Ukraine CDC-RFA-JG-25-0059 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 21, 2025

Sustaining HIV services for key and priority populations through enhanced differentiated testing, innovative treatment and prevention approaches, and continuous support to Ukraine Ministry of Health, Public Health Center, and communities under PEPFAR

Opportunity number: CDC-RFA-JG-25-0059

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 35

Get registered 36

Questions 37

Step 3: Prepare Your Application 38

Application contents and format 39

Step 4: Learn About Review and Award 49

Application review 50

Award notices 57

Step 5: Submit Your Application 58

Application submission and deadlines 59

Application checklist 61

Step 6: Learn What Happens After Award 63

Post-award requirements and administration 64

Contacts and Support 71

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 21, 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:

Sustaining HIV services for key and priority populations through enhanced differentiated testing, innovative treatment and prevention approaches, and continuous support to Ukraine Ministry of Health, Public Health Center, and communities under PEPFAR

Opportunity number:

CDC-RFA-JG-25-0059

Announcement type:

New

Assistance listing: 93.067 Global AIDS Program

Key dates

Application deadline:

February 21, 2025

Expected award and start date: September 30, 2025

We will inform you of your application status by the end of August 2025.

See other submissions for other time frames that may apply to this

NOFO.

Summary The NOFO aims to help the Ministry of Health of Ukraine (MOH), the Ukraine Public Health Center (PHC), and communities improve HIV testing, prevention, and treatment activities among key and priority populations amid the ongoing war.

The expected outcomes of the NOFO are:

• Improve access to and use of comprehensive HIV services for key and priority populations.

• Implement differentiated service delivery (DSD) models at medical facilities and communities to improve the quality of service delivery.

• Expand access to and quality of medication-assisted therapy (MAT) for key populations.

• Align national policies and guidelines with international standards.

The activities required to accomplish the goals of the NOFO include:

• Train healthcare professionals and community health workers to provide comprehensive HIV services in a way that is free of stigma and discrimination.

• Use social network strategy (SNS), mobile testing models, HIV self-testing (HIVST), and other innovative HIV case-finding modalities to connect with key and priority populations that are harder to reach.

• Ensure wide access to comprehensive HIV services for key and priority populations by leveraging communities.

• Expand access to and coverage of high-quality MAT services, including to people in prisons and other closed settings.

Step 1: Review the Opportunity 5

• Use data and evaluation results to guide improvements and make recommendations for policy development, program, and service delivery.

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $8,000,000 This is the expected total Year 1 funding for all awards made under this

NOFO.

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

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

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

Funding strategy

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

You may not request more than this amount.

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

• Availability of funds.

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

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

Component funding

Overview

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

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

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

Step 1: Review the Opportunity 6

Setting up components

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

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

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

◦ Component 1: COP Q1 Targets and Activities.

◦ Component 2: COP Q2 Targets and Activities.

◦ Component 3: COP Q3 Targets and Activities.

◦ Component 4: COP Q4 Targets and Activities.

◦ Component 5: COP Additional Targets and Activities.

For information on how to incorporate component funding into your application, see the following sections:

• Budget narrative

• Component funding instructions for SF-424A

PEPFAR Local partner funding preference This NOFO includes a funding preference for local partners. Your organization will receive 30 extra points during the selection process if you provide sufficient documentation demonstrating you meet the PEPFAR local partner definition.

Step 1: Review the Opportunity 7

Eligibility Statutory authority This program is authorized under:

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

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

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

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

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

• State governments.

• County governments.

• City or township governments.

• Special district governments.

• Independent school districts.

• Public and state-controlled institutions of higher education.

• Native American tribal governments (federally recognized).

• Public housing authorities and Indian housing authorities.

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

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

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

• Private institutions of higher education.

• For-profit organizations other than small businesses.

• Small businesses.

• Foreign or non-U.S. based entities.

Step 1: Review the Opportunity 8

Other required qualifying factors

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

Responsiveness criteria We will review your application to make sure it meets these requirements.

These are the basic requirements you must meet to move forward in the competition. We won’t consider an application that:

• Is from an organization that doesn’t meet eligibility criteria. See requirements in eligibility.

• Is submitted after the deadline.

• Proposes research activities. See 45 CFR 75.2 for the definition of research.

• Requests more funding than the expected total NOFO funding for Year 1.

• Exceeds the 20-page limit for the project narrative (see the project narrative section for what counts toward the page limit).

• Is not in English.

• Includes a budget or budget narrative that uses a currency other than U.S. dollars.

• Does not respond to and is outside the scope of this NOFO.

See the application checklist to understand your application requirements.

Application limits We do not limit the number of applications an organization may submit.

Cost sharing and matching funds This program has no cost-sharing or matching funds requirement. We will not consider cost-sharing fund contributions during your application review.

However, if you submit voluntary cost-sharing funds and we fund your project, we will require you to report on these funds.

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

Step 1: Review the Opportunity 9 https://www.ecfr.gov/current/title-45/part-75#p-75.2(Research)

Program description Background overview and related work The state of the HIV and AIDS epidemic in Ukraine From its onset, the HIV/AIDS epidemic in Ukraine has primarily been concentrated in the following key populations:

• People who inject drugs.

• Men who have sex with men.

• Sex workers.

• People in prisons and other closed settings.

• These groups’ sexual and social networks.

These populations usually have much greater HIV prevalence, incidence, related morbidity and mortality, and lower viral load suppression (VLS) compared to general populations.

Past efforts, achievements, and challenges Past work in Ukraine, through PEPFAR and the expiring cooperative agreement under CDC-RFA-GH18-1818, has put in place targeted and effective interventions to reach key populations, including:

• Providing community-based HIV testing.

• Linking people who test positive to HIV care.

• Ensuring patients adhere to their antiretroviral therapy (ART) treatment.

• Using social network testing strategies to find cases among people who inject drugs and other priority populations.

• Referring people from HIV testing entry points to MAT and pre-exposure prophylaxis (PrEP).

Past achievements include:

• Tracking people who missed appointments at ART sites.

• Deduplicating the national HIV testing results.

• Improving linkages to treatment from 60% to nearly 100% through case management.

• A 30% increase in people receiving PrEP nationwide by immediately linking them with services.

Step 1: Review the Opportunity 10

• Scaling up MAT by implementing immediate referrals and linkages from testing programs.

• Improving the quality of MAT services through community engagement and person-centered approaches.

Challenges identified include:

• Patients drop out of treatment after 12 months of intensive case management because they were not integrated into the regular medical system.

• MAT scale-up that is behind the targets established by the National Strategy on countering HIV/TB and viral hepatitis.

• The slow expansion of new stationary MAT sites in areas with low coverage.

• Late HIV diagnoses, with many being diagnosed with or near AIDS.

The impact of the Russian invasion and ensuing war Since February 2022, the PEPFAR program in Ukraine has encountered unprecedented challenges. Amid the ongoing war, it’s been especially challenging to meet the expanding needs of key and emerging priority populations.

The destruction of Ukrainian health and other key infrastructure has created substantial risk of service interruptions and devastating challenges to accessing life-saving services. This is especially true in areas close to the frontline and in occupied territories.

Key and priority populations, especially those displaced or living in areas where health services were disrupted, have needed even more intensive support since the war began. These included new ways to provide services, and increased support to re-engage with HIV care.

Since the war, data from Ukraine’s ART patients’ electronic register, the Information System for Monitoring of Socially Significant Diseases, shows significant movement of ART patients across the country and abroad. These trends likely apply across the entire population of people living with HIV, including key populations.

Despite expanding MAT, coverage remains too low. According to program data, average MAT coverage nationally is 12% of the total estimated size of the population of people who inject opioids. This coverage falls short of

Step 1: Review the Opportunity 11

Ukraine’s National Strategy on countering HIV/TB and viral hepatitis goals of 15% by 2025 and 40% by 2030.

PEPFAR also continues to expand PrEP coverage:

• In 2019, PrEP was included in Ukraine’s National HIV Guidelines.

• In 2021, oral PrEP was included in the Program of Medical Guarantees Ukraine.

• In the same year, the National Health Service of Ukraine started funding PrEP services at ART sites.

• In 2022, PEPFAR supported the latest revision to the National HIV Guidelines, recommending event-driven PrEP for all cisgender men.

• In 2024, PEPFAR successfully launched long-acting injectable cabotegravir (CAB-LA) PrEP.

To achieve the UNAIDS 95-95-95 targets, activities should include:

• Establishing innovative case-finding and testing strategies, including mobile testing, HIVST, and SNS.

• Using data to sustainably track outcomes like adherence to treatment, re-engagement, and retention in comprehensive HIV services.

• Implementing interventions that provide better counseling on adherence to treatment and managing HIV and related comorbidities.

Purpose The purpose of the NOFO is to support the MOH, PHC, and communities in Ukraine to enhance comprehensive HIV services (including testing, prevention, care, and treatment) among key and priority populations amid the ongoing war and resulting service disruptions.

We expect this NOFO’s outcomes to be achieved through:

• Implementing innovative strategies for finding people with HIV.

• Using DSD models to improve the quality of services.

• Expanding access to and quality of MAT.

• Aligning national policies and guidelines with international standards.

Step 1: Review the Opportunity 12

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

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

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

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

Step 1: Review the Opportunity 13

Table: Strategies and outcomes

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes

Strategy 1: Facilitate wide access to and use of comprehensive HIV services for key and other priority populations through innovative, data-driven community engagement and support.

Strategy 2: Implement innovative DSD models in communities and medical facilities to enhance the quality of comprehensive HIV services for all populations.

Strategy 3: Expand accessibility and improve the quality of MAT for key populations.

Strategy 4: Support harmonization in implementation of evidence-based policies and guidelines with national and international standards.

Increased access to comprehensive HIV services for key and priority populations.*

Increased linkage to comprehensive HIV services for key and priority populations.*

Increased use of DSD models in communities and medical facilities.*

Increased access to MAT services for key populations.*

Increased harmonization of evidence-based policies and guidelines to national and international standards.*

Increased access to hepatitis C virus (HCV) services for people living with HIV who are enrolled in MAT services.*

Increased use of comprehensive HIV services by key and priority populations.*

Increased adherence to treatment for people living with HIV.*

Increased retention in comprehensive HIV services for key and priority populations.*

Sustained use of DSD models in communities and medical facilities.*

Increased quality of comprehensive HIV services for all populations.*

Increased use of MAT services for key populations.*

Increased decriminalization of drug use to align with national and international standards.*

Increased integration of gender-based violence (GBV) policies and guidelines within national and international standards.*

Increased use of HCV services for people living with HIV who are enrolled in MAT services.*

Increased VLS for people living with HIV.*

Decreased morbidity and mortality for people living with HIV.

Decreased new HIV infections for all populations.*

Sustained use of MAT services by key populations.

Sustained decriminalization of drug use to align with national and international standards.

Decreased risk of HIV infection for survivors of

GBV.

Decreased incidence of HCV among people living with HIV who are enrolled in MAT services.*

Decreased advanced HIV disease (AHD) for people living with HIV.

Step 1: Review the Opportunity 14

The following is additional information on outcomes in the logic model:

• Comprehensive HIV services include, but are not limited to:

◦ Prevention: Oral PrEP, long-acting PrEP (such as CAB-LA), post-exposure prophylaxis, and GBV.

◦ Case-finding and testing: Mobile case finding, SNS for case finding, HIV, index testing, HIVST, and HCV.

◦ Linkage to appropriate prevention or treatment services.

◦ Care and treatment: Retention support, adherence counseling, and GBV counseling.

• Key and other priority populations include but are not limited to:

◦ People who inject drugs and their partners.

◦ Transgender individuals.

◦ People in prisons and other closed settings.

◦ Displaced people.

◦ Post-military and uniformed services and their families.

◦ Mobile populations.

◦ People who use non-injecting drugs.

• Increased access to MAT services includes, but is not limited to:

◦ Coverage of services in geographically remote areas and areas that have had a disruption in regular services.

◦ Coverage of services in closed settings.

◦ Mobile service delivery.

• Increased quality of comprehensive HIV services includes, but is not limited to:

◦ Test and Start.

◦ Management of AHD and other HIV comorbidities.

◦ Enhanced counseling on and support for adhering to treatment.

◦ Support for viral load coverage and VLS.

◦ DSD for HIV treatment.

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.

Step 1: Review the Opportunity 15

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

Strategy 1: Facilitate wide access to and use of comprehensive HIV services for key and other priority populations through innovative, data-driven community engagement and support.

Required activities:

• Use innovative testing methods for key and priority populations, including SNS, index testing, and HIVST.

• Use mobile testing innovations to identify people living with HIV in remote geographic areas or where normal services have been disrupted.

• Implement rapid linkage to comprehensive HIV prevention services for people who test negative for HIV.

• Implement rapid linkage to care and treatment for people who test positive for HIV.

• Support adherence to treatment for people living with HIV through community engagement.

• Work with local organizations to maintain program success.

• Address health equity gaps in access and use of comprehensive HIV services for key and priority populations with strategies like community-led leadership roles.

• Use data to effectively expand comprehensive HIV services to populations that would most benefit from them, and to target emerging public health threats.

Strategy 2: Implement innovative DSD models in communities and medical facilities to enhance the quality of comprehensive HIV services for all populations.

Required activities:

• Enhance delivery of ART and other treatment options through innovative DSD models, including extended service hours, treatments at community settings, and mobile settings.

• Help people living with HIV to adhere to treatment.

• Help people living with HIV to stay in care and treatment services through community-based interventions.

Step 1: Review the Opportunity 16

• Help all populations remain in prevention services through community-based interventions.

• Help people living with HIV who have completed case management integrate into the routine state health system.

• Use data to effectively monitor treatment and prevent interruptions in treatment through early detection of interruptions and re-engagement on treatment.

• Add AHD and other HIV comorbidities management into standard service delivery at medical facilities.

• Build capacity among health care professionals and community health workers through:

◦ Trainings like anti-stigma and discrimination.

◦ Mental health services to prevent burnout.

◦ Mentorship programs.

• Support the sustainable scale-up of blood sample transportation for viral load (VL) and CD4 as part of the management of AHD and other HIV comorbidities.

Strategy 3: Expand accessibility and improve the quality of MAT for key populations.

Required activities:

• Ensure rapid MAT initiation for all key populations with specific indications for this treatment method.

• Provide referrals from HIV testing and harm reduction entry points, and quickly connect eligible candidates to MAT.

• Support innovative MAT service delivery models for hard-to-reach populations, including those in remote areas or those who have experienced service delivery disruption.

• Expand MAT services for people in prisons and other closed settings, including continued care for those who are no longer in those settings.

• Implement HCV testing and treatment interventions for people living with HIV who use MAT services.

• Ensure rapid linkage to ART of newly enrolled MAT HIV-positive patients.

• Implement a plan to continue MAT services to people who were on MAT before incarceration or detainment.

Step 1: Review the Opportunity 17

• Support the provision of take-home doses for people who use MAT services to ensure sustained use, adaptability of the program, and reduction of daily workload for care providers.

• Ensure the quality of MAT services using electronic information management systems and tools.

• Ensure timely monitoring of strategic information, programmatic data, and data quality to improve program delivery.

• Collect, organize, and report program data using electronic management information systems.

• Ensure MAT service quality and enhance its delivery using timely data monitoring, reporting, and evaluation.

• Engage and collaborate with communities to ensure the sustainability of the MAT program, including procuring supplies and testing devices.

• Use community engagement to lead prevention efforts and participate in strategic planning.

• Organize and conduct site visits to improve the quality of MAT services at the site level.

• Monitor and evaluate MAT programs at the national, regional, and site levels.

• Report on MER indicators at the site and regional levels.

• Work with the MAT hotline to:

◦ Ensure better access to services.

◦ Address stigma and discrimination against patients, candidates, and providers.

◦ Refer patients to HIV care and other integrated services, such as TB and viral hepatitis care, mental health care, and support for social and psychological issues, including those related to the ongoing war.

• Develop and maintain mobile MAT application.

• Plan, organize, and implement a national information campaign to increase access to MAT.

• Organize international education technical visits for MAT stakeholders.

Step 1: Review the Opportunity 18

Strategy 4: Support harmonization in implementation of evidence-based policies and guidelines that align with national and international standards.

Required activities:

• Analyze current narcotic legislation and policies in Ukraine.

• Sustain program gains, propose and implement evidence-based updates and recommendations to national policies, guidelines, and regulations in line with international standards.

• Include GBV prevention and support in national policies and guidelines to align with international standards.

• Work with the MOH to develop and implement policies that expand the scope of care for nurses in delivering comprehensive HIV and MAT services.

• Introduce evidence-based interventions into policies and guidelines to promote expanding MAT services.

• Update guidelines and treatment standards on opioid dependency.

• Update training materials and certification programs for MAT providers.

• Work routinely with government and non-government organizations to evaluate and ensure policies, regulations, and standards are aligned with international recommendations and best practices.

• Support with relevant data the development of regulations and policies that enable MAT implementation, including service delivery models, innovative treatment standards, and logistics.

• Ensure that the national MAT treatment standards are adopted at the regional and site levels.

• Support the optimization of the local MAT treatment protocols and patients’ pathways at the local level to ensure that eligible candidates are quickly linked to MAT services.

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

Step 1: Review the Opportunity 19 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.

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 20 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:

• Key populations:

◦ People who inject drugs.

◦ People in prisons and other closed settings.

◦ Transgender individuals.

• Other priority populations:

◦ Post-military and other uniformed service members and their families.

◦ Displaced populations.

◦ Mobile populations.

◦ People who use non-injecting drugs.

◦ Health care professionals.

◦ Community 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 21

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

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

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

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

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

• Reduce HIV and TB stigma and discrimination.

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

• Make the workforce more inclusive.

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

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

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

Government agencies and programs:

• MOH.

• PHC.

• Local government agencies.

• PEPFAR agencies and programs.

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

Step 1: Review the Opportunity 22 https://www.cdc.gov/about/priorities/why-is-addressing-sdoh-important.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html

Nongovernment organizations and programs:

• Community groups.

• Key and priority populations.

• Multilateral organizations.

• Global Fund recipients.

• Private-sector organizations.

• Current CDC-funded implementing partners supporting activities in:

◦ Case finding.

◦ Prevention and treatment.

◦ Testing and linkage to care.

◦ Information management systems.

◦ Laboratory information management systems.

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

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

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

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

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

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

Step 1: Review the Opportunity 23

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

In your application budget, you should allocate at least 10% of funds for monitoring activities and 5% for evaluation activities. We will discuss these percentages and finalize them at or after award. These are estimates for the total funding over the 5-year project.

Required performance measures

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

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

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

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

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

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

• KP_MAT: Number of people who inject drugs (PWID) on medication-assisted therapy (MAT) for at least 6 months. [Target: 10,000; Reporting Frequency: Annual]

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

Step 1: Review the Opportunity 24 https://help.datim.org/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

• HTS_INDEX: Number of individuals who were identified and tested using Index testing services and received their results. [Target: 5,000; Reporting Frequency: Quarterly]

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

20,000; Reporting Frequency: Quarterly]

• HTS_TST: Number of individuals who received HIV Testing Services (HTS) and received their test results. [Target: 120,000; 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: 30,000;

Reporting Frequency: Semi-Annual]

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

• Number of people in prisons or other closed settings on medication-assisted therapy (MAT) for 6 months and longer. [Target Q4: 1,000;

Reporting Frequency: Quarterly]

• Percentage of stable MAT patients on MAT with buprenorphine in prisons and other closed settings receiving doses equal to or over 8 mg of buprenorphine. [Target: 90%; Reporting Frequency: Quarterly]

• Percentage of stable MAT patients on MAT with methadone in prisons and other closed settings receiving doses equal to or over 60 mg of methadone. [Target: 90%; Reporting Frequency: Quarterly]

• Number of HIV-positive and HCV-positive MAT patients who completed the course of HCV treatment and tested HCV-negative upon completion of the HCV treatment course. [Target Q4: 600; Reporting Frequency:

Quarterly]

• Number of people on medication-assisted therapy (MAT) for 6 months and longer at the end of the quarter. [Target Q4: 10,000; Reporting Frequency: Quarterly]

• Number of MAT eligible candidates referred from HIV testing entry points who started MAT within 2 working days since the referral was made.

[Target Q4: 2,000; Reporting Frequency: Quarterly]

• Number of ART eligible candidates initiated on ART within 3 days of enrolling in MAT services. [Target Q4: 300; Reporting Frequency:

Quarterly]

Step 1: Review the Opportunity 25

• Percentage of individuals who tested negative for HIV who were referred to comprehensive HIV prevention services. [Target: 20%; Reporting Frequency: Quarterly]

• Percentage of individuals who tested negative for HIV who were referred to comprehensive HIV prevention services and started PrEP. [Target: 20%;

Reporting Frequency: Quarterly]

• Percentage of individuals who tested positive for HIV who were initiated on ART. [Target: 100%; Reporting Frequency: Quarterly]

• Percentage of individuals started on ART who are tested for viral load after 6 months of treatment. [Target: 95%; Reporting Frequency:

Quarterly]

• Percentage of individuals started on ART who are tested for viral load after 12 months of treatment. [Target: 90%; Reporting Frequency:

Quarterly]

• Percentage of individuals tested for VL that have a VL of less than 50 copies/mL. [Target: 95%; Reporting Frequency: Quarterly]

• Number of stigma and discrimination trainings conducted for healthcare professionals. [Target: 3; Reporting Frequency: Quarterly]

• Number of mentorship programs implemented for healthcare professionals. [Target: 8; Reporting Frequency: Quarterly]

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 an end-term evaluation.

• Effects of DSD models on achieving epidemic control: outcome evaluation.

• Effects of referring candidates who are eligible for MAT from HIV testing entry points on the overall expansion of MAT services at the municipal and national level: outcome evaluation.

• Costs and benefits of DSD models at communities and medical facilities:

economic evaluation.

Step 1: Review the Opportunity 26

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

Dissemination of evaluation results Dissemination channels could include:

• Local and international conferences and forum abstract presentations.

• Conference poster displays.

• Manuscripts.

• Bulletins.

• Reports.

• Presentations to technical working groups and stakeholder meetings.

• Other approved products in print and electronic media.

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

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

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

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

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.

Step 1: Review the Opportunity 27

Methods Describe how you will:

• Collect the performance measures.

• Respond to the evaluation topics.

• Use evaluation findings for continuous program quality improvement.

• Incorporate evaluation and performance measurement into planning, implementing, and reporting of project activities.

Additionally, explain:

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

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

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

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

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

Evaluation activities You must carry out specific evaluation activities.

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

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

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

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

Describe:

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

Step 1: Review the Opportunity 28

• Key evaluation questions these evaluations will address.

• Other information, such as measures and data sources.

Data management plan (DMP) For all public health data you plan to collect, a DMP is required. For a definition of “public health data” and other key information, see AR 25: Data Management and Access on our website.

You must submit an initial draft of your DMP with your application. You must submit a more detailed plan within the first six months of the award. See reporting.

Submit your initial DMP with your application and include:

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

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

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

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

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

• Archival and long-term data preservation plans.

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

In addition to the other requirements listed, also include:

• Cybersecurity plans.

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

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

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

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

Step 1: Review the Opportunity 29 https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html

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.

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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.

• 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.

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

Step 1: Review the Opportunity 31 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

• 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, 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.

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