Zambia CDC-RFA-JG-25-0062 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 24, 2025

Providing targeted technical assistance to the HIV/TB prevention-care-treatment continuum using cost efficient and scalable quality improvement approaches to address program gaps in support of sustainable HIV services in Zambia under PEPFAR

Opportunity number: CDC-RFA-JG-25-0062

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 30

Get registered 31

Questions 32

Step 3: Prepare Your Application 33

Application contents and format 34

Step 4: Learn About Review and Award 44

Application review 45

Award notices 50

Step 5: Submit Your Application 51

Application submission and deadlines 52

Application checklist 54

Step 6: Learn What Happens After Award 56

Post-award requirements and administration 57

Contacts and Support 64

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.

Havequestions?

See Contacts and Support.

Key facts

Opportunity name:

Providing targeted technical assistance to the HIV/TB prevention-care-treatment continuum using cost efficient and scalable quality improvement approaches to address program gaps in support of sustainable HIV services in Zambia under

PEPFAR

Opportunity number:

CDC-RFA-JG-25-0062

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 This NOFO aims to support health systems strengthening efforts and the delivery of HIV/TB prevention, care, and treatment services to meet the Joint United Nations Programme on HIV and AIDS 95-95-95 targets from the current 89-98-96 before 2030. Through technical assistance (TA) you are expected to:

• Use continuous quality improvement (CQI) approaches informed by program data to address poor antiretroviral therapy (ART) coverage.

• Use surveys, evaluations, studies, and program data to identify and address program gaps in underserved, vulnerable, and key populations.

◦ Closing the gap in the first 95 among men who have sex with men, female sex workers, people who inject drugs, and other key populations in Zambia is the priority.

• Address the following gaps in the national HIV/AIDS response:

◦ Human resources for health (HRH).

◦ Laboratory capacity.

◦ Data management.

◦ Information systems.

◦ Supply chain coordination and logistics management.

• Optimize HIV/TB service delivery quality management systems at designated sub-national levels.

• Develop and establish effective HIV/TB management and leadership capacity at the facility, district, and provincial levels to optimize program outcomes.

Step 1: Review the Opportunity 5

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $15,000,000 This is the expected total Year 1 funding for all awards made under this

NOFO.

Expected number of awards: 1 to 3 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 (buffer component if needed).

◦ Component 6: Emerging Public Health Threats (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 15 extra points during the selection process if you provide sufficient documentation demonstrating you meet the PEPFAR local partner definition.

Step 1: Review the Opportunity 7

Eligibility Statutory authority This program is authorized under:

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

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

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

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

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

• State governments.

• County governments.

• City or township governments.

• Special district governments.

• Independent school districts.

• Public and state-controlled institutions of higher education.

• Native American tribal governments (federally recognized).

• Public housing authorities and Indian housing authorities.

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

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

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

• Private institutions of higher education.

• For-profit organizations other than small businesses.

• Small businesses.

• Foreign or non-U.S. based entities.

Step 1: Review the Opportunity 8

Other required qualifying factors

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

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 Zambia has an estimated population of 21 million people with a generalized HIV epidemic and a prevalence of 11.1% among adults aged 15 to 59 years.

Prevalence among adult women is disproportionately higher at 14.6% compared to males at 9.3%.

HIV prevalence among children under 15 years is estimated to be 1.1%.

Disease burden is highest in the densely populated Lusaka province with a prevalence of 14.4%, while other provincial rates range from 13.6% in Western to 5.8% in Northern. The overall national 95-95-95 cascade was reported as 89-98-96 during the 2021 population level HIV impact assessment survey.

This is a follow-on NOFO to CDC-RFA-GH20-2075. Accomplishments and lessons learned from this previous NOFO include:

• Optimized implementation of effective case identification approaches through targeted TA.

• Improved treatment coverage in all the CDC-supported provinces resulting from enhanced case finding and linkage to treatment.

• Improved viral load (VL) suppression by transitioning to Dolutegravir-based regimen.

• Pivoting from generalized TA covering all areas across the continuum from prevention to care to a focused approach based on gaps including quality of service delivery.

• Building provincial health offices’ capacity where they now can provide comprehensive HIV services without substantial support from a TA partner.

Some of the challenges identified include:

• Unequal progress across sites as the TA was initially focused on larger volume sites.

• Smaller volume sites lagged with quality of ART services.

• Site-level duplication due to the scaling up of the district mentorship program with enhanced TA capabilities. This requires active review to ensure there is no duplication for support. There should also be prioritization based on gaps, expertise, and needs.

Step 1: Review the Opportunity 10

If awarded, we expect you to provide TA support for prevention, care, and treatment programs with a focus on the following:

• Expanding confidential counseling and testing programs linked with evidence-based behavioral change communication interventions and relevant services.

• Strengthening current programs to reduce mother-to-child transmission.

• Improving the quality of care and treatment of people living with HIV by providing person-centered care.

• Supporting interventions that sustain the treatment cohort. These include but are not limited to adherence, treatment continuity, differentiated person-centered services, and co-morbidity management among the aging treatment cohort.

• Supporting service integration of chronic conditions such as hypertension and diabetes.

• Providing care to areas with sub-optimal ART coverage, poor VL suppression, and underserved populations.

• Establishing effective HIV program management and leadership capacity at the facility, district, and provincial levels to optimize program outcomes.

Your TA will be expected to:

• Increase HIV case identification.

• Improve linkage to treatment among people living with HIV.

• Use enhanced pretest and posttest counselling approaches to correctly report and identify ART clients who have re-engaged in care among newly identified clients.

• Enhance the use of available biomedical tests such as VL and other emerging points of care metabolites in innovative ways to identify previous ART clients who have re-engaged in treatment.

• Improve treatment continuity among pediatrics, adolescents, and young people as well as men.

◦ These subpopulations tend to have higher interruption in treatment than the national average of 3-5%. This should be done by implementing evidence-based and person-centered models that meet the unique needs of each of these subpopulations.

To identify areas in need of TA and remedial measures, you should utilize CQI approaches and methodologies along with surveillance data to better target burden and transmission hot spots.

Step 1: Review the Opportunity 11

Your TA in strengthening health systems will significantly enhance the critical elements essential for an effective national HIV/TB response. This will involve reinforcing key areas crucial to optimizing HIV service delivery at all levels such as:

• HRH.

• Laboratory capacity.

• Data management systems.

• Coordination mechanisms.

• Logistics.

• Quality management systems.

Purpose The purpose of this NOFO is to provide targeted TA support to the HIV/TB prevention, care, and treatment continuum through cost-efficient and scalable quality improvement approaches. The aim is to address program gaps in targeted areas with unmet needs and support sustainable HIV/TB services in select CDC-supported provinces in Zambia to ensure subnational and national targets are met or exceeded.

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: Enhance the capacity of site level staff and healthcare workers to deliver HIV/TB and related services.

Strategy 2: Support provincial and district health leadership to ensure effective coordination and program oversight.

Strategy 3: Support the Government of Zambia to enhance the functionality of core HIV/TB health systems (for example, laboratory, HRH, CQI).

Strategy 4: Support established health informatics and monitoring and evaluation systems for quality program improvement.

Increased knowledge and skills of healthcare workers to provide services for chronic conditions in addition to HIV/TB.*

Increased coverage and quality of core HIV/TB and related services across clinical cascade, age, and sex.*

Improved data management capacity and data quality.*

Increased capacity of provincial and district leadership to provide coordination and program oversight.*

Improved essential HIV/TB and related health system response functions.*

Increased access to laboratory services.*

Reduced healthcare worker-to-patient ratio.*

Decreased occurrence of commodity stockouts.*

Improved electronic health records system use in health care facilities.*

Reduced treatment interruption among people living with

HIV.*

Improved treatment and VL coverage.

Improved VL suppression rates among people living with HIV.*

Increased compliance with national and international policies, guidelines, and standards for HIV/TB, noncommunicable diseases, and related services.*

Improved maintenance, quality control, management, and use of data systems for decision making.*

Improved coordination and oversight of HIV/TB programs in districts/ provinces.*

Increased HIV/TB program monitoring at primary level by district/provincial teams.*

Improved efficiency in laboratory and

Reduced HIV and TB incidence.

Reduced HIV- and TB-related morbidity and mortality.

Elimination of mother-to-child transmission of HIV.

Improved health system sustainability.

Step 1: Review the Opportunity 13

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes commodities management.*

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

Strategy 1: Enhance the capacity of site level staff and healthcare workers to deliver HIV/TB and related services.

Required activities

• Enhance staff capacity at all levels to provide HIV testing services focusing on at-risk, hard-to-reach, and underserved populations, including all key population groups.

• Link identified, at-risk HIV-negative individuals to HIV prevention services.

• Build staff capacity to provide relevant HIV services across the cascade that meet the needs of vulnerable and key populations while addressing stigma and discrimination.

• Build healthcare workers’ capacity to timely link newly identified people living with HIV into care and treatment at both facility and community levels.

• Build capacity of staff to conduct recent infection surveillance.

• Build capacity of staff in elimination of mother-to-child transmission services at all service points and community levels.

• Provide support for early infant diagnosis testing among HIV-exposed infants.

• Provide training and mentorship to provincial, district, facility, and community level technical staff in quality HIV/TB services including:

◦ Pre-exposure prophylaxis.

◦ Post gender-based violence care.

Step 1: Review the Opportunity 14

◦ Cervical cancer.

◦ Voluntary medical male circumcision.

• Build capacity for staff to optimize retention. This will be done by providing differentiated service delivery including TA for implementation of a full package of retention interventions. These should target all sub-populations by using person-centered approaches.

• Build healthcare workers’ capacity to screen and manage non-communicable diseases within ART clinics.

• Provide technical support for staff to increase treatment and VL coverage.

• Deliver targeted support for optimized management of unsuppressed clients and HIV drug resistance.

• Support (within HIV care) non-communicable disease screening and management integration and scale-up.

• Enhance CQI project implementation to relieve challenges at the facility level.

• Provide support for supply chain and commodities coordination at the facility level.

• Develop and provide program management and budget training for staff involved in program implementation at all levels.

Optional activities

• Support procurement of bulk equipment in furtherance of above activities for CDC-supported partners as necessary.

Strategy 2: Support provincial and district health leadership to ensure effective coordination and program oversight.

Required activities

• Support dissemination of HIV/TB guidelines and policies.

• Support provincial-level implementation and monitoring of HIV/TB-related health systems such as:

◦ Commodity and logistics management.

◦ Sample courier and results return.

◦ Ensuring adequate well-trained HRH.

• Support oversight of coordination meetings (review meetings).

• Build quality assurance and improvement capacity to ensure the high quality of data points at the site, provincial, and district levels.

Step 1: Review the Opportunity 15

• Strengthen coordination and monitoring of supply chain/commodities at district and facility levels.

• Optimize an efficient and effective VL specimen and results coordination system through intra and inter district courier.

• Optimize laboratory monitoring and diagnostic services for HIV/TB patients, including but not limited to GeneXpert, Chemistries.

• Build the capacity of provincial and district-level mentorship teams to ensure the delivery of quality HIV prevention, care, and treatment services.

• Provide support to provincial and district health offices to coordinate HIV/TB technical services.

• Build provincial and district health offices’ capacity to provide TA to facility-level staff on opportunistic infection diagnostic and management.

• Support implementation and coordination of the courier and specimen transport network system.

• Strengthen staff ability at provincial and district levels to use high-quality data for programmatic decision-making.

• Optimize district and provincial managers’ capacity for HIV patient and program management.

Strategy 3: Support the Government of Zambia to enhance the functionality of core HIV/TB health systems (for example, laboratory, HRH, CQI).

Required activities

• Enhance sample referral and results return systems between facilities, district hubs, and beyond for all HIV/TB diagnostic and monitoring laboratory services.

• Optimize the logistics and management systems of HIV-related commodities in facilities, districts, and provinces to prevent and address any supply stockouts.

• Support CQI intervention implementation to address persistent health system challenges in HIV/TB programming.

Step 1: Review the Opportunity 16

Strategy 4: Support established health informatics and monitoring and evaluation systems for quality program improvement.

Required activities

• Ensure electronic health record systems are functional across supported regions and build workforce capacity to use these systems.

• Build program staff’s capacity to maintain, ensure quality control of, and manage data systems to increase access and use to monitor performance routinely.

• Develop and implement standardized protocols to ensure the availability of high-quality systems for data collection, analysis, and use at all levels, including the community.

• Build capacity in person-centered data analytics and use it to improve service delivery.

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 17 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 18 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:

• Health care providers.

• Staff at provincial and district levels.

• Key populations.

• Subpopulations (including but not limited to men, at-risk, hard-to-reach, and underserved populations).

• People living with HIV.

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:

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

Step 1: Review the Opportunity 19 https://www.cdc.gov/about/priorities/why-is-addressing-sdoh-important.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html

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

• Reduce HIV and TB stigma and discrimination.

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

• Make the workforce more inclusive.

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

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

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

• CDC programs from other centers and divisions through the CDC Zambia Office.

• The following CDC-funded organizations:

◦ Ministry of Health: for human resources development and preparation of national guidelines and policies for clinical, prevention, and laboratory services.

◦ Other implementing partners to complement efforts and ensure continuity of care.

◦ Provincial health authorities in CDC-supported provinces.

• Other organizations such as:

◦ District Health Offices.

◦ Traditional, faith, and other community leaders.

◦ Multilateral organizations such as the United Nations.

◦ Implementing partners not funded by CDC.

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:

Step 1: Review the Opportunity 20

• 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 5% 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 There are currently no MER indicators applicable for this NOFO, but that may change in future project years.

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

Step 1: Review the Opportunity 21 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

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 facilities successfully deployed and using SmartCare in ART, maternal child health (MCH), and TB clinics. [Target: 80%; Reporting Frequency: Quarterly]

• Proportion of staff working in ART, MCH, and TB clinics who are trained in SmartCare. [Target: 80%; Reporting Frequency: Quarterly]

• Percentage of people living with HIV who know their HIV status. [Target:

95%; Reporting Frequency: Quarterly]

• Percentage of people living with HIV with VL suppression (all age/sex).

[Target: 95%; Reporting Frequency: Quarterly]

• Percentage of interruption in treatment among people living with HIV (all age/sex). [Target: <2%; Reporting Frequency: Quarterly]

• VL sample turnaround time. [Target: <14 days; Reporting Frequency:

Quarterly]

• VL results return: Percentage of VL results that returned to patient file among samples sent to the laboratory. [Target 95%; Reporting Frequency: Monthly]

• VL sample collection rate: Percentage of VL samples collected among eligible patients in the period under review. [Target: 95%; Reporting Frequency: Monthly]

• Percentage of health facilities and service points that use SmartCare (HIV, TB, cervical cancer, antenatal clinic/MCH/prevention of mother-to-child transmission). [Target: 80% of supported facilities and 100% of all service points at facilities using SmartCare; Reporting Frequency: Monthly]

• Percentage of pregnant women with known HIV status. [Target: 95%;

Reporting Frequency: Quarterly]

• Percentage of people living with HIV on ART for six months or more who have a valid VL result on file. [Target: 95%; Reporting Frequency: Monthly]

• Percentage of children and adults receiving ART. [Target: 98%; Reporting Frequency: Monthly]

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

Step 1: Review the Opportunity 22

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 evaluation.

• Most efficient approaches in targeted case finding: process evaluation.

• Effectiveness of interventions for closing treatment gaps among underserved populations in supported provinces: outcome evaluation.

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

Dissemination of evaluation results Dissemination channels 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.

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.

Step 1: Review the Opportunity 23

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.

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

Step 1: Review the Opportunity 24

• 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.

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

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

Step 1: Review the Opportunity 25 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

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 determine if a proposed activity requires PRA approval, contact your project officer. Collections include items like surveys and questionnaires. If you have

Step 1: Review the Opportunity 26 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 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 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 28 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 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 NOFO; if there are conflicts with this award, contact the Grants Management Officer.

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

Step 1: Review the Opportunity 29 https://www.ecfr.gov/current/title-45/part-75#p-75.403(d) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.307 https://www.cdc.gov/grants/documents/PEPFAR-Terms-and-Conditions.pdf

Step 2:

Get Ready to Apply

In this step

Get registered 31

Questions 32

Get registered You must be registered in both SAM.gov and Grants.gov to apply. You can review the requirements and get started on developing your application before your registrations are complete.

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

To register, go to SAM.gov Entity Registration and select Get Started. From the same page, you can also select the Entity Registration Checklist for the information you will need to register.

When you register or update your SAM.gov registration, you must agree to the financial assistance general certifications and representations. You must agree to those for grants specifically, as opposed to contracts, because the two sets of agreements are different. You will have to maintain your registration throughout the life of any award.

Grants.gov You must also have an active account with Grants.gov. You can see step-by-step instructions at the Grants.gov Quick Start Guide for Applicants.

Find the application package The application package has all the forms you need to apply. You can find it online. Go to Grants Search at Grants.gov and search for opportunity number

CDC-RFA-JG-25-0062.

If you can’t use Grants.gov to download application materials or have other technical difficulties, including issues with application submission, contact Grants.gov for assistance. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, except U.S. federal holidays. The Contact Center is available by phone at 1-800-518-4726 (U.S.) and 1-606-545-5035 (international) or by email at support@grants.gov.

We will post any changes, updates, or amendments on Grants.gov. To get updates on changes to this NOFO, select Subscribe from the View Grant Opportunity page for this NOFO on Grants.gov.

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

Step 2: Get Ready to Apply 31 https://sam.gov/content/entity-registration…