Central America CDC-RFA-JG-25-0067 Final NOFO for Publication..pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 24, 2025

Building capacity along the HIV continuum from prevention to care and treatment in the Central American region under the President’s Emergency Plan for AIDS Relief

(PEPFAR)

Opportunity number: CDC-RFA-JG-25-0067

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 8

Program description 11

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 55

Step 5: Submit Your Application 56

Application submission and deadlines 57

Application checklist 59

Step 6: Learn What Happens After Award 61

Post-award requirements and administration 62

Contacts and Support 69

Contents 2

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

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

See Step 2: Get Ready to Apply

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

See Step 2: Get Ready to Apply

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

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

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

Jump to a step

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

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 8

Program description 11

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:

Building capacity along the HIV continuum from prevention to care and treatment in the Central American region under the President’s Emergency Plan for AIDS Relief (PEPFAR)

Opportunity number:

CDC-RFA-JG-25-0067

Announcement type:

New

Assistance listing: 93.067 Global AIDS Program

Key dates

Application deadline:

February 24, 2025

Expected award and start date: September 30, 2025

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

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

NOFO.

Summary This NOFO will enhance the capacity of El Salvador, Guatemala, Honduras, Nicaragua, Panama, and any future PEPFAR-approved countries in the region, by addressing gaps in HIV prevention, diagnosis, and treatment and accelerate progress towards achieving the 10-10-10 prevention objectives and 95-95-95 care targets.

These focuses include:

• Scale-up access to HIV prevention for key populations through the Sentinel Surveillance and Control of STIs (VICITS/CLAM) strategy.

◦ Differentiated models will be used to provide pre- and post-exposure prophylaxis (PrEP and PEP), diagnosis, and treatment of sexually transmitted infections (STIs), distribution of condoms and lubricants, HIV testing, linkage to treatment and prevention services, and surveillance systems.

• Improve access to HIV testing through active case-finding strategies, including, but not limited to, testing as part of outreach for key and priority populations; index, provider-initiated, and community testing;

social network strategy; and self-testing.

• Support early treatment initiation, retention, adherence, management of advanced HIV disease (AHD), TB, and opportunistic infections (OIs), access to CD4 count, and viral load (VL) monitoring/suppression, expansion of differentiated service delivery (DSD) models, and provision of complementary services.

Step 1: Review the Opportunity 5

• Enhance skills of healthcare workers to provide high quality HIV prevention, testing, and treatment services through training and continuous quality improvement (CQI) initiatives.

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $20,000,000 This is the expected total Year 1 funding for all awards made under this

NOFO.

Expected number of awards: 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: ROP Q1 Targets and Activities.

◦ Component 2: ROP Q2 Targets and Activities.

◦ Component 3: ROP Q3 Targets and Activities.

◦ Component 4: ROP Q4 Targets and Activities.

◦ Component 5: ROP 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 20 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 Central America Region (El Salvador, Guatemala, Honduras, Nicaragua, and Panama).

Countries in the region may have unique requirements to conduct these activities; applicants must show either that they have met these requirements or are willing and able to meet those requirements for each country in the region. Failure to provide a statement of this ability or willingness in the application will result in the application being deemed nonresponsive.

Nonresponsive applications will not be considered for Phase II review. Note:

Applicants should refrain from requesting MOUs or any other documentation of support from Ministries of Health prior to receiving an award.

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.

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)

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.

Step 1: Review the Opportunity 10

Program description Background overview and related work CDC implements program activities in five countries in Central America (CA):

El Salvador, Guatemala, Honduras, Nicaragua, and Panama. Together, these nations have:

• A population of 46 million.

• An estimated 139,000 people are living with HIV.

• 4,500 new HIV infections in 2022, according to UNAIDS.

CA has a concentrated HIV epidemic with a low prevalence (<1%) among the general population but higher (>5%) among key populations, particularly men who have sex with men and transgender women. Approximately 30% of people living with HIV on treatment report same sex behavior, with the remaining self-identifying as heterosexual.

Mobile populations have also been found to be at higher risk for HIV, with a recent study estimating prevalence of HIV among migrants to range from 1.3% to 1.7% in these PEPFAR-supported countries. All five countries are committed to achieving 95-95-95 diagnosis, treatment, and viral suppression goals by 2030, as well as the target of 95% of people at substantial risk of HIV using effective HIV combination prevention.

Targeted HIV prevention strategies in CA include the Sentinel Surveillance of STI and HIV Strategy (VICITS, by its Spanish acronym), also known as Clinicas Amigables (CLAM) strategy, a combination prevention package for key populations that offers access to PrEP, PEP, STI diagnosis and treatment, tailored counseling, condom and lubricant distribution, peer promotion and navigation to services, and a Ministry of Health (MoH) run information system to monitor trends in STI and HIV prevention and diagnosis, and behavioral indicators related to HIV risk.

While the region has made advances in closing the gap in the first 95, there are high rates of late diagnosis and AHD. Policy and programmatic barriers to widespread testing (varying by country) include:

• Noncompliance with testing guidance.

• Lack of access to self-testing.

• Suboptimal index testing.

• Gaps in key population outreach.

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

Step 1: Review the Opportunity 11 https://www.transparencia.gob.sv/system/documents/documents/000/590/335/original/Lineamientos_t%C3%A9cnicos_para_la_atenci%C3%B3n_de_las_poblaciones_clave_en_las_cl%C3%ADnicas_de_vigilancia_centinela_de_las_infecciones_de_transmisi%C3%B3n_sexual.pdf?1720534673 https://www.transparencia.gob.sv/system/documents/documents/000/590/335/original/Lineamientos_t%C3%A9cnicos_para_la_atenci%C3%B3n_de_las_poblaciones_clave_en_las_cl%C3%ADnicas_de_vigilancia_centinela_de_las_infecciones_de_transmisi%C3%B3n_sexual.pdf?1720534673

• Lack of active case-finding plans.

• Test-kit stock-outs.

• Mandatory pre-test counseling.

• Age restrictions.

• Legal restrictions for HIV testing by certified lay and peer providers.

• Burdensome testing request forms.

For the second 95, all five countries have significant disparities between diagnosed people living with HIV and those on treatment, meaning there are gaps in linkage to treatment after diagnosis and in continuity of treatment.

Contributors to this gap include:

• Geographical access (people living with HIV in rural areas must travel long distances to access treatment).

• DSD models are not scaled.

• There is a lack of tailored services for difficult to reach populations, including regional and internal mobile populations and indigenous communities.

The percentage of people living with HIV who are virally suppressed has steadily increased over the past ten years and is relatively high across the region (between 90% and 93%, except for Nicaragua). However, gaps in diagnosis, linkage, and continuity of treatment and viral load coverage (VLC) illustrate that all countries need to make significant progress to reach epidemic control.

This NOFO will support CA MoHs and other key stakeholders in the region to address these gaps by introducing and/or scaling up high-impact, World Health Organization (WHO)- and PEPFAR-recommended site-level interventions and facilitate the adoption of these interventions into government response strategies.

This NOFO will support surveillance efforts and granular epidemiological analyses at the site level for program implementation, ensuring that activities are informed by the latest evidence and trends. By leveraging data-driven insights, the program aims to enhance the effectiveness and efficiency of interventions, adapting strategies to address emerging challenges and opportunities in the field. Further site and above-site level interventions may be added based on changing epidemiological contexts, updates in WHO recommendations and PEPFAR guidance, and national priorities.

This NOFO builds on the continuing partnership between CDC and respective CA MoHs, including the previous award GH002261-05, which included:

Step 1: Review the Opportunity 12

• Increasing access to HIV prevention among key populations through the VICITS/CLAM Strategy.

• Increasing access to HIV testing and effective linkage through key population outreach, index testing, provider-initiated testing, and targeted community testing.

• Improving clinical outcomes among people living with HIV through early treatment initiation, optimized treatment regimens, AHD management, intensified adherence counseling, and DSD models.

• Strengthening VL access and suppression.

Prior site-level implementation has highlighted the need for country-specific adaptation of guidelines and policies to contextualize and leverage available resources, particularly those targeting key populations. Partner versatility, communication, and maintaining relationships with key regional collaborators such as the Global Fund and Pan American Health Organization have been vital to gaining sustainable implementation of the HIV response in CA.

Purpose The purpose of this NOFO is to support respective MoHs and other key stakeholders in CA and any other future PEPFAR-approved countries in the region, to address gaps in HIV prevention, testing, and treatment. This will be achieved by introducing and/or scaling up high-impact, WHO and PEPFAR-recommended site-level and above-site interventions to accelerate achievement of 95-95-95 targets by 2030, while advancing the integration and sustainability of these strategies into government health systems.

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: Provide comprehensive HIV prevention services to key populations and other groups at substantial risk of HIV infection.

Strategy 2: Implement active HIV targeted and case-finding strategies to promote early diagnosis among people living with HIV unaware of their status.

Strategy 3: Implement effective and innovative linkage strategies to people who test negative for HIV and are at substantial risk of infection to prevention services and people who test positive to treatment services.

Strategy 4: Support provision of a person-centered and comprehensive package of care and treatment and retention services and viral load suppression (VLS) to people living with

HIV.

Strategy 5: Advance adoption and scale-up of PEPFAR-supported strategies by MoH.

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

Improved effective linkage to treatment among individuals newly diagnosed with HIV.*

Increased early treatment initiation among people living with HIV.*

Improved access to VL testing and results among people living with HIV.*

Increased adoption of PEPFAR-supported strategies within national guidelines and manuals.*

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

Sustained negative HIV test results among people on PrEP.*

Reduced late HIV diagnosis among newly diagnosed people living with HIV.*

Increased accelerated progress towards achievement of first 95 goal.*

Improved treatment and clinical outcomes among people living with HIV.*

Increased VLC among people living with HIV.*

Improved retention in HIV services for key and priority populations.*

Increased adherence to HIV services for key and priority populations.*

Increased coverage of PEPFAR-supported strategies at the national level.*

Reduced

HIV

incidence.

Reduced

HIV

morbidity and mortality.*

Increased country ownership of HIV and

TB

programs.

Sustained

VLS

among people living with

HIV.*

Step 1: Review the Opportunity 14

Additional information on outcomes in the logic model:

• Increased access to HIV prevention and testing services for key and priority populations includes, but is not limited, to members of those populations that access an HIV prevention package in VICITS/Clinicas Amigables or though other platforms. This includes:

◦ STI diagnosis and treatment.

◦ HIV testing.

◦ Condoms and lubricants.

◦ Counseling.

◦ PrEP and PEP.

◦ Navigation to treatment and other services.

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

◦ Testing among key populations.

◦ Index testing.

◦ Social Network testing.

◦ Provider-initiated testing and counseling.

◦ Self-testing.

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

Following are strategies and the required and optional activities under this NOFO. Applicants should develop a proposal to carry out activities in all 5 countries. Exact funding amounts and official geographic assignments of selected recipient(s) will be determined at the time of award. You may also propose additional related strategies and activities to achieve the expected outcomes.

Step 1: Review the Opportunity 15

Strategy 1: Provide comprehensive HIV prevention services to key populations and other groups at substantial risk of HIV infection.

Required activities:

• Support MoH and community-based organizations in the implementation of the STI surveillance, prevention, and control strategy, known as VICITS/ CLAM, by its Spanish acronym, providing differentiated HIV prevention and testing service package to men who have sex with men, transgender women, and sex workers.

This package includes:

◦ Tailored counseling.

◦ PrEP.

◦ Enhanced STI diagnosis and treatment.

◦ Condom and lubricant distribution.

◦ HIV testing.

◦ Peer navigation for linkage to treatment.

◦ A surveillance information system.

• Expand PrEP access and tailored prevention services to other people at substantial risk of HIV infection.

• Support efforts to address stigma and discrimination against key populations and people living with HIV.

• Expand PEP to people at substantial risk of HIV infection.

• Conduct granular site-level surveillance efforts to monitor and analyze trends in HIV prevention, transmission, STI prevalence, and the effectiveness of intervention strategies.

Step 1: Review the Opportunity 16

Strategy 2: Implement active HIV targeted and case-finding strategies to promote early diagnosis among people living with HIV unaware of their status.

Required activities:

• Expand access to HIV testing among undiagnosed people living with HIV by supporting evidence-based active case finding strategies, including:

◦ Testing as part of outreach strategies for key populations.

◦ Index testing services.

◦ Provider-initiated testing.

◦ Community testing.

• Identify and address hotspots of mother-to-child transmission of HIV and pediatric cases.

• Strengthen MoH capacity to monitor and address late HIV diagnosis.

• Conduct granular site-level surveillance and epidemiologic efforts to monitor and analyze trends in HIV testing interventions by modality, geography, and other characteristics to inform targeted responses and optimize program implementation.

Strategy 3: Implement effective and innovative linkage strategies for people who test negative for HIV and are at substantial risk of infection to prevention services and people who test positive to treatment services.

Required activities:

• Support MoH to develop or scale-up solutions to enable them to track linkage and retention of people who test negative for HIV and are at substantial risk of infection to prevention services (including PrEP and PEP) and people who test positive to treatment services.

• Support implementation of these solutions, including training of healthcare workers and monitoring, and integration into broader MoH healthcare and information systems.

• Implement a Testing for Prevention approach which prioritizes opportunities to address the needs of the broader community by providing or linking to comprehensive sexual health and supportive services, including PrEP access for clients who test negative but report behaviors leading to substantial risk of infection.

Step 1: Review the Opportunity 17

• Track and Trace Pre-antiretroviral therapy (ART) to strengthen the linkage of newly diagnosed people living with HIV from the community and non-governmental organization health centers to ART clinics.

• Ensure linkage to care for new HIV cases within 7 days of HIV diagnosis.

Strategy 4: Support provision of a person-centered and comprehensive package of care and treatment and retention services and VLS to people living with HIV.

Required activities:

• Support MoH in the provision of comprehensive services to people living with HIV, including:

◦ Test & start rapid ART initiation.

◦ Diagnosing and treating people living with HIV with AHD, focused on three populations at high risk of AHD.

▪ People living with HIV starting treatment with low baseline CD4 counts.

▪ People living with HIV re-engaging in treatment after an interruption.

▪ People living with HIV who are not virally suppressed.

◦ Screen, test, treat, and prevent OI.

◦ TB and HIV coinfection.

◦ Access to CD4 and VL testing.

• Accelerate addressing gaps to increase TB diagnosis, prophylaxis, and TB cure rate in people living with HIV.

• Gather data and support MOH to provide screening/treatment of premalignant lesions for the prevention and elimination of cervical cancer.

• Scale DSD Models per national guidelines such as pharmacy fast-track refills, multi-month dispensing and other age and culturally appropriate services.

• Implement advanced adherence package and reengagement of people living with HIV interrupting treatment.

• Strengthen adherence and retention strategies to achieve sustained VLS, such as clinical appointment spacing, ART delivery models.

• Support health communication strategies for people living with HIV and populations identified at an increased risk for HIV.

• Improve VLC, as well as high VL tracking and management.

Step 1: Review the Opportunity 18

• Support the reduction of preventable causes of death (e.g., HIV/AIDS, OIs, and TB).

• Implement screening of comorbidities, as well as comorbidity management per national guidelines.

• Identify gaps in programmatic activities and interventions to provide comprehensive supportive services for people living with HIV.

• Increase interventions to address gender-based violence among people living with HIV.

• Facilitate integration of sexual and reproductive health services for people living with HIV, including expanding STI testing and management, per national guidelines.

• Conduct granular site level surveillance and epidemiological efforts to monitor and analyze trends in HIV treatment interventions by geography and other characteristics to inform targeted implementation progress and optimize program implementation.

Strategy 5: Advance adoption and scale-up of PEPFAR-supported strategies by MoH.

Required activities:

• Implement CQI Training Initiatives to improve service quality.

• Support workforce development through targeted technical assistance to improve the quality of HIV and TB services.

• Support updating of national policies in coordination with other PEPFAR partners.

Optional activities:

• Conduct economic evaluations to ensure optimal use of funding for programs. For example, economic evaluations of specific differentiated service models for HIV 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 country governments and other partners. Together, we assess the needs of

Step 1: Review the Opportunity 19 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:

• Individuals with undiagnosed HIV infections.

• Highest-prevalence key populations (particularly men who have sex with men and transgender women).

• Index cases and their partners.

• Populations identified through review of data sources suggesting elevated risk of HIV transmission by MOH or PEPFAR partners.

• People living with HIV in CA and any approved countries.

Within people living with HIV, the focus of NOFO activities must be on the missing, (i.e., those individuals living with HIV who are still undiagnosed, diagnosed but not linked to services, linked but not initiated on treatment, or on treatment but not virally suppressed).

Secondary populations include:

• Healthcare workers providing HIV testing and care and treatment services.

• Other cadres involved in HIV service provision including, but not limited to:

◦ Counselors.

◦ Psychologists.

◦ Laboratory staff.

◦ Pharmacists.

◦ Epidemiologists.

◦ Peer promoters/navigators.

◦ Partner service specialists.

◦ Other lay providers.

Step 1: Review the Opportunity 21

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

• Race.

• Color.

• National origin.

• Disability.

• Age.

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

• Other constitutionally protected statuses.

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

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

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

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

• 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.

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

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 CDC CA office and other CDC-funded implementing partners working across the HIV continuum of care and above-site support.

You will also be expected to collaborate with:

• National Public Health Institutes.

• MoH, including but not limited to National HIV Programs and National Epidemiology Centers.

• Other non-CDC, PEPFAR-funded implementing partners.

• International agencies including but not limited to Pan American Health Organization/WHO, UNAIDS, and Global Fund and its recipients.

• HIV Country and Regional Coordination mechanisms (e.g., Country Coordinating Mechanism, Regional Coordination Mechanism).

• Civil society groups and community-based organizations working in the HIV field.

• Other organizations that collaborate across the continuum of care in activities described.

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.

Step 1: Review the Opportunity 23

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

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

In your application budget, you should allocate at least 3% of funds for 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.

Required performance measures

Overview This program includes four 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.

• Site Improvement Through Monitoring Systems (SIMS) indicators. As part of programmatic implementation, you can find more information on the Core Essential Elements in the SIMS Implementation Guide provided to PEPFAR implementing partners.

• CDC DGHT CAR specific tools to monitor site-level performance. Site-level implementing partners are provided CAR-specific tools for routine monitoring of MER and custom indicators.

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.

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

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

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_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: 35,713;

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:

3,122; 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: 5,531; Reporting Frequency: Quarterly]

• HTS_TST: Number of individuals who received HIV Testing Services (HTS) and received their test results. [Target: 72,624; Reporting Frequency:

Quarterly]

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

26,707; Reporting Frequency: Quarterly]

• HTS_INDEX: Number of individuals who were identified and tested using Index testing services and received their results. [Target: 9,058; Reporting Frequency: Quarterly]

• TX_CURR: Number of adults and children currently receiving antiretroviral therapy (ART). [Target: 32,994; Reporting Frequency:

Quarterly]

• TX_NEW: Number of adults and children newly enrolled on antiretroviral therapy (ART) [Target: 2,969; Reporting Frequency: Quarterly]

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

[Target: Not Assigned; Reporting Frequency: Quarterly]

• TX_RTT: Number of ART patients who experienced an 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]

Step 1: Review the Opportunity 25

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

[Target: 95%; Reporting Frequency: Quarterly]

• GEND_GBV: Number of people receiving post-gender-based violence (GBV) clinical care based on the minimum package. [Target: 9,000;

Reporting Frequency: Semi-Annual]

• CXCA_SCRN: Number of women living with HIV on ART screened for cervical cancer. [Target: 1,971; Reporting Frequency: Semi-Annual]

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

>90%; Reporting Frequency: Semi-Annual]

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

• TX_TB: Proportion of ART patients screened for TB in the semiannual reporting period who start TB treatment. [Target: >2%; 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 PEPFAR-supported health workers providing HIV direct service delivery, as well as total spend on these workers. [Target: 257; Reporting Frequency: Annual]

• Percentage of CDC-supported sites that monitor index testing cascade.

[Target: 95%; Reporting Frequency: Quarterly]

• Percentage of newly diagnosed individuals linked to HIV care and start treatment within 7 days. [Target: >95%; Reporting Frequency: Quarterly]

• Number of adverse events occurring to people living with HIV that are on treatment following partner notification (disaggregated by type of event).

[Target: <2; Reporting Frequency: Quarterly]

• Percentage of people who received oral PrEP who have discontinued or interrupted PrEP due to a serious ARV-associated toxicity in the last 12 months. [Target: <5%; Reporting Frequency: Quarterly]

• Percentage of people living with HIV who were lost to follow- up and then who were re-engaged into treatment that are still active TX_CURR at 6 months. [Target: >90%; Reporting Frequency: Semi-annual]

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Data sources for MER and custom indicators Data sources may include HIV testing and linkage logs, key population sentinel surveillance data, Partner services logs, electronic or paper-based medical and laboratory records, patient tracking systems, registers, tally sheets, electronic and paper patient records, quarterly progress reports, surveillance and survey reports, and other program monitoring tools.

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

• Extent that the program’s prevention, testing, and treatment strategies, including index testing, self-testing, and PrEP, have been implemented as intended: Process Evaluation

• Extent to which the program reached key expected intermediate-term outcomes, as described in the logic model: Outcome Evaluation

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

Dissemination of evaluation results Dissemination channels could include:

• Local and international conferences and forum abstract presentations.

• Conference poster displays.

• Manuscripts.

• Bulletins.

• Reports.

• Presentations to technical working groups and stakeholder meetings.

• Other approved products in print and electronic media.

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

CDC and stakeholders will use overall evaluation findings during the 5-year project period to share and implement key recommendations to strengthen

Step 1: Review the Opportunity 27 program implementation and effectiveness, sustainability, and continued program improvement after the award ends.

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

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

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

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

Methods Describe how you will:

• Collect the performance measures.

• Respond to the evaluation topics.

• Use evaluation findings for continuous program quality improvement.

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

Additionally, explain:

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

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

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

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

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

Evaluation activities You must carry out specific evaluation activities.

Step 1: Review the Opportunity 28

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

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

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

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

Describe:

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

• Key evaluation questions these evaluations will address.

• Other information, such as measures and data sources.

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

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

Submit your initial DMP with your application and include:

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

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

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

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

That documentation should describe collection methods, what the data represents, 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.

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

In addition to the other requirements listed, also include:

• Cybersecurity plans.

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

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

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

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