OGH HRSA-22-160 (UV9) Leveraging Health Service Equity_Final_6-6-22.pdf

U.S. Department of Health and Human Services

Office of Special Health Initiatives

Office of Global Health

Leveraging Health Service Equity Approaches for Sustainable HIV Epidemic Control

Funding Opportunity Number: HRSA-22-160

Funding Opportunity Type(s): New

Assistance Listings (AL/CFDA) Number: 93.266

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2022

Application Due Date: August 5, 2022 Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

HRSA will not approve deadline extensions for lack of registration.

Registration in all systems may take up to 1 month to complete.

Issuance Date: June 7, 2022

Laura Foradori Office of Global Health, Office of Special Health Initiatives Telephone: (301) 443-3502 Email: lforadori@hrsa.gov

See Section VII for a complete list of agency contacts.

Authority: United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 (P. L.

108-25); as amended by the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (P. L. 110-293); the PEPFAR Stewardship and Oversight Act of 2013 (P. L. 113-56); and the PEPFAR Extension Act of 2018 (P.L.

115-305) (22 U.S.C. 7601 et seq.).

mailto:lforadori@hrsa.gov

508 COMPLIANCE DISCLAIMER

Note: Persons using assistive technology may not be able to fully access information in this file. For assistance, please email or call one of the HRSA staff listed in Section VII.

Agency Contacts.

EXECUTIVE SUMMARY

Supported through the President’s Emergency Plan for AIDS Relief (PEPFAR), the Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2022 Leveraging Health Service Equity Approaches for Sustainable HIV Epidemic Control program. The purpose of this program is to develop and expand unique platforms to bring best practices from domestic experiences to assist the global HIV/AIDS program to sustain the goal of reaching epidemic control in Malawi, Zambia and other PEPFAR countries as identified. Funds will be used to scale current activities for impact in HIV/AIDS treatment services in these PEPFAR-supported countries.

The successful recipient will work with HRSA to develop and implement strategies to address social determinants and health inequalities found within the healthcare system to improve the delivery of quality HIV/AIDS services in Malawi, Zambia, and potentially in other identified PEPFAR-supported countries. This funding will focus on addressing the following:

• promote empowerment and linkage to health services among all adolescent girls and young women residing in targeted areas;

• increase the capacity of health facilities to improve linkage to and continuity of HIV care;

• partner with high-volume treatment sites to provide differentiated service delivery (DSD) models that address treatment interruption and improve viral suppression rates;

• use quality improvement and family-centered strategies to support the care needs of mothers and their HIV-exposed infants throughout pregnancy and the post-partum breastfeeding period up to 24 months;

• ensure optimized client care records and reporting and related data use to improve the HIV continuum of care at all stages.

The successful recipient must contribute to PEPFAR priorities for achieving the Joint United Nations Programme on HIV/AIDS (UNAIDS) 95-95-95 treatment goals in Malawi, Zambia, and may also contribute to such priorities in other PEPFAR-supported countries identified by the Department of State/Office of Global AIDS Coordinator https://www.state.gov/where-we-work-pepfar/

HRSA-22-160 i

(S/GAC) to receive such support during the period of performance. The activities introduced to work towards these goals will be developed with local stakeholders and with a plan to transition to local institutions for additional scale up and sustainability.

Funding Opportunity Title: Leveraging Health Service Equity Approaches for Sustainable HIV Epidemic Control

Funding Opportunity Number: HRSA-22-160

Due Date for Applications: August 5, 2022

Anticipated FY 2022 Total Annual Available:

$10,000,000 subject to the availability of funds

Estimated Number and Type of Award(s): 1 cooperative agreement

Estimated Annual Award Amount:

Up to $10,000,000 subject to the availability of funds

Cost Sharing/Match Required: No

Period of Performance: September 30, 2022 through September 29, 2027 (5 years)

Eligible Applicants: Eligible applicants include domestic and foreign public and private nonprofit entities, including institutions of higher education, faith-based and community-based organizations, Tribes and tribal organizations, and for-profit entities.

See Section III.1 of this notice of funding opportunity (NOFO) for complete eligibility information.

Application Guide

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in this NOFO and in HRSA’s SF-424 Application Guide. Visit HRSA’s How to Prepare Your Application page for more information.

Technical Assistance

A technical assistance webinar has been scheduled to assist potential applicants in preparing applications that address the requirements of this NOFO. HRSA strongly encourages participation.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application

HRSA-22-160 ii

HRSA has scheduled following technical assistance:

Webinar:

Day and Date: Tuesday, June 14, 2022 Time: 11 a.m. ET Call-In Number: 1-646-828-7666 (New York); 1-669-254-5252 (San Jose); International numbers available here: https://hrsa-gov.zoomgov.com/zoomconference?m=MTYwODEzMjg1Mg.3pG_9CvoyoFCILIxDI9NC vlZ5yBAxEK9 Passcode: 06880053

Webinar ID: 160 813 2852 Webinar link: https://hrsa-gov.zoomgov.com/s/1608132852?pwd=K1lOT0dFVCsxZ0 Rmc0RiNldTYWlYZz09

Passcode; HRSA2022 https://hrsa-gov.zoomgov.com/zoomconference?m=MTYwODEzMjg1Mg.3pG_9CvoyoFCILIxDI9NCvlZ5yBAxEK9 https://hrsa-gov.zoomgov.com/zoomconference?m=MTYwODEzMjg1Mg.3pG_9CvoyoFCILIxDI9NCvlZ5yBAxEK9 https://hrsa-gov.zoomgov.com/zoomconference?m=MTYwODEzMjg1Mg.3pG_9CvoyoFCILIxDI9NCvlZ5yBAxEK9 https://hrsa-gov.zoomgov.com/s/1608132852?pwd=K1lOT0dFVCsxZ0Rmc0RiNldTYWlYZz09 https://hrsa-gov.zoomgov.com/s/1608132852?pwd=K1lOT0dFVCsxZ0Rmc0RiNldTYWlYZz09

HRSA-22-160 iii

Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Program-Specific Forms

vi. Attachments

3. UNIQUE ENTITY IDENTIFIER (UEI) AND SYSTEM FOR AWARD MANAGEMENT (SAM)

4. SUBMISSION DATES AND TIMES

5. INTERGOVERNMENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSMENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

HRSA-22-160 1

I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the program Leveraging Health Service Equity Approaches for Sustainable HIV Epidemic Control.

The purpose of this program is to develop and expand unique platforms to bring best practices from domestic experiences to assist the global HIV/AIDS program to sustain the goal of reaching epidemic control in Malawi, Zambia and other PEPFAR-supported countries. Funds will be used to continue and scale current HRSA activities for impact in HIV/AIDS treatment services in Malawi, Zambia and other PEPFAR-supported countries.

The successful recipient will work with HRSA to develop and implement strategies to address social determinants and health inequalities found within the healthcare system to improve the delivery of quality HIV/AIDS services in Malawi, Zambia and other PEPFAR-supported countries. This funding will focus on addressing the following and continuing successful activities in these areas:

• promote empowerment and linkage to health services among all adolescent girls and young women residing in targeted areas;

• increase the capacity of health facilities to improve linkage to and continuity of HIV care;

• partner with high-volume treatment sites to provide differentiated service delivery models that address treatment interruption and improve viral suppression rates;

• use quality improvement and family-centered strategies to support the care needs of mothers and their HIV-exposed infants throughout pregnancy and the postpartum breastfeeding period up to 24 months;

• ensure optimized client care records and reporting and related data use to improve the HIV continuum of care at all stages.

The successful recipient must contribute to PEPFAR priorities for achieving the UNAIDS 95-95-95 treatment goals in Malawi, Zambia, and other PEPFAR-supported countries as identified by Department of State/Office of Global AIDS Coordinator (S/GAC) to receive such support for the period of performance. The activities introduced by the recipient to work towards these UNAIDS goals must be developed with local stakeholders and with a plan to transition to local institutions for additional scale up and sustainability. This focus on local ownership must be central to all recipient activities to enhance the impact, efficiency, and sustainability of PEPFAR investments.

Priorities for this program should aim to (1) advance equity of access to high-quality person-centered care, (2) introduce innovations that target HIV care and treatment services in sub-populations that lag behind in reaching and sustaining epidemic control, and (3) integrate HIV prevention, care, and treatment services into country led programs in PEPFAR-supported countries to ensure continued gains towards reaching and sustaining HIV epidemic control.

HRSA-22-160 2

This is a collaborative effort aimed at formulating and delivering assistance for high-impact solutions across the range of interventions that are necessary to attain durable HIV epidemic control. The project will compile and disseminate best practices for setting up and scaling equitable, person-centered health services that address social determinants of health and the impact of global pandemics. This will ensure resilient and efficient systems of health service delivery that can manage unanticipated challenges and adjustments of programs while maintaining the quality of care. These efforts will maintain gains made by PEPFAR investments in health services and improvements in health outcomes of people living with HIV.

The key objectives of Leveraging Health Service Equity for Sustainable HIV Epidemic Control, in collaboration with HRSA, are to:

• Provide strategies for advancing health equity in host countries toward continued sustainability of HIV programs, as they approach the achievement of PEPFAR goals;

• Introduce innovations to reach sub-populations with unmet needs, and provide result-driven innovative implementation models for sustainable HIV epidemic control;

• Determine and disseminate best practices and innovative models that are person-centered and address social determinants of health to deliver high-quality health services;

• Strengthen health system capacities to enable seamless transition of HIV services to host country governments across PEPFAR-supported countries; and

• Monitor and evaluate the process of transition efforts to assure maintenance of positive health outcomes and performance results.

To meet these objectives, the program will work with country and multilateral stakeholders to collectively prioritize and develop country-led solutions to meet the purposes of this program

2. Background

The PEPFAR program is authorized under the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 (P. L. 108-25), as amended by the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (P. L. 110-293); the PEPFAR Stewardship and Oversight Act of 2013 (P. L. 113-56); and the PEPFAR Extension Act of 2018 (P.L. 115-305) (22 U.S.C. 7601 et seq.).

Under PEPFAR, the President is authorized to furnish assistance, on such terms and conditions as the President may determine, for HIV/AIDS, including preventing, treating, and monitoring HIV/AIDS, and carrying out related activities, in selected countries of sub-Saharan Africa, the Caribbean, Asia, Eastern Europe, Latin America, and other countries and areas, particularly with respect to refugee populations or those in post-conflict settings in such countries and areas with significant or increasing HIV incidence rates. Specifically, the United States Government’s (USG’s) role is to:

HRSA-22-160 3

• Invest appropriated resources under PEPFAR;

• Carry out activities to strengthen HIV/AIDS, TB, and malaria health policies and health systems;

• Provide workforce training and capacity-building consistent with the goals and objectives of PEPFAR; and

• Support a sound policy environment which aligns with partner countries to advance equity in economic and educational opportunities to increase the countries’ ability to maximize utilization of health care resources from donor countries; to increase host country investments in health services expertise through education and maximize the effectiveness of such investments; to improve host country HIV/AIDS, TB, and malaria strategies; to effectively and efficiently deliver evidence-based services; and to reduce barriers that prevent recipients of services from achieving maximum benefit from such services.

Under the leadership of S/GAC, as part of the USG global HIV response, HRSA works with countries and other key partners to assess the needs of each country and design a customized program of assistance that fits within the country’s strategic plan. Achieving the PEPFAR goal of an AIDS-free generation requires sustainable, accessible, and high-quality health services. A well-functioning and resilient health system is critical in each PEPFAR country to meet these needs, effectively supporting prevention, care, and treatment for PLHIV, TB, malaria, and other diseases.

This program supports and builds on previously funded activities in Zambia and Malawi.

In Zambia, previous program activities have focused on Differentiated Service Delivery (DSD) models for reaching priority populations with prevention and care and treatment activities and those at risk of interruption in HIV treatment. These populations include adolescent girls and young women (AGYW), mother-infant pairs, stable clients that need more efficient and accessible care, and clients with barriers to accessing services.

Successful projects have been able to demonstrate that the DSD model being employed has achieved sustained improvements in efficiencies to decrease client wait time at the clinic, increase continuity of care, viral suppression, and linkage to care, including immediate initiation of anti-retroviral treatment (ART) for clients newly diagnosed. In Malawi, previous program activities have contributed towards AGYW prevention activities by offering additional economic strengthening and employment opportunities as part of the secondary package of services under the Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe (DREAMS) programs.

II. Award Information

1. Type of Application and Award

Type(s) of applications sought: New.

HRSA will provide funding in the form of a cooperative agreement. A cooperative agreement is a financial assistance mechanism where substantial involvement is anticipated between HRSA and the recipient during the performance of the contemplated project.

HRSA-22-160 4

In addition to the usual monitoring and technical assistance (TA) provided directly to award recipients, HRSA program involvement will include:

• Participate in planning, implementing, and evaluating program activities, including identifying and selecting additional in-country impact partners.

• Facilitate the coordination and collaboration among program partners, such as the Office of the U.S. Global AIDS Coordinator at the Department of State (S/GAC), other HHS agencies, the USAID, host governments, international donors, and other key stakeholders.

• Review, contribute, and provide comments and recommendations for documents, curricula, program plans, budgets, contracts, personnel (including consultants), revisions of work plans, etc., before printing, dissemination, or implementation.

• Participate, as appropriate, in planning and conducting all meetings or workgroups during the period of performance.

• Maintain ongoing dialogue with the recipients concerning program plans, policies, and other issues that have major implications for any activities under the cooperative agreement.

• Support the engagement of relevant stakeholders and assist in developing and periodically reviewing the recipient’s monitoring and evaluation plan (M&E), ensuring compliance with the strategic information guidance established by

S/GAC.

• Provide technical assistance, as mutually agreed upon, and revise annually during validation of the first and subsequent annual work plans. This could include expert technical assistance and targeted training activities in specialized areas, such as strategic information, project management, confidential counseling and testing, palliative care, treatment literacy, and adult learning techniques.

• Collect and analyze data relative to unmet needs, special populations, other key health indicators, and emerging priorities or policy shifts to guide current/future strategic planning, developmental efforts, and program activities.

• Provide guidance on PEPFAR monitoring tools (e.g., Site Improvement through Monitoring System - SIMS) tools and HRSA site visit tools. These tools articulate required standards and can be used for program design and self-assessment.

• Provide guidance and support on PEPFAR reporting tools (e.g. Expenditure Reporting [ER], Monitoring, Evaluation, and Reporting [MER], etc.)

• Support access to the expertise of HRSA personnel and other relevant resources to the project.

• Participate in the dissemination of project findings, best practices, and lessons learned across the initiative.

HRSA-22-160 5

In addition to adhering to all applicable federal regulations and public policy requirements, the cooperative agreement recipient’s responsibilities will include:

• Adhere to HRSA guidelines pertaining to acknowledgement and disclaimer on all products produced by HRSA award funds, per Section 2 of the Application Guide (Compliance Requirements at a Glance).

• Collaborate closely with HRSA, in-country USG teams, and USG agencies, host governments, and other key stakeholders to gain a greater understanding of the following in the PEPFAR country of implementation: health system resources, systemic and population gaps and vulnerabilities, short and long term needs and priorities to better mobilize, build consensus, and efficiently plan and coordinate successful interventions for the highest impact and to achieve program objectives.

• Consult with HRSA and field teams as applicable, to inform HRSA on program progress and barriers encountered, identify activities to be planned jointly, and discuss matters that require HRSA and USG input and approval.

• Implement strategies for facilitating scale-up and sustainability of activities supported under this agreement that include building on and strengthening previous and/or existing efforts by governments, local networks, and institutions that benefit the populations served. Strategies should strengthen indigenous capacity in all aspects of the agreement.

• Develop and execute a final M&E plan within the first six months of the period of performance, in consultation with HRSA and key stakeholders.

• Support the relevant governmental, academic, and regulatory bodies by partnering with local organizations and providing technical support to the government. The partnerships are expected to expand through the period of performance.

• Respond to the health needs of the people of the identified LMICs in their unique political, economic, and health system circumstances.

• Identify resource-poor, or policy-poor considerations that possess uniquely complicated characteristics requiring customized approaches.

2. Summary of Funding

HRSA estimates approximately $10,000,000 to be available annually to fund one recipient. You may apply for a ceiling amount of up to $10,000,000 in total cost (including both direct and indirect, facilities and administrative costs) per year. This program notice is subject to the appropriation of funds through program-specific Congressional Notification, and is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can process applications and award funds appropriately.

HRSA-22-160 6

The period of performance is September 30, 2022 through September 29, 2027 (5 years). Funding beyond the first year is dependent on the availability of appropriated funds through program-specific Congressional Notification for the project “Leveraging Health Service Equity Approaches for Sustainable HIV Epidemic Control” in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government. HRSA may reduce recipient funding levels beyond the first year if the recipient is unable to demonstrate full success in achieving the objectives outlined in the application.

All HRSA awards are subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements at 45 CFR part 75.

III. Eligibility Information

1. Eligible Applicants

Eligible applicants include domestic and foreign public or private, nonprofit entities, including institutions of higher education, and for-profit entities.

Faith-based and community-based organizations, Indian Tribes, and tribal organizations are eligible to apply.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

Eligible applicants that form a consortium of members with a demonstrated history of collaboration to support activities for HIV prevention, care and treatment in underserved areas both in the U.S. and globally is recommended. A consortium model enables the recipient to provide effective and efficient collaboration across multiple partners with different contributions for the greatest, sustained impact. Consortium members will function in PEPFAR countries as one unified entity under one name when interacting with the host government, USG PEPFAR country team, and stakeholders.

Applicants should provide documentation (e.g., a letter of commitment) describing the responsibilities of consortium members for the proposed work plan, signed by all consortium members in Attachment 4 as depicted on the organizational chart for the consortium in Attachment 5.

The consortium lead applicant must meet the eligibility requirements and assumes all legal, programmatic, and financial responsibilities under the award. Consortium participants would be considered sub-recipients of award funding, irrespective of whether the agreement between them is labeled as a contract, memorandum of understanding, or something else, and are subject to all terms and conditions of the http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75

HRSA-22-160 7

award. If awarded, the recipient must notify consortium members who will be serving as subcontractors/sub-recipients that they must be registered in SAM.

HRSA may not consider an application for funding if it contains any of the non-responsive criteria below:

• Exceeds the funding ceiling amount

• Exceeds the application page limitations referenced in Section IV.2

• Fails to satisfy the deadline requirements referenced in Section IV.4

NOTE: Multiple applications from the same entity are not allowed. HRSA will only accept and review your last validated electronic submission before the Grants.gov application due date.

IV. Application and Submission Information

1. Address to Request Application Package

HRSA requires you to apply electronically. HRSA encourages you to apply through Grants.gov using the SF-424 workspace application package associated with this notice of funding opportunity (NOFO) following the directions provided at Grants.gov: HOW TO APPLY FOR GRANTS. If you use an alternative electronic submission, see Grants.gov:

APPLICANT SYSTEM-TO-SYSTEM.

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for HRSA-22-160 in order to receive notifications including modifications, clarifications, and/or republications of the NOFO on Grants.gov.

You will also receive notifications of documents placed in the RELATED DOCUMENTS tab on Grants.gov that may affect the NOFO and your application. You are ultimately responsible for reviewing the For Applicants page for all information relevant to this

NOFO.

2. Content and Form of Application Submission

Application Format Requirements Section 4 of HRSA’s SF-424 Application Guide provides general instructions for the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, etc. You must submit the information outlined in the HRSA SF-424 Application Guide in addition to the program-specific information below. You are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide except where instructed in the NOFO to do otherwise. You must submit the application in the English language and in the terms of U.S. dollars (45 CFR § 75.111(a)).

https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/s2s/applicant-system-to-system.html https://www.grants.gov/web/grants/s2s/applicant-system-to-system.html https://www.grants.gov/web/grants/applicants.html http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

HRSA-22-160 8

See Section 8.5 of the HRSA SF-424 Application Guide for the Application Completeness Checklist.

Application Page Limit

The total of uploaded attachment pages that count against the page limit shall be no more than the equivalent of 80 pages when printed by HRSA. Standard OMB-approved forms included in the workspace application package do not count in the page limit. The abstract is the standard form (SF) "Project_Abstract Summary.” If there are other attachments that do not count against the page limit, this will be clearly denoted in Section IV.2.vi Attachments.

The abstract is no longer an attachment that counts in the page limit. Additionally, Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. However, if you use an OMB-approved form that is not included in the workspace application package for HRSA-22-160, it will count against the page limit.

Therefore, we strongly recommend you only use Grants.gov workspace forms associated with this NOFO to avoid exceeding the page limit.

It is important to take appropriate measures to ensure your application does not exceed the specified page limit. Any application exceeding the page limit will not be read, evaluated, or considered for funding.

Applications must be complete, within the maximum specified page limit, and validated by Grants.gov with the correct funding opportunity number before the deadline to be considered under the announcement.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) You certify on behalf of the applicant organization, by submission of your proposal, that neither you nor your principals are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

2) Failure to make required disclosures can result in any of the remedies described in 45 CFR § 75.371, including suspension or debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C. § 3354).

3) If you are unable to attest to the statements in this certification, you must include an explanation in Attachment 12: Other Relevant Documents.

See Section 4.1 viii of HRSA’s SF-424 Application Guide for additional information on all certifications.

Program Requirements and Expectations The applicant must demonstrate understanding of the following three (3) priority areas:

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1371

HRSA-22-160 9

Priority Area 1: Support advancing equity of access to high quality person-centered care

Focusing on equity of access to care across PEPFAR-supported countries is critical to ensure services are tailored for sub-populations that are disproportionately impacted by new infections and lag behind in reaching benchmarks for epidemic control. Poverty, lack of access to quality services, stigma and discrimination of vulnerable populations creates conditions that exacerbates poor health outcomes. While equality extends the same services to all clients, equity tailors services and advances policies to achieve optimal outcome for all, while addressing social determinants of health. Advancing equity means tailoring health services to the unique needs of populations facing an increased risk of new HIV infection, delayed diagnosis or treatment that does not yield long-term viral suppression. Ensuring an equity approach will result in addressing key and priority populations facing gaps in coverage and promote equitable person-centered care. Promotion of health equity that addresses social determinants of health and complementarity of health care provider roles will be key to maintaining a continuum of care. Collaboration with local health care systems and community stakeholders, including civil society organizations (CSOs) are key in designing and implementing programs that remove barriers to continuous care, address stigma and discrimination, increase equity and ensure high quality person-centered care.

Priority Area 2: Support prioritization of services for geographic locations and sub-populations that need to significantly advance towards attaining epidemic control

Ensuring continued leveraging of health service equity for sustainable HIV epidemic control will require specialized planning strategies, and solutions for reaching sub-populations with unmet needs. Several PEPFAR-supported countries are on track to attain their goals of 95-95-95 within the general population over the next several years.

Health surveillance data is identifying geographic locations and sub-populations that are not on track to reach the 95-95-95 goals and will need prioritized support. This focus will aim to address gaps to attain long-term epidemic control through both prevention and care and treatment activities, decrease HIV-related mortality, and improve chronic disease management of HIV and other non-communicable diseases.

Priority Area 3: Support integration of quality HIV prevention and care and treatment services into country-led programs

PEPFAR has strategically refocused support to ensure host country-led HIV responses informed by civil society and other local key stakeholders to maximize positive health outcomes and achieve epidemic control. As host countries assume more responsibility for HIV prevention and care and treatment services, there is a need to ensure ongoing prioritization of geographic and population focus based on emerging epidemiologic and real-time programmatic data, including community-led monitoring. Sustaining the quality and availability of services during this transition will require strategies to ensure the capacitation of health facilities and sub-national units and the application of DSD models that are responsive to client-defined needs, emerging threats, changing demographics and new technologies.

HRSA-22-160 10

In addition to the three priorities, you must provide information on how you will expand the following existing activities:

Improving Linkage, Continuity of Care and HIV Care and Treatment:

Collaborate with high volume health facilities in selected countries to improve linkage to, and continuity of HIV care and treatment for 15 to 24 year old HIV-positive females to:

• Promote empowerment and linkage to health services among all AGYW residing in targeted catchment areas.

• Increase the capacity of health facilities in selected countries to improve linkage to and continuity of HIV care and treatment for AGYW living with HIV.

• Partner with existing HIV testing and DREAMS partners to implement adolescent-friendly HIV peer navigation services that efficiently link newly diagnosed HIV-positive AGYW to HIV care, treatment, and psychosocial support.

• Utilize the successes and lessons learned to improve and expand the quality and accessibility of AGYW-friendly services at other facilities through youth-friendly spaces both within and outside of the health facilities.

• Ensure that sites that are supported directly by the program achieve continuity of care and viral suppression rates of 95% for enrolled AGYW and that these rates are maintained after program direct support ends, to contribute to the country’s 95-95-95 goals.

Improving Service Delivery and Optimizing HIV-Related Clinical Outcomes through Innovations for Better Care Coordination:

Partner with high-volume ART sites to address treatment interruption and strengthen linkage and viral suppression rates. Specific objectives include:

• Reduce congestion and waiting time by implementing multi-month dispensing (MMD) of medications, a spaced appointment system and clinic efficiencies, such as clinic workflow redesign.

• Improve linkage, adherence, continuity of care, and viral suppression among clients through peer support, client engagement and tracking interventions, enhanced adherence counseling, and community client tracing;

• Improve quality of ART care through enhanced screening services for opportunistic infections and adverse drug reactions and referrals, as appropriate, including telemedicine referrals;

• Build capacity of clinical staff on the implementation of program specific DSD models, pharmacovigilance, behavioral health screening and services, management of complicated ART clients, and telemedicine where available or appropriate to introduce.

• Continue and expand telemedicine interventions with program components that will provide access to clinical specialists for client consultations, available behavioral health and other integrated services, options for more accessible care for clients with access challenges, and locations and facilities that can help reduce clients’ stigma concerns.

• Share best practices with other PEPFAR partners and countries.

HRSA-22-160 11

Improving Maternal and Child Health

Support the care needs of mothers and their HIV-exposed infants to reduce maternal to child HIV transmission. Specific objectives include:

• Apply clinical quality improvements and family-centered strategies such as mother-infant pairing and peer support to selected regions to continue to improve and enhance HIV clinical services and the continuum of care throughout pregnancy and the postpartum breastfeeding period up to 24 months;

• Include training and mentoring for staff at supported facilities on data harmonization of records into the electronic system, data reporting, analysis and utilization to improve program performance and further refine work plans;

• Identify best practices for ensuring all HIV-exposed infants have a known final outcome status per national guidelines and family-centered strategies for ensuring continuity of care and disseminate these project findings to in-country stakeholders and more broadly, as appropriate.

• Support clinic flow and human resources for health efficiencies to ensure provision of all essential health services for HIV prevention, care and treatment in maternal child health clinics. This includes both facility-based staff and community outreach staff.

Increasing formal employment opportunities for DREAMS AGYW:

• Contribute to curriculum program development for the selected cadres of healthcare workers aligned with host government policies and guidelines for HIV-related healthcare services with a focus on the health needs of AGYW.

• Provide opportunities for community healthcare worker training and on-the-job placement with Ministries of Health for DREAMS-enrolled participants.

• Design activities to mentor secondary school AGYW on health careers to promote secondary school completion, improve health literacy, and decrease the risk of HIV infection.

Program-Specific Instructions In addition to application requirements and instructions in Section 4 of HRSA’s SF-424 Application Guide (including the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract), include the following:

i. Project Abstract Use the Standard OMB-approved Project Abstract Summary Form that is included in the workspace application package. Do not upload the abstract as an attachment or it may count toward the page limit. For information required in the Project Abstract Summary Form, see Section 4.1.ix of HRSA’s SF-424 Application Guide.

NARRATIVE GUIDANCE

To ensure that you fully address the review criteria, the table below provides a crosswalk between the narrative language and where each section falls within the review criteria. Any forms or attachments referenced in a narrative section may be considered during the objective review.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

HRSA-22-160 12

Narrative Section Review Criteria

Introduction (1) Need

Needs Assessment (1) Need

Methodology (2) Response and (4) Impact

Work Plan (2) Response and (4) Impact

Resolution of Challenges (2) Response

Evaluation and Technical Support Capacity

(3) Evaluative Measures (4) Impact, and

(5) Resources/Capabilities

Organizational Information (5) Resources/Capabilities

Budget Narrative (6) Support Requested - The budget section should include sufficient justification to allow reviewers to determine the reasonableness of the support requested.

ii. Project Narrative This section provides a comprehensive description of all aspects of the proposed project. It should be succinct, self-explanatory, consistent with forms and attachments, and organized in alignment with the sections and format below so that reviewers can understand the proposed project.

Successful applications will contain the information below. Please use the following section headers for the narrative:

• INTRODUCTION -- Corresponds to Section V’s Review Criteria # 1

Briefly describe the purpose, design, and rationale of the proposed project.

Discuss how the program will engage and collaborate with stakeholders to collectively develop practical, effective, and innovative solutions that take into account evolving public health considerations.

Describe your responsibility for carrying out activities and abilities related to the project activities. Describe your partners’ role/contributions as they relate to current PEPFAR priorities. Include a discussion that exhibits an expert understanding of the issues related to the activities included in this funding opportunity announcement among your partners/consortium members.

• NEEDS ASSESSMENT -- Corresponds to Section V’s Review Criteria #1

Summarize the gaps and challenges in achieving and sustaining HIV epidemic control and UNAIDS 95-95-95 goals in PEPFAR countries with a specific focus on Zambia, Malawi, and one other PEPFAR country. Outline the needs of specific populations and geographical areas that have lagged behind in performance results with an emphasis on barriers to accessing care and social determinants of

HRSA-22-160 13

health. Describe the complexity of providing HIV care to patients with coexisting conditions such as TB, other infectious and chronic diseases, mental illness, or substance use disorder. Discuss health system challenges that affect health service delivery and the availability, effectiveness, and capacity of the health workforce that this project will need to take into consideration. Discuss the need to develop sustainable differentiated models of care that incorporate community and lay support with HIV prevention, testing, care, and treatment.

Provide a concise summary of the literature related to transitions of HIV and other health programs implemented by foreign entities to host country governments and best practices to ensure their sustainability. Detail current health system and health management issues and components requiring additional support to ensure the sustainability of HIV services. Please minimize background information and emphasize systems, processes, capabilities, and results.

• METHODOLOGY -- Corresponds to Section V’s Review Criterion #2 and #4

Describe in detail the objectives, goals and intended outcomes of the proposed project in Zambia, Malawi, and one other PEPFAR country. Objectives should be specific, measurable, realistic, and achievable within the period of performance.

Clearly relate the project objectives and goals to the program expectations outlined in this NOFO. Activities must reflect the goals outlined in PEPFAR 3.0, as well as priorities noted in PEPFAR annual country operational plan guidance (https://www.state.gov/2022-country-operational-plan-guidance/).

Describe the key activities proposed for accomplishing project goals and objectives related to the three priorities described in the Program Requirements and Expectations section above.

For your description of objectives and activities in Zambia, focus on prevention, care, and treatment plans for AGYW, mother-infant pairs, advancement and integration of telemedicine, service efficiencies and continuity for stable clients, and integration of behavioral health interventions. For your description of objectives and activities in Malawi, focus on prevention, care and treatment plans for AGYW and interventions to address social determinants of health and risk factors for HIV. For the additional PEPFAR country selected, focus on the appropriate interventions for needs identified in your assessment. Refer to Section IV.2 Program Requirements and Expectations for more details on these activities.

Discuss how you will build and maintain effective strategic partnerships with relevant government agencies, education institutions, regulatory bodies, health management teams, civil society organizations, multilateral organizations, other USG-funded programs, and other stakeholders to collectively develop practical, unique, and innovative solutions. Discuss how the proposed program aligns with needs identified in existing national health strategic plans and how the program will contribute to long-term, sustainable health outcomes. Discuss how the proposed strategies will support, complement, and innovate on existing PEPFAR and Global Fund efforts within countries. Discuss the strategies for evaluation and integration https://www.state.gov/2022-country-operational-plan-guidance/

HRSA-22-160 14

or adoption of effective and efficient service delivery and health workforce models into host country health systems.

Describe in detail your experience addressing improvements to patient-centered care in healthcare systems and services for people living with HIV, including delivering services to increase access to people living with HIV who have reported stigma, discrimination, or barriers to service based on the healthcare system factors. Discuss how you will leverage your experience in this current program.

The initiative requires a substantive approach to producing and disseminating innovative solutions. Please comment on your approach that assures that any supported activities are consistently assessed for effectiveness in producing desired results and efficiency and reshaped as necessary. Include relevant examples of your experience in your response. Describe how you will monitor, adapt, and align your program activities with updates to PEPFAR guidance.

Please demonstrate your capacity to support improvements in key PEPFAR minimum program requirements (MPR) at the facility level as referenced in the COP22 Guidance: https://www.state.gov/wp-content/uploads/2022/01/COP22- Guidance-Final_508-Compliant.pdf as part of your project approach. Particularly, discuss how the proposed approach will address strategic planning and capacity building needs leveraging health service equity toward continued sustainability and HIV epidemic control.

Opportunities may arise in monitoring and evaluation, program performance and quality improvement, leadership, governance, and policy. Discuss the strategies for evaluation of gaps and needs in these areas that impact provision of high quality services efficiently that address equity and access to care issues. Demonstrate the capacity to draw from quality improvement (QI) tools and methods and formulate targeted, cost-effective, and timely QI interventions. Then provide input on integration or adoption of effective and efficient service delivery and health workforce models into host country health facilities and systems on a broad scale.

• WORK PLAN -- Corresponds to Section V’s Review Criterion #2 and #4

Describe the interventions you will use to achieve each of the objectives proposed in the Methodology section. Use a timeline that includes each intervention and identifies responsible staff. As appropriate, identify meaningful support and collaboration with key stakeholders in planning, designing, and implementing all activities, including developing the application.

Discuss how goals and objectives directly relate to the requirements and expectations of this initiative. Provide a work plan that demonstrates how the outcomes, strategies, and activities will take place throughout the period of performance. Include a detailed work plan for the first year of the project and a high-level plan for the four subsequent years.

The work plan should include goals, objectives, and outcomes that are SMART (specific, measurable, achievable, realistic, and time-measured). Include all https://www.state.gov/wp-content/uploads/2022/01/COP22-Guidance-Final_508-Compliant.pdf https://www.state.gov/wp-content/uploads/2022/01/COP22-Guidance-Final_508-Compliant.pdf

HRSA-22-160 15

aspects of planning, implementation, and evaluation. The work plan should relate to the needs identified in the needs assessment and to the activities described in the project narrative, to discuss the following:

• Goals

• Objectives

• Action steps or Interventions

• Responsible staff (to complete or monitor each activity)

• Timeline for activity, intervention, and completion

• Measurable Outcomes

The work plan should include sufficient detail to support understanding while recognizing that you will revise the work plan after the cooperative agreement is awarded and after initial consultations with HRSA and in-country stakeholders.

Include the project’s work plan as Attachment 1.

Logic Models

Submit a logic model for designing and managing the project. A logic model is a one-page diagram that presents the conceptual framework for a proposed project and explains the links among program elements. While there are many versions of logic models, for this notice, the logic model should summarize the connections between the:

• Goals of the project (the mission or purpose of intervention);

• Assumptions (e.g., beliefs about how the program will work and support resources. Base assumptions on research, best practices, and experience.);

• Inputs (organizational profile, collaborative partners, key personnel, budget, investments and other resources such as time, staff and money);

• Target population (i.e., the individuals to be served);

• Activities (approach, key interventions, action steps, etc.);

• Outputs (the direct products or deliverables of program activities and the targeted participants/populations to be reached); and

• Outcomes (the results of a program, typically describing a change in people or systems, short-term, intermediate, and long-term results of the program).

Although there are similarities, a logic model is not a work plan. A work plan is an “action” guide with a timeline used during program implementation; the work plan provides the “how-to” steps. You can find additional information on developing logic models at the following website:

https://www.cdc.gov/evaluation/logicmodels/index.htm.

• RESOLUTION OF CHALLENGES -- Corresponds to Section V’s Review Criterion #2

Discuss challenges that you are likely to encounter in designing and implementing the activities described in the work plan. Provide realistic and appropriate approaches that will be used to resolve such challenges. Identify and describe https://www.cdc.gov/evaluation/logicmodels/index.htm

HRSA-22-160 16

potential barriers to program implementation, including challenges inherent in working in low-resource settings, across multiple countries, and with local governments. Provide reasonable and actionable solutions to address these barriers.

EVALUATION AND TECHNICAL SUPPORT CAPACITY -- Corresponds to Section V’s Review Criterion # 3, #4 and #5

Describe your capacity to monitor program goals and objectives. Describe plans to track and quantify results through the utilization of tools, systems, and strategies developed through custom indicators and standard PEPFAR indicators (MER, SIMS, ER, HRH, etc.).