Malawi CDC-RFA-JG-25-0048 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 18, 2025

Strengthening comprehensive HIV prevention interventions in Malawi under the President's Emergency Plan for AIDS Relief (PEPFAR) Opportunity number: CDC-RFA-JG-25-0048

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 8

Program description 10

Step 2: Get Ready to Apply 32

Get registered 33

Questions 34

Step 3: Prepare Your Application 35

Application contents and format 36

Step 4: Learn About Review and Award 46

Application review 47

Award notices 52

Step 5: Submit Your Application 53

Application submission and deadlines 54

Application checklist 56

Step 6: Learn What Happens After Award 58

Post-award requirements and administration 59

Contacts and Support 66

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 18, 2025.

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

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

Jump to a step

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

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 8

Program description 10

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

Global Health Center

Division of Global HIV and Tuberculosis

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

Have questions?

See Contacts and Support.

Key facts

Opportunity name:

Strengthening comprehensive HIV prevention interventions in Malawi under the President’s Emergency Plan for AIDS Relief (PEPFAR)

Opportunity number:

CDC-RFA-JG-25-0048

Announcement type:

New

Assistance listing:

93.067 Global AIDS

Program

Key dates

Application deadline:

February 18, 2025

Expected award and start date: September 30, 2025

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

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

NOFO.

Summary This NOFO will support the Ministry of Health (MOH) to scale comprehensive HIV prevention interventions in select Malawi districts that have high HIV incidence, prevalence, and large gaps in HIV testing. Implementing a comprehensive HIV prevention program promotes a combination of biomedical, behavioral, and structural interventions to meet the HIV prevention needs of specific population groups and communities.

The provision of combined HIV prevention interventions aim to:

• Provide a broad range of options to the focus populations based on the HIV risk factors.

• Promote an enabling environment for service uptake.

• Promote the adoption of positive behaviors to reduce HIV risk factors.

The goal is to reduce the number of new infections through person-centered activities with a greater sustained impact.

Step 1: Review the Opportunity 5

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $5,000,000 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.

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

Funding strategy

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

You may not request more than this amount.

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

• Availability of funds.

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

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

Component funding

Overview

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

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

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

Step 1: Review the Opportunity 6

Setting up components

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

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

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

◦ Component 1: COP Q1 Targets and Activities.

◦ Component 2: COP Q2 Targets and Activities.

◦ Component 3: COP Q3 Targets and Activities.

◦ Component 4: COP Q4 Targets and Activities.

◦ Component 5: COP Additional Targets and Activities.

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

• Budget narrative

• Component funding instructions for SF-424A

PEPFAR Local partner funding preference This NOFO includes a funding preference for local partners. Your organization will receive 15 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 Malawi.

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 Malawi is very close to reaching the 95-95-95 UNAIDS targets to eliminate HIV as a public health threat by 2030. The National HIV Strategic Plan goal is to accelerate the reduction of new HIV infections from 16,400 in 2022 to 7,400 by 2027. This will be achieved through the delivery of evidence-based comprehensive HIV prevention interventions to people who are at higher risk for HIV.

Malawi HIV spectrum 2024 estimates indicate:

• 941,000 people are currently living with HIV:

◦ 591,000 women.

◦ 350,000 men.

◦ 52,000 children under 15.

• 7.7% HIV prevalence among adults 15 years and above:

◦ 9.2% in women.

◦ 6.0% in men.

• HIV prevalence for key populations:

◦ 50% for female sex workers.

◦ 12.7% for men who have sex with men.

◦ 14.3% for transgender persons.

◦ 27.4% for people who inject drugs.

• 0.07% HIV incidence overall.

• Approximately 14,000 new cases are reported each year including:

◦ 8,200 women.

◦ 4,800 men aged 15-49 years.

◦ 1,900 children aged 0-14 years.

◦ 3,300 or 22% of adolescent girls and young women (aged 15-24) account for the total new HIV infections annually.

Step 1: Review the Opportunity 10

• Incidence for key populations:

◦ 7.69% for female sex workers.

◦ 0.49% for men who have sex with men.

◦ 0.48% for transgenders persons.

◦ 1.15% for people who inject drugs.

Despite the reductions in annual new HIV infections, there are still groups at disproportionate risk. New HIV infections are three times higher among adolescent girls and young women aged 15 to 24 years when compared to their male counterparts. Several factors increase the risk of HIV infection among adolescent girls and young women, including:

• Early sexual debut.

• An increased risk of sexually transmitted infections (STIs).

• Gender and social disparities in service accessibility.

Knowing your HIV status (i.e., HIV awareness) is a gateway to prevention interventions, care, and treatment. Malawi has reached 94-98-94 of the 95-95-95 UNAIDS targets. Men aged 25 to 34 years and young people aged 15 to 24 years are among those lagging in knowing their HIV status. There are also large gaps among children aged 0 to 14 years.

Through the expiring CDC-RFA-GH-20-2051 NOFO, PEPFAR CDC has:

• Supported voluntary medical male circumcision (VMMC) services in the Lilongwe district since 2016.

• Supported the performance of close to 200,000 circumcisions in Lilongwe district, with more than 80,000 in 2024.

Through other prevention NOFOs, PEPFAR CDC has:

• Supported the implementation of the Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe (DREAMS) program, reaching over 30,000 adolescent girls and young women in two districts.

• Supported implementation of DREAMS Lite interventions in Lilongwe district, focusing on women aged 20 to 29 years old.

• Supported HIV programs for key populations in four districts.

• Supported the implementation of targeted community-based HIV testing for men in high-burden cities.

• Supported the initiation of more than 20,000 people on Pre-exposure Prophylaxis (PrEP).

Step 1: Review the Opportunity 11

Lessons learned include the importance of:

• Collaborating with the District Health Office and MOH leadership to plan, implement, and monitor HIV prevention program implementation.

• Participating in quality assurance and supervisory activities led by District Health Office staff.

• Involving the community (e.g. gatekeepers, recipients of care, and community influencers) in demand creation to promote acceptance and uptake of HIV prevention services.

• Addressing structural barriers for key populations to improve accessibility to HIV services.

• Implementing person-centered approaches at facility and community levels.

• Establishing a bi-directional referral system between facilities and communities.

• Tailored services for men which include male-specific clinics and flexible operating hours.

We expect you to implement the following comprehensive HIV prevention activities:

• Support implementation of VMMC focusing on men over 15 years old, serving as a gateway to other HIV prevention services.

• Support MOH to scale VMMC services through the integration of VMMC in MOH sites.

• Support provision of PrEP and Post-exposure Prophylaxis (PEP) for populations at high risk of HIV infection.

• Support implementation of interventions addressing structural barriers for key populations to improve accessibility to HIV services.

• Support implementation of targeted and evidence-based HIV prevention and violence prevention programs focusing on adolescents (10 to 19 years), young people (20 to 29 years), and key populations to reduce HIV risk behaviors.

• Support implementation of HIV testing strategies focusing on men to improve access to HIV testing services (HTS) and promote awareness of HIV status.

• Support scale-up dissemination of Undetectable=Untransmissible messages and integrated HIV prevention messages to promote treatment as prevention and access to different HIV prevention services.

Step 1: Review the Opportunity 12

Purpose The purpose of this NOFO is to reduce new HIV infections in Malawi by implementing comprehensive HIV prevention strategies. These strategies will focus on promotion of competent HIV prevention services for all focus populations at increased risk of HIV infection as defined in the NOFO.

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

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

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

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

Table: Strategies and outcomes

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes

Strategy 1: Support implementation of VMMC services to sustainably transition to government-led service provision.

Strategy 2: Support scale-up of PrEP and PEP implementation to populations at high risk of HIV infection.

Strategy 3: Support implementation of interventions addressing structural barriers for key

Increased availability of VMMC services across different levels of health facilities.*

Increased awareness of comprehensive HIV prevention services.*

Increased capacity of interest holders to provide focus population competent services.*

Increased engagement with focus population-led organizations to

Reduced reliance on implementing partners (IPs) support within MOH facilities providing VMMC services.*

Increased uptake of comprehensive HIV prevention services by focus populations.*

Decreased stigma and discrimination for focus populations accessing public health facilities.*

Sustained provision of VMMC services by

MOH.

Sustained use of comprehensive HIV prevention services by focus populations.*

Sustained provision of key population competent care in public health facilities.*

Reduced new HIV infections in focus populations.*

Step 1: Review the Opportunity 13

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes populations to improve accessibility to HIV services.

Strategy 4: Support implementation of evidence-based HIV and violence prevention interventions focused on adolescents and young people.

Strategy 5: Support implementation of evidence-based community-based HTS strategies focused on men.

implement HIV programming.*

Increased implementation of focus population competent services in public health facilities.*

Increased access to comprehensive prevention HIV services for focus populations.*

Increased linkage to appropriate HIV services for focus populations.*

Increased provision of stigma and discrimination-free HIV prevention services by interest holders.*

Increased collaboration with focus population-led organizations to implement HIV programming.*

Increased provision of evidence-based community-based testing strategies for focus populations.*

Reduced HIV risk behaviors among focus populations.

Sustained collaboration with focus population-led organizations for HIV programming.

Additional information on outcomes in the logic model:

• Focus populations include, but are not limited to:

◦ Adolescent girls and young women.

◦ Adolescent boys and young men.

◦ Key populations.

◦ Men.

◦ Other populations at higher risk for HIV infection.

◦ Interest holders include, but are not limited to:

▪ Law enforcement.

▪ Judicial staff.

▪ Faith leaders.

▪ Community leaders.

▪ Policy makers.

▪ Healthcare workers (HCWs).

▪ Focus population-led organizations.

• Focus population competent services include, but are not limited to:

Step 1: Review the Opportunity 14

◦ Gender-based violence.

◦ Prevention.

◦ Care and treatment.

◦ Mental health.

◦ Social economic.

◦ Peer support.

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

◦ PrEP.

◦ PEP.

◦ HTS.

◦ Condoms.

◦ Lubricant.

◦ VMMC.

◦ Harm reduction.

◦ STI services.

◦ Risk reduction.

• Linkage to appropriate HIV services includes linkage to prevention services for those who test negative for HIV and linkage to care and treatment services for those living with HIV.

• Public health facilities include, but are not limited to:

◦ Faith-based healthcare facilities.

◦ Public healthcare facilities.

• Priority areas include high-burden districts and hot spots as evidenced by the most recent data.

• Sustained provision of VMMC services by MOH includes, but is not limited to management of service delivery by the district councils in public health facilities.

Step 1: Review the Opportunity 15

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: Support implementation of VMMC services to sustainably transition to government-led service provision.

Required activities:

• Implement minimum package for VMMC.

• Use a combination of different service delivery models for VMMC.

• Establish a response team to conduct outreach services to other high-burden districts and/or hot spots, as determined by recency testing, with no VMMC services.

• Develop a referral mechanism to ensure clients from other service delivery points are referred to VMMC.

• Facilitate training of MOH staff as VMMC providers to ensure that public facilities have adequately trained VMMC providers.

• Provide technical support to MOH staff to be able to provide VMMC services in selected sites in the absence of an IP provider.

• Prioritize VMMC services in settings where HIV incidence is high (e.g., urban setting or hot spots).

• Implement multifaceted demand creation activities for VMMC, engaging key interest holders.

• Develop and implement a feasible and sustainable transition plan for shifting delivery of VMMC services to government.

Strategy 2: Support scale-up of PrEP and PEP implementation to populations at high risk of HIV infection.

Required activities:

• Conduct training for different cadres to support PrEP and PEP services.

• Implement community PrEP and PEP services for focus populations.

• Conduct supportive supervision of staff implementing PrEP and PEP to ensure quality of services.

Step 1: Review the Opportunity 16

• Collaborate with MOH supply chain team on PrEP commodities required for community setting.

• Implement multifaceted demand-creation activities for PrEP and PEP.

• Support rollout of new PrEP and PEP products, as applicable.

• Develop and implement a feasible and sustainable transition plan for shifting delivery of PrEP and PEP services to government.

• Collaborate with other IPs to develop a comprehensive training program for PrEP and PEP service delivery.

Strategy 3: Support implementation of interventions addressing structural barriers for key populations to improve accessibility to HIV services.

Required activities:

• Implement innovative solutions for identifying hard-to-reach key populations.

• Build capacity of HCWs to provide key population competent services.

• Coordinate with key population-led organizations in development and implementation of interventions to reduce stigma and discrimination.

• Use community-led monitoring to improve program delivery for key populations.

• Promote collaboration between interest holders to ensure key populations receive the full comprehensive HIV package of services.

• Collaborate with other IPs to develop a comprehensive training program that incorporates key population-led organizations into service delivery for program sustainability.

• Provide technical assistance to key population-led organizations to manage comprehensive HIV programs.

Strategy 4: Support implementation of evidence-based HIV and violence prevention interventions focused on adolescents and young people.

Required activities:

• Implement innovative solutions for identifying hard-to-reach adolescents and young people and their sexual partners.

• Collaborate with interest holders to build capacity of HCWs to provide youth-responsive HIV services.

• Develop referral pathways to services for adolescents and young people.

Step 1: Review the Opportunity 17

• Work with youth-led organizations to implement violence prevention and youth-responsive services at community level.

• Collaborate with interest holders to ensure program sustainability.

Strategy 5: Support implementation of evidence-based community-based HTS strategies focused on men.

Required activities:

• Implement innovative solutions for reaching men.

• Develop referral pathways to services for men.

• Build capacity of HTS providers to ensure quality services for men.

• Implement innovative solutions to increase awareness and demand creation for HTS for men.

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.

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, Step 1: Review the Opportunity 18 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.

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 population for this NOFO include:

• Males aged over 15 years old.

• Adolescent girls and young women.

• Adolescent boys and young men.

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

Step 1: Review the Opportunity 19 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/

• Key populations, including:

◦ Female sex workers.

◦ Men who have sex with men.

◦ Transgender persons.

◦ People who inject drugs.

• HCWs

◦ Nurses.

◦ Clinicians.

◦ HIV testing cadres.

◦ Data clerks.

Community-level focus populations for this NOFO include, but are not limited to:

• Law enforcement.

• Judicial staff.

• Faith leaders.

• Community leaders.

• Policy makers.

• Focus population-led organizations.

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

• Race.

• Color.

• National origin.

• Disability.

• Age.

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

• Other constitutionally protected statuses.

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

Step 1: Review the Opportunity 20

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

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

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

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

• Reduce HIV and TB stigma and discrimination.

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

• Make the workforce more inclusive.

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

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

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

• US government funded IPs implementing HIV services.

• CDC-funded IPs.

• USAID-funded IPs.

• Malawi government sectors (e.g., MOH, Ministry of Gender, Ministry of Youth, etc.).

• National AIDS Commission.

• Private sector.

• Non-government organizations.

• Civil society organizations.

• Interest holders as defined in the NOFO.

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

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

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

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

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

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

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

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

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

Required performance measures

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

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

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

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

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

Step 1: Review the Opportunity 22 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

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.

• VMMC_CIRC: Number of males circumcised as part of the voluntary medical male circumcision (VMMC) for HIV prevention program within the reporting period. [Target: 50,000; Reporting Frequency: Quarterly]

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

Quarterly]

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

• Percentage of government-led sites implementing VMMC services within Lilongwe city. [Target: 25%; Reporting Frequency: Quarterly]

• Percentage of moderate or severe adverse events reported within one month of circumcision. [Target: <2%; Reporting Frequency: Quarterly]

• Number of demand creation activities implemented about prevention strategies. [Target: 3; Reporting Frequency: Annual]

• Percentage of men who were reached by a demand creation campaign and who received VMMC services. [Target: >25%; Reporting Frequency:

Annual]

• Number of VMMC trainings implemented for MOH staff. [Target: 4;

Reporting Frequency: Quarterly]

• Percentage of HCWs trained to provide VMMC services at government-led sites, disaggregated by site. [Target: 10%; Reporting Frequency:

Quarterly]

• Number of HIV hot spots outside of Lilongwe district supported by VMMC clinic outreach event. [Target: 2; Reporting Frequency: Quarterly]

Step 1: Review the Opportunity 23

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

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

• Effectiveness of different strategies on reaching population groups with HIV prevention interventions: outcome evaluation.

• Cost effectiveness of different prevention interventions for sustaining the HIV response in transitioning to government-led service provision:

economic evaluation.

• Facilitators/barriers to uptake of VMMC services among men aged greater than 15 years old in Lilongwe city: process evaluation.

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

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 interest holders.

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

Step 1: Review the Opportunity 24 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 25

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

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

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

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

Describe:

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

• Key evaluation questions these evaluations will address.

• Other information, such as measures and data sources.

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

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

Submit your initial DMP with your application and include:

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

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

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

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

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

• 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 26 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.

Step 1: Review the Opportunity 27

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

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

Funding policies and limitations General policies

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

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

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

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

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

dollars.

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

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Satisfactory progress in meeting your project’s objectives.

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

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

Step 1: Review the Opportunity 28 https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=13f24ea1f961f5f0d14b87ec1b39b25f&term_occur=999&term_src=Title:45:Chapter:A:Subchapter:A:Part:75:Subpart:E:Subjgrp:39:75.440

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

◦ Funding more applicants.

◦ Extending the period of performance.

◦ Awarding supplemental funding.

See also program-specific limitations.

Unallowable costs You may not use funds for:

• Research.

• Clinical care, except as allowed by law.

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

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

◦ Publicity or propaganda purposes, including preparing, distributing, or using any material designed to support or defeat the enactment of legislation before any legislative body.

◦ The salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or executive order proposed or pending before any legislative body.

◦ See Anti-Lobbying Restrictions for CDC Recipients.

• Needle exchange programs.

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

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

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

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

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

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

Step 1: Review the Opportunity 29 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

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

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

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

Other indirect cost policies

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

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

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.

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

Step 1: Review the Opportunity 30 https://www.ecfr.gov/current/title-2/section-200.414 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC)) https://www.ecfr.gov/current/title-45/part-75#p-75.403(d) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-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 31 https://www.cdc.gov/grants/documents/PEPFAR-Terms-and-Conditions.pdf

Step 2:

Get Ready to Apply

In this step

Get registered 33

Questions 34

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-25-0048.

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 33 https://sam.gov/content/entity-registration…