Dominican Republic CDC-RFA-JG-25-0069 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 21, 2025

Improving HIV prevention and treatment in the Dominican Republic with a focus on priority populations under the President's Emergency Plan for AIDS Relief (PEPFAR) Opportunity number: CDC-RFA-JG-25-0069

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 29

Get registered 30

Questions 31

Step 3: Prepare Your Application 32

Application contents and format 33

Step 4: Learn About Review and Award 43

Application review 44

Award notices 49

Step 5: Submit Your Application 50

Application submission and deadlines 51

Application checklist 53

Step 6: Learn What Happens After Award 55

Post-award requirements and administration 56

Contacts and Support 63

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:

Improving HIV prevention and treatment in the Dominican Republic with a focus on priority populations under the President’s Emergency Plan for AIDS Relief

(PEPFAR)

Opportunity number:

CDC-RFA-JG-25-0069

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 goal of this NOFO is to provide high-quality, friendly HIV clinical services to people living with HIV, focusing on priority populations in the Dominican Republic (DR). Priority populations in DR include people who are living with HIV, particularly Haitian migrants and their descendants, hereafter referred to as the priority population. This includes improving access to HIV testing, providing HIV treatment and TB preventive therapy (TPT), and retaining people living with HIV on lifelong quality treatment to ensure they are virally suppressed.

The work will include using the latest international standards for clinical services to reach this population, including:

• Same-day start on antiretroviral therapy [ART] and multi-month dispensing;

• Using optimal approaches to reach and provide for priority populations and their needs.

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $5,600,000 This is the expected total Year 1 funding for all awards made under this

NOFO.

Expected number of awards: 1-2 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.

Step 1: Review the Opportunity 5

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.

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.

Step 1: Review the Opportunity 6

◦ Component 5: COP Additional Targets and Activities.

◦ Component 6: Emerging public health priorities (buffer component if needed).

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

• Budget narrative

• Component funding instructions for SF-424A

PEPFAR Local partner funding preference This NOFO includes a funding preference for local partners. Your organization will receive 10 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 Dominican Republic.

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 At the direction of the Global Health Security and Diplomacy Bureau, PEPFAR DR’s COP strategy focusses its HIV efforts on persons of Haitian descent.

Persons of Haitian descent (15% of which are also other key populations) account for 40% of people living with HIV not on treatment and half of new infections. They also have limited access to healthcare and fear deportation.

Achieving epidemic control and the 95 95 95 is therefore not possible without closing the gap in this hard-to-reach and harder-to-retain population, and PEPFAR is the only entity that is doing this. The Global Fund uses its resources to focus on other key populations (men who have sex with men, female sex workers, transgender people, and people who inject drugs), and the Government of DR focuses its work on the general population. With PEPFAR’s unique contribution, the needs of all vulnerable populations are addressed.

This NOFO aims to use a flexible approach to ensure that people of Haitian descent who live in DR receive quality testing and treatment. Emphasis should be placed on:

• Finding high-risk people in the community.

• Placing people with new HIV infections on treatment.

• Keeping people on HIV treatment.

• Finding and placing those who stopped treatment back on treatment.

Ensuring that people living with HIV stay on high-quality, lifelong HIV treatment is a priority. Using community health workers and peer support systems to help the priority population stay on treatment are integral to this effort. In addition, interventions that reduce the number of people who stop treatment and ensure individuals are virally suppressed and have a high quality of life are priorities. A personalized approach that evolves with the context and challenges faced by the priority population is important for success.

This NOFO builds on lessons learned from the previous award (CDC-RFA- GH20-2020), which showed that community outreach is critical for finding new HIV infections in the priority population and ensuring those who stopped treatment start again. It showed that flexibility and adaptability are crucial for managing the complexities of serving members of the priority population. We are committed to using these lessons to improve access to HIV services.

Step 1: Review the Opportunity 10

Lessons learned also showed that your approach should include expanding community efforts and working with DR government authorities to sustain the HIV response.

Some key outcomes of this NOFO are to have:

• More people on HIV treatment: We expect your efforts to find more people with newly diagnosed HIV infections and start them on HIV treatment. You should also find those who stopped treatment and place them back on treatment.

• Better retention: We expect more people will stay on HIV treatment through activities that will reduce the number who stop treatment and improve overall long-term adherence.

• Higher rates of viral suppression: We expect more people to become and stay virally suppressed. This will help people stay healthier, reduce their risk of spreading HIV to others, and help us reach HIV epidemic control.

Purpose The purpose of this NOFO is to decrease the number of new HIV infections in DR by starting more people from the priority population on high-quality HIV treatment and helping them stay on treatment for life. This NOFO will use community outreach and flexible approaches to address the needs of this population, including:

• Stigma and limited access to care.

• Challenges with getting tested for HIV, starting HIV treatment, staying on HIV treatment, and staying healthy in general.

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.

Step 1: Review the Opportunity 11

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:

Prevent new HIV infections and find undiagnosed infections using proven and creative approaches, focusing on the priority population.

Strategy 2:

Ensure people living with HIV start and stay on ART, and complete TPT through creative and proven methods, focusing on the priority population.

Strategy 3:

Work with the DR government to ensure compliance with national and international standards to provide quality services and improve patient treatment experiences.

Increased diagnosis of new HIV cases and early HIV treatment initiation.

Improved use of biometric technology and national health information systems by healthcare staff.*

Improved responsiveness of HIV services to the needs of the priority population.*

Increased use of HIV and TB services by people living with HIV (PLHIV) from the priority population.*

Increased viral load testing among all eligible people living with HIV.*

Increased initiation and completion of TPT among all eligible people living with

HIV.*

Improved adherence of people living with HIV on HIV treatment.*

Improved collaboration with government and key stakeholders.*

Improved treatment retention of people living with HIV.

Increased viral load suppression among people living with

HIV.*

Improved abilities of healthcare staff to use data to make decisions and plan programs.*

Improved awareness that high viral suppression is an effective and proven way to prevent HIV.*

Improved consistency in compliance by healthcare staff with HIV and TB national and international policies and guidelines.*

Improved quality of clinical management for people living with

HIV.*

Decreased HIV and TB incidence.

Increased quality of life for people living with HIV.

Decreased HIV-related illness and death among people living with HIV.*

Improved alignment of national HIV and TB policies and guidelines with international standards.

Increased engagement of the priority population in the HIV response.

Sustained use of national health information systems by healthcare workers.

Sustained achievement of HIV epidemic control in DR.

Step 1: Review the Opportunity 12

Additional information on outcomes:

• Finding newly diagnosed cases and starting them on treatment early should be done in both facilities and communities.

• Government and key stakeholders include the DR government, The Global Fund, U.S. government agencies, and UNAIDS.

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

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

Strategy 1: Prevent new HIV infections and find undiagnosed infections using proven and creative approaches, focusing on the priority population.

Required activities

• Conduct HIV testing using methods that are effective for people of Haitian descent in both community and facility settings. Examples include social networking strategies, use of key informants, index testing, and use of other approaches as they are made available, such as HIV self-testing.

• Conduct household testing for high-risk families to improve case finding.

• Identify factors and characteristics unique to people of Haitian descent that increase their risk of HIV infection and make them harder to find.

• Use communication technologies that better reach Haitian migrants for HIV testing, HIV prevention education, and HIV treatment services.

• Link Haitian migrants to prevention and treatment services that meet their unique needs.

• Support prevention interventions including pre-exposure prophylaxis (PrEP), condoms, and HIV educational/risk reduction sessions that promote behavior change.

Step 1: Review the Opportunity 13

Strategy 2: Ensure people living with HIV start and stay on ART, and complete TPT using creative and proven methods, focusing on the priority population.

Required activities

• Support routine viral load monitoring and use viral load test results for patient management.

• Ensure all eligible people living with HIV start and finish TPT.

• Make referrals for TB screening, diagnosis and treatment.

• Develop and implement proven and creative service delivery approaches that prevent interruptions in treatment and remove barriers to HIV treatment access. This includes:

◦ Extended clinic hours.

◦ Multi-month dispensing.

◦ Community outreach, etc.

• Use communication technologies that keep Haitian migrants on treatment or help bring them back into treatment if they stop treatment.

• Ensure data are complete, entered in the appropriate data systems, and used regularly for program planning and improvement.

• Implement continuous quality improvement and quality management systems at facilities.

• Strengthen facility-community referrals and linkages.

• Support referrals for diagnosis and management of advanced HIV disease and comorbidities, including opportunistic infections.

• Work with DR‘s government and other partners to offer a more comprehensive package of services, including but not limited to screening, diagnosis, and treatment for sexually transmitted infections and opportunistic infections and diseases.

• Ensure healthcare workers comply with national policies and guidelines for service delivery and national reporting.

• Communicate lessons learned to DR‘s government to share findings about delivering health services to the priority population.

• Provide sample transport support during emergencies when the national transport system faces challenges.

• Provide sample storage options to protect sample integrity in the event of transportation delays and other challenges.

Step 1: Review the Opportunity 14

• Strengthen the skills and abilities of local health staff to provide quality HIV services to Haitian migrants.

• Conduct joint monitoring and evaluation activities with the DR government to ensure compliance with national and international guidelines. Monitoring and evaluation activities could include data quality assessments.

Strategy 3: Work with the DR government to ensure compliance with national and international standards to provide quality services and improve patient treatment experiences.

Required activities

• Participate in activities led by the DR government to update national HIV and TB policies and guidelines so that they align with international standards.

• Strengthen the use of national HIV information systems to comply with national guidelines and policies by training the health workforce.

National HIV information systems include:

◦ Sistema de Registro de Poblaciones Claves – SRPC.

◦ Sistema de Registro Nominal de Pruebas de VIH (SIREN-P).

◦ Formulario de Aplicación de Políticas Públicas Sociales (FAPPS).

◦ Sistema Nacional de Vigilancia Epidemiológica (SINAVE).

◦ Sistema de Registro Nacional de Atención Integral -SIRNAI, including PrEP module.

• Support approaches that ensure consistent use of biometrics in facilities as required by national policies.

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

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

Step 1: Review the Opportunity 15

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 16 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:

• Haitian Migrants: people living with HIV born in Haiti and living in DR.

• Haitian descendants: individuals born in DR with at least one parent who was born in Haiti.

• Ministry of Health, National Health Services staff, and healthcare workers serving people living with HIV in DR.

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 17

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:

• CDC-funded partners implementing HIV and TB prevention, care, and treatment activities.

• CDC-funded partners implementing other public health programs.

• U.S. Government-funded PEPFAR agencies, such as USAID and PEPFAR implementing partners.

• Government of the DR entities, including but not limited to the:

◦ Ministry of Health.

◦ National Health Services (locally known as SNS).

◦ DR President’s Council on AIDS (locally known as CONAVIHSIDA).

◦ National Program for the Control of STIs and AIDS (locally known as

DIGETICSS).

• Private organizations implementing related public health programs.

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

Step 1: Review the Opportunity 18 https://www.cdc.gov/about/priorities/why-is-addressing-sdoh-important.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html

• Multilateral partners, including but not limited to the:

◦ World Health Organization.

◦ Pan American Health Organization.

◦ International Organization for Migration.

◦ Joint United Nations Programme on HIV/AIDS

◦ Global Fund.

• Grassroots organizations and other non-governmental organizations led by or offering services to Haitian migrants and/or their descendants.

• Faith-based organizations, civil society organizations, community-based organizations, and other stakeholders.

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 to manage the program. You are expected to hold regular review meetings, including with CDC-DR, to discuss how to improve the program.

In your application budget, you should allocate at least 5% of funds to monitoring activities and 3% 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 19

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: 98,132; Reporting Frequency:

Quarterly]

• HTS_INDEX: Number of individuals who were identified and tested using Index testing services and received their results. [Target: 2,306; Reporting Frequency: Quarterly]

• TX_NEW: Number of adults and children newly enrolled on antiretroviral therapy (ART). [Target: 3,500; Reporting Frequency: Quarterly]

• TX_CURR: Number of adults and children currently receiving antiretroviral therapy (ART). [Target: 25,873; Reporting Frequency:

Quarterly]

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

[Target: 98%; 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

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

Step 1: Review the Opportunity 20 https://help.datim.org/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides 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 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: 45%; Reporting Frequency: Semi-Annual]

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

684; Reporting Frequency: Quarterly]

• PrEP_NEW: Number of individuals who were newly enrolled on pre-exposure prophylaxis (PrEP) to prevent HIV infection in the reporting period. [Target: 493; Reporting Frequency: Quarterly]

• GEND_GBV: Number of people receiving post-gender-based violence (GBV) clinical care based on the minimum package. [Target: 1,624;

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: 58,252; Reporting Frequency: Semi-Annual]

Custom indicators There are currently no custom indicators anticipated for this NOFO; however, that may change in future project years. You may also propose custom indicators if they are applicable to your approach.

Data sources for MER and custom indicators Applicants are required to comply with the use of DR Government HMIS, including systems like FAPPS, SIRENP, SRPC, and SINAVE. Whenever possible, these systems should serve as the primary data sources for MER indicators.

Applicants must also adhere to SNS guidelines on the correct filling, storage, and use of pen-and-paper data (such as clinical records).

Applicants may use proprietary systems if needed. Data sources can include registers, tally sheets, electronic and paper patient records, quarterly progress reports, surveillance and survey reports, and other program monitoring tools.

Step 1: Review the Opportunity 21

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.

• Facilitators/Barriers to identifying and managing people that have dropped out of treatment: process evaluation.

• Effectiveness of approaches used to ensure patient retention in treatment: outcome evaluation.

• Effectiveness of approaches used to re-engage patients who have discontinued treatment: outcome evaluation.

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

Dissemination of evaluation results Dissemination channels could include:

• Local and international conferences and forum abstract presentations.

• Conference poster displays.

• Manuscripts.

• Bulletins.

• Reports.

• Presentations to technical working groups and stakeholder meetings.

• Other approved products in print and electronic media.

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

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

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

Step 1: Review the Opportunity 22

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

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

Include the following elements in your evaluation and performance measurement plan.

Methods Describe how you will:

• Collect the performance measures.

• Respond to the evaluation topics.

• Use evaluation findings for continuous program quality improvement.

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

Additionally, explain:

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

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

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

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

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

Evaluation activities You must carry out specific evaluation activities.

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

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

Step 1: Review the Opportunity 23

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

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

Describe:

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

• Key evaluation questions these evaluations will address.

• Other information, such as measures and data sources.

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

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

Submit your initial DMP with your application and include:

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

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

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

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

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

• Archival and long-term data preservation plans.

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

In addition to the other requirements listed, also include:

• Cybersecurity plans.

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

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

Step 1: Review the Opportunity 24 https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html

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

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

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

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

Table: Sample format

Activities you will implement

Progress or process measures

From the data, monitoring, and evaluation section.

Relevant period of performance outcomes

From the logic model.

Responsible position or party

Funding component / completion date

Strategy 1:

1.

2.

3.

Strategy 2:

1.

2.

3.

Paperwork Reduction Act Any activities involving information collection from 10 or more individuals or organizations may require Paperwork Reduction Act (PRA) approval. The PRA requires review and approval of the information collection by the White House Office of Management and Budget. For further information to

Step 1: Review the Opportunity 25 determine if a proposed activity requires PRA approval, contact your project officer. Collections include items like surveys and questionnaires. If you have collections requiring PRA approval, CDC is responsible for working with OMB to gain the approval.

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

Funding policies and limitations General policies

• Your budget is arranged in eight categories: salaries and wages, fringe benefits, consultant costs, equipment, supplies, travel, other, and contractual.

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

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

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

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

dollars.

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

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Satisfactory progress in meeting your project’s objectives.

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

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

◦ Funding more applicants.

◦ Extending the period of performance.

◦ Awarding supplemental funding.

See also program-specific limitations.

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

Step 1: Review the Opportunity 26 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 27 http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.cdc.gov/grants/documents/budget-preparation-guidance.pdf https://www.cdc.gov/grants/documents/budget-preparation-guidance.pdf https://www.ecfr.gov/current/title-2/section-200.414 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC))

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

Other indirect cost policies

• As described in 45 CFR 75.403(d), you must consistently charge items as either indirect or direct costs and may not double charge.

• Indirect costs may include the cost of collecting, managing, sharing, and preserving data.

Salary rate limitation As of January 2024, the HHS/CDC salary rate limitation is $221,900. This salary rate limitation does not apply to PEPFAR funds, which are part of an appropriation from the U.S. Department of State; but to the extent that HHS/ CDC funds are added to an award, this limitation applies. We will update this limitation in future years.

Program income Program income is money earned as a result of your award-supported project activities. You must use program income for the purposes and under the conditions of the award. Find more about program income at 45 CFR 75.307.

Program-specific limitations

CDC PEPFAR terms and conditions You can find a list of PEPFAR-specific terms and conditions on our website.

They apply to all PEPFAR awards, so we strongly encourage you to read them and ask questions if you need more information. These terms and conditions will apply if you are selected for an award so you should confirm that you are able to comply with them prior to applying.

Host country laws and regulations If funded, you are expected to follow applicable host country laws and regulations related to the strategies under this NOFO; if there are conflicts with this award, contact the Grants Management Officer.

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

Step 1: Review the Opportunity 28 https://www.ecfr.gov/current/title-45/part-75#p-75.403(d) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.307 https://www.cdc.gov/grants/documents/PEPFAR-Terms-and-Conditions.pdf

Step 2:

Get Ready to Apply

In this step

Get registered 30

Questions 31

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

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

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

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

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

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

CDC-RFA-JG-25-0069.

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

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

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

Step 2: Get Ready to Apply 30 https://sam.gov/content/entity-registration https://www.hhs.gov/sites/default/files/financial-assistance-general-certification-representations.pdf https://grants.gov/applicants/applicant-registration http://www.grants.gov/quick-start-guide/applicants https://grants.gov/search-grants https://www.grants.gov/support https://www.grants.gov/support mailto:support@grants.gov

Need help? See Contacts and Support.

Help applying For help related to the application…