WAR SL CDC-RFA-JG-25-0060 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 24, 2025

Strengthening the national HIV care and treatment program in Sierra Leone (SL) to accelerate the response to end the HIV/AIDS pandemic as a public health threat by 2030, under the President’s Emergency Plan for AIDS Relief (PEPFAR)

Opportunity number: CDC-RFA-JG-25-0060

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 24, 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:

Strengthening the national HIV care and treatment program in Sierra Leone (SL) to accelerate the response to end the HIV/AIDS pandemic as a public health threat by 2030, under the President’s Emergency Plan for AIDS Relief (PEPFAR)

Opportunity number:

CDC-RFA-JG-25-0060

Announcement type:

New

Assistance listing: 93.067 Global AIDS Program

Key dates

Application deadline:

February 24, 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 NOFO will support the government of Sierra Leone (SL) in speeding up progress to end the HIV/AIDS pandemic as a public health threat by 2030 through direct service delivery (DSD) and technical assistance (TA), including:

• Carrying out a sustainable HIV care and treatment program and quality improvement projects.

• Building local capacity, human resources for health, and partnerships to strengthen sustainable public health systems.

This NOFO has several objectives, including to:

• Carry out sustainable, high-quality HIV care and treatment services and reach the 95-95-95 treatment targets for people living with HIV by age, gender, and population group.

• Close equity gaps for key and priority populations, including adolescent girls, young women, and children.

• Improve and sustain monitoring and evaluation (M&E) systems to build capacity for high-quality data collection, analysis, and use of data for decision-making at the community and facility levels.

• Support national policies, guidelines, materials, and procurement for a full package of HIV prevention, care, and treatment.

• Optimize quality improvement and quality assurance (QI/QA) and related support services at the facility level.

• Collaborate with the government of SL to strengthen the technical and managerial capacity of national and district health management teams (DHMT) and civil society organizations (CSO) to carry out service delivery models that are customized for country ownership of the HIV response.

Step 1: Review the Opportunity 5

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $12,000,000 This is the expected total Year 1 funding for all awards made under this

NOFO.

Expected number of awards: 1 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: ROP Q1 Targets and Activities.

◦ Component 2: ROP Q2 Targets and Activities.

◦ Component 3: ROP Q3 Targets and Activities.

◦ Component 4: ROP Q4 Targets and Activities.

◦ Component 5: ROP 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 Sierra Leone.

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 The state of HIV in Sierra Leone In SL, the estimated HIV prevalence among adults ages 15 to 49 is 1.7%, with about 77,000 people living with HIV. Women and key populations are disproportionately affected by the epidemic, with women twice as likely to be affected by HIV. Young women ages 15 to 24 are more severely impacted, being three times as likely to be affected by HIV than their male peers.

The following reflect the HIV prevalence among key populations:

• 11.85% for female sex workers.

• 3.2% for men who have sex with men.

• 4.2% for transgender individuals.

• 4.2% for people who inject drugs.

• 3.7% for people in prison and other closed settings.

Recent achievements and remaining gaps In 2023, SL achieved 83-82-65 out of the Joint United Nations Programme on HIV/AIDS (UNAIDS) 95-95-95 targets. Despite these achievements, there is concern the number of people living with HIV may be underestimated. Men and children notably lag in the HIV response, with HIV testing services (HTS) coverage for men at around 53% and treatment coverage for children under 30%.

Geographically, over 50% of people living with HIV reside in four high-burden districts:

• Western Area Urban.

• Western Area Rural.

• Bo.

• Port Loko.

Coordinated efforts and funding The National AIDS Control Program oversees and guides the country’s HIV response through the National Strategic Plan and National Treatment Guidelines. The national HIV response is supported by funding from the

Step 1: Review the Opportunity 10

Global Fund to Fight AIDS, TB, and Malaria (GF) and contributions from various stakeholders, including UNAIDS and PEPFAR.

The GF has committed over $125 million for Grant Cycle 7, with over $38 million allocated to HIV. GF and PEPFAR have agreed on the geographical distribution of key population support to ensure that efforts are complementary and do not overlap.

PEPFAR’s impact on HIV treatment coverage in SL PEPFAR began supporting HIV treatment programs in SL in October 2020. By the end of 2023, it significantly impacted HIV treatment coverage in the country:

• The number of people living with HIV on treatment increased from 38,003 to 69,629.

• The number of PEPFAR-supported health facilities increased from 15 to 89 facilities and nine drop-in centers across seven districts.

With the transition from the U.S. Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) to the U.S. HHS Centers for Disease Control and Prevention (CDC) in January 2024, activities began to focus more on a comprehensive approach to providing prevention, care, and treatment to key and priority populations.

PEPFAR’s efforts align with SL’s updated HIV strategic plan, aiming to improve health outcomes and achieve epidemic control.

PEPFAR Fiscal Year 2024 (FY24) semiannual program results (SAPR) show the program is heading toward meeting its targets for both general and key populations.

This NOFO’s objectives and outcomes This NOFO is a follow-on to a HRSA NOFO HRSA-21-144 (2021), which was transitioned to CDC in January 2024 (UH6OA45170) and expires September 2025. The NOFO will promote:

• Client-centered approaches, community engagement, and resilient and adaptive strategies.

• Sustainable, targeted, in-service capacity building and training for clinical and non-clinical workforces to improve service delivery and system performance, and to develop the capacity of eligible local partners for program transition.

Step 1: Review the Opportunity 11

• Sustained and active approaches to implementing continuous quality improvement (CQI) at the site level for comprehensive HIV prevention, testing, and treatment services.

• Advancement of key policy requirements, particularly those directly related to project interventions and coordination of the national response and performance.

The expected outcomes of this NOFO are:

• Increased access to and use of complete HIV prevention, testing, and treatment services.

• Increased capacity and skills of healthcare workers to provide quality HIV services.

• Sustained implementation of CQI and quality management system initiatives at the site level.

• Increased inclusion of clients and communities in planning and delivering HIV services.

• Improved resiliency and adaptability of HIV programs to respond to challenges.

• Increased capacity of local partners to manage and sustain HIV programs.

• Improved policies and national coordination processes for the HIV response.

Purpose The purpose of this NOFO is to work together to create and deliver high-quality solutions for sustainable HIV epidemic control through the following program areas:

• HIV DSD.

• Human resources for health.

• QI/QA.

• Health systems strengthening.

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:

Strengthen person-centered HIV services for general and key populations and engagements with communities to enhance access to and use of comprehensive HIV prevention and treatment services.

Strategy 2: Enhance the capacity of the healthcare workforce to improve service delivery and performance through a mentorship program.

Strategy 3: Help healthcare workers carry out CQI

Increased access to comprehensive HIV services among all populations.*

Increased involvement by interest holders in the planning and delivery of HIV services.*

Improved capacity of healthcare workers to provide quality HIV services.*

Improved implementation of CQI initiatives by healthcare workers.*

Improved use of HIV treatment services by people living with

HIV.*

Increased use of comprehensive HIV services among all populations.*

Increased adherence to treatment by people living with

HIV.*

Increased retention in HIV services by people living with HIV.*

Increased VL testing coverage for people living with HIV.*

Improved quality HIV services provided by healthcare workers.*

Improved implementation of strategies responding

Sustained VL suppression among people living with

HIV.*

Sustained participation of interest holders in HIV programs.

Increased resilience of adaptable HIV program.*

Sustained high-quality HIV service delivery for all populations.

Sustained capacity of local organizations to independently manage HIV programs.

Sustained implementation of

Step 1: Review the Opportunity 13

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes initiatives at facilities across prevention and treatment cascades and within the clinical and laboratory interface.

Strategy 4: Support the SL government in strengthening health systems and key policies that enhance the national HIV response, coordination, and performance.

Increased capacity of local partners to sustainably manage HIV programs.*

Improved national coordination mechanisms for program implementation.*

Improved information management systems for health and laboratory.* to program challenges.*

Increased capacity of local organizations to implement and manage HIV programs.*

Improved coordination among national HIV response stakeholders.*

Increased implementation of policy recommendations.*

CQI practices within health facilities.

Sustained HIV control through supportive health systems.

Sustained epidemic control.

Additional information on outcomes in the logic model:

• All populations include:

◦ The general population.

◦ Key populations.

◦ Priority populations.

• Comprehensive HIV services include:

◦ Prevention.

◦ Testing.

◦ Care and treatment.

• Interest holders include:

◦ Communities.

◦ People using comprehensive HIV services.

◦ Local organizations.

◦ Key population-led organizations.

• Improved capacity of healthcare workers to provide quality HIV services, including knowledge and skills.

• National coordination mechanisms include policies for program implementation.

Step 1: Review the Opportunity 14

• Healthcare workers include clinical and non-clinical workers.

• Strategies responding to programmatic challenges should be adaptive and innovative.

• Programmatic challenges include challenges identified in HIV service delivery and HIV testing services.

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.

The 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 person-centered HIV services for general and key populations and engagements with communities to enhance access to and use of comprehensive HIV prevention and treatment services.

Required activities

• Expand HTS outreach programs in high-burden districts.

• Implement community-based testing initiatives.

• Establish peer support groups and counseling services.

• Develop and distribute educational materials tailored to different service delivery methods.

• Conduct regular community consultations and feedback sessions.

• Train community health workers and leaders to promote HIV services.

• Organize community outreach events to raise awareness and reduce stigma.

• Scale-up differentiated HTS, treatment literacy, and linkage to treatment initiatives.

• Expand antiretroviral therapy (ART) services using DSD and TA site support strategies.

• Decentralize pediatric ART services and expand age-appropriate ART services for children and adolescents living with HIV.

• Expand complete HIV prevention and treatment services for pregnant and breastfeeding women.

Step 1: Review the Opportunity 15

• Promote VL literacy for both care providers and patients to improve VL testing coverage.

• Use e-mentoring technology such as WhatsApp and ECHO to build the capacity of large (hub) and small (spoke) facilities and to promote case-based learning.

• Scale up implementation of DSD to improve the quality of and access to HIV services.

• Scale up complete HIV prevention and treatment services for key populations.

• Provide technical support to strengthen waste management and biosafety procedures.

• Provide technical support to strengthen HIV testing QA (for example, proficiency testing) and quality control.

• Scale up advanced HIV disease screening, diagnosis, and management.

• Include the management of non-communicable diseases in HIV case management.

• Scale up TB infection screening, diagnosis, and management among people living with HIV.

• Implement a patient-level biometric unique identification system.

Strategy 2: Enhance the capacity of the healthcare workforce to improve service delivery and performance through a mentorship program.

Required activities

• Provide capacity building to national, DHMT, and facility providers to improve HIV services using CQI initiatives at supported health facilities.

• Establish a clinical mentorship program with nurses as mentors to train healthcare workers nationwide.

• Support clinical mentors in building the capacity of national, DHMT, and facility providers to improve the quality of HIV and integrated health programs.

• Establish continuous professional development opportunities for healthcare workers through the clinical mentorship program.

Step 1: Review the Opportunity 16

Strategy 3: Help healthcare workers carry out CQI initiatives at facilities across prevention and treatment cascades and within the clinical and laboratory interface.

Required activities

• Support DHMTs and Ministries of Health (MOH) to establish a robust and harmonized data quality framework.

• Identify and support sites for CQI initiatives.

• Train staff on CQI processes and methodologies.

• Regularly review and assess CQI project outcomes.

• Develop adaptive strategies for emerging HIV challenges.

• Establish crisis response plans for HIV service continuity.

Strategy 4: Support efforts the SL government in strengthening health systems and key policies that enhance the national HIV response, coordination, and performance.

Required activities

• Develop and deliver complete HIV care and treatment training programs.

• Establish continuous professional development opportunities for healthcare workers.

• Conduct M&E on training effectiveness.

• Develop and maintain an integrated national and implementing partner data capture and reporting system.

• Provide high-quality data and meet PEPFAR reporting requirements to track progress to targets.

• Improve capacity for data use among SL government health staff at the facility level.

• Support the use of a technology-driven M&E system for data reporting and use.

• Support DHMTs and MOH in establishing a robust and harmonized data quality framework.

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.

Step 1: Review the Opportunity 17

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 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.

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

Step 1: Review the Opportunity 18 https://www.state.gov/reports-pepfar/

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.

Focus populations The focus populations for this NOFO include:

• Key and priority populations:

◦ Men who have sex with men.

◦ Female sex workers.

◦ People who inject drugs.

◦ Adolescent girls and young women.

◦ Children.

• General populations:

◦ People living with HIV.

◦ Pregnant women and breastfeeding mothers.

◦ Adults.

◦ Discordant couples.

◦ Adolescent boys.

◦ HIV-exposed infants.

• Healthcare workers.

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

Step 1: Review the Opportunity 19 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

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.

• 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.

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

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:

• UNAIDS.

• SL MOH.

• National HIV/AIDS Control Programme.

• National Leprosy and Tuberculosis Programme.

• National Public Health Agency.

• National HIV/AIDS Secretariate.

• GF principal and sub-recipients.

• CSOs that are competent in and managed by key populations.

• The current CDC implementing partner for care and treatment.

• Partners supporting people living with HIV/AIDS and HIV care and treatment programs.

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.

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

Step 1: Review the Opportunity 21

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 10% of funds for monitoring activities and 5% 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.

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.

• GEND_GBV: Number of people receiving post-gender-based violence (GBV) clinical care based on the minimum package. [Target: 200;

Reporting Frequency: Semi-Annual]

• HRH_PRE: Number of new health workers who graduated from a pre-service training institution or program as a result of PEPFAR-supported

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

Step 1: Review the Opportunity 22 https://help.datim.org/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides strengthening efforts, within the reporting period, by select cadre.

[Target: Not Assigned; Reporting Frequency: Annual]

• HTS_INDEX: Number of individuals who were identified and tested using index testing services and received their results. [Target: 28,300;

Reporting Frequency: Quarterly]

• HTS_SELF: Number of individual HIV self-test kits distributed. [Target:

3,180; Reporting Frequency: Quarterly]

• HTS_TST: Number of individuals who received HIV Testing Services (HTS) and received their test results. [Target: 77,100; Reporting Frequency:

Quarterly]

• KP_PREV: Number of key populations reached at least once with individual and/or small group-level HIV primary or secondary prevention interventions designed for the target population. [Target: 9,000;

Reporting Frequency: Semi-Annual]

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

• PMTCT_ART: Percentage of pregnant women living with HIV who received ART to reduce the risk of mother-to-child-transmission (MTCT) during pregnancy. [Target: 95%; Reporting Frequency: Quarterly]

• PMTCT_EID: Percentage of infants born to women living with HIV who received a virologic HIV test (sample collected) by 12 months of age.

[Target: 95%; Reporting Frequency: Quarterly]

• PMTCT_HEI_POS: Number of newly identified infants living with HIV with a positive virologic HIV test result returned in the reporting period, whose diagnostic sample was collected by 12 months of age. [Target: Not Assigned; Reporting Frequency: Quarterly]

• PMTCT_STAT: Percentage of pregnant women with known HIV status at antenatal care (includes those who already knew their HIV status prior to ANC). [Target: 95%; Reporting Frequency: Quarterly]

• PrEP_CT: Number of individuals, excluding those newly enrolled, that return for a follow-up visit or reinitiation visit to receive pre-exposure prophylaxis (PrEP) to prevent HIV during the reporting period. [Target:

15,000; Reporting Frequency: Quarterly]

• PrEP_NEW: Number of individuals who were newly enrolled on pre-exposure prophylaxis (PrEP) to prevent HIV infection in the reporting period. [Target: 9,000; Reporting Frequency: Quarterly]

Step 1: Review the Opportunity 23

• TX_CURR: Number of adults and children currently receiving antiretroviral therapy (ART). [Target: 37,500; Reporting Frequency:

Quarterly]

• TX_ML: Number of ART patients (who were on ART at the beginning of the quarterly reporting period or initiated treatment during the reporting period) and then had no clinical contact since their last expected contact.

[Target: Not Assigned; Reporting Frequency: Quarterly]

• TX_NEW: Number of adults and children newly enrolled on antiretroviral therapy (ART). [Target: 9,250; Reporting Frequency: Quarterly]

• TX_PVLS: Percentage of ART patients with a suppressed viral load (VL) result (<1000 copies/ml) documented in the medical or laboratory records/laboratory information systems (LIS) within the past 12 months.

[Target: 95%; Reporting Frequency: Quarterly]

• TX_RTT: Number of ART patients who experienced IIT during any previous reporting period, who successfully restarted ARVs within the reporting period and remained on treatment until the end of the reporting period.

[Target: Not Assigned; Reporting Frequency: Quarterly]

• TX_TB: Proportion of ART patients screened for TB in the semiannual reporting period who start TB treatment. [Target: Not Assigned;

Reporting Frequency: Semi-Annual]

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

• The percentage of health facilities that have implemented improvements to health information systems. [Target: 75%; Reporting Frequency:

Annual]

• The number of healthcare workers trained through the clinical mentorship program. [Target: 200; 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.

Step 1: Review the Opportunity 24

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 an end-term evaluation.

• Effect of scaled-up, differentiated HIV testing services, treatment literacy, and linkage to treatment on levels of treatment uptake and retention:

outcome evaluation.

• Facilitators and barriers to scaling up differentiated HIV testing services, treatment literacy, and linkage to treatment: process evaluation.

• Facilitators and barriers to implementing decentralized pediatric ART services and expanding age-appropriate ART services for children and adolescents: process 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.

• Other 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.

Step 1: Review the Opportunity 25

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.

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.

Step 1: Review the Opportunity 26

• 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).

• 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.

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

• 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 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

Step 1: Review the Opportunity 28 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.

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.

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

Step 1: Review the Opportunity 29 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 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

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:

◦ 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.

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))

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.

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…