India CDC-RFA-JG-25-0103 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 24, 2025

Ending HIV as a public health threat by sustaining and accelerating a comprehensive HIV and TB response in India under the President's Emergency Plan for AIDS Relief (PEPFAR) Opportunity number: CDC-RFA-JG-25-0103

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 7

Program description 10

Step 2: Get Ready to Apply 33

Get registered 34

Questions 35

Step 3: Prepare Your Application 36

Application contents and format 37

Step 4: Learn About Review and Award 46

Application review 47

Award notices 52

Step 5: Submit Your Application 53

Application submission and deadlines 54

Application checklist 56

Step 6: Learn What Happens After Award 57

Post-award requirements and administration 58

Contacts and Support 68

Contents 2

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

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

See Step 2: Get Ready to Apply

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

See Step 2: Get Ready to Apply

Apply by the application due date Applications are due by 11:59 p.m. Eastern Time on February 24, 2025.

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

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

Jump to a step

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

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 7

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:

Ending HIV as a public health threat by sustaining and accelerating a comprehensive HIV and TB response in India under PEPFAR

Opportunity number:

CDC-RFA-JG-25-0103

Announcement type:

New

Assistance listing:

93.067 Global AIDS

Program; 93.494 Global Tuberculosis 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 We seek to support the National AIDS Control Program (NACP) to sustain and accelerate HIV epidemic control in priority geographies (e.g. Andhra Pradesh and others as applicable) across the prevention to treatment cascade including viral load suppression (VLS). In alignment with the NACP Phase V, you will build on innovative, evidence-based, person-centered strategies to improve:

• HIV and TB prevention.

• HIV and TB case-finding.

• Improved tools for TB case identification.

• Linkage to care continuum.

• Treatment retention and viral load suppression.

You should demonstrate an innovative plan to collaborate with and support district, state, national teams, communities, private sector organizations, and other stakeholders to address program gaps and strengthen the HIV/TB response. Technical assistance activities may include, but are not limited to:

• Closing testing, treatment, and equity gaps.

• Reinforcing collaborations to complement NACP.

• Improving data use for impact.

• Expanding ability to respond to emerging public health threats.

Step 1: Review the Opportunity 5

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $4,000,000 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 2 through 5 will be set at continuation. We will continue funding based on:

• Availability of funds.

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

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

Component funding

Overview

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

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

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

Step 1: Review the Opportunity 6

Setting up components

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

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

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

◦ Component 1: COP Q1 Targets and Activities.

◦ Component 2: COP Q2 Targets and Activities.

◦ Component 3: COP Q3 Targets and Activities.

◦ Component 4: COP Q4 Targets and Activities.

◦ Component 5: COP Additional Targets and Activities.

◦ Component 6: Global TB Activities.

◦ Component 7: 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

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).

Non-PEPFAR funds (Global Tuberculosis): This program is also authorized under Section 301(a) of the Public Health Service Act [42 USC 241(a)], as amended.

Step 1: Review the Opportunity 7

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.

Other required qualifying factors

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

FCRA registration Any local partner (prime applicant or proposed sub-partner), applying for this NOFO must be compliant with Government of India’s Foreign Contribution Regulation Act (FCRA) and must submit documentation of active FCRA registration.

Step 1: Review the Opportunity 8

The prime partner applicant must have the capability to engage local sub-partners, as needed, to meet the program objectives.

Failure to provide FCRA registration as part of the application will render an application nonresponsive and your application will not move forward.

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.

• Does not provide FCRA registration as part of the application.

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 India has the second largest HIV epidemic in the world, accounting for around 6.3% of all people living with HIV worldwide.

Estimated epidemiological data for India in 2023 show that there are:

• 2.54 million people living with HIV.

• 68,000 new cases annually.

The HIV/AIDS epidemic continues to be concentrated among key and priority populations which differ based on geography and demographics. Significant progress has been made under the NACP to contain the epidemic in India through the integrated approaches of prevention, detection, and treatment of HIV and associated comorbidities, but inequities persist. PEPFAR and CDC are committed to supporting progress towards the UNAIDS 10-10-10 targets to:

• Reduce disciplinary legal and policy situations that deny or limit access to services.

• Reduce stigma and discrimination.

• Reduce gender inequality and violence.

India has the highest TB burden worldwide, with 25% of the global TB burden existing in India alone. The country has implemented a comprehensive TB control program, including ambitious targets and expansion of services. The national strategic plan focuses on developing strategies to decrease TB-related deaths and comorbidities.

Building on the previous award under CDC-RFA-GH20-2038, PEPFAR and CDC are committed to supporting the national program to achieve and sustain the 95-95-95 targets and eliminate TB across populations and geographies.

The NOFO aims to implement the shared vision of providing impactful and evidence-based technical support to the Government of India (GOI) towards ending HIV as a public health threat ahead of the 2030 target.

Step 1: Review the Opportunity 10

Strategic goals and priorities include:

• Develop and implement comprehensive, stigma-free HIV/TB prevention services.

• Implement innovative case-finding activities to ensure early diagnosis and linkage to appropriate comprehensive, stigma-free HIV/TB services for all priority populations.

• Enhance adherence to, retention in, and reengagement with comprehensive, stigma-free HIV/TB care and treatment services through integration of person-centered approaches for HIV and associated comorbidities.

• Expand collaborations and community partnerships at the national and sub-national levels to promote equitable access to HIV/TB services and enhance capacity to manage the HIV epidemic, sustain gains, and respond to emerging public health threats.

Some expected outcomes of this NOFO will include:

• Increasing proportion of people living with HIV who know their HIV and TB status.

• Increasing access to and use of comprehensive, stigma-free HIV/TB services.

• Increasing national rates of VLS.

Purpose The purpose of this NOFO is to provide impactful and evidence-based technical support to GOI in ending HIV as a public health threat by:

• Accelerating the HIV/TB response within priority and emerging geographies with focus on priority populations.

• Building sustainable and comprehensive, stigma-free HIV/TB services that leverage efficiencies across health systems.

You will build on prior efforts, while embracing innovative approaches to HIV/ TB prevention, case finding, treatment continuity, treatment reengagement, durable VLS, and reduction of HIV drug resistance.

Step 1: Review the Opportunity 11

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

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

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

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

Table: Strategies and outcomes

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes

Strategy 1: Develop and implement evidence-based, person-centered, and sustainable programming for integrated comprehensive HIV/ TB prevention approaches for priority populations.

Strategy 2: Support the scale-up of integrated, evidence-based testing services for early diagnosis, and timely linkage to comprehensive, stigma-free HIV/TB services for all priority populations.

Strategy 3: Facilitate the implementation of

Increased equitable access to comprehensive, stigma-free HIV/TB services by priority populations.*

Improved early diagnosis of TB for priority populations.*

Improved knowledge of serological status among people living with HIV.*

Increased capacity of healthcare workers to deliver quality, comprehensive HIV/ TB services.*

Improved capacity of healthcare workers to use innovative strategies to find

Increased equitable use of comprehensive, stigma-free HIV/TB prevention services by priority populations.*

Reduced TB transmission for priority populations.*

Increased viral load coverage for people living with HIV.*

Increased adherence to treatment among people living with HIV/

TB.*

Increased retention of people living with HIV on treatment.*

Increased case finding with same day linkage

Reduced national rate of HIV and HIV/TB incidence.*

Sustained VLS for people living with

HIV.*

Decreased HIV/TB related morbidity and mortality for priority populations and people living with HIV.

Sustained use of high-quality, timely evaluation data to inform policy development and program services.

Increased progress towards achieving

UNAIDS 10-10-10

targets.

Step 1: Review the Opportunity 12

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes integrated, person-centered HIV and associated comorbidity care and treatment for people living with HIV to enhance access to and retention in services.

Strategy 4:

Strengthen the capacity of the national and sub-national levels to effectively manage HIV/TB programs to ensure HIV/TB epidemic control, sustain impactful programmatic gains, and respond to emerging public health threats.

cases among priority populations.*

Increased access to quality, timely data for monitoring of emerging public health threats.*

Increased implementation of innovative activities to support treatment continuity for people living with HIV.* to comprehensive HIV/TB services for priority populations.*

Sustained ability of healthcare workers to deliver high-quality, comprehensive HIV/ TB services.*

Increased use of high-quality, timely data for programmatic improvement.*

Increased TB preventative treatment (TPT) coverage for people living with HIV.*

Increased progress towards eliminating HIV as a public health threat.

Increased community ownership in the HIV response.

Additional information on outcomes in the logic model:

• Comprehensive, stigma-free HIV/TB services refers to outcomes for HIV and TB.

• Comprehensive, stigma-free HIV/TB services for HIV, STIs, TB, and/or associated comorbidities include, but is not limited to:

◦ Prevention (e.g., biomedical preventions, harm reduction, TB preventive treatment (TPT), mental health, etc.) services.

◦ Testing services.

◦ Care and treatment services.

• Comprehensive, stigma-free HIV/TB services include, but are not limited to, services accessed at the facility and community levels.

• People living with HIV includes, but is not limited to:

◦ Adults.

Step 1: Review the Opportunity 13

◦ Pregnant and breastfeeding women.

◦ Children living with HIV.

• High-quality, timely evaluation data includes, but is not limited to all programmatic data and results from any mid or end-term evaluations.

• Healthcare workers include, but are not limited to:

◦ Community healthcare workers.

◦ Frontline workers.

◦ Facility-based workers.

◦ Peer educators.

◦ Outreach workers.

◦ Lay providers, etc.

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

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

Strategy 1: Develop and implement evidence-based, person-centered, and sustainable programming for integrated comprehensive HIV/TB prevention approaches for priority populations.

Required activities:

• Develop and implement innovative, sustainable, and stigma-free prevention strategies for priority populations.

• Use the most recent epidemiological and geographical data to develop and implement innovative, evidence-based prevention strategies for priority populations.

• Use national, local, and community partnerships and collaborations to develop equitable prevention strategies for priority populations.

• Engage with priority populations and communities to provide access to equitable, integrated, and comprehensive HIV/TB prevention services.

Step 1: Review the Opportunity 14

• Integrate evidence-based prevention services into existing national programs for sustained program response.

• Support expansion of TB prevention activities, the use of improved and innovative diagnostic tools, and shorter treatment regimens for drug-susceptible and drug-resistant TB.

Strategy 2: Support the scale-up of integrated, evidence-based testing services for early diagnosis, and timely linkage to comprehensive, stigma-free HIV/TB services for all priority populations.

Required activities:

• Develop and implement innovative and sustainable, stigma-free case finding strategies for priority populations including, but not limited to, HIV/TB testing services (HTS) tailored to:

◦ Geographic or programmatic setting.

◦ Population type.

• Continue to identify case-finding and linkage gaps and develop strategies to address those barriers, including but not limited to:

◦ Index testing services.

◦ Social network testing models.

◦ Other case finding modalities.

• Use the latest epidemiological and program data to develop and implement innovative, evidence-based case finding strategies for priority populations.

• Integrate HTS with other clinical diagnostic programs for person-centered delivery of services.

• Identify and develop sustainable peer-led linkage to care models to ensure rapid linkage to treatment and prevention services and to prevent linkage loss to care.

• Develop and implement person-centered, innovative demand creation strategies (e.g., Undetectable = Untransmittable, virtual outreach, etc.) for priority populations to enhance comprehensive, stigma-free HIV/TB service uptake.

Step 1: Review the Opportunity 15

Strategy 3: Facilitate the implementation of integrated, person-centered HIV and associated comorbidity care and treatment for people living with HIV to enhance access to and retention in services.

Required activities:

• Develop and implement integrated strategies to provide comprehensive, person-centered care and treatment for people living with HIV and related comorbidities.

• Use the latest epidemiological data to develop and implement innovative, evidence-based care and treatment services that is inclusive of HIV-associated comorbidities for people living with HIV.

• Continue to design and implement a person-centered approach for differentiated service delivery models to improve treatment outcomes.

• Develop and implement innovative, community-focused approaches that promote adherence to treatment for people living with HIV in a stigma-free environment.

• Develop and implement innovative and community-focused approaches to promote viral load coverage among people living with HIV in a stigma-free environment.

• Develop an innovative and collaborative model with the laboratory strengthening implementation partner to implement innovative strategies for early detection and linkage to care for cervical cancer in women living with HIV.

• Develop and implement innovative, person-centered approaches that promote retention and re-engagement in care for people living with HIV in a stigma-free environment.

• Develop and implement a system to use drug resistance data for clinical case management.

• Build the capacity of Centers of Excellence to support the national technical assistance system for treatment.

Step 1: Review the Opportunity 16

Strategy 4: Strengthen the capacity of the national and sub-national levels to effectively manage HIV/TB programs to ensure HIV/TB epidemic control, sustain impactful programmatic gains, and respond to emerging public health threats.

Required activities:

• Build capacity of healthcare workers to deliver equitable, high-quality prevention, care, and treatment services for HIV and associated comorbidities.

• Expand collaborations and community partnerships at the national and local levels to promote equitable access to HIV/TB services and enhance capacity to manage the HIV epidemic, sustain gains, and respond to emerging public health threats.

• Implement and sustain quality improvement activities using high-quality data and evaluation findings.

• Use the latest epidemiological, program, and surveillance data to develop guidance, policies, and program improvement plans.

• Strengthen the HIV and associated comorbidities coordination efforts at the district, state, and national levels.

• Facilitate the adoption of best practices and innovations in comprehensive, stigma-free HIV/TB services at the national level.

• Build the capacity of healthcare staff at all levels to efficiently input and monitor data in sub-national, and national data systems for timely response and surveillance of HIV, HIV associated comorbidities, and emerging public health threats.

• Provide technical support to NACP, State AIDS Control Society (SACS), District Integrated Strategy for HIV/ AIDS (DISHA), and National TB Elimination Program (NTEP), to scale-up program improvements using high-quality, timely data and evaluation findings.

To support the purpose of this NOFO, you are expected to provide copies of and/or access to all data, software, tools, training materials, guidelines, and systems developed under this NOFO to Ministry of Health and other relevant stakeholders, including HHS/CDC, for appropriate use consistent with underlying authorities.

Step 1: Review the Opportunity 17

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Non-PEPFAR funds (Global Tuberculosis) This NOFO aligns with CDC’s current Global Health Strategy including:

protecting Americans and populations across the globe by strengthening global public health prevention, detection, and response; saving lives, improving health outcomes, and fostering healthy populations globally; and leading the advancement of global public health science and practice and serving as a leading source of credible scientific information.

This program also addresses the “Healthy People 2030” focus area of Global Health, Goal: Improve health by preventing, detecting, and responding to public health events worldwide.

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:

• People affected by and living with HIV.

• Key populations:

◦ Men who have sex with men.

◦ Female sex workers.

◦ Hijra/transgender people.

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

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

◦ People who inject drugs.

◦ People in prisons and other closed settings.

• Priority populations:

◦ Adolescent girls and young women.

◦ Adolescent boys and young men.

◦ Adult men.

◦ Partners of sex workers.

◦ Displaced persons.

◦ Mobile populations.

• Other populations that have a higher risk of HIV incidence compared to general population groups.

• HIV/TB patients who would be directly benefitting from services.

• Healthcare workers, as defined by the NOFO.

• Pregnant and breastfeeding women.

• Populations in virtual spaces.

• Other underserved populations.

Equal opportunities This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of:

• Race.

• Color.

• National origin.

• Disability.

• Age.

• Sex (including gender identity, sexual orientation, and pregnancy).

• Other constitutionally protected statuses.

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

Step 1: Review the Opportunity 20

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

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

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

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

• Reduce HIV and TB stigma and discrimination.

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

• Make the workforce more inclusive.

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

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

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

Government agencies and programs:

• Ministry of Health (MoH).

• NACP.

• SACS.

• NTEP.

• DISHA.

• PEPFAR agencies and programs.

• Local government agencies.

Non-government organizations and programs:

• Community groups.

• Key, priority, and underserved populations.

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

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

• Multilateral organizations.

• Global Fund recipients.

• Private sector organizations.

• Current CDC-funded implementing partners supporting activities in:

◦ Prevention, treatment, and laboratory services.

◦ Strategic information.

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 10% of funds for monitoring activities and 5% for evaluation activities. We will discuss these percentages and finalize them at or after award. These are estimates for the total funding over the 5-year project.

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

Step 1: Review the Opportunity 22

Required performance measures

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

• PEPFAR’s Monitoring, Evaluation, and Reporting (MER) indicators common to all awards. You can find additional information regarding MER reporting in the MER Guidance and resource materials, available at DATIM’s MER Indicator Reference Guides.

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

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

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

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

• HTS_TST: Number of individuals who received HIV Testing Services (HTS) and received their test results. [Target: 35,000; Reporting Frequency:

Quarterly]

• HTS_INDEX: Number of individuals who were identified and tested using index testing services and received their results. [Target: 31,000;

Reporting Frequency: Quarterly]

• KP_PREV: Number of key populations reached at least once with individual and/or small group-level HIV primary or secondary prevention interventions designed for the target population. [Target: 15,000;

Reporting Frequency: Semi-Annual]

• PP_PREV: Number of priority populations (PP) reached with the standardized, evidence-based intervention(s) required that are designed to promote the adoption of HIV prevention behaviors and service uptake.

[Target: 5,000; Reporting Frequency: Semi-Annual]

• KP_MAT: Number of people who inject drugs (PWID) on medication-assisted therapy (MAT) for at least 6 months. [Target: 500; Reporting Frequency: Annual]

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

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

• TX_CURR: Number of adults and children currently receiving antiretroviral therapy (ART). [Target: 223,000; Reporting Frequency:

Quarterly]

• TX_NEW: Number of adults and children newly enrolled on antiretroviral therapy (ART). [Target: 23,803; Reporting Frequency: Quarterly]

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

[Target: Not Assigned; Reporting Frequency: Quarterly]

• TX_RTT: Number of ART patients who experienced an interruption in treatment (IIT) during any previous reporting period, who successfully restarted ARVs within the reporting period and remained on treatment until the end of the reporting period. [Target: Not Assigned; Reporting Frequency: Quarterly]

• 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: 90%; Reporting Frequency: Semi-Annual]

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

Reporting Frequency: Semi-Annual]

• 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: Not Assigned; 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]

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 people tested who were diagnosed with HIV and were initiated on HIV treatment as per national guidelines. [Target: >95%;

Reporting Frequency: Quarterly]

• Percentage of people tested for HIV who received a negative test result and were linked to the appropriate comprehensive, stigma-free HIV/TB prevention services. [Target: >95%; Reporting Frequency: Quarterly]

Step 1: Review the Opportunity 24

• Percentage of healthcare workers trained on comprehensive, stigma-free HIV/TB services during the time frame. [Target: 25%; 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 Below, we include examples of evaluation topics that we may expect you to answer through process, outcome, or economic evaluation. In your application, include at least one, but no more than three potential evaluation questions. We will expect you to conduct a mid-term and/or end-term evaluation.

• Facilitators/Barriers to implementation of innovative approaches for prevention, case-finding, care and treatment: process evaluation.

• Effects of innovative, integrated service delivery models on reaching priority populations for HTS: 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.

Step 1: Review the Opportunity 25

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.

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.

Step 1: Review the Opportunity 26

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.

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.

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

Step 1: Review the Opportunity 27 https://www.cdc.gov/grants/additional-requirements/ar-25.html

• 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.

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

Step 1: Review the Opportunity 28

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 collections requiring PRA approval, CDC is responsible for working with OMB to gain the approval.

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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 30 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 31 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.