Revised Foa_Content_of_CDC-RFA-GH-24-0093 (1).pdf

Centers for Disease Control and Prevention

Center for Global Health

Integrated Data Management and Analysis for Informed Public Health Decision-Making in Ukraine under the President's Emergency Plan for AIDS Relief (PEPFAR)

CDC-RFA-GH-24-0093

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-24-0093. 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:

Integrated Data Management and Analysis for Informed Public Health Decision-Making 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)).

Amendment I: Questions and Answers (Q&A), Application Due Date Extension, and Additional Updates

The purpose of this amendment is to include the updates as listed below.

• The amendment includes questions and answers (Q&A) in Section H. Other Information.

• The amendment also extends the Application Due Date from February 17, 2024 (2/17/2024) to February 21, 2024 (2/21/2024).

• There may be some NOFOs uploaded under the “Related Documents” tab of www.grants.gov with the search and copy/paste functions disabled, but this is an error CDC is working to fix. In the meantime, applicants may also access the NOFO document by clicking on the “Package” tab of the opportunity on www.grants.gov, clicking the “Preview” button under the “Actions” column of the Opportunity Package, and then clicking on the “Download Instructions” button. This should allow applicants to download the full NOFO PDF document with the search and copy/paste functions enabled.

• CDC has retired the Risk Assessment Questionnaire Requirement and applicants are no longer required to submit the CDC Risk Questionnaire as part of their NOFO application.

CDC continues to conduct the review of risk posed by applicants described in Phase III Review and may ask for additional information prior to the award based on the results of the review. Risk Questionnaires that are submitted will not be included in this risk review.

• In F. Award Administration Information, 2. Administrative and National Policy Requirements, CDC has added AR-38: Health Information Technology (IT) Interoperability to the list of Organization Specific Administrative Requirements.

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-24-0093

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 This NOFO aims to support the Center for Public Health of the Ministry of Health of Ukraine (PHC) to improve health outcomes and enhance evidence-based decision-making through the effective use of integrated data and will revolutionize public health data analysis in Ukraine. This NOFO aims to develop reporting tools, trend analysis and visualizations to present interpreted data effectively. This will enable the PHC to make informed decisions based on the processed data, which will improve health outcomes, and support evidence-based decision-making. By implementing advanced techniques, the recipient(s) will integrate and analyze diverse datasets to identify patterns, trends, and relationships. The PHC will receive comprehensive trainings to strengthen their team in data management and analysis skills, enabling evidence-based decision-making using integrated data repositories. The recipient(s) will also play a pivotal role in advancing accurate and precise health information for a sustainable and informed HIV response.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards The expected number of awards is 1-2.

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:

$800,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $800,000. The expected number of awards is 1-2. 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 In Ukraine, strategic information (SI) plays a critical role in shaping and guiding the HIV response.

Since February 2022, the implementation of the PEPFAR program in Ukraine has encountered unprecedented challenges, especially to meet the expanding needs of key and emerging priority populations due to the ongoing war with Russia. The availability and effective use of accurate, timely, and relevant data is crucial for evidence-based decision-making, resource allocation, program planning, monitoring of HIV prevention and treatment services.

Despite the ongoing war, Ukraine remains committed to health systems recovery, based on international best practices, by improving the quality of HIV data to inform effective service-delivery, building workforce capacity; and investing in person-centered care that addresses additional needs for people living with HIV (PLHIV).

Due to the war, Ukraine operates in an environment where most of the previously available surveillance data is outdated and cannot be used to inform programming. Before the full-scale invasion, Ukraine had a strong surveillance system that encompassed routine HIV data and biobehavioral surveys (BBS) in key populations (KPs). Effective data analysis will support implementation of PEPFAR programs.

The approach used in this NOFO is focused on integrated data management and analysis to support informed public health decision-making. The rationale behind this approach is that by utilizing advanced techniques and integrating diverse datasets, valuable insights can be generated to inform policies, interventions, and resource allocation.

The NOFO will aim to enhance the skills and capacity of the PHC in the Ministry of Health (MOH) of Ukraine and other stakeholders in data management and analysis to improve the quality, accessibility, and utilization of SI for decision-making. The PHC is PEPFAR’s primary government interlocutor, as an implementer and as the designated policy and coordination lead for the MOH on HIV and public health broadly. Rigorous analysis of the different data sets from medical information system monitoring socially significant diseases (IS MSSD) will contribute substantially to prevention of antiretroviral therapy (ART) interruption, re-engagement of PLHIV experiencing interruption in treatment (IIT) on ART and timely viral load (VL) testing.

The project will seek to inform and strengthen HIV prevention, treatment, and care programs by utilizing data-driven insights to identify gaps, tailor interventions, and improve program coverage and effectiveness.

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 CDC Ukraine’s priorities are broken down across five strategic pillars, reflecting PEPFAR’s 5x3 strategy.

CDC Ukraine’s priorities are designed to support the ongoing wartime recovery of HIV service delivery in cooperation with the GOU, civil society, particularly KP and patient-led civil society, and other partners. CDC Ukraine’s strategic priorities include sustaining the public health response through SI and data analysis.

Recognizing the importance of having rigorous SI about the HIV epidemic in Ukraine and its progress towards 95-95-95 goals, this NOFO will seek to strengthen data analysis from national information systems. CDC Ukraine’s invested in development of IS MSSD, formerly known as HIV Medical Information System (HIV MIS IS MSSD) is the most advanced information system operating in the Ukrainian Public Health sector. It allows data analysis for decision making, and generates national and international reporting, including PEPFAR reporting. Through the award CDC-RFA-GH18-1817, CDC Ukraine extended its assistance to IS MSSD from 2018 to 2023, with the current PHC implementing partner streamlining and coordinating efforts of stakeholders in IS MSSD advancement.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-Term Outcomes

Intermediate Outcomes

Long-Term Outcomes

Strategy 1:

Develop and implement integrated data repositories, data collection mechanisms, and quality control measures for PHC to strengthen data management systems and processes

Strategy 2:

Employ advanced analytical techniques for PHC to analyze diverse datasets, patterns, and trends to generate actionable insights

Strategy 3:

Strengthen data management and analysis capacity of PHC and other regional stakeholders through comprehensive trainings to enable informed decision-making

Increased adherence to data management protocols, policies, and procedures among data managers

Improved capacity of PHC to effectively collect, produce, and analyze high-quality data for decision-

Increased utilization of modeling techniques to analyze HIV-related data

Improved access to critical health information and data through the establishment of a SI portal for PHC and regional CDCs

Improved accountability and transparency in data management practices

Improved analysis and use of high-quality data for strategic program planning and evidence-based decision making

Increased efficiency in addressing HIV-related challenges through advancements in data analysis

Enhanced capacity for real-time monitoring and response to HIV outbreaks and epidemiological changes

Improved data confidentiality and security

Increased utilization of the SI portal, leading to more informed decision-

Reduced HIV incidence and mortality rates through targeted and evidence-based interventions driven by data analysis outcomes

Increased data management and analytics capacity of public health professionals to inform data-driven interventions

i. Purpose The purpose of this NOFO is to enable the PHC to effectively leverage SI for decision-making.

This approach will strengthen PHC data management and analysis capacity, leading to enhanced quality, accessibility, and application of SI for evidence-based decision-making. The recipient(s) will use data-driven insights to bolster HIV prevention, treatment programs, identifying areas for improvement, and enhancing program coverage and effectiveness.

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:

• Increased adherence to data management protocols, policies, and procedures among data managers

• Improved capacity of PHC to effectively collect, produce, and analyze high quality data for decision-making

• Increased utilization of modeling techniques to analyze HIV-related data

• Improved access to critical health information and data through the establishment of a SI portal for PHC and regional CDCs

Intermediate Outcomes:

• Improved accountability and transparency in data management practices

• Increased efficiency in addressing HIV-related challenges through advancements in data analysis

• Enhanced capacity for real-time monitoring and response to HIV outbreaks and epidemiological changes

• Improved data confidentiality and security

• Increased utilization of the SI portal, leading to more informed decision-making

Long-Term Outcomes:

• Increased data management and analytics capacity of public health professionals to inform data-driven interventions

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: Develop and implement integrated data repositories, data collection mechanisms and quality control measures for PHC to strengthen data management systems and processes

• Train healthcare professionals and data managers on data management protocols

• Develop and implement Data Governance Policies and Procedures

• Upgrade data collection mechanisms through technology integration

• Establish Role-Based Data Access Controls

• Establish mechanisms for merging different data sources

• Establish a SI portal-knowledge management platform for PHC and regional CDCs

Strategy 2: Employ advanced analytical techniques for PHC to analyze diverse datasets, patterns, and trends to generate actionable insights

• Conduct advanced data analysis and data triangulation with a specific focus on HIV-related data

• Develop customized dashboards for HIV data utilizing Open-source BI tools, Power BI/Tableau, MicroStrategy

• Implement modeling techniques to analyze data related to HIV programs, including recency, epidemiology, outbreaks, mortality, and incidence

• Provide training sessions on modeling tools

Strategy 3: Strengthen data management and analysis capacity of PHC and other regional stakeholders through comprehensive trainings to enable informed decision-making

• Develop distance learning and online courses: data management, advanced data analytics, ArcGIS for spatial data management and analysis, facilitating geospatial insights for public health interventions

• Train PHC staff on data security best practices

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 implementing partners (IPs) including non-governmental organizations, universities, and other host governmental bodies and multi-lateral organizations that receive CDC funds. Interaction with the PHC, Regional CDCs, WHO, UNAIDS and KP-led civil society organizations are mandatory as these are the key players for achieving epidemic control of HIV in Ukraine. The aim of these collaborations is to strengthen, coordinated joint efforts to efficiently use SI and then sustain HIV epidemic control in Ukraine. The recipient(s) 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 will be expected to foster strong collaboration with National Health Service of Ukraine (NHSU), USAID partners, and the Global Fund, as well as other regional and international partners involved in the SI field. Effective partnerships with these organizations will play a pivotal role in enhancing the utilization of SI for evidence-based decision-making and programmatic actions in the public health sector.

2. Population(s) of Focus The populations of focus for this NOFO include KP, PLHIV, as well as PHC and regional CDC staff who will receive technical assistance to build their capacity to manage and analyze SI for evidence-based decision-making, and public health officials and policymakers to ensure that SI is used to shape policies and resource allocation for the HIV response and actions to make necessary program improvements.

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 $800,000 with the below listed components:

• Component 1 – COP Q1-Q2 Targets/Activities;

• Component 2 – COP Q3-Q4Targets/Activities;

• Component 3 – 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 1% of funds should be used for evaluation activities. These are estimates for the total funding over the 5-year project.

PERFORMANCE MONITORING

Some anticipated PEPFAR (non-MER indicators, targets, and reporting frequencies corresponding to Year 1 of the NOFO are shown below. Applicants should also propose any additional relevant PEPFAR MER and non-MER 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.

Strategy 1: Strengthening Data Management Systems (Custom Indicators)

• Percentage reduction in unauthorized access to sensitive health data [Target: 10%;

Reporting Frequency: Annual]

• Number of data integration initiatives implemented [Target: 2; Reporting Frequency:

Annual]

• Proportion of data management systems meeting national data security standards [Target:

100%; Reporting Frequency: Annual]

• Number of data visualization tools developed and implemented [Target: 3; Reporting Frequency: Quarterly]

• Number of data products (e.g., dashboards, reports, etc.) available for decision-makers [Target: 20; Reporting Frequency: Semi-annual]

• Number of data management system audits conducted [Target: 2; Reporting Frequency:

Annual]

• Proportion of data management staff utilizing the strategic information portal [Target:

100%; Reporting Frequency: Semi-annual]

• Number of PHC staff trained on data security protocols [Target: 50; Reporting Frequency: Quarterly]

Strategy 2: Advanced Data Analysis

• Number of staff trained in advanced data analysis techniques (statistical) [Target: 20;

Reporting Frequency: Quarterly]

• Number of staff trained in advanced data analysis techniques (modeling) [Target: 20;

Reporting Frequency: Quarterly]

• Number of staff trained in advanced data analysis techniques (hot spot spatial analysis) [Target: 20; Reporting Frequency: Quarterly]

• Number of staff trained in advanced data analysis techniques (relative risk regression) [Target: 20; Reporting Frequency: Quarterly]

• Number of geospatial analysis projects conducted for targeted interventions [Target: 4;

Reporting Frequency: Annual]

• Number of predictive modeling exercises completed [Target: 3; Reporting Frequency:

Annual]

Strategy 3: Capacity Building and Trainings

• Number of data analysis/utilization requests from PHC staff placed [Target: 15;

Reporting Frequency: Annual]

• Number of distance learning and online courses developed and implemented [Target: 5;

Reporting Frequency: Annual]

• Proportion of PHC staff trained in data management and advanced data analytics [Target:

80%; Reporting Frequency: Semi-annual]

• Number of PHC staff trained in ArcGIS for spatial data management and analysis [Target: 50; Reporting Frequency: Annual]

• Percentage increase in the utilization of geospatial insights in public health interventions [Target: 30%; Reporting Frequency: Semi-annual]

• Number of training sessions on data security best practices conducted [Target: 10;

Reporting Frequency: Annual]

• Number of PHC participants engaging in knowledge-sharing sessions [Target: 3;

Reporting Frequency: Annual]

• Number of data management capacity-building workshops conducted [Target: 3;

Reporting Frequency: Quarterly]

• Proportion of PHC data management staff trained in using data analysis tools [Target:

80%; Reporting Frequency: Semi-annual]

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:

• Strengthening of data management systems and its contributions to improve HIV program data management and decision-making [Process/Outcome evaluation]

• Effectiveness of targeted HIV prevention interventions and the identification of high-risk areas through geospatial insights in Ukraine using advanced data analysis [Outcome Evaluation]

• Extent to which capacity building and trainings enhanced the skills and knowledge of primary healthcare staff in data management, advanced data analytics, and ArcGIS, and how has this translated into improved public health interventions and outcomes [Outcome Evaluation]

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. In addition, the initial DMP should include a description about how data will be de-identified in intermediate and final data sets. Finally, where data collected or generated under this award may be sought by PEPFAR or CDC, recipient(s) will be informed about the need to share such information and how to send such information to PEPFAR or CDC.

c. Organizational Capacity of Recipients to Implement the Approach Applicants must provide supporting documentation to show evidence of their organizational capacity to implement the approach. Documentation supporting this element must be submitted in the appendix, be clearly labeled, and be easily identifiable. Applicants must submit the following materials in their appendix:

• Statement of Experience demonstrating organizational capacity to address the requirements of the NOFO, specifically in the following areas:

o Strengthening Data Management Systems:

▪ Previous experience in managing and analyzing health data, including data collection, storage, and security protocols, especially related to HIV/TB programs or public health in Ukraine.

▪ Demonstration of how the organization ensures data quality, accuracy, and completeness through regular data audits and validation processes.

▪ Explanation of the organization's ability to integrate and manage diverse datasets to provide comprehensive SI.

▪ Details of any existing partnerships with national and regional health authorities or institutions related to data management and surveillance.

o Advanced Data Analysis:

▪ Description of the organization's expertise in using advanced data analysis techniques, such as predictive modeling, geospatial analysis, and statistical methods, specifically related to public health programs or HIV/TB interventions and how this was applied to improve program outcomes or inform evidence-based decision-making in previous projects.

o Capacity Building:

▪ Evidence of successful capacity-building initiatives that have strengthened the skills and knowledge of healthcare staff and other stakeholders.

▪ Explanation of how the organization tailors capacity-building approaches to address the specific needs of different target groups, such as healthcare…