach to effectively organize and strengthen health systems to bring health services closer to communities, including health promotion, prevention, diagnosis, and treatment.4 PHC is essential to high-performing health systems, delivering

3 USAID’s Youth in Development Policy defines youth as individuals between the ages of 10 and 29.

4 https://www.who.int/health-topics/primary-health-care#tab=tab_1 https://www.usaid.gov/policy/policy-framework https://www.usaid.gov/sites/default/files/2022-12/USAID-Youth-in-Development-Policy-2022-Update-508.pdf effective, affordable, and inclusive care to people when needed. PHC is the most inclusive, equitable, and cost-effective way to achieve universal health coverage (UHC).

USAID promotes a mix of public, private and civil society-based primary health systems that lead to more responsive services, lower or equivalent costs, higher standards of quality, greater efficiencies, and broader acceptance by local communities.

Strong PHC systems pave the way for countries to build healthy families, stable communities, productive economies and promote self-reliance. PHC is often the first point of contact between individuals and the health system. It also provides education and support to individuals and communities to help improve their health and prevent illness. By providing preventive and basic curative health care services, PHC helps to reduce the burden of disease on the individual and on the healthcare system, and improve quality of life.

PHC can help reduce healthcare costs with its potential for early detection and treatment of health issues, before they become more serious. Furthermore, strong PHC systems help safeguard national security as the first line of defense against public health threats, infectious disease outbreaks and other events that can overburden health systems. In emergency situations, PHC can provide routine health services, identify and manage emergency cases, prevent disease outbreaks with effective public health measures and play a key role in disease surveillance. A primary health care approach develops resilience within health systems and can advance global health security.5

Resilient PHC-oriented health systems, anchored by robust and well-supported health workforces, can improve life expectancy, increase health equity, and respond intuitively to disease outbreaks and emerging health threats. Many USAID-supported services, such as HIV, maternal, neonatal and child health (MNCH), ANC, nutrition, and malaria programs, are delivered as components of PHC. Advancing delivery of essential HIV prevention, care, and treatment services at the PHC level will enable delivery of “whole person” care across individuals’ life stages and optimize resources for cross-cutting systems investments that address systems bottlenecks, including a strengthened health workforce.6

Primary Impact, USAID’s renewed PHC focus, builds more intentional linkages across USAID’s current global health programs and initiatives, aiming to demonstrate a model to further strengthen PHC, working in a set of focus countries. By utilizing USAID’s global health programs to further strengthen PHC, USAID will have greater alignment and continuity of whole-person care across lifespans. This will better equip country health systems and health workforce to respond to health emergencies and address their population’s lifetime health needs.

5 WHO Technical Brief: Primary Health Care and Health Emergencies. https://www.who.int/docs/default-source/primary-health-care-conference/emergencies.pdf. Accessed Oct 30, 2023.

6https://www.usaid.gov/news-information/press-releases/dec-13-2022-usaid-announces-400-million-partnership-five-african-nations-accelerate-primary-health-care https://www.who.int/docs/default-source/primary-health-care-conference/emergencies.pdf https://www.who.int/docs/default-source/primary-health-care-conference/emergencies.pdf

USAID has identified five priority domains for its work under Primary Impact. These five priorities reflect strategic, high-impact processes that USAID will focus on through Primary Impact to further the advancement of primary healthcare and drive expected outcomes and results. These priorities will ensure efforts are distinct, non-duplicative, and focused on streamlining USAID funding streams into existing country-driven programs. The five key priorities are as follows:

1. Promote effective models of PHC delivery: USAID’s priority will be to implement the most effective models of PHC delivery, including strengthening facility and community-based PHC service delivery, supporting harmonization of services and referrals across health elements, increasing sustainability of healthcare services, improving active community outreach, and enhancing care for the most vulnerable populations.

2. Enhance community engagement and partnership in PHC: USAID believes PHC must be established fully at the community level and be delivered through community ownership using a systems lens and a truly harmonized approach.

3. Optimize quality sub-national and facility management: USAID’s focus will be on strengthening financial management and budget systems, and health workforce management capacity and performance at the sub-national level in support of a stronger overall PHC system. Improving these elements at a sub-national level will contribute to greater quality of care as well as equity of access and coverage for country-wide PHC.

4. Boost unified and interoperability of systems: USAID’s priority will be to strengthen supply chain systems, health management information systems, and reporting across disease areas to inform decision-making, streamline systems for managers, and enhance the patient experience.

5. Bolster resilient health systems and services: USAID will focus on strengthening linkages between primary healthcare and essential public health functions, and global health security in order to improve overall health system and service resilience, preparedness, and agility for whatever the future holds.

E. USAID’s Locally Led Development

USAID’s Locally Led Development is the process in which local actors – encompassing individuals, communities, networks, organizations, private entities, and governments – set their own agendas, develop solutions, and bring the capacity, leadership, and resources to make those solutions a reality. USAID recognizes that local leadership and ownership are essential for fostering sustainable results across our development and humanitarian assistance work. USAID is catalyzing and facilitating local leadership of development and humanitarian assistance in a variety of ways throughout the design, procurement, management, and measurement of assistance. As part of local leadership, USAID recognizes that locally-led development is not a single approach, but a range of ways that USAID, its partners, and communities can work together to shift agenda-setting and decision-making power into the hands of local actors.

III. Project Stakeholder A. Previous/Current Mechanisms

As USAID redesigned central mechanisms for implementation of PEPFAR funding, HARMONIZE builds on components of multiple central mechanisms that will implement activities with HIV/AIDS funding, including:

1) Adolescents and Children, HIV Incidence Reduction, Empowerment and Virus Elimination (ACHIEVE) 4/15/2019 - 12/30/2026: USAID-funded global project to reach and sustain HIV epidemic control among pregnant and breastfeeding women, adolescents, infants, and children. The two primary objectives of the activity are to: (1) Attain and sustain HIV epidemic control among at-risk and hard to reach PBF women, infants, children, and youth, as well as to mitigate the impact of HIV/AIDS and prevent HIV transmission among these populations; and

(2) Support the transition of prime funding and implementation to capable local partners.

2) Data for Implementation (Data.FI) 4/15/2019 - 12/15/2025: Data.FI works with a range of stakeholders to support partner governments to further enhance existing health information systems to inform management responses to well-defined gaps in HIV/AIDS programming. This mechanism bolsters data quality, utilizes available data, performs analyses and translates findings in a way that facilitates rapid, efficient implementation, as well as generates information to provide rationales for costs and outcomes for scale-up and maintenance.

3) Meeting Targets and Maintaining Epidemic Control (EpiC) 4/15/2019 - 12/30/2027: Provides HIV/AIDS technical assistance and service delivery and implements programs in over 60 USAID presence and non-presence countries across Africa, Asia, and Latin America and the Caribbean. EpiC helps countries meet or exceed PEPFAR targets for reaching adult, key, and priority populations by finding those who have not yet been identified as positive, linking those who are positive to treatment, and by keeping those on treatment virally suppressed.

EpiC works with a range of stakeholders to ensure that partner countries can maintain program gains with appropriately decreasing dependence on

PEPFAR/USAID.

4) Reaching Impact, Saturation, and Epidemic Control (RISE) 4/15/2019 - 12/30/2027: Helps meet or exceed PEPFAR targets for reaching at-risk men, women, key populations, and priority populations by finding those who have not yet been identified as positive, linking those who are positive to treatment, and by keeping those on treatment virally suppressed. This mechanism works with a range of stakeholders to ensure that partner government health systems and partner countries are able to maintain program gains with appropriately decreasing dependence on PEPFAR/USAID. The mechanism also supports the transition of direct funding and implementation to capable local partners.

5) Global Health Risk and Capacity (GHRC) (anticipated): If USAID proceeds with the anticipated GHRC award as planned, it will provide partners and Missions support for sustainably working with local organizations across USAID/Global Health's portfolio, building on the successes and lessons learned from PEPFAR's local partner transition, as well as other localization efforts across the Agency. The award has three primary objectives: a) support USAID Operating Units’ engagement with local partners, b) support capacity strengthening of USAID-funded local health partners through technical assistance to individual organizations or government entities, and c) support capacity of USAID funded local health partners through global activities that promote knowledge exchange.

6) Maximizing Options to Advance Informed Choice for HIV Prevention (MOSAIC) 8/15/2021 - 8/14/2026: The MOSAIC award is designed to accelerate introduction and scale-up of new biomedical prevention products and expedite their availability, acceptance, uptake, and impact in PEPFAR programs to help individuals, especially women, prevent HIV and other infectious diseases.

B. New USAID Office of HIV/AIDS Mechanisms

The USAID Global Health Bureau’s Office of HIV/AIDS (OHA) will procure new awards to more rapidly reach epidemic control and ensure maintenance while reducing costs to PEPFAR by employing targeted interventions to address key gaps, ensure at-scale programs, and meet goals for transition to local partners. These mechanisms will coordinate and collaborate proactively at the headquarters and field levels to maximize US Government investment and efficiencies and minimize duplication. USAID will provide funds to Missions to better support the use of Annual Program Statements to increase bilateral local partner awards. OHA’s future projects are designed to more rapidly reach epidemic control and 95-95-95 goals and ensure maintenance while reducing costs to PEPFAR. All new projects will support countries in directly meeting PEPFAR targets while supporting in-country teams to work with partner governments and local partners to achieve sustainability. OHA’s two major new technical projects include: (1) achieving the 95-95-95 goals and sustaining epidemic control for key and priority populations (Accelerate and Sustain), and (2) harmonization of systems and services to embed HIV service delivery into primary health care (HARMONIZE).

The goal of the Accelerate and Sustain activity is to accelerate achievement of the 95- 95-95 goals and sustain HIV epidemic control for key and priority populations in partnership with governments and communities. Targeted populations include adolescents, youth, men, PBFW, children, key populations, and other priority populations. Evidence-based strategies will be used to prevent HIV infection, find, engage, and retain priority and key populations in the clinical cascade, and to provide differentiated service delivery tailored to achieve epidemic control in specific populations with heterogeneous risk. Programming exclusively focused on providing equitable HIV services to specific priority populations, such as key populations and adolescent girls and young women (AGYW), falls within the purview of the Accelerate and Sustain mechanism whereas HARMONIZE’s scope is broader, and will focus on ensuring that HIV services are available within primary healthcare for all populations.

There will also be OHA support to Missions to better support use of Annual Program Statements to increase bilateral local partner awards. Additionally, all new projects will be based on the current (and future) evidence-based solutions that have been proven effective and are scalable. See “Collaboration and Coordination” below for additional details about the new projects.

IV. Project Goal and Objectives

The goal of HARMONIZE is to contribute to sustaining the gains in the HIV response and enable pandemic preparedness and resilience in the face of other health threats by supporting existing country health systems and primary health care programs to manage and provide HIV prevention, care, and treatment services with other health services.

By building upon a primary health care program’s ability to manage and provide HIV prevention, care, and treatment services, we describe the shift from siloed HIV services to those offered as part of or alongside other health services. This approach enables people to receive “a continuum of health promotion, disease prevention, diagnosis, treatment, disease management, rehabilitation, and palliative care services, coordinated across different levels and sites of care within and beyond the health sector, and according to their needs throughout the life course.”7 The main focus is the merging of health services, leading to the co-location and co-scheduling of HIV services with other essential primary healthcare services for the client and coordinated through networks of care. Merging services for marginalized populations (e.g., KPs) may require specialized approaches. Consideration of cross-cutting health systems building blocks (e.g.

health workforce, lab, supply chain, HIS) is necessary to support the coordinated delivery of relevant health services across facility and community settings. For example, to support merging HIV with NCD services, service models, workforce, and associated system requirements would need to be configured so that HIV and NCD care can be provided at the same time and in the same place. To ensure harmonization, monitoring tools and medical records for both conditions must be interoperable. Harmonization can take a variety of forms7, such as:

7 Goodwin N. Understanding Integrated Care. Int J Integr Care. 2016 Oct 28;16(4):6. doi: 10.5334/ijic.2530. PMID:

28316546; PMCID: PMC5354214.

Horizontal: Care between health services, social services, and other care providers that is based on the development of multi-disciplinary teams and/or care networks that support a specific client group (e.g., for older people with complex needs).

Vertical: Care across primary, community, hospital and tertiary care services manifests in protocol-driven (best practice) care pathways for people with specific diseases (such as COPD and diabetes) and/or care transitions between hospitals and intermediate and community-based care providers.

Sectoral: Care focused within a single sector, such as combining horizontal and vertical coordinated care programs within mental health services through multi-professional teams and networks of primary, community, and secondary care providers.

People-centered: Care between providers, patients and other service users to engage and empower people through health education, shared decision-making, supported self-management, and community engagement.

Whole-system: Care that embraces public health to support both a population-based and person-centered approach to care. This is health care at its most ambitious since it focuses on the multiple needs of whole populations, not just care groups or diseases.

Table 1: HARMONIZE Results Framework

Strategic Objective 1: Support health facilities and community sites to achieve and maintain sustained epidemic control by embedding HIV and other related services into the existing health system while strengthening PHC systems and services.

Strategic Objective 2: Build local system and governance structure capacity necessary for the design, administration, management, and implementation of essential HIV prevention, care, and treatment services delivered as part of primary health care.

Strategic Objective 3: Strengthen the investment in health services, service delivery programs, and health and surveillance systems to rapidly prevent, detect, and respond to emerging new HIV infections to sustain the HIV response and strengthen the prevention, detection, and

GOAL: Contribute to sustaining the gains in the HIV response, accelerate the response to close remaining gaps, and enable pandemic preparedness and resilience in the face of other health threats by supporting existing country health systems and primary health care programs to manage and provide HIV prevention, care, and treatment services with other health services.

Strategic Objective 1: Harmonizing HIV and other related services

Support health facilities and community sites to achieve and maintain sustained epidemic control by embedding HIV and other related services into the existing health system while strengthening PHC systems and services.

Strategic Objective 2: Supporting health systems for harmonization

Build local system and governance structure capacity necessary for the design, administration, management, and implementation of essential HIV prevention, care, and treatment services delivered as part of primary health care.

Strategic Objective 3: Strengthening global health security

Strengthen the investment in health services, service delivery programs, and health and surveillance systems to rapidly prevent, detect, and respond to emerging new HIV infections to sustain the HIV response and strengthen the prevention, detection, and

Result 1: Improved harmonization of health services across community and facility settings for people living with HIV and individuals at risk of HIV acquisition or who could benefit from prevention services

Result 2: Improved health systems and governance structures for harmonizing HIV services with primary health care

Result 3: Improved public health systems to prevent, detect, and respond to HIV and other health threats

IR 1.1:Strengthened delivery of people-centered and simplified HIV services delivered through the local primary health care system, at the community level, and the private sector, while supporting partner governments to achieve and maintain epidemic control.

IR 2.1: Identification of bottlenecks and weaknesses of existing health systems that limit the ability to achieve sustainable epidemic control or harmonized services for clients

IR 3.1: Enhanced fiscal investments in surveillance and accountability to strengthen national systems for monitoring HIV and other diseases effectively.

IR 1.2: Increased implementation of person-centered differentiated service delivery models, through facility and community programs, that address the evolving and various needs of clients

IR 2.2:Improved health system capacity to provide HIV services within primary healthcare settings

IR 3.2:Improved health systems capacity to mitigate the spread of public health threats

IR 1.3 Improved demand and utilization of quality services for HIV positive and individuals at risk of HIV acquisition

IR 2.3 Increased capacity of country-level systems to fund, implement, monitor, and sustain high-quality social and behavior change (SBC) interventions that address harmonization of HIV and PHC health services

IR. 3.3: Increased local organizational capacity and expanded transformative partnerships to maintain, manage, use, and disseminate data and system analytics to inform program interventions in response to emerging health threats

IR 2.4: Improved coordinated community and facility responses and services that address the holistic needs of people living with HIV and individuals at risk of HIV acquisition

Strategic Objective 1: Harmonizing HIV and other related services

Support health facilities and community sites to achieve and maintain sustained epidemic control by embedding HIV and other related services into the existing health system while strengthening PHC systems and services.

Embedding HIV services into primary health care can help countries achieve epidemic control and the UNAIDS 95-95-95 goals and ensure that these gains are sustained. This objective is focused on merging HIV services into primary health care services such that stable HIV clients and those at risk for HIV do not need to see a different provider, go to a different building, or attend a different appointment from that of their primary healthcare needs. HARMONIZE should de-silo HIV prevention, care, and treatment services, provide client-centered care instead of disease-centered care, and support the service delivery needs to ensure harmonized care. In settings without a strong primary health care system, comprehensive HIV prevention, diagnosis, care, and treatment services in the community and facility can be embedded into other health services to facilitate providing the skeletal framework for a primary health care system.

A one-size-fits-all approach to embedding HIV prevention, care, and treatment services into primary health care does not exist and is not realistic. Effective strategies under HARMONIZE will be age-appropriate and context-specific, and vary depending on the local epidemic, health system, and population. Engagement of PLHIV, local communities (including KPs and youth), ministries of health, and other relevant line ministries are essential to determining appropriate interventions to facilitate the merging of HIV services with partner government primary health care packages delivered through PHC structures.

Result 1: Improved harmonization of health services across community and facility settings for people living with HIV and individuals at risk of HIV acquisition or who could benefit from…