fullFoa_Content_of_CDC-RFA-GH-24-0094.pdf

Centers for Disease Control and Prevention

Center for Global Health

Enhancing HIV Prevention, Care and Treatment Services through Patient Empowerment, Community Engagement and Improved Public Health Information Systems in Ukraine under the

President's Emergency Plan for AIDS Relief (PEPFAR)

CDC-RFA-GH-24-0094

02/21/2024

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- GH-24-0094. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Enhancing HIV Prevention, Care and Treatment Services through Patient Empowerment, Community Engagement and Improved Public Health Information Systems in Ukraine under the President's Emergency Plan for AIDS Relief (PEPFAR) C. Announcement Type: New - Type 1:

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For purposes of this NOFO, research is defined as set forth in 45 CFR 75.2 and, for further clarity, as set forth in 42 CFR 52.2 (see eCFR :: 45 CFR 75.2 -- Definitions and https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR- 2007-title42-vol1-sec52-2.pdf. In addition, for purposes of research involving human subjects and available exceptions for public health activities, please see 45 CFR 46.102(l) (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section- 46.102#p-46.102(l)).

Applicants should note that a Letter of Intent (LOI) is not requested or required as part of the application for this NOFO or for any CDC PEPFAR FY24 NOFO. Applicants should not submit LOIs.

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH-24-0094

E. Assistance Listings Number:

93.067 F. Dates:

1. Due Date for Letter of Intent (LOI):

2. Due Date for Applications:

02/21/2024 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph Successful leadership of community-based organizations (CBOs) in strengthening national public health information systems (PHIS) in Ukraine has been proven since 2012 when PEPFAR started support for the development and implementation of an HIV management information system (MIS HIV). MIS HIV embraced electronic medical records on HIV, TB, and medication assisted treatment (MAT) clients and was renamed to information system “Monitoring socially significant diseases” (IS MSSD). IS MSSD is the most advanced information system (IS) operating in the Ukrainian Public Health sector. It allows data analysis for decision-making and generates national and international reporting, including PEPFAR reporting.

This NOFO will aim to use the unique expertise of communities in PHIS improvement. The leading potential of communities will be used for strengthening and improvement of the entire PHIS in terms of planning, monitoring and evaluation (M&E), data standardization, and interoperability. Simultaneously communities will be improving results of their own HIV prevention, care, and treatment using innovative mobile applications, electronic instruments, and tools (MA EIT), and an HIV hotline.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$0 The Approximate Project Period of Performance Funding/Estimated Total Funding for the Total 5 year Project Period is None. The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for years 2-5 will be set at continuation.

e. Average One Year Award Amount:

$1,200,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $1,200,000. The expected number of awards is 1. Exact amounts for each award under this NOFO will be determined at the time of award. Applicants are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount.

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

September 30, 2024

h. Cost Sharing and / or Matching Requirements:

No Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview CDC Ukraine prioritizes improved outcomes for clients through HIV prevention, care, and treatment interventions to achieve the 95-95-95 strategic goals in countering the HIV/AIDS epidemics. There is a strong need for good quality strategic information (SI) for analysis, decision-making, effective planning, and support for public health interventions to achieve the 95-95-95 strategic goals.

Strengthening of PHIS is an enabling factor for the access of decision-makers to SI. This NOFO will aim to use the unique expertise of communities in PHIS strengthening. Under this NOFO, improved outcomes for clients in prevention, care, and treatment services will be achieved through the combined efforts in community engagement, patient empowerment, and improved IS.

Since 2012, PEPFAR has supported the development, implementation, and sustainability of MIS HIV through establishment, development, capacity building of providers and in MIS HIV transition to the ownership of the national public health institution, Ukrainian Public Health Center of the Ministry of Health of Ukraine (PHC).

MIS HIV underwent transformation and expanded its functionalities. The system embraced electronic medical records on HIV, TB, and MAT clients and was renamed into IS MSSD. IS MSSD is the most advanced management information system operating in the Ukrainian Public Health sector; however, data integrity in IS MSSD can only be ensured through its interoperability with the national PHIS named “e-Health Central Data Base” (e-Health), Laboratory Information

Management system (LIMS), other MISs operating in the healthcare sector, with other registers and repositories containing statistical, biomedical, civil status data, and data on HIV prevention and care services rendered by non-governmental organizations at the community level.

Establishment of such interoperability is a prerequisite for accessibility to the comprehensive data sets needed for analysis and decision-making.

Cooperation and coordination of stakeholders at the national level is needed along with long-term planning for PHIS strengthening and interoperability. Within this planning PHIS stakeholders need to develop a M&E system for the universal PHIS environment. Core indicators are to be defined and set to track the progress in the domains of health determinants, health system, and health status.

Universal national system of standards on electronic variables, data sets, codes, and indicators are to be established. The leading potential of communities will be used for improvement of the entire PHIS in terms of planning, M&E, data standardization, and interoperability. Simultaneously communities will be improving results of their own HIV prevention, care, and treatment using innovative MA EIT, such as the HIV hotline.

Communities will identify and address gaps in service provision for the most vulnerable populations using electronic platforms and tools aimed at improved service provision models and results. They will sustain a continuous process of defining and addressing gaps and improving service provision for the most vulnerable populations. The HIV hotline will improve its service provision modes to address the needs of the most vulnerable populations in HIV prevention, care, and treatment services.

b. Statutory Authorities This program is authorized under Public Law 108-25 (the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003) [22 U.S.C. 7601, et seq.] and Public Law 110-293 (the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008), and Public Law 113-56 (PEPFAR Stewardship and Oversight Act of 2013).

The President’s Emergency Plan for AIDS Relief (PEPFAR) has called for immediate, comprehensive and evidence-based action to turn the tide of global HIV/AIDS. The overarching purpose of this NOFO is to fund activities to prevent or control disease or injury and improve health, or to improve a public health program or service.

c. Healthy People 2030 N/A

d. Other National Public Health Priorities and Strategies Under the leadership of the Global Health Security and Diplomacy Bureau (GHSD Bureau), as part of PEPFAR, the U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (HHS/CDC) works in partnership with host country governments and other key partners to assess the needs of each country and design a customized program of assistance that fits within the host nation's strategic plan in a manner consistent with the purposes of this NOFO. Goals and priorities include the following:

• Reducing the prevention and treatment gaps for adolescent girls and young women (AGYW), children, and key populations (KPs);

• Strengthening national and local programmatic, financial, and community leadership;

• Designing new partnerships with key private, public, and multi sector entities that can complement existing programs and expand reach;

• Utilizing the PEPFAR platform for broader disease surveillance and public health programming, consistent with the PEPFAR legislative and funding authority;

• Investing in the scale-up of cutting edge behavioral and implementation science to bend the curve on new infections;

• Improving the care and treatment of HIV/AIDS, sexually transmitted infections (STIs), and related opportunistic infections by improving STI management; enhancing laboratory diagnostic capacity and the care and treatment of opportunistic infections; interventions for intercurrent diseases impacting HIV infected patients including tuberculosis (TB); and initiating programs to provide anti-retroviral therapy (ART);

• Strengthening the capacity of countries to collect, use, and share surveillance data and manage national HIV/AIDS programs by expanding HIV/STI/TB surveillance programs and strengthening laboratory support for surveillance, diagnosis, treatment, disease monitoring, and HIV screening for blood safety; and

• Developing, validating, and/or evaluating public health programs to inform, improve, and target appropriate interventions, as related to the prevention, care and treatment of HIV/AIDS, TB, and opportunistic infections.

In an effort to ensure maximum cost efficiencies and program effectiveness, HHS/CDC also supports coordination with and among relevant partners. Recipients may be requested to participate in the following programmatic activities:

• Scale-up evidence-based programs to identify and close the major HIV gaps among AGYW, children, and KPs;

• Increase impact through strategic coordination and integration;

• Strengthen and leverage key multilateral organizations, global health partnerships, and private sector engagement;

• Encourage country ownership and invest in country-led plans, putting our national and local partners in the lead and actively enabling their growth through design of the program at all phases;

• Build sustainability through investments in health systems;

• Enhance health equity and reduce disparities in access to and uptake of HIV services;

• Improve performance metrics, monitoring and evaluation and the quality of related data;

and

• Promote research, development, and innovation to develop a body of knowledge, enhance awareness and increase the skills and abilities of stakeholders (research is not supported by this NOFO).

PEPFAR defines national HIV epidemic control as the point at which the number of new infections falls below the declining number of deaths among people living with HIV (PLHIV).

This definition of epidemic control does not suggest near-term elimination or eradication of HIV as may be possible with other infectious diseases, but rather suggests a decline of HIV-infected persons in a population, achieved through the reduction of new HIV infections when mortality among PLHIV is steady or declining, consistent with natural aging. Critically, however, a country will not be able to maintain epidemic control if program efforts are not sufficiently sustained and new infections are allowed to rebound or death rates to increase.

In addition to the specific activities listed in the Strategies and Activities section of this NOFO, all CDC PEPFAR cooperative agreements resulting from this NOFO may address the following activities, where and when appropriate, that focus U.S. government resources and activities toward achieving and sustaining the HIV/AIDS epidemic:

• Optimize HIV testing and treatment strategies to reach undiagnosed populations living with HIV, especially young adults, men, and KP. These strategies may include or build upon traditional methods and activities related to outbreak detection, investigation, and response, including efforts to reduce or remove evidenced barriers to services such as stigma and discrimination and inequitable gender norms. Responding to recent infections or ongoing patterns of transmission will be prioritized.

• Focus on prevention among children, adolescents, young adults, and members of vulnerable and key populations.

• Support surveillance activities and programs, along with information systems, that improve understanding of HIV epidemiology, help identify inequities and remaining gaps (e.g., societal impediments to HIV services), and inform future programming.

• Support efforts to maintain quality for laboratory systems and activities, including diagnostics and viral load measurement.

• Actively use epidemiologic, program, and financial/cost data to ensure implementation of high quality, cost-effective programs to improve partner performance and increase epidemiologic impact.

• Support country-led, sustainable programming by working with and implementing activities through local partners, including faith communities and faith-based organizations (FBOs), HIV network organizations and community-based organizations (CBOs) directly servicing communities and populations at-risk and most affected by HIV to build local capacity.

• Strengthen programmatic, financial, and community contributions by partner governments in the HIV/AIDS response.

• Support activities, interventions, and programs (e.g., including those intended to reduce or remove evidenced societal impediments to services such as stigma, discrimination, and inequitable gender norms) to find, treat, and prevent TB among PLHIV and to identify and treat HIV among people infected with TB.

• Support efforts to prevent, detect, respond, and treat infectious and non-infectious diseases that impact PLHIV and populations affected by HIV.

Any activities outside of HIV or TB activities will be consistent with the direction set forth in PEPFAR’s Five-Year Strategy, PEPFAR’s annual Country/Regional Operational Plan (COP/ROP) Guidance, annual COPs/ROPs, or other similar forthcoming strategy, guidance, or planning documents as may be consistent with applicable law.

Geographic prioritization may change over the course of the period of performance based on the burden of disease and changing program and PEPFAR priorities.

If the scope of activities to be conducted by the recipient(s) of funds under this NOFO includes work with KP, the recipient(s) will be expected to collaborate with KP organizations in the design and delivery of appropriate optimal and quality HIV services to KP.

Any Personally Identifiable Information (PII) collected for continuity of service provision should be managed in a manner that ultimately protects individual-level data to the extent allowed by applicable law.

In addition, PEPFAR is committed to protecting children from abuse, exploitation, and neglect in order to decrease their vulnerability to HIV/AIDS. Consistent with underlying authorities, PEPFAR seeks to ensure that children and youth obtaining services through PEPFAR programming are also protected from abuse, exploitation, and neglect in CDC PEPFAR-supported programs. To that end, because activities to be funded under this NOFO may involve children or personnel coming into contact with children, Recipients of CDC PEPFAR funds agree to ensure compliance with host country and local child welfare and protection legislation or international standards, whichever gives greater protection, and with U.S. law, where applicable. Further, Recipients of CDC PEPFAR funding are strongly encouraged to: 1) have in place policies and procedures that prohibit recipient personnel from engaging in child abuse, exploitation, or neglect; 2) consider child safeguarding in project planning and implementation to determine potential risks to children that are associated with project activities and operations; 3) apply measures to reduce the risk of child abuse, exploitation, or neglect, including, but not limited to, limiting unsupervised interactions with children; prohibiting exposure to pornography; and complying with applicable laws, regulations, or customs regarding the photographing, filming, or other image-generating activities of children; 4) promote child-safe screening procedures for personnel, particularly personnel whose work brings them in direct contact with children; and 5) have a process for ensuring that personnel and others recognize child abuse, exploitation, or neglect, report allegations, investigate and manage allegations, and take appropriate action in response to such allegations. It is also strongly encouraged that Recipients include the above provisions in any applicable code of conduct for its personnel implementing PEPFAR-funded activities.

In its work with partners, CDC seeks to help control HIV epidemics and to achieve and maintain low levels of HIV incidence and mortality. Now and in the future, viable, capable, durable, and successful local partners will play an important role in achieving and sustaining control of national HIV epidemics. To that end, CDC strongly encourages direct applications from local organizations (i.e., institutions located, registered, and managed in the country and/or sub-region where work occurs and led by national of that country and/or sub-region). U.S.-based partners working in international settings also offer unique capabilities and will continue to make important contributions. Partnerships between local organizations and U.S.-based organizations may also offer benefits and are encouraged in such cases.

This NOFO is only for non-research activities supported by CDC. Recipients may not use funds for research. Certain activities that may require human subjects review due to institutional requirements but that are generally considered not to constitute research (e.g., formative assessments, surveys, disease surveillance, program monitoring and evaluation, field evaluation of diagnostic tests, etc.) may be funded through this mechanism. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102

e. Relevant Work To reach the 95-95-95 strategic goals and priorities, PEPFAR, along with the current implementing partner (IP), have supported development and implementation of MIS HIV since FY2012.

Successful MIS HIV development and implementation were determined by the high professionalism of IPs along with community engagement and initiative. CBO coordinated stakeholders developed good quality software, built capacities of providers, and launched MIS HIV operations.

CDC Ukraine’s continued support for MIS HIV is important to expand its functions, improve data quality, and sustainability. This award has also been addressing permanent need in SI and PEPFAR reporting while supporting further MIS HIV development. With the previous award, CDC-RFA- GH18-1817, PEPFAR extended its assistance to MIS HIV from 2018 to 2023 with the current IP streamlining and coordinating efforts of stakeholders in MIS HIV advancement. MIS HIV embraced electronic medical records on HIV, TB, and MAT clients, was renamed into IS MSSD and handed over to the Government of Ukraine (GoU) public health agency PHC. IS MSSD is the most advanced MIS operating in the Ukrainian Public Health sector. It allows data analysis for decision-making and generates national and international reporting, including PEPFAR reporting.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-Term Outcomes

Intermediate Outcomes

Long-Term

Strategy 1:

Strengthen patient accessibility to comprehensive HIV services, including prevention, care, and treatment through the MA

EIT

Strategy 2:

Strengthen PHIS standards, M&E frameworks, and interoperability

Strategy 3:

Strengthen HIV prevention, care, and treatment services among CBOs to enhance reach and effectiveness of essential services for HIV-affected, vulnerable populations

Improved awareness and use of MA EIT among HIV-positive clients

Increased competencies of public health sector in M&E frameworks and national electronic standards

Improved standardization and interoperability of PHIS, MA EIT, and other MISs operating in the public health sector

Improved accuracy, reliability, integrity, and timeliness of HIV program data

Improved collaboration and engagement among CBOs within community-led monitoring (CLM) intervention

Improved capacity of operators of the HIV hotline to address the needs of the most

Improved access and use of HIV prevention, care, and treatment services by clients

Increased use of MA EIT for patient access to HIV prevention, care, and treatment services

Improved coordination and accountability of HIV prevention, care, and treatment services

Increased adherence to national standards on electronic variables, data sets, codes, indicators, and M&E frameworks in the public health sector

Improved quality of service provision for the most vulnerable

Improved capacity of community-led organizations to effectively collect, produce, and analyze high-quality data to inform HIV

Reduced HIV incidence

Decreased HIV mortality and morbidity

Improved health outcomes of clients in HIV prevention, care, and treatment

Increased reliable coordination among HIV prevention, care, and treatment

Increased civil society and community organizations capacity to effectively lead

CLM

mechanisms for the most

Strategies and Activities

Short-Term

Intermediate Outcomes

Long-Term programming and implementation

i. Purpose The purpose of this NOFO is to improve HIV prevention, care, and treatment through community engagement, better access to SI for decision-making, and use of MA EIT for clients. Expertise of communities in PHIS improvement will be used for PHIS strengthening, planning, M&E, data standardization, and interoperability. Communities will improve results in their own HIV prevention, care, and treatment using innovative MA EIT. Services for the most vulnerable populations will be improved with the HIV hotline.

ii. Outcomes CDC may require or allow applicants to propose additional related project period outcomes other than those identified in the NOFO.

Short-Term Outcomes:

• Improved awareness and use of MA EIT among HIV-positive clients

• Increased competencies of public health sector in M&E frameworks and national electronic standards

• Improved standardization and interoperability of PHIS, MA EIT, and other MISs operating in the public health sector

• Improved accuracy, reliability, integrity, and timeliness of HIV program data

• Improved collaboration and engagement among CBOs within CLM intervention

• Improved capacity of operators of the HIV hotline to address the needs of the most vulnerable populations

Intermediate Outcomes:

• Improved access and use of HIV prevention, care, and treatment services by clients

• Increased use of MA EIT for patient access to HIV prevention, care, and treatment services

• Improved coordination and accountability of HIV prevention, care, and treatment services

• Increased adherence to national standards on electronic variables, data sets, codes, indicators, and M&E frameworks in the public health sector

• Improved quality of service provision for the most vulnerable populations

• Improved capacity of community-led organizations to effectively collect, produce, and analyze high-quality data to inform HIV programming and implementation

Long-Term Outcomes:

• Improved health outcomes of clients in HIV prevention, care, and treatment services

• Increased reliable coordination among HIV prevention, care, and treatment services

• Increased civil society and community organizations capacity to effectively lead CLM mechanisms for the most vulnerable populations

iii. Strategies and Activities CDC may require or allow applicants to propose additional related strategies and activities other than those identified in the NOFO to achieve the expected Outcomes.

Strategy 1: Strengthen patient accessibility to comprehensive HIV services, including prevention, care, and treatment through the MA EIT

• Conduct landscape assessment for the PHIS in use at the community levels

• Develop recommendations on modifications of electronic instruments, tools and mobile applications used at the community level

• Draft strategic directions on the composition, development, and implementation of the

MA EIT used at the community level

• Facilitate development and implementation of MA EIT for clients

• Disseminate information to community level organizations and clients to raise awareness on MA EIT in the communities and among other designated users

• Contribute into sustainability and adaptation of MA EIT to the evolving needs of communities

Strategy 2: Strengthen PHIS standards, M&E frameworks, and interoperability

• Establish national committee responsible for leadership and coordination of public health information systems (hereafter NC PHIS), for data standardization and interoperability among information systems

• Develop and adopt at the national level strategic plan on the development of the public health information systems (hereafter NSP PHIS), electronic standards and M&E frameworks

• Draft and adopt unifying enabling regulatory framework for public health information systems allowing smooth implementation of the NSP PHIS

• Support implementation of NSP PHIS and follow-up its implementation progress

• Expand implementation of interoperability among health information systems or tools

• Develop standardized M&E framework for assessing interoperability

• Implement and evaluate public health information system

• Improve HIV, TB data quality and use at all levels of health systems

• Roll out patient-level systems for facility and community settings

• Setup and maintain necessary infrastructure of health information exchanges and community platforms

• Implement technological, management and policy solutions to support data and information security

Strategy 3: Strengthen HIV prevention, care, and treatment services among CBOs to enhance reach and effectiveness of essential services for HIV-affected, vulnerable populations

• Define the most vulnerable groups of population in the area of HIV prevention, care, and treatment services

• Map service providers of HIV prevention, care and treatment services

• Prioritize service delivery areas for the most vulnerable groups of population

• Coordinate service delivery areas among CLM providers

• Build capacities of CLM providers in terms of data collection, storage management and analysis

• Establish collaboration among service providers and GoU stakeholders who are decision makers under CLM initiative

• Develop and implement electronic platforms and tools for CLM data collection, storage management, interpretation and presentation

• Identify and address gaps in service provision for the most vulnerable population using

CLM electronic platforms and tools aiming at improved service provision models and results

• Build sustainability of CLM mechanisms

• Sustain continuous process of defining and addressing gaps, improving service provision for the most vulnerable populations with use of electronic platforms and tools

• Develop new capacities of HIV hotline to address the needs of the most vulnerable groups of population.

• Improve service provision by HIV hotline to address the needs of the most vulnerable

In furtherance of the underlying purposes of this NOFO, Recipient is expected to provide copies of and/or access to all data, software, tools, training materials, guidelines, and systems developed under this NOFO to Ministry of Health and other relevant stakeholders, including HHS/CDC, for appropriate use consistent with underlying authorities.

1. Collaborations

a. With other CDC projects and CDC-funded organizations:

The recipient will be expected to collaborate with the CDC Ukraine country office, PHC and with other CDC-funded IPs including non-governmental organizations, universities, and other host governmental bodies and multi-lateral organizations that receive CDC funds. Interaction with the PHC and key population (KP)- led civil society are encouraged as these are the key players for achieving epidemic control of HIV in Ukraine. The aim of these collaborations is to streamline coordinated joint efforts to strengthen PHIS in terms of planning, M&E, and standardize its variables, allowing for better access of patients to HIV prevention, care, and treatment services through the MA EIT and community engagement under CLM intervention and then sustain HIV epidemic control in Ukraine.

The recipient should ensure their proposed activities are not duplicating activities already implemented by other CDC-funded organizations.

b. With organizations not funded by CDC:

The recipient is expected to establish and maintain collaboration with MOH, Regional CDCs, National Health Service of Ukraine (NHSU), USAID partners, UNAIDS, and the Global Fund, indigenous non-governmental CBOs as well as other regional and international partners involved into PHIS strengthening, improving access of patients to HIV care prevention and treatment services through the MA EIT and community engagement within CLM intervention. The goal of collaboration with stakeholders is to establish sustainable mechanisms allowing continuous improvement of results in HIV prevention, care and treatment services with engagement of communities.

2. Population(s) of Focus The populations of focus for this NOFO are KP, people living with HIV (PLHIV) and specific most vulnerable communities of PLHIV, as well as programmatic staff of Ukrainian indigenous CBOs, operating in the area of HIV prevention, care and treatments, who are developing and implementing MA EIT for communities; GoU staff and staff of public health institutions in charge of development and implementation of PHIS, public health officials and policymakers responsible for better access to HIV prevention, care and treatment services, sustainable development of these services and better HIV treatment results. The populations of the focus are consistent with key populations mentioned in the "PEPFAR 2023 Country and Regional Operational Plan (COP/ROP) Guidance for all PEPFAR-Supported Countries" https://www.state.gov/wp-content/uploads/2023/02/PEPFAR-2023-Country-and-Regional-Operational-Plan.pdf on pages 32-34; Item 3.1.1.3 Key Populations.

This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of race, color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy) or other constitutionally protected statuses.

a. Health Disparities The goal of health equity is for everyone to have a fair and just opportunity to attain their highest level of health. Achieving this requires focused and ongoing societal efforts to address historical and contemporary injustices; overcome economic, social, and other obstacles to health and healthcare; and eliminate preventable health disparities.

Broadly defined, social determinants of health are non-medical factors that influence health outcomes. They are the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life. These forces (e.g., racism, climate) and systems include economic policies and systems, development agendas, social norms, social policies, and political systems. See content below and in other sections (e.g., Approach, Collaborations, Populations of Focus) for information on how this specific NOFO affects social determinants of health.

A health disparity is a preventable difference in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by populations that have been socially, economically, geographically, and environmentally disadvantaged. Health disparities are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these diseases and conditions.

In an effort to assure that activities funded through this NOFO (1) affirm and advance, as appropriate, the role of health equity and an equitable, diverse, and inclusive workforce as core principles, and (2) advance the reduction of stigma and discrimination through the promotion, consistent with applicable laws, of civil and human rights to improve the health outcomes of persons at risk of, or living with, HIV and/or TB infection, CDC PEPFAR awards resulting from this NOFO may address the following activities, where and when appropriate:

• Community involvement in the design, implementation, and monitoring of HIV and TB services.

• Training for implementing partners involved in the design, implementation, and/or monitoring of activities on stigma, discrimination, gender equitable norms, human rights, and community engagement to minimize the likelihood for activities to unintentionally increase stigma and discrimination directed towards PLHIV, people with TB, and other

KP.

• Programs to address evidenced health disparities and social barriers (e.g., HIV-related stigma) to HIV and TB services.

• Use of data to monitor disparities and implement strategies to improve access, service use, and outcomes.

iv. Funding Strategy Applicants to this NOFO are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount. Applications must not exceed this amount.

Component Funding: It is required that all PEPFAR-funded cooperative agreements be formulated for component funding. A component is a discrete set of activities with an associated budget. CDC will use component funding to provide funding for activities proposed in an application that received merit review but were not selected for funding in the initial award (i.e., at the onset of budget period 1) but may be funded at a later point in the budget period as programmatically necessary and as funding becomes available. Please review the following key points about component funding:

• Component funding must be setup at the time of the application. While preparing the application, applicants should review the expectations listed in the NOFO for Year 1 activities and group them under the anticipated components listed below. Only activities planned for Year 1 should be grouped into components; applicants do not need to group activities in the high-level plan for the subsequent years 2-5 of the award into components. Funding amounts and components for years 2-5 will be determined at continuation.

• Each component must be a discrete set of activities with an associated budget.

Distinguishable component budget narratives are required. Setting up components based on time (i.e., quarterly) is an appropriate distinction of activities, provided activities are clearly outlined.

• Applicants should submit the anticipated components on an SF-424A form as part of their application which shows all components for the budget period. The amounts should exactly match what is being requested for funding. Each component has its own approved amount and cannot be funded above the established amount. The combined total of all components must total the requested amount.

• If more than 4 components are proposed, multiple SF-424As will be needed. Applicants may include the first 4 components on one SF-424A form and the remaining components on a second SF-424A form. Applicants may download additional SF-424A forms and upload them as PDFs under “Budget Narrative Attachment Form” or “Other Attachments Form.” These should be clearly labeled for easy identification and included in the Table of Contents for the entire submission.

• If possible, applicants are encouraged to submit a separate budget justification for each component, but it is not a requirement. Applicants will not be deemed incomplete if separate budget justifications are not provided with the submission. A separate budget justification will ultimately be required for all components that are funded.

• Any component that is not funded at the time of a new award may be deemed “Approved but Unfunded (ABU)”. There is no guarantee that all components will be funded in a budget period as ABU components are subject to the availability of funds and the underlying legal authority for the work.

o Components may not be awarded in order. All ABU components are eligible to receive funding once (and if) funds become available.

o If funding becomes available, multiple components can be funded through the same funding action (single NOA).

o If funding is awarded for an amount less than the ABU component approved amount, it is not possible to fund the difference at a later time. Components can only be funded once.

• If, during the funding confirmation, the Program Office approves a budget that differs from what was submitted at the time of application (reflected in the budget markup), a revised budget may be required in addition to the technical review responses. If required, the revised budget is due within thirty (30) days of the start of the budget period. If required, technical review responses will also be due within thirty (30) days of the start of the budget period and must be submitted separately from revised budget applications.

Future funding for ABU components will not be awarded until a revised budget, if required, is submitted and approved by CDC.

• Once components are awarded, funds cannot be redirected between components.

However, funds may be redirected within a component between object class categories.

It is critical to ensure accountability, transparency, and programmatic performance of all U.S.

taxpayer dollars. When developing the annual work plan, please be advised that the annual COP/ROP guidance requires that CDC take decisive action if an implementing partner is underperforming programmatically during any quarter of a fiscal year.

Applicants are encouraged to consider the following in the development of their budgets and budget narratives:

For Year 1, CDC anticipates an Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award of $1,200,000 with the below listed components:

• Component 1 – COP Q1 Targets/Activities;

• Component 2 – COP Q2 Targets/Activities;

• Component 3 – COP Q3 Targets/Activities;

• Component 4 – COP Q4 Targets/Activities;

• Component 5 – COP Additional Targets/Activities.

Applicants must specify a descriptive title for each corresponding column shown on the SF- 424A, followed by the total (cumulative) in the column to the far right of the SF-424A.

Applicants are encouraged to use the components listed above, but may propose alternative budget components so long as the general component funding guidance is followed.

Funding provided under this NOFO is subject to the availability of funds. The total number of years for which federal support has been programmatically approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. All future year funding will be based on satisfactory programmatic progress and the availability of funds.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

CDC expects that the routine performance data is reviewed, cleaned, and used for program management. To this effect, the recipient should hold regular review meetings to discuss performance and use data in program quality improvement activities.

The recipient should allocate funds made available under this NOFO for both evaluation activities and performance monitoring. While the final funding amount will be agreed upon by both CDC and the recipient, a minimum of 5% of funds should be allocated for monitoring activities and 5% of funds should be used for evaluation activities. These are estimates for the total funding over the 5-year project.

PERFORMANCE MONITORING

Currently, reporting on PEPFAR monitoring, evaluation, and reporting (MER) indicators is not applicable to the scope of this NOFO, although that is subject to change in future project years.

Some custom (non-MER) indicators, targets, and reporting frequencies corresponding to Year 1 of the NOFO are shown below. The applicant should also propose additional relevant custom indicators as part of their initial Evaluation and Performance Measurement Strategy.

Applicants should note that these may be adjusted, or new targets and indicators may be identified in subsequent years based on implementation of HIV/AIDS epidemic control strategies and program priorities. Any gaps or unmet needs not fulfilled in the first year may affect the targets of the subsequent years.

Unless otherwise indicated, the reporting periods for MER indicators will mirror the PEPFAR MER indicator reporting frequency (quarterly, semi-annually, and annually). Additional information regarding MER reporting is included in the MER Guidance and resource materials, available at the following link (copy/paste into web browser to access):

https://datim.zendesk.com/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides.

Non-MER: Additional Performance Measures (Custom Indicators)

Applicants should propose additional custom performance measures to monitor achievement of outcomes not directly measured by PEPFAR (MER) indicators. Custom indicators should include process and outcome measures directly correlated with the logic model. Below are examples of additional process and outcome measures for the strategies/activities and outcomes previously discussed in the logic model and associated sections.

• Number of key provincial and national meetings held with stakeholders to disseminate and promote responses to CLM findings [Target: 3; Reporting Frequency: Annual]

• Percentage of HIV-positive clients registered in care through MA EIT [Target: 50%;

Reporting Frequency: Annual]

• Percentage of clients, who scheduled their appointment with providers rendering prevention, care, and treatment services through MA EIT [Target: 40%; Reporting Frequency: Semi-annual]

• Number of IS and/or MA EIT that are interoperable with PHIS [Target: 3; Reporting Frequency: Annual]

• Number of IS and/or MA EIT incorporating the system of electronic standards, which is adopted for common use in the Ukrainian Public Health sector [Target: 20; Reporting Frequency: Annual]

• Number of up-to-date and adopted national standards (on electronic variables, data sets, codes, indicators) and M&E frameworks [Target: 150; Reporting Frequency: Annual]

• Number of interventions or referrals provided through HIV hotline [Target: 200;

Reporting Frequency: Annual]

• Number of calls to HIV hotline [Target: 350; Reporting frequency: Monthly]

• Percentage of health facilities that assess HIV prevention, care, and treatment service gaps and implement effective resolutions [Target: 80%; Reporting Frequency: Annual]

• Percentage of HIV-affected, vulnerable populations accessing HIV services [Target:

+20% from baseline; Reporting Frequency: Quarterly]

• Number of CBOs demonstrating capacity to use innovative MA EIT and available electronic platforms to improve patient clinical management and service provision [Target: 3; Reporting Frequency: Quarterly]

• Number of CBOs that timely collect, analyze, report and use their own data for program and service delivery improvement [Target: 3; Reporting Frequency: Quarterly]

Data Sources for MER and Custom Indicators: Data sources may include registers, tally sheets, electronic and paper patient records, quarterly progress reports, surveillance and survey reports, and other program monitoring tools.

Evaluation

The evaluation topics below are examples of areas that the recipient may be expected to answer through process or outcome evaluation(s). Applicants should include at least 1, but no more than 3 potential evaluation topic areas. Recipients will be expected to conduct an end-year evaluation.

Sample Evaluation Topics:

1. Effectiveness of MA EIT in improving clients’ access to HIV prevention, care, and treatment [Outcome]

2. Assessment of interoperability of PHIS [Process]

3. Assessment of HIV prevention, care, and treatment services reach among HIV-affected, vulnerable populations [Process]

Evaluation Data Sources: Data sources may include registers, tally sheets, electronic and paper patient records, recipient progress reports, focus groups, in-depth interviews, surveys, and other program monitoring tools.

Dissemination of Evaluation Results: Dissemination channels may include local and international conferences and forum abstract presentations, conference poster displays, manuscripts, bulletins, reports, presentations to technical working groups and stakeholder meetings, and other approved products in print and electronic media. The primary intended users of evaluation results and findings will be the wider program stakeholders. All evaluation reports will be publicly available on PEPFAR resource sites. CDC and stakeholders will use overall evaluation findings during the five-year NOFO period to share and implement key recommendations to strengthen program implementation and effectiveness, sustainability, and continued program improvement upon completion of the award.

Evaluations and strategy should align with national, PEPFAR, and agency requirements and priorities, and will be reviewed and may require approval as part of the COP/ROP. As such, the example evaluation topics listed in this NOFO may be amended based on feedback from the GHSD Bureau during the annual COP/ROP review process.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

• How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement, including, as applicable to the award, how findings will contribute to reducing or eliminating health disparities and inequities.

• How key program partners will participate in the evaluation and performance measurement planning processes.

• Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant).

• How evaluation findings will be disseminated to communities and populations of interest in a manner that is suitable to their needs.

• Plans for updating the Data Management Plan (DMP) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data;

data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additional-requirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, the applicant should be directed to:

• Describe the type of evaluations (i.e., process, outcome, or both).

• Describe key evaluation questions to be addressed by these evaluations.

• Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

Applicants should submit their initial data management plan (DMP) as part of their initial evaluation and performance measurement plan (EPMP). This should include cybersecurity plans and information about how PII will be protected when collected, stored, in transit, and in use.