Zimbabwe CDC-RFA-JG-25-0099 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due Tuesday, February 18, 2025

Supporting the implementation of comprehensive HIV prevention and treatment programs to achieve and sustain epidemic control in Zimbabwe under the President's Emergency Plan for AIDS Relief

(PEPFAR)

Opportunity number: CDC-RFA-JG-25-0099

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 53

Step 5: Submit Your Application 54

Application submission and deadlines 55

Application checklist 57

Step 6: Learn What Happens After Award 59

Post-award requirements and administration 60

Contacts and Support 67

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 Tuesday, February 18, 2025.

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

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

Jump to a step

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

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 8

Program description 10

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

Global Health Center

Division of Global HIV and Tuberculosis

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

Have questions?

See Contacts and Support.

Key facts

Opportunity name:

Supporting the implementation of comprehensive HIV prevention and treatment programs to achieve and sustain epidemic control in Zimbabwe under

PEPFAR

Opportunity number:

CDC-RFA-JG-25-0099

Announcement type:

New

Assistance listing:

93.067 Global AIDS

Program

Key dates

Application deadline:

February 18, 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 You will support the Zimbabwe Ministry of Health and Child Care (MoHCC) to deliver HIV services, including:

• Differentiated HIV prevention, testing, linkage to treatment, and retention in care.

• Viral load (VL) monitoring.

• Advanced HIV disease (AHD) management.

• Non-communicable disease (NCD) prevention and control.

• TB-HIV program collaboration.

• Gender-based violence (GBV) response, including post-violence care.

• Cervical cancer screening and treatment.

Your work will focus on these key priorities:

• Keep people living with HIV on treatment.

• Close HIV diagnosis and VL suppression gaps among priority populations.

• Improve access to prevention services for key populations (Female sex workers, men who have sex with men, transgender people, people in prisons and people who inject drugs), children, adolescent girls and young women, and men at high risk for HIV.

• Improve TB and HIV service delivery quality.

• Improve screening for cervical cancer and treatment of pre-cancerous lesions among people living with HIV.

• Eliminate mother-to-child transmission of HIV, viral hepatitis, and syphilis.

Step 1: Review the Opportunity 5

You will work in CDC-supported provinces (Mashonaland West, Mashonaland East, Mashonaland Central, Harare and Matabeleland North):

• Scale up differentiated service delivery models like community posts to reach priority populations (for example, men, young people, key populations) with HIV services.

• Engage faith communities and civil society to support health promotion, health education, and HIV service delivery.

• Set up and support community posts to deliver comprehensive HIV services and community-led initiatives.

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $10,000,000 This is the expected total Year 1 funding for all awards made under this

NOFO.

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

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

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

Funding strategy

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

You may not request more than this amount.

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

• Availability of funds.

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

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

Step 1: Review the Opportunity 6

Component funding

Overview

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

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

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

Setting up components

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

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

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

◦ Component 1: COP Q1 Targets and Activities.

◦ Component 2: COP Q2 Targets and Activities.

◦ Component 3: COP Q3 Targets and Activities.

◦ Component 4: COP Q4 Targets and Activities.

◦ Component 5: COP Additional Targets and Activities.

◦ 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.

• 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 Zimbabwe.

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 Recent gains in HIV epidemic control in Zimbabwe Zimbabwe has recorded significant progress in the prevention and control of HIV infections, achieving HIV epidemic control for the general population.

Zimbabwe is on track to end HIV as a public health threat if people living with HIV stay in treatment and program gaps are addressed.

According to the Joint United Nations Programme on HIV/AIDS (UNAIDS) Global AIDS Report (2024), Zimbabwe reduced the number of new HIV infections by 75%. HIV treatment coverage among people living with HIV increased from 68% in 2016 to 99% in 2024, according to the UNAIDS 2023 spectrum estimates.

Achievements from the previous NOFO, CDC RFA-GH19-1944 include:

• Reducing HIV case-finding gaps among high-risk subpopulations.

• Reducing vertical transmission of HIV.

• Scaling up community-based approaches to providing HIV services, such as community posts.

• Improving HIV treatment coverage and outcomes in people living with

HIV.

• Expanding HIV prevention options.

• Increasing access to cervical cancer screening and treatment services.

Gaps in HIV diagnosis and treatment in Zimbabwe While Zimbabwe has achieved the 95-95-95 targets for the adult population, gaps remain:

• Only 68% of children living with HIV have been diagnosed.

• While 98% of children who tested HIV positive started on antiretroviral therapy (ART), only 89% are considered virally suppressed.

• Men and the younger age groups (ages 15 to 34) have lower achievement of the UNAIDS 95-95-95 targets compared to women and older people living with HIV, according to the second Zimbabwe Population-Based HIV Impact Assessment (2020).

Step 1: Review the Opportunity 10

• Zimbabwe’s MoHCC has highlighted human resource challenges across the continuum of service delivery.

Previous program implementation identified the need to do the following:

• Improve the quality and accessibility of services for young people.

• Enhance collaboration with social protection services and other government departments besides health.

• Improve inter-facility collaboration to make sure patient follow-up is accurate and improve retention in care.

• Improve fidelity and uptake of efficient HIV case-finding strategies such as index testing and community-based HIV testing.

• Improving adherence, treatment literacy, retention in care, and VL coverage among people living with HIV, especially priority populations.

• Increase early uptake of antenatal care services among pregnant women.

• Improve pre-exposure prophylaxis (PrEP) use among high-risk populations and pregnant and breastfeeding women.

Increasing the sustainability, efficiency, and acceleration of HIV control efforts As part of this award, you will provide direct support and technical assistance to faith-based hospitals and other health facilities to sustain people living with HIV on treatment and ensure they achieve and remain virally suppressed.

You will also provide support and technical assistance to:

• Reduce AIDS-related morbidity and mortality.

• Speed up the delivery of HIV services.

• Diagnose and manage AHD, NCDs, and other HIV co-morbidities (such as TB) among people living with HIV.

• Close gaps in access to HIV prevention and treatment for key and priority populations.

• Increase use of HIV testing and prevention services, including HIV PrEP, post-exposure prophylaxis (PEP), and new biomedical interventions as they become available.

• Increase coverage of cervical cancer screening and treatment.

• Improve HIV and related program data quality.

• Increase HIV prevention and treatment literacy in the population.

• Improve VL coverage for all populations.

Step 1: Review the Opportunity 11

To achieve these outcomes and make HIV control efforts more sustainable and efficient, this NOFO asks you to:

• Help simplify service delivery interventions and use data to guide program approaches.

• Help deliver high-quality, person-centered services to people in the area served by a health facility.

• Address the gaps within the Zimbabwe HIV response by engaging with faith-based organizations (FBOs), MoHCC, community-based organizations (CBOs), and other health-related institutions.

• Contribute to efforts to:

◦ Strengthen the public health systems and institutions.

◦ Promote a favorable policy environment.

◦ Close health equity gaps.

• Show a focus on youth to make sure that the youth bulge does not threaten long-term gains and promote access to quality HIV services for this population.

• Support an optimal mix of community- and facility-based approaches to help Zimbabwe sustain epidemic control among adults, achieve epidemic control among children, and eliminate vertical transmission.

These efforts will help sustain the progress made through PEPFAR and support the shift from a crisis to a sustainable, manageable national program through ambitious, equitable, bold, and evidence-based strategies.

Purpose The purpose of this NOFO is to sustain and accelerate the HIV response towards epidemic control in Zimbabwe through direct support and technical assistance to the MoHCC. The NOFO also supports collaborative relationships with FBOs, CBOs, and other public health stakeholders.

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.

Step 1: Review the Opportunity 12

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:

Collaborate with FBOs and other CBOs to strengthen health systems and enhance collaboration with MoHCC.

Strategy 2: Implement integrated and comprehensive HIV programs for all populations to improve prevention service uptake and treatment adherence.

Strategy 3: Implement differentiated HIV testing and treatment services for all populations to improve HIV literacy and treatment coverage.

Strategy 4: Provide client-centered prevention and treatment services for people living with HIV to improve the prevention and management of comorbidities.

• Increased capacity of government and faith-based health facilities to deliver high-quality HIV services.*

• Improved community-clinic collaboration in HIV program.*

• Increased uptake of HIV prevention services for those at risk of HIV infection.*

• Increased HIV diagnosis in priority populations.*

• Increased uptake of VL testing.*

• Improved tracking of clients with interrupted treatment and high

VL.

• Increased ART coverage in people living with HIV.*

• Improved retention rates in

• Improved HIV program oversight by FBOs and CBOs.*

• Improved HIV clinical management for all populations.

• Increased provision of post-violence care to affected clients.

• Increased treatment literacy within communities.

• Increased awareness of HIV status within communities.*

• Improved treatment adherence among people living with

HIV.

• Improved VL suppression among people living with HIV.

• Improved HIV comorbidities and

• Increased investment and accountability in FBOs and CBOs within the HIV program.*

• Sustained capacity to deliver and monitor high-quality health services.*

• Reduced stigma and discrimination toward people living with HIV.*

• Improved quality of life among people living with

HIV.*

• Reduced HIV-related morbidity and mortality.

• Reduced incidence of HIV.*

• Sustained epidemic control.

Step 1: Review the Opportunity 13

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes

Strategy 5:

Strengthen MoHCC’s capacity to collect, analyze, and use data to improve program quality.

HIV treatment programs.

• Increased participation in GBV prevention and response interventions.*

• Improved HIV/TB program collaboration.*

• Improved capacity to manage common HIV comorbidities.*

• Increased NCD screening and management among people living with HIV.*

• Increased cervical cancer screening and treatment.

• Improved data quality and use.*

AHD detection and management.

• Improved data-driven planning and decision-making.*

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

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

Step 1: Review the Opportunity 14

Strategy 1: Collaborate with FBOs and other CBOs to strengthen health systems and enhance collaboration with MoHCC.

Required activities:

• Train healthcare workers from FBOs, CBOs and MoHCC-supported health facilities to provide high-quality, comprehensive HIV services.

• Hire staff to address health gaps created due to attrition and evolving program requirements.

• Facilitate agile deployment of human resources for health to respond to program needs.

• Scale up care and support services within faith-based health facilities and communities.

• Implement capacity-building and continuous quality improvement initiatives.

• Expand mentorship program to health service providers at all health system levels.

• Scale up mentorship and supervision activities within health facilities and community posts.

• Build capacity of MoHCC district and provincial staff to provide quality HIV services and take on innovations, including biomedical interventions.

• Ensure differentiated service delivery models are efficient and sustainable.

Strategy 2: Implement integrated and comprehensive HIV programs for all populations to improve prevention service uptake and treatment adherence.

Required activities:

• Expand PrEP and PEP use among priority populations, including new technologies as they become available.

• Scale up HIV testing services within priority populations.

• Expand the use of HIV self-testing in HIV screening and monitoring of prevention programs.

• Identify and fix barriers to efficient HIV prevention within health facilities and communities.

• Expand PEP access beyond occupational exposure and sexual violence.

• Scale up the provision of post-violence care for affected clients.

Step 1: Review the Opportunity 15

Strategy 3: Implement differentiated HIV testing and treatment services for all populations to improve HIV literacy and treatment coverage.

Required activities:

• Implement innovative HIV testing services for prevention and treatment to all priority populations.

• Scale up community posts and other evidence-informed community-based HIV testing services.

• As evidenced by data, target prevention and testing activities by geography and subpopulation.

• Refresh and disseminate HIV testing messages and health education.

• Develop and implement appropriate and effective out-of-facility testing models to reach specific subpopulations.

• Support appropriate, validated screening tools and tests to improve testing efficiency.

• Improve the quality and uptake of index testing and self-testing among priority populations.

• Improve pediatric HIV case-finding through a strategic mix of testing modalities.

• Provide early infant diagnosis services for HIV-exposed infants.

• Use innovative strategies to reach pregnant mothers who start antenatal care late into their pregnancy.

• Improve ART uptake and retention of those who are HIV positive throughout pregnancy and the breastfeeding period.

• Increase PrEP uptake among pregnant and breastfeeding women.

Strategy 4: Provide client-centered prevention and treatment services for people living with HIV to improve the prevention and management of comorbidities.

Required activities:

• Provide cervical cancer screening services for all women living with HIV.

• Provide treatment of precancerous lesions in women living with HIV.

• Expand mental health screening services in priority populations.

• Screen for and manage AHD and NCDs among people living with HIV.

• Scale up and sustain TB screening and diagnosis for people living with

HIV.

Step 1: Review the Opportunity 16

• Scale up HIV testing in TB patients.

• Scale up provision of TB preventive therapy in people living with HIV.

• Implement capacity-building activities for healthcare workers to better manage comorbidities.

• Provide regular communication pathways with communities, FBOs, civil society organizations, and networks of people living with HIV to address stigma and discrimination.

Strategy 5: Strengthen MoHCC’s capacity to collect, analyze, and use data to improve program quality.

Required activities:

• Improve capacity for routine and consistent data collection and reporting.

• Roll out, maintain, and update data collection tools and systems used in HIV programs.

• Scale up and optimize the use of electronic health records to support the HIV program.

• Conduct supportive supervision of sites to ensure the quality of reported results.

• Conduct routine data quality assessments and review meetings at all health system levels.

• Collaborate with CDC, MoHCC, and other stakeholders in HIV and related surveillance activities.

• Conduct regular monitoring and evaluation assessments at all levels of the health system.

• Actively engage communities in the design and implementation of monitoring and evaluation activities.

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

Step 1: Review the Opportunity 17 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. 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.

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/

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 the following:

• As evidenced by available data, people at high risk of acquiring HIV, such as men, key populations, children, adolescent girls and young women, and pregnant and breastfeeding women, will be prioritized for HIV prevention.

• People living with HIV who receive HIV treatment and support services.

Similar emphasis will be placed on key populations, men, and children, who continue to have sub-optimal treatment outcomes.

• Healthcare workers within the public health delivery system who participate in capacity-building interventions, including those working in FBOs, faith-related health facilities, and other facilities.

• District/provincial staff who support health workers.

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.

Step 1: Review the Opportunity 19

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, during your award, we may ask you to conduct activities consistent with local laws to:

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

• Reduce HIV and TB stigma and discrimination.

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

• Make the workforce more inclusive.

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

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

Collaborations If funded, we will expect you to collaborate with United States Government (USG) and non-USG funded organizations, including:

• MoHCC AIDS and TB Unit, National AIDS Council, and the Maternal and Child Health Department.

• FBOs such as church-related health facilities that support public health activities.

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

• US Agency for International Development (USAID) and USAID-funded organizations.

• CDC, USAID, and other donor-funded implementing partners for HIV prevention, care and treatment, strategic information, and laboratory support.

• Civil society organizations.

• HIV program stakeholders, community leadership, and community service organizations.

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

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

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

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

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

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

In your application budget, you should allocate at least 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.

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

Step 1: Review the Opportunity 21

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 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 In the following list, 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.

• KP_PREV: Number of key populations reached with individual and/or small group-level HIV prevention interventions designed for the target population. [Target: 2,400; Reporting Frequency: Semi-Annual]

• PrEP_NEW: Number of individuals who were newly enrolled on pre-exposure prophylaxis (PrEP) to prevent HIV infection in the reporting period. [Target: 2,236; Reporting Frequency: Quarterly]

• TB_PREV: Proportion of ART patients who started on a standard course of TB preventive treatment (TPT) in the previous reporting period who completed therapy. [Target: 95%; Reporting Frequency: Semi-Annual]

• CXCA_SCRN: Number of women living with HIV on ART screened for cervical cancer. [Target: 25,000; Reporting Frequency: Semi-Annual]

• HTS_INDEX: Number of individuals who were identified and tested using Index testing services and received their results. [Target: 4,090; Reporting Frequency: Quarterly]

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

10,772; Reporting Frequency: Quarterly]

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

• HTS_TST: Number of individuals who received HIV Testing Services and received their test results. [Target: 103,550; Reporting Frequency:

Quarterly]

• PMTCT_FO: Percentage of final outcomes among HIV-exposed infants registered in a birth cohort. [Target: Not Assigned; Reporting Frequency:

Annual]

• PMTCT_EID: Percentage of infants born to women living with HIV who receive a virologic test by 12 months of age. [Target: 100%; 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: 100%; Reporting Frequency: Quarterly]

• TB_STAT: Percentage of new and relapse TB cases with documented HIV status. [Target: 100%; Reporting Frequency: Quarterly]

• CXCA_TX: Percentage of cervical cancer screen-positive women who are living with HIV and on ART eligible for cryotherapy, thermocoagulation or LEEP who received cryotherapy, thermocoagulation or LEEP. [Target:

90%; Reporting Frequency: Semi-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: 100%; Reporting Frequency: Quarterly]

• TB_ART: Proportion of new and relapsed TB cases living with HIV on ART during TB treatment. [Target: 98%; Reporting Frequency: Annual]

• TX_CURR: Number of adults and children currently receiving antiretroviral therapy (ART). [Target: 101,828; Reporting Frequency:

Quarterly]

• TX_NEW: Number of adults and children newly enrolled on antiretroviral therapy (ART). [Target: 3,777; Reporting Frequency: Quarterly]

• TX_TB: Proportion of ART patients screened for TB in the semiannual reporting period who start TB treatment. [Target: 100%; Reporting Frequency: Semi-Annual]

• 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]

• GEND_GBV: Number of people receiving post-gender-based violence (GBV) clinical care based on the minimum package. [Target: 1,500;

Reporting frequency: Quarterly]

Step 1: Review the Opportunity 23

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

• Proportion of clients with missed opportunities with documented tracking outcome. [Target: 95%; Reporting Frequency: Quarterly]

• Proportion of clients with unsuppressed VL who subsequently report a suppressed VL. [Target: 95%; Reporting Frequency: Semi-Annual]

• Proportion of people who test HIV negative that are linked to prevention services. [Target: 100%; Reporting Frequency: Quarterly]

• Coverage of maternal re-testing for HIV for eligible pregnant and breastfeeding women. [Target: 100%, Reporting Frequency: Semi-Annual]

• Proportion of health facilities that received supportive supervision visits.

[Target: 95%; Reporting Frequency: Semi-Annual]

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

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

• Facilitators and barriers to sustainable implementation of comprehensive HIV programs by FBOs: process evaluation.

• Effect of HIV prevention and treatment interventions implementation on achieving and sustaining epidemic control in all populations: outcome evaluation.

• Facilitators and barriers to achieving and sustaining HIV epidemic control:

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.

Step 1: Review the Opportunity 24

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 various media.

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

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

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

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

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

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.

Step 1: Review the Opportunity 25

Additionally, explain:

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

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

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

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

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

Evaluation activities You must carry out specific evaluation activities.

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

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

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

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

Describe:

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

• 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.

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

Step 1: Review the Opportunity 26 https://www.cdc.gov/grants/additional-requirements/ar-25.html

Submit your initial DMP with your application and include:

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

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

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

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

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

• Archival and long-term data preservation plans.

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

In addition to the other requirements listed, also include:

• Cybersecurity plans.

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

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

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

Work plan You must provide a work plan for your project. The work plan connects your performance outcomes, strategies and activities, and measures. It provides more detail on how you will measure outcomes and processes. A sample work plan is provided as follows.

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

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

Step 1: Review the Opportunity 27

Table: Sample format

Activities you will implement

Progress or process measures

From the data, monitoring, and evaluation section.

Relevant period of performance outcomes

From the logic model.

Responsible position or party

Funding component / completion date

Strategy 1:

1.

2.

3.

Strategy 2:

1.

2.

3.

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

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

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.

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

Step 1: Review the Opportunity 28 https://www.cdc.gov/scientific-integrity/php/public-information-collection/index.html https://www.cdc.gov/scientific-integrity/php/public-information-collection/index.html

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

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

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

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

dollars.

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

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Satisfactory progress in meeting your project’s objectives.

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

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

◦ Funding more applicants.

◦ Extending the period of performance.

◦ Awarding supplemental funding.

See also program-specific limitations.

Unallowable costs You may not use funds for:

• Research.

• Clinical care, except as allowed by law.

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

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

◦ 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,

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

Step 1: Review the Opportunity 29 https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=13f24ea1f961f5f0d14b87ec1b39b25f&term_occur=999&term_src=Title:45:Chapter:A:Subchapter:A:Part:75:Subpart:E:Subjgrp:39:75.440 administrative action, or executive order proposed or pending before any legislative body.

◦ See Anti-Lobbying Restrictions for CDC Recipients.

• Needle exchange programs.

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

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

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

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

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

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

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

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

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.

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)) https://www.ecfr.gov/current/title-45/part-75#p-75.403(d)

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.