Kenya CDC-RFA-JG-25-0164 NOFO_Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 20, 2025

Supporting sustainable, accessible, integrated and quality laboratory systems for HIV/TB and related health threats in the Republic of Kenya under the President's Emergency Plan for AIDS Relief (PEPFAR) Opportunity number: CDC-RFA-JG-25-0164

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 31

Get registered 32

Questions 33

Step 3: Prepare Your Application 34

Application contents and format 35

Step 4: Learn About Review and Award 45

Application review 46

Award notices 52

Step 5: Submit Your Application 53

Application submission and deadlines 54

Application checklist 56

Step 6: Learn What Happens After Award 58

Post-award requirements and administration 59

Contacts and Support 66

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 20, 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:

Supporting sustainable, accessible, integrated and quality laboratory systems for HIV/TB and related health threats in the Republic of Kenya under the President’s Emergency Plan for AIDS Relief (PEPFAR)

Opportunity number:

CDC-RFA-JG-25-0164

Announcement type:

New

Assistance listing: 93.067 Global AIDS Program

Key dates

Application deadline:

February 20, 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 The goal of this NOFO is to strengthen Kenya’s healthcare system by developing sustainable, accessible, and integrated laboratory systems for HIV/TB and their related threats. Building on the past achievements of Kenya’s HIV/TB programs, this NOFO aligns with the country’s vision of universal health coverage and reaching the UNAIDS 95-95-95 targets. You are expected to provide technical assistance to the Ministry of Health (MOH), county governments, and PEPFAR-funded partners to help ensure universal access to timely, high-quality diagnostic services for the general population, including people living with HIV.

Key strategies include:

• Implementing quality assurance programs.

• Strengthening sample referral systems.

• Optimizing diagnostic networks.

• Enhancing equipment efficiency.

• Leveraging information systems for improved data management and patient tracking.

• Prioritizing biosafety and infection prevention protocols.

The activities outlined will promote HIV/TB laboratory systems integration into broader healthcare systems and improve efficiencies through innovative approaches.

To ensure long-term financial stability, this NOFO aims to implement cost-recovery systems for lab services and to support local production of lab supplies. By building on existing HIV/TB program achievements, this NOFO

Step 1: Review the Opportunity 5 will help sustain lasting impact, supporting Kenya’s journey toward stronger, more responsive laboratory systems that can meet current and future health challenges.

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $6,000,000 This is the expected total Year 1 funding for all awards made under this

NOFO.

Expected number of awards: 1 to 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.

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.

Step 1: Review the Opportunity 6

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.

◦ Component 6: Emerging Public Health Priorities (buffer component if needed).

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 30 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 Kenya.

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 Access to high-quality laboratory and diagnostic services is essential for integrated HIV/TB diagnosis, treatment, and health management. These services are vital for ensuring optimal clinical outcomes, reaching the UNAIDS 95-95-95 targets, and ensuring capacity to detect and respond to public health risks.

Statistics for the HIV epidemic in Kenya include:

• High HIV burden

◦ About 68,000 children (ages 0 to 14) are living with HIV.

◦ About 1.4 million people are living with HIV.

• Overall HIV prevalence is 3.7% with:

◦ 2.6% among males.

◦ 5.3% among females.

• High mother-to-child transmission rate at 8.6%.

• 50% reduction in HIV incidence in the last four years, but still approximately 22,000 new infections annually.

◦ 41% of adult new infections occur among individuals aged 15 to 24.

• 18,743 HIV-related deaths annually.

Annual statistics for Kenyan laboratory services include:

• Over 10 million rapid HIV tests are conducted at more than 4,000 sites.

• A centralized network of 12 referral laboratories conduct:

◦ More than 1.2 million viral load (VL) tests.

◦ 120,000 early infant diagnosis (EID) tests.

• Regional laboratories conduct 250,000 TB tests on GeneXpert.

• 300 sites conduct TB Lipoarabinomannan (LAM).

• 1,000 sites conduct sputum smear microscopy.

Working with the MOH and county governments, CDC, through our PEPFAR-funded partners, aims to strengthen laboratory systems to improve HIV/TB response and enhance overall population health outcomes.

This NOFO will build on CDC’s previously funded work under CDC-RFA- GH20-2039 to develop and roll out policies and guidelines for strengthening

Step 1: Review the Opportunity 10 laboratory systems for HIV/TB and related diagnoses. These past efforts have significantly improved Kenya’s capacity to improve access to quality laboratory services.

Key successes include:

• Improved accessibility of decentralized VL/EID testing services to county and training institutions’ laboratories.

• Established a national integrated External Quality Assurance (EQA) scheme to provide Proficiency Testing (PT) panels to over 22,000 rapid HIV testing services providers and laboratories testing for HIV/TB and related illnesses.

• Implementation of Rapid Testing Continuous Quality Improvement (RT- CQI) for 55,000 rapid HIV testing sites in 1,920 facilities.

• Biosafety enhancements:

◦ By training 120 Trainer of Trainers and 760 laboratory personnel.

◦ Virtual refresher training to 1,752 staff across all counties.

◦ Training 90 biomedical engineers to maintain biosafety cabinets and other equipment nationwide.

• Achievement of International Organization for Standardization 15189 accreditation for all national referral laboratories and most county referral hospitals.

• Supported accreditation efforts through the launch of the Laboratory Continuous Quality Improvement (LCQI) 2023 guidelines.

• Implementation of multi-disease testing approaches in some national reference laboratories for VL, COVID-19, and human papillomavirus

(HPV).

This NOFO aligns with Kenya’s HIV Prevention and Treatment Guidelines (2022) and PEPFAR’s Laboratory Implementation Strategy as a component of PEPFAR’s 5-Year Strategy 2023-2027. You are expected to provide technical assistance to strengthen activities through the MOH, National Public Health Laboratories, National Public Health Institute (NPHI), and relevant national and county health departments to implement accessible, integrated, quality, and sustainable systems for monitoring and testing HIV, TB, and diseases of public health concern.

The five-year outcomes for strengthening Kenya’s laboratory systems include:

• Improved quality management through implementing quality systems and enhancing EQA schemes.

• Optimized HIV/TB services.

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

Step 1: Review the Opportunity 11 https://hivpreventioncoalition.unaids.org/sites/default/files/attachments/kenya-arv-guidelines-2022-final-1.pdf https://hivpreventioncoalition.unaids.org/sites/default/files/attachments/kenya-arv-guidelines-2022-final-1.pdf

• Enhanced multi-disease testing.

• Strengthened surveillance capabilities.

• Optimized laboratory networks.

• Improved sample referral systems.

• Expanded diagnostic capabilities.

• Improved laboratory-clinical collaboration.

• Enhanced data integration.

• Increased test access and coverage for HIV, TB, and diseases of public health concern.

• Improved infection control and waste management.

• Strengthened biosafety measures.

To improve financial sustainability, this NOFO will:

• Improve MOH coordination and stakeholder engagement.

• Implement cost recovery models.

• Promote local production of laboratory diagnostics and consumables.

Purpose The purpose of this NOFO is to support implementation of integrated and sustainable laboratory systems. This will complement Kenya’s efforts to attain and sustain HIV/TB epidemic control while responding to current and future emerging health threats.

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.

Step 1: Review the Opportunity 12

Table: Strategies and outcomes

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes

Strategy 1:

Strengthen and sustain national and county laboratory systems to help ensure accurate, timely, and reliable diagnostic services for HIV/TB and related health threats.

Strategy 2:

Strengthen and sustain integrated laboratory networks and laboratory-clinical interface for the MOH, ensuring universal access and use of laboratory services.

Strategy 3:

Strengthen national and regional public health institute laboratories to manage and sustain programs, systems, and networks for HIV, TB, and related health threats.

Strategy 4: Develop diverse revenue streams and optimize resource use to enhance laboratory sustainability.

Improved laboratory quality through implementing quality management systems

(QMS).*

Increased capacity of laboratory staff to perform high-quality diagnostic services.*

Improved optimization of HIV/TB laboratory services for timely delivery of diagnoses.*

Increased use of HIV/ TB laboratory services by clinicians for reliable diagnoses.*

Improved laboratory capacity for multi-disease testing.*

Improved surveillance capabilities to detect new and re-emerging diseases.*

Improved coordination between laboratory services and public health departments.*

Increased implementation of cost recovery mechanisms for laboratory services.*

Sustained quality of laboratories through use of QMS.*

Sustained implementation of quality laboratory practices by laboratory staff.*

Increased performance of laboratory systems and networks for service delivery.*

Sustained use of HIV/ TB laboratory services for reliable diagnoses.*

Increased diagnostic capabilities at national and regional levels within the public health laboratory network.*

Improved financial sustainability for laboratory services.*

Increased local production capacities for select laboratory supplies.*

Increased stakeholder engagement to strengthen and maintain laboratory systems.*

Sustained high-quality laboratory systems that effectively respond to HIV, TB, and related diseases.*

Improved financial sustainability of laboratory systems.*

Reduced dependence on external funding to maintain laboratory systems.*

Sustained diagnostic capabilities within the public health laboratory network.*

Additional information on outcomes in the logic model follows:

Step 1: Review the Opportunity 13

• QMS include, but are not limited to:

◦ The Kenya Quality Model for Health.

◦ LCQI.

◦ Stepwise Laboratory Improvement Process Towards Accreditation.

◦ RT-CQI.

◦ Point-of-care testing (POCT) CQI programs.

◦ EQA and its quality control panels.

• Increased capacity of laboratory staff to perform high-quality diagnostic services includes but is not limited to:

◦ Training on QMS.

◦ Implementing best practices and achievement of competencies.

◦ Laboratory staff refers to laboratory staff across all tiers in Kenya.

• Optimization of HIV/TB laboratory services includes, but is not limited to:

◦ Enhanced sample referral systems.

◦ Access and coverage of HIV-related tests.

◦ Using a patient-centric approach to service delivery.

• Improving laboratory capacity for multi-disease testing includes:

◦ MOH coordination and integration of lab systems.

◦ Expanding regional labs.

◦ Multi-disease testing at both national and regional laboratories.

◦ Enhanced infection control and waste management.

◦ Staff adherence to biosafety guidelines.

• Public health departments within the Kenya MOH include but are not limited to the Division of Diseases Surveillance and Response (DDSR) and

NPHI.

• Knowledge of sustainable laboratory management includes, but is not limited to awareness of:

◦ The benefits of cost recovery and local manufacturing.

◦ Necessary regulatory and quality standards for local manufacturing.

• Increased performance of laboratory systems includes, but is not limited to:

◦ Turnaround time for all testing services.

◦ Accuracy and reliability of test results.

Step 1: Review the Opportunity 14

◦ Expansion of the range of diagnostic services through integration of multi-disease testing services.

◦ Use of laboratory management systems and supply chain management systems.

• Increased diagnostic capabilities includes, but is not limited to:

◦ An expanded range of diagnostic tests available.

◦ Sustaining laboratory capacity for multi-disease testing.

◦ Integration of laboratory data in national surveillance systems.

◦ Continued coordination between laboratory services and public health departments.

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: Strengthen and sustain national and county laboratory systems to help ensure accurate, timely, and reliable diagnostic services for HIV/TB and related health threats.

Required activities:

• Support expansion of national integrated EQA program to support patient-centered diagnostic testing across diseases and conditions (such as HIV, advanced HIV disease, cryptococcal meningitis, HPV, TB, lateral flow urine TB-LAM, TB molecular, TB culture, syphilis rapid test, and hepatitis.

• Support implementation of comprehensive and sustainable QMS, LCQI, and RT-CQI, including POCT-CQI programs.

• Develop capacity building and sustainability plans and tools for country-led maintenance of laboratory accreditation to international standards.

• Manage national and county laboratory equipment calibration and maintenance.

• Optimize diagnostic networks for VL, EID, TB, and other diseases of public health concern.

Step 1: Review the Opportunity 15

• Develop and implement innovative strategies to optimize molecular laboratory testing through multiple disease testing and the integration of existing platforms with other diseases of public health concern to ensure optimal test capacity use and to improve testing access.

• Support MOH to use electronic quantification tools to ensure accurate and data-driven forecasting and quantification for HIV- and TB- related supplies.

• Integrate laboratory information management systems (LIMS) and other laboratory data systems with national health information systems to ensure that data tools are interoperable and scalable. This will be achieved by working closely with health information systems and strategic information partners.

• Strengthen national capacity for evidence-based decision-making by providing comprehensive technical assistance. This will include monitoring and evaluation and ensuring quality data management, analysis, and dissemination for HIV, TB, and other critical public health concerns.

• Create performance-monitoring dashboards for laboratories.

Strategy 2: Strengthen and sustain integrated laboratory networks and laboratory-clinical interface for the MOH, ensuring universal access and use of laboratory services.

Required activities:

• Enhance and optimize integrated sample referral networks for laboratory and POCT facilities to increase access to laboratory services for HIV, TB, and other diseases of public health concern.

• Implement recommendations from diagnostic network assessments and optimization exercises to establish systems to measure outcomes using performance indicators. This will ensure efficient and optimal resource use in HIV, TB, and related testing.

• Coordinate the laboratory-clinical interface at national and county levels in collaboration with the National AIDS and STI Control Program, National AIDS Control Council, County Health Management Teams, and other key stakeholders for timely patient management.

• Develop and monitor key performance indicators for the laboratory-clinical interface.

• Enhance adaptation of e-technologies for laboratory requisitions and results transmission.

Step 1: Review the Opportunity 16

• Develop strategies to create demand for laboratory testing.

• Forge public-private partnerships to drive sustainable service delivery.

Strategy 3: Strengthen national and regional public health institute laboratories to manage and sustain programs, systems, and networks for HIV, TB, and related health threats.

Required activities:

• Collaborate with national and regional public health institutes to develop, implement, and operationalize national laboratory policies and strategic plans to manage sustainable lab systems.

• Support the development and validation of new diagnostic techniques for TB, HIV, and other diseases of public health concern.

• Build capacity and train laboratory staff on coordination skills such as leadership and governance and technical skills such as multi-disease testing techniques to manage and sustain laboratory programs.

• Strengthen sample referral systems for HIV, TB, and other diseases of public health concern.

• Implement integrated LIMS to strengthen reporting for laboratory surveillance data.

• Establish and/or improve waste management facilities and systems.

• Improve biosafety practices in laboratories.

• Implement real-time data-sharing mechanisms between laboratories and surveillance units.

• Develop key performance indicators for laboratory services and use data to inform CQI strategies.

• Expand and strengthen HIV surveillance systems to inform the public health response to HIV, TB, and emerging public health threats through coordination with stakeholders including Kenya Medical Research Institute, DDSR, NPHI, and academic and private institutions.

Strategy 4: Develop diverse revenue streams and optimize resource use to enhance laboratory sustainability.

Required activities:

• Conduct laboratory service assessment to identify services suitable for cost recovery.

Step 1: Review the Opportunity 17

• Develop and pilot cost recovery models and monitor and evaluate the impact on service use and revenue.

• Promote local manufacturing capacity for laboratory-related commodities.

• Advocate for the inclusion of locally manufactured products in national procurement systems.

• Create marketing strategies for cost recovery services and locally manufactured products.

• Determine and use laboratory capacity and service cost estimates to optimize resource allocation.

• Empower MOH to bolster and sustain laboratory programs through diversified financial resources.

• Increase partnerships with local manufacturers or manufacturing facilities.

• Increase small-scale production of selected laboratory diagnostics and consumables (such as test kits, PT panels, and quality control materials).

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.

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

Step 1: Review the Opportunity 18 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.

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.

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/

Focus populations The focus populations for this NOFO include:

• The general population, including people living with HIV/TB and related health conditions.

• National and county leaders.

• The facility and community-based health workforce.

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.

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.

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

Step 1: Review the Opportunity 20 https://www.cdc.gov/about/priorities/why-is-addressing-sdoh-important.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html

• 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 the following partners to promote synergy and efficient coordination of laboratory and health systems:

• US government-funded entities, including:

◦ CDC Kenya.

◦ U.S. Agency for International Development.

◦ Department of Defense.

◦ US government-funded partners.

• Government of Kenya entities, including:

◦ National and county governments.

◦ MOH.

• Faith-based and private facilities.

• Civil society organizations.

• Multilateral partners, including but not limited to:

◦ UNICEF.

◦ UNAIDS.

◦ Global Fund.

◦ World Bank.

◦ World Health Organization.

◦ Africa Centres for Disease Control and Prevention (Africa CDC).

◦ Private-sector players.

◦ Academic and training institutions.

Through the PEPFAR program, CDC works with partners to help prevent HIV infection, provide life-saving treatment to people living with HIV, and reduce

Step 1: Review the Opportunity 21

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 4% of funds for monitoring activities and 6% 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 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.

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

Step 1: Review the Opportunity 22 https://www.state.gov/reports-pepfar/ https://www.state.gov/reports-pepfar/ https://help.datim.org/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

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 Below, we show some anticipated MER indicators, targets, and reporting frequencies for the first year. You can propose any additional relevant MER indicators as part of your initial Evaluation and Performance Measurement Plan.

• LAB_PTCQI: Number of PEPFAR-supported laboratory-based testing and/ or Point-of-Care Testing (POCT) sites engaged in continuous quality Improvement (CQI) and PT activities. [Target: Not Assigned; Reporting Frequency: Annual]

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

• Percentage of LCQI-implementing facilities per county. [Target: 40%;

Reporting Frequency: Annual]

• Proportion of equipment use rates for major HIV/TB molecular diagnostic platforms within the national laboratory network. [Target: 80%; Reporting Frequency: Annual]

• Number of laboratories in the national VL/EID laboratory network with multiplexing capabilities. [Target: 5; Reporting Frequency: Annual]

• Number of pilot projects initiated for cost recovery models. [Target: 1;

Reporting Frequency: 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 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.

Step 1: Review the Opportunity 23

• Effects of optimization of diagnostic networks for VL/EID, TB, and other diseases on access to testing services: outcome evaluation.

• Facilitators/barriers in implementing laboratory strengthening initiatives at national and regional levels: process evaluation.

• Impact of cost recovery models on the operational efficiency of laboratory services: economic 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 could include:

• Local and international conferences and forum abstract presentations.

• Conference poster displays.

• Manuscripts.

• Bulletins.

• Reports.

• Presentations to technical working groups and stakeholder meetings.

• Approved products in print and electronic media.

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

CDC and stakeholders 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.

Step 1: Review the Opportunity 24

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

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 25

• 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 26 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 27 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 28 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 29 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 terms and conditions You can find a list of PEPFAR-specific terms and conditions on our website.

They apply to all PEPFAR awards, so we strongly encourage you to read them and ask questions if you need more information. These terms and conditions will apply if you are selected for an award so you should confirm that you are able to comply with them prior to applying.

Host country laws and regulations If funded, you are expected to follow applicable host country laws and regulations related to the strategies under this…