Malawi CDC-RFA-JG-25-0050 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 21, 2025

Improving quality of care and health outcomes through innovative systems and technologies in Malawi under the President’s Emergency Plan for AIDS Relief (PEPFAR) Opportunity number: CDC-RFA-JG-25-0050

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 8

Program description 10

Step 2: Get Ready to Apply 32

Get registered 33

Questions 34

Step 3: Prepare Your Application 35

Application contents and format 36

Step 4: Learn About Review and Award 46

Application review 47

Award notices 54

Step 5: Submit Your Application 55

Application submission and deadlines 56

Application checklist 58

Step 6: Learn What Happens After Award 60

Post-award requirements and administration 61

Contacts and Support 68

Contents 2

Before you begin If you believe you are a good candidate for this funding opportunity, secure your SAM.gov and Grants.gov registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks) You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI).

See Step 2: Get Ready to Apply

Grants.gov registration (this can take several days) You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get Ready to Apply

Apply by the application due date Applications are due by 11:59 p.m. Eastern Time on February 21, 2025.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command + Left Arrow (Mac) on your keyboard.

Before you begin 3 https://sam.gov/ https://grants.gov/

Jump to a step

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 8

Program description 10

Basic information U.S. Centers for Disease Control and Prevention (CDC)

Global Health Center

Division of Global HIV and Tuberculosis

Reducing HIV and TB incidence and mortality in global settings through data-driven programs and strengthened public health systems.

Have questions?

See Contacts and Support.

Key facts

Opportunity name:

Improving quality of care and health outcomes through innovative systems and technologies in Malawi under the President’s Emergency Plan for AIDS Relief (PEPFAR)

Opportunity number:

CDC-RFA-JG-25-0050

Announcement type:

New

Assistance listing:

93.067 Global AIDS

Program

Key dates

Application deadline:

February 21, 2025

Expected award and start date: September 30, 2025.

We will inform you of your application status by the end of August 2025.

See other submissions for other time frames that may apply to this

NOFO.

Summary This NOFO builds on gains made in Malawi’s HIV health information systems (HIS) by:

• Strengthening existing data systems.

• Improving security through application of International Organization for Standardization (ISO).

• Enhancing and expanding HIS to ensure reported data at the facility, district, and national levels are accurate, reliable, timely, and useable.

• Maintaining and strengthening HIS infrastructure.

• Improving interoperability and data sharing at all levels of the health care system.

• Supporting patient records management, program monitoring, and timely reporting for the Ministry of Health (MOH) and PEPFAR.

Activities under this NOFO are expected to:

• Improve data reliability and accuracy.

• Enhance use and reporting.

• Increase use of a sustainable nationwide HIV HIS that provides aggregate and case surveillance for reporting and analysis.

• Improve Malawi health information system (MaHIS) governance and implementation by MOH.

• Increase data exchange across systems.

• Improve site-level client identification and deduplication.

Step 1: Review the Opportunity 5

This NOFO supports modernization of a government-owned, sustainable, secure, and integrated HIS for data collection and management. This is to be used at all levels, while improving patient health outcomes. The scope covers building and maintaining associated hardware systems, building MOH capacity to support the systems, increasing user support services, and introducing new and sustainable technologies. These efforts strive to improve the usability, flexibility, and integration of these systems.

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $7,000,000 This is the expected total Year 1 funding for all awards made under this

NOFO.

Expected number of awards: 1-2 The number of awards is subject to available funds and program priorities.

Exact amounts for each award under this NOFO will be determined upon award.

We plan to award projects for five 12-month budget periods for a five-year period of performance.

Funding strategy

Funding amounts We encourage you to apply for the expected total NOFO funding for Year 1.

You may not request more than this amount.

Funding amounts for years two through five will be set at continuation. We will continue funding based on:

• Availability of funds.

• Evidence of satisfactory progress, as documented in your required reports.

• The determination that continued funding is in the best interest of the federal government.

Step 1: Review the Opportunity 6

Component funding

Overview

We fund all President’s Emergency Plan for AIDS Relief (PEPFAR) cooperative agreements using component funding.

Component funding allows us to provide funding as it becomes available. To do so, we fund sets of activities by quarter and project.

CDC may fund one or more of your components to start the budget period, and then consider other components based on available funding later.

Setting up components

You must set up your components in your application. While preparing your application:

• Review the expectations for year one activities in the strategies and activities section.

• Group your activities under the following anticipated components. Only include the activities planned for year one.

◦ Component 1: COP Q1 Targets and Activities.

◦ Component 2: COP Q2 Targets and Activities.

◦ Component 3: COP Q3 Targets and Activities.

◦ Component 4: COP Q4 Targets and Activities.

◦ Component 5: COP Additional Targets and Activities.

For information on how to incorporate component funding into your application, see the following sections:

• Budget narrative

• Component funding instructions for SF-424A

PEPFAR Local partner funding preference This NOFO includes a funding preference for local partners. Your organization will receive 15 extra points during the selection process if you provide sufficient documentation demonstrating you meet the PEPFAR local partner definition.

Step 1: Review the Opportunity 7

Eligibility Statutory authority This program is authorized under:

• The United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003, Public Law 108-25 (22 U.S.C. 7601, et seq.).

• The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, Public Law 110-293.

• The PEPFAR Stewardship and Oversight Act of 2013, Public Law 113-56.

• Public Health Service Act (42 U.S.C. 242I).

Eligible applicants This is a fully competitive NOFO, and eligibility is unrestricted. Any and all types of organizations are eligible and encouraged to apply, including but not limited to those listed below.

• State governments.

• County governments.

• City or township governments.

• Special district governments.

• Independent school districts.

• Public and state-controlled institutions of higher education.

• Native American tribal governments (federally recognized).

• Public housing authorities and Indian housing authorities.

• Native American tribal organizations, other than federally recognized tribal governments.

• Nonprofits having a 501(c)(3) status, other than institutions of higher education.

• Nonprofits without 501(c)(3) status, other than institutions of higher education.

• Private institutions of higher education.

• For-profit organizations other than small businesses.

• Small businesses.

• Foreign or non-U.S. based entities.

Step 1: Review the Opportunity 8

Other required qualifying factors

Delivery location While any type of organization may apply, you must conduct the project in Malawi.

Responsiveness criteria We will review your application to make sure it meets these requirements.

These are the basic requirements you must meet to move forward in the competition. We won’t consider an application that:

• Is from an organization that doesn’t meet eligibility criteria. See requirements in eligibility.

• Is submitted after the deadline.

• Proposes research activities. See 45 CFR 75.2 for the definition of research.

• Requests more funding than the expected total NOFO funding for Year 1.

• Exceeds the 20-page limit for the project narrative (see the project narrative section for what counts toward the page limit).

• Is not in English.

• Includes a budget or budget narrative that uses a currency other than U.S. dollars.

• Does not respond to and is outside the scope of this NOFO.

See the application checklist to understand your application requirements.

Application limits We do not limit the number of applications an organization may submit.

Cost sharing and matching funds This program has no cost-sharing or matching funds requirement. We will not consider cost-sharing fund contributions during your application review.

However, if you submit voluntary cost-sharing funds and we fund your project, we will require you to report on these funds.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 9 https://www.ecfr.gov/current/title-45/part-75#p-75.2(Research)

Program description Background overview and related work Malawi is very close to reaching the 95-95-95 UNAIDS targets to eliminate HIV as a public health threat by 2030. As continued strides are made in controlling the epidemic, a robust electronic medical record (EMR) system is required to provide comprehensive, accurate, and real-time data that will adequately monitor the epidemic.

The current HIV EMR system covers about 98% of all people living with HIV in Malawi; however, there are gaps in EMR coverage and a continued need to improve case surveillance along with separate and combined data reports.

Additionally, MOH seeks to use the HIV EMR to serve as the backbone technology for the MaHIS. MaHIS is a robust and cost-effective EMR system for HIV and other health conditions. This effort addresses a key gap in patient records and provides a system that allows for patient records to be centrally located instead of relying on individual, paper-based health passports and facility-based paper registers.

A centralized EMR can be effective in reducing duplicate patient records. With a centralized EMR system, patient records can easily be restored to sites after natural disasters and other disruptions, improving continuity of care.

EMRs can also facilitate improved care and treatment by providing a longitudinal medical record so that medical personnel can view medication history, HIV viral load (VL), and other health trends.

The next stage in developing these data systems is to:

• Implement reliable and sustainable connectivity for all EMR sites.

• Link the existing data system to other MOH systems (e.g. District Health Information System 2).

• Ensure HIS implementation and innovations maintain compliance with Open Source Medical Records System (OpenMRS) and Open health information exchange (OpenHIE) standards.

• Increase the availability of in-time data for policymakers, clinicians, PEPFAR, researchers, and other key interest holders.

This NOFO builds on the EMR and Laboratory Information Management System (LIMS) investments and gains made for the HIV response by

Step 1: Review the Opportunity 10 leveraging and expanding existing technologies. The current system is comprised of multiple components including:

• The facility-level Point of Care (POC) and eMasterCard systems.

• A Central Data Repository (CDR).

• Two LIMS.

• Early Infant Detection/VL.

• Basic Laboratory Information System (iBLIS) for non-HIV lab tests.

• National LIMS.

• An electronic Civil Birth and Vital Records system (CRVS).

The POC system is a real-time, facility-based system for managing antiretroviral therapy and other key records for HIV clients. eMasterCard is a retrospective system for entering paper-based records into electronic data from sites with a low number of clients (<1000) and limited connectivity. All patient data from both the POC and eMasterCard systems are entered into a single patient record in the CDR; however, connectivity and power backup remain key roadblocks for the system to function effectively.

Current EMR systems statistics are below:

• 766 facility sites operating EMR in Malawi.

• 257 sites with the POC system.

• 50 sites consistently transmit data to the CDR in real-time.

• 207 sites have recurrent connectivity issues preventing consistent transmission of data in real-time.

• 509 sites with the eMastercard system.

For eMasterCard, sites must connect to the data network prior to quarterly reporting deadlines to transmit data to the CDR. Currently there are approximately 259 sites that have some connectivity but only approximately 126 have stable connectivity. Ideally, all sites would have full connectivity, but this is cost prohibitive with current technology and a solution is needed.

While CDR is interoperable with the Malawi civil registration, vital statistics, and lab information systems, improvements are still required to ensure ease of use, data mining, and record management. Several lessons have been learned from the previous NOFO CDC-RFA-GH20-2081 and other donor investments in HIV HIS in Malawi. These include the need to:

• Extensively involve all key interest holders throughout all phases of implementation, including design, to ensure usability and that the system addresses user needs and performance.

Step 1: Review the Opportunity 11

• Ensure interoperability with other MOH systems.

• Address unreliable connectivity and power outages.

◦ Connectivity in Malawi is a challenge with many sites unable to maintain connections.

• Power supply is also unreliable, requiring sites to have effective primary and backup power at site level.

• Build capacity of MOH staff to maintain and manage the HIS investments.

• Technical assistance (TA) and training are needed to increase the knowledge and ability of MOH staff to take full ownership and governance of the HIS.

• Strengthen partnership and collaboration with local consultants and technology providers to identify sustainable solutions with MOH staff.

This NOFO identifies mechanisms to resolve these challenges and successfully achieve the goals.

Purpose The purpose of this NOFO is to improve the quality of care and health outcomes of people living with HIV at all levels of Malawi’s health delivery system by strengthening and expanding innovation within the MaHIS. The NOFO will support enhancing the existing EMR modules, power, and network infrastructure to promote:

• Support of existing HIV EMR across all levels of health facilities.

• Accurate and timely reporting and tracking of HIV data.

• Availability of quality, reliable, and accessible data to support evidence-based decision-making at site and national levels.

Step 1: Review the Opportunity 12

Approach Program logic model The following logic model includes the expected strategies under this NOFO.

The logic model also includes the program’s expected outcomes. Outcomes are the results that you intend to achieve and usually show the intended direction of change, such as increase or decrease.

The asterisked ( * ) outcomes are those we expect you to achieve or substantially contribute to during the five-year period of performance. You must report on these outcomes.

Not all outcomes apply to all strategies. You will use these outcomes as a guide for developing performance measures.

Table: Strategies and outcomes

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes

Strategy 1: Develop a reliable and sustainable, real-time HIS for MOH HIV reporting and case surveillance.

Strategy 2: Maintain existing EMR system and ensure compliance with OpenMRS, OpenHIE, and ISO security standards.

Strategy 3: Implement and support a fully functional single LIMS that is integrated with National LIMS, CDR, and MaHIS.

Strategy 4: Provide connectivity and hardware support to

Increased HIV reporting by CDR for PEPFAR and MOH.*

Increased generation of case surveillance data sets for reporting and research.*

Improved EMR modules that continually adapt to user needs.*

Improved harmony between laboratory data entry and sample processing.*

Decreased time between results being available and result production.*

Improved site-level power backups

Increased availability of reliable, accurate health data for reporting and surveillance.*

Increased use of nationwide HIV EMR for case management.*

Improved data quality at the site and CDR levels.*

Increased data exchange across EMR modules.*

Improved integration of EMR through enhanced data unification.*

Improved modern infrastructure to

Increased use of real-time data for reporting and policy making.*

Increased availability of real-time data for use by interest holders.*

Improved clinical care provision through use of EMR for patient management.

Increased concurrence with OpenMRS and OpenHIE data model through data unification.*

Increased data security through maintenance of ISO standards.*

Step 1: Review the Opportunity 13

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes

MOH and National Reference Bureau to maintain the HIS and

CRVS.

Strategy 5: Enhance capacity of MOH to maintain and govern HIS system for transition to MaHIS.

through installation of upgrades.*

Improved connectivity for HIS/CRVS through sustainable solutions.*

Increased capacity of MOH staff to govern, maintain, and secure

HIS.*

support large databases.*

Increased efficient input of laboratory data by staff.*

Reduced downtime due to lack of power.*

Improved reliable, functional connectivity system for all sites.*

Increased input on development and implementation of MaHIS from competent MOH staff.*

Increased transition of management of HIS to

MOH.*

Improved availability of laboratory results in EMR/MaHIS for clinical case management.*

Improved real-time synchronization of data from all sites with the CDR.*

Increased sustainable management of MaHIS by MOH.*

Additional information on outcomes in the logic model:

• Improved EMR modules that continually adapt to user needs includes upgrading the modules based on user requirements and to address and meet the dynamic needs of interest holders.

• Improved data quality includes, but is not limited to, the completeness and accuracy of real-time data, cleaned and free of duplication.

• Increased data exchange across EMR modules includes both horizontal and vertical data exchange.

• Improved modern infrastructure to support large databases includes but is not limited to LIMS and National LIMS databases.

• Increased efficient input of laboratory data by staff includes a unified laboratory interface for ease of use.

• Competent MOH staff includes staff that are trained in management, quality control, and implementation of MaHIS.

• Increased transition of management of HIS to MOH includes, but is not limited to, transitioning management of the:

Step 1: Review the Opportunity 14

◦ HelpDesk.

◦ Site maintenance.

◦ OpenMRS and OpenHIE standards.

◦ ISO security standards.

◦ Innovations and implementation in HIS that are responsive to the needs of the population.

• Interest holders include, but are not limited to:

◦ Government ministries, departments, and agencies

◦ MOH.

◦ Others, as applicable.

◦ Academic Institutions.

◦ Other HIV-related institutions.

Strategies and activities This section elaborates on the strategies described in the logic model by providing expected activities and details about how you expect to implement your program.

Following are strategies and the required activities under this NOFO. You may also propose additional related strategies and activities to achieve the expected outcomes.

Strategy 1: Develop a reliable and sustainable, real-time HIS for MOH HIV reporting and case surveillance.

Required activities:

• Ensure the CDR is fully functional and ISO information technology security compliant, including but not limited to:

◦ ISO 27001.

◦ ISO 27002.

◦ Other related standards.

• Assess and ensure that any identified security issues are monitored and addressed across the entire HIS ecosystem, including but not limited to:

◦ Site-level.

◦ LIMS.

◦ National LIMS.

Step 1: Review the Opportunity 15

◦ EMR.

◦ CRVS.

• Develop an innovative and simple processing tool for running reports and data sets (e.g., PEPFAR and MOH annual and quarterly reporting) and analytical data sets, as needed at the central, district, and facility- level.

• Integrate the HIS with other central-level systems including ScanForm technology.

• Collaborate with MOH, CDC, and relevant interest holders to ensure that there is an efficient, cost-effective, and reliable process in place for data transmission from CDR to Department of HIV/AID Information Management System.

• Use innovative and evidence-based strategies to demonstrate the feasibility of transitioning from paper-based registers to an EMR.

• Use Malawi National identifiers when appropriate for client registration and system-wide identification.

• Generate reports to monitor the progress of real-time synchronization of data by POC sites to submit to CDC on a routine basis.

◦ Ensure that generated reports are complete and include identified problems, solutions, and timelines for resolution.

Strategy 2: Maintain existing EMR system and ensure compliance with OpenMRS, OpenHIE, and ISO security standards.

Required activities:

• Conduct regular maintenance on EMR modules and associated hardware.

• Develop and implement EMR module upgrades based on user and interest holder feedback.

• Enhance EMR data model to improve performance, data unification, and compliance with OpenMRS, OpenHIE, and ISO security standards.

• Provide TA on the system architecture to MOH and other donors who are building modules in the system.

• Conduct regular upgrades on existing HIV-related modules (e.g., antiretroviral therapy, cervical cancer, outpatient department, etc.).

• Ensure interoperability of HIS with other systems, including government systems.

Step 1: Review the Opportunity 16

Strategy 3: Implement and support a fully functional single LIMS that is integrated with National LIMS, CDR, and MaHIS.

Required activities:

• Continue current integration work on LIMS-National LIMS-Sample Transportation feedback loop to fully integrate EMR with sample transportation network’s tracking system to provide real-time tracking of samples and results.

• Assess if the current mix of iBLIS and early infant diagnosis (EID)/VL system is optimal and propose a solution for a single user interface to the LIMS.

• Develop a single-user interface for laboratory data entry and sample processing.

• Implement and support single lab user interfaces and back-end systems (e.g., iBLIS and EID/VL systems).

• Improve functionality of LIMS to cover all essential laboratory tests, including but not limited to:

◦ Advanced HIV disease.

◦ VL.

◦ EID.

◦ Hematology.

◦ Blood chemistry.

◦ Cervical cancer screening, etc.

• Modernize infrastructure supporting LIMS and National LIMS to handle larger databases.

• Ensure LIMs and National LIMS are aligned with ISO security standards.

Strategy 4: Provide connectivity and hardware support to MOH and National Reference Bureau to maintain the HIS and CRVS.

Required activities:

• Implement a connectivity solution across all sites, both local and wide area, that is secure and can be transitioned to Government of Malawi.

• Install and properly maintain power backup systems at site and central levels.

◦ Ensure all backup systems are integrated and compliant with the Government of Malawi’s solarization initiative.

Step 1: Review the Opportunity 17

• Procure and install hardware as needed for functional EMR and National Registration Bureau.

• Link all systems to MaHIS through software, connectivity, and power back-up.

Strategy 5: Enhance capacity of MOH to maintain and govern system for transition to MaHIS.

Required activities:

• Provide TA to MOH for troubleshooting process to address system problems reported in the Helpdesk and other feedback on system functionality.

• Provide needed TA to repair hardware and other issues through the Helpdesk and maintenance reporting tool.

• Transition all Helpdesk operations to MOH and/or Government of Malawi District Council Office.

• Provide direct TA and training to MOH staff on site-level use, data quality standards, information technology project management, and functionality and management of EMR.

• Conduct data quality assessments to ensure that staff are following quality standards, and that site-level data is accurate and reliable.

• Develop and implement a site-level maintenance reporting tool to ensure that facilities are operational and that any issues are addressed appropriately in collaboration with interest holders.

To support the purpose of this NOFO, you are 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.

Epidemic control activities In coordination with the Global Health Security and Diplomacy (GHSD) Bureau at the U.S. Department of State, and as part of PEPFAR, CDC works with host country governments and other partners. Together, we assess the needs of each country and design a plan for assistance that fits within the host nation’s strategic plan.

We consider a national HIV epidemic to be under control when:

• The number of HIV-related deaths is declining, and

• The number of new infections is less than the number of deaths.

Step 1: Review the Opportunity 18

Controlling the epidemic does not mean that HIV will be eliminated. Instead, it means that the number of people with HIV in the population is decreasing. If new infections or death rates increase, this means the epidemic is no longer under control.

Our work doesn’t end when we reach epidemic control; we must sustain the gains. During your award we may ask you to conduct additional activities to reach and maintain epidemic control, consistent with the scope of this NOFO and the related policies below. This may include:

• Improving prevention, testing, and treatment efforts for HIV/AIDS, TB, sexually transmitted infections (STI), and related opportunistic infections, especially among vulnerable, key, and priority populations as defined in PEPFAR’s annual Country/Regional Operational Plan (COP/ROP) Guidance.

• Promoting sustainable, country-led approaches to managing HIV/AIDS and TB and empowering national and local partners to take the lead in designing and conducting high-quality and cost-effective programs. This could involve forming new partnerships with private, public, local, and multisector entities that can complement and expand the reach of existing programs.

• Improving and expanding laboratory, surveillance, and information systems and using the PEPFAR platform for broader disease surveillance and public health programs in ways that align with PEPFAR goals and initiatives.

• Enhancing efforts to prevent, detect, respond to, and treat other diseases affecting people living with or at risk of HIV.

Related policies If awarded, any activities you conduct must follow the directions in:

• Reimagining PEPFAR’s Strategic Direction: Fulfilling America’s Promise to End the HIV/AIDS Pandemic by 2030.

• PEPFAR’s annual COP/ROP Guidance and approved COPs/ROPs.

• Similar forthcoming strategy, guidance, or planning documents that are consistent with relevant laws.

Geographic focus The geographic focus of this program may change during the period of performance, based on the burden of disease and changing program and PEPFAR priorities.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 19 https://www.state.gov/reports-pepfar/ https://www.state.gov/wp-content/uploads/2022/09/PEPFAR-Strategic-Direction_FINAL.pdf https://www.state.gov/wp-content/uploads/2022/09/PEPFAR-Strategic-Direction_FINAL.pdf https://www.state.gov/reports-pepfar/

Outcomes We expect you to achieve or substantially contribute to the outcomes asterisked ( * ) in the logic model by the end of the five-year period of performance. You will be expected to report on these outcomes.

Focus populations The focus populations for this NOFO include but are not limited to:

• District health management teams.

• People living with HIV.

• Infants receiving EID HIV services.

• Laboratorians.

• Data managers.

• Information technology professionals.

• Interest holders, including:

◦ MOH.

◦ Non-governmental organizations.

◦ Universities.

◦ Other HIV-related institutions.

Equal opportunities 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).

• Other constitutionally protected statuses.

Health disparities The goal of health equity is for everyone to have a fair and just opportunity to be as healthy as possible. Health disparities are often caused by social determinants of health. Social determinants of health are conditions in the environments where people are born, live, learn, work, play, worship, and age.

Step 1: Review the Opportunity 20

These determinants affect a wide range of health, functioning, and quality-of-life outcomes and risks. They also influence which populations are most affected by health conditions.

A health disparity is a difference in health burdens between groups of people with differing social determinants of health.

We expect all proposed activities to affirm and advance health equity and an equitable, diverse, and inclusive workforce as core principles. In addition to the strategies and activities listed above, during your award, we may ask you to conduct activities consistent with local laws to:

• Address health disparities in access to and use of HIV and TB services.

• Reduce HIV and TB stigma and discrimination.

• Promote civil and human rights to improve health outcomes of people living with or at risk of HIV and TB.

• Make the workforce more inclusive.

Organizational capacity You must include a heading in your Project Narrative titled Organizational Capacity, under which you should include a brief description of your organizational capacity to carry out these strategies and activities.

You must also provide supporting documentation in your attachments. See the attachments section for full instructions.

Collaborations If funded, we will expect you to collaborate with:

• U.S. Government agencies, such as:

◦ U.S. Agency for International Development.

◦ State Department.

◦ Department of Defense.

◦ Peace Corps.

• Malawi MOH

◦ Central Monitoring and Evaluation Department.

◦ Digital health division.

◦ Directorate of HIV, STIs and Viral Hepatitis.

◦ Health Technical Support Services – Diagnostics Department.

• National Registration Bureau.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 21 https://www.cdc.gov/about/priorities/why-is-addressing-sdoh-important.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html

• National AIDS Commission.

• District health management teams.

• Data use implementing partner.

• Bilateral and multilateral donors.

• Non-governmental organizations.

Through the PEPFAR program, CDC works with partners to help prevent HIV infection, provide life-saving treatment to people living with HIV, and reduce HIV-related deaths. We encourage our partners to collaborate with local organizations, U.S.-based organizations, and international partners. The goal of this collaboration is to complement efforts to lower costs, make programs more effective, sustain the gains, and accelerate progress towards the three UNAIDS 95-95-95 targets:

• At least 95% of people living with HIV know their HIV status.

• At least 95% of people who know their HIV status are on treatment.

• At least 95% of people on treatment have a suppressed viral load.

If you work with key populations as defined in PEPFAR’s annual COP/ROP Guidance, we will expect you to collaborate with them when designing, delivering, and monitoring HIV services.

Data, monitoring, and evaluation CDC expectations CDC expects you to review, clean, and use routine performance data for program management. As a result, you should hold regular review meetings to discuss performance and use data to inform program quality improvement activities.

In your application budget, you should allocate at least 8% of funds for monitoring activities and 3% for evaluation activities. We will discuss these percentages and finalize them at or after award. These are estimates for the total funding over the 5-year project.

Required performance measures

Overview This program includes two types of indicators. These include:

• PEPFAR’s Monitoring, Evaluation, and Reporting (MER) indicators common to all awards. You can find additional information regarding

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 22

MER reporting in the MER Guidance and resource materials, available at DATIM’s MER Indicator Reference Guides.

• Custom indicators that either we or you create. These monitor achievement of outcomes not directly measured by MER indicators.

These include process and outcome measures that directly correlate with the logic model.

The indicators shown below may change before award or in future years. For example, any gaps or unmet needs not fulfilled in the first year may affect the targets in later years.

MER indicators There are currently no MER indicators applicable for this NOFO, but that may change in future project years.

Custom indicators Below we show some anticipated custom indicators, targets, and reporting frequencies for the first year. You may also propose custom indicators.

• Number of PEPFAR MER indicators pulled from CDR for entry into Data for Accountability, Transparency, and Impact Monitoring by appropriate interest holders. [Target: 22; Reporting Frequency: Quarterly]

• Number of reports generated for MOH supervision to address data quality at site level. [Target: 4; Reporting Frequency: Quarterly]

• Percentage of sites that reported 100% concordance between site EMR and CDR data. [Target: 100%; Reporting Frequency: Quarterly]

• Percentage of sites synchronizing data with CDR. [Target: 100%;

Reporting Frequency: Quarterly]

• Percentage of POC sites synchronizing real-time data to the CDR. [Target:

>95%; Reporting Frequency: Monthly]

• Percentage of completed reports generated to monitor progress of real-time synchronization of data by POC sites that are submitted to CDC during the required timeframe. [Target: 100%; Reporting Frequency: Bi-weekly]

• Percentage of POC laboratories with functional single interface LIMS.

[Target: 100%; Reporting Frequency: Annual]

• Percentage of VL results returned to sites electronically within 48 hours of availability at laboratory. [Target: 100%; Reporting Frequency:

Quarterly]

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 23 https://help.datim.org/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

• Percentage of tests available within 48 hours after approval by molecular laboratory. [Target: ≥95%; Reporting Frequency: Monthly]

• Percentage of sites that submit a completed site maintenance report.

[Target: >50%; Reporting Frequency: Monthly]

• Percentage of POC sites receiving electronic EMR updates. [Target: 100%;

Reporting Frequency: Semi-Annual]

• Percentage of eMasterCard sites that are updated within 5 working days of new EMR updates. [Target: 100%; Reporting Frequency: Semi-Annual]

• Percentage of sites that have received EMR updates and trained staff on updates within 3 working days of the update. [Target: >50%; Reporting Frequency: Semi-Annual]

• Percentage of sites that reported no unauthorized users in the EMR system during the routine audit. [Target: >75%; Reporting Frequency:

Monthly]

• Percentage of POC sites with functional electricity backup >75% of the time. [Target: 90%; Reporting Frequency: Monthly]

• Percentage of POC sites with functional network >95% of the time.

[Target: >70%; Reporting Frequency: Monthly]

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 Below, we include examples of evaluation topics that we may expect you to answer through process, outcome, or economic evaluation. In your application, include at least one, but no more than three potential evaluation questions. We will expect you to conduct a mid-term and end-term evaluation.

• Effect of reliable, sustainable real-time HIS for MOH on availability of data and reports: outcome evaluation.

• Facilitators/barriers to use of EMR at site level: process evaluation.

• Facilitators/barriers to use of CDR data for PEPFAR quarterly and MOH supervision reports: process evaluation.

Step 1: Review the Opportunity 24

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 could include:

• Local and international conferences and forum abstract presentations.

• Conference poster displays.

• Manuscripts.

• Bulletins.

• Reports.

• Presentations to technical working groups and stakeholder meetings.

• Other approved products in print and electronic media.

The primary intended users of evaluation results and findings will be the wider program interest holders.

CDC and interest holders will use overall evaluation findings during the 5-year project period to share and implement key recommendations to strengthen program implementation and effectiveness, sustainability, and continued program improvement after the award ends.

All evaluation reports will be publicly available on PEPFAR resource sites.

Evaluation and performance measurement plan You must submit an initial draft of your evaluation and performance measurement plan with your application. You must submit a more detailed plan within the first six months of the award. See reporting.

As you develop your evaluation and performance measurement plan, align it with national, PEPFAR, and agency priorities as detailed in the NOFO. If awarded, we will work with you to finalize the plan and ensure it takes into account agreements made during COP/ROP planning.

Include the following elements in your evaluation and performance measurement plan.

Step 1: Review the Opportunity 25

Methods Describe how you will:

• Collect the performance measures.

• Respond to the evaluation topics.

• Use evaluation findings for continuous program quality improvement.

• Incorporate evaluation and performance measurement into planning, implementing, and reporting of project activities.

Additionally, explain:

• How findings will contribute to reducing or eliminating health disparities, as relevant.

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

• How feasible it will be to collect appropriate evaluation and performance data.

• How you will share evaluation findings with communities and populations of interest in a way that meets their needs.

• Other relevant information, such as performance measures you propose.

Evaluation activities You must carry out specific evaluation activities.

At least one evaluation must be carried out for each cooperative agreement during the course of funding. The evaluation can be:

• Process evaluation: Measures how the intervention was delivered, what worked and did not, the differences between the intended population and the population served, and access to the intervention.

• Outcome evaluation: Determines the effects of the intervention in the focus population, such as change in knowledge, attitudes, behavior, or capacity.

• Economic evaluation: Determines cost, cost drivers, cost effectiveness, efficiency, factors influencing economic behavior and choices, or the economic impact of interventions or activities to justify the investment.

Describe:

• The type of evaluations you will complete (process, outcome, and/or economic).

Step 1: Review the Opportunity 26

• Key evaluation questions these evaluations will address.

• Other information, such as measures and data sources.

Data management plan (DMP) For all public health data you plan to collect, a DMP is required. For a definition of “public health data” and other key information, see AR 25: Data Management and Access on our website.

You must submit an initial draft of your DMP with your application. You must submit a more detailed plan within the first six months of the award.

See reporting.

Submit your initial DMP with your application and include:

• The data you will collect or generate and their sources.

• Any reasons why you cannot share this data with CDC. These could include legal, regulatory, policy, or technical reasons.

• Who can access the data and how you will protect and secure it.

• Data standards that explain what documentation released data will have.

That documentation should describe collection methods, what the data represent, and data limitations.

• Archival and long-term data preservation plans.

• How you will update the DMP as new information becomes available during the project. You will provide updates to the DMP in annual reports. For more information about CDC’s policy on the DMP, see Data Management and Access Requirement at CDC’s website.

In addition to the other requirements listed, also include:

• Cybersecurity plans.

• How you will protect personally identifiable information (PII) when you collect, store, transfer, and use this data.

• How you will remove information from the data that could reveal participants’ identities (de-identify the data) in intermediate and final data sets.

CDC and PEPFAR will inform you of data you need to share with us and how and when it should be shared.

Work plan You must provide a work plan for your project. The work plan connects your performance outcomes, strategies and activities, and measures. It provides

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 27 https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html more detail on how you will measure outcomes and processes. A sample work plan is provided below.

You should provide a detailed work plan for the first year and a high-level work plan for later years.

Table: Sample format

Activities you will implement

Progress or process measures

From the data, monitoring, and evaluation section.

Relevant period of performance outcomes

From the logic model.

Responsible position or party

Funding component / completion date

Strategy 1:

1.

2.

3.

Strategy 2:

1.

2.

3.

Paperwork Reduction Act Any activities involving information collection from 10 or more individuals or organizations may require Paperwork Reduction Act (PRA) approval. The PRA requires review and approval of the information collection by the White House Office of Management and Budget. For further information to determine if a proposed activity requires PRA approval, contact your project officer. Collections include items like surveys and questionnaires. If you have collections requiring PRA approval, CDC is responsible for working with OMB to gain the approval.

For more information about CDC’s requirements under PRA see CDC Paperwork Reduction Act Compliance.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 28 https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm

Funding policies and limitations General policies

• Your budget is arranged in eight categories: salaries and wages, fringe benefits, consultant costs, equipment, supplies, travel, other, and contractual.

• You may use funds only for reasonable program purposes consistent with the award, its terms and conditions, and federal laws and regulations that apply to the award. If you have questions about this determination, ask the grants management officer.

• Generally, you may not use funds to purchase furniture or equipment.

Clearly identify and justify any such proposed spending in the budget.

• All requests for funds contained in the budget should be stated in U.S.

dollars.

• Cost increases due to changes in exchange rates are allowed if enough funding is available. If an increase in the exchange rate would reduce the scope of the project or cause you to need more federal funding, you must get prior approval for exchange rate fluctuations.

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Satisfactory progress in meeting your project’s objectives.

◦ A decision that continued funding is in the government’s best interest.

• If we receive more funding for this program, we will consider:

◦ Funding more applicants.

◦ Extending the period of performance.

◦ Awarding supplemental funding.

See also program-specific limitations.

Unallowable costs You may not use funds for:

• Research.

• Clinical care, except as allowed by law.

• Pre-award costs, unless we give you prior written approval.

• Other than for normal and recognized executive-legislative relationships:

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 29 https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=13f24ea1f961f5f0d14b87ec1b39b25f&term_occur=999&term_src=Title:45:Chapter:A:Subchapter:A:Part:75:Subpart:E:Subjgrp:39:75.440

◦ Publicity or propaganda purposes, including preparing, distributing, or using any material designed to support or defeat the enactment of legislation before any legislative body.

◦ The salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or executive order proposed or pending before any legislative body.

◦ See Anti-Lobbying Restrictions for CDC Recipients.

• Needle exchange programs.

For guidance on some types of costs that we restrict or do not allow, see 45 CFR part 75, General Provisions for Selected Items of Cost.

Indirect costs Indirect costs have a common or joint purpose across more than one project and cannot be easily separated by project. Learn more at CDC Budget Preparation Guidelines.

To charge indirect costs you can select one of two methods:

Method 1 — Approved rate. You currently have an indirect cost rate approved by your cognizant federal agency.

Provide a summary of the rate. Enclose a copy of the current approved rate agreement in your attachments.

Method 2 — De minimis rate. Per 2 CFR 200.414(f), if you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs.

This rate is 15% of modified total direct costs (MTDC). See 2 CFR 200.1 for the definition of MTDC. You can use this rate indefinitely.

Foreign organizations and foreign public entities Indirect costs on awards to foreign organizations and foreign public entities performed fully outside of the U.S. and its territories may be paid to support the costs of complying with federal requirements. This rate is fixed at eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. Negotiated indirect costs may be paid to the American University, Beirut, and the World Health Organization.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 30 http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.cdc.gov/grants/documents/budget-preparation-guidance.pdf https://www.cdc.gov/grants/documents/budget-preparation-guidance.pdf https://www.ecfr.gov/current/title-2/section-200.414 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC))

Other indirect cost policies

• As described in 45 CFR 75.403(d), you must consistently charge items as either indirect or direct costs and may not double charge.

• Indirect costs may include the cost of collecting, managing, sharing, and preserving data.

Salary rate limitation As of January 2024, the HHS/CDC salary rate limitation is $221,900. This salary rate limitation does not apply to PEPFAR funds, which are part of an appropriation from the U.S. Department of State; but to the extent that HHS/ CDC funds are added to an award, this limitation applies. We will update this limitation in future years.

Program income Program income is money earned as a result of your award-supported project activities. You must use program income for the purposes and under the conditions of the award. Find more about program income at 45 CFR 75.307.

Program-specific limitations

CDC PEPFAR…