Namibia CDC-RFA-JG-25-0092 Final NOFO for Publication.pdf

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Strengthening comprehensive HIV and TB services and health systems in high-burden areas of Namibia under the President's Emergency Plan for AIDS Relief (PEPFAR)
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CDC-RFA-JG-25-0092
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About this file

This is a Notice of Funding Opportunity (NOFO) from the CDC's Division of Global HIV and Tuberculosis for strengthening HIV and TB services in Namibia under PEPFAR. The opportunity number is CDC-RFA-JG-25-0092 with applications due February 19, 2025 and an expected award date of September 30, 2025.

The NOFO will provide $15 million in first-year funding through cooperative agreements to 1-3 recipients to enhance comprehensive HIV and TB services in high-burden areas of Namibia. Key activities include supporting facility and community-based service delivery, quality management, mentorship, monitoring and evaluation, and surveillance through routine data collection. Specific focus areas include HIV services for adults and children, TB prevention and treatment, elimination of mother-to-child transmission, cervical cancer screening, laboratory systems strengthening, and implementation of differentiated service delivery models. The program aims to decrease HIV/TB incidence, improve health data quality and use, optimize the healthcare workforce, ensure consistent access to critical medical supplies, and enhance Namibia's government capacity to manage these health challenges. Eligibility is unrestricted and includes U.S. and non-U.S. organizations. A local partner funding preference will provide an additional 15 points during application review for organizations meeting PEPFAR's local partner definition.

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Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 19, 2025

Strengthening comprehensive HIV and TB services and health systems in high-burden areas of Namibia under the President’s Emergency Plan for AIDS Relief (PEPFAR) Opportunity number: CDC-RFA-JG-25-0092

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 34

Get registered 35

Questions 36

Step 3: Prepare Your Application 37

Application contents and format 38

Step 4: Learn About Review and Award 48

Application review 49

Award notices 55

Step 5: Submit Your Application 57

Application submission and deadlines 58

Application checklist 60

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 19, 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 Centers for Disease Control to 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 and TB services and health systems in high-burden areas of Namibia under the President’s Emergency Plan for AIDS Relief (PEPFAR)

Opportunity number:

CDC-RFA-JG-25-0092

Announcement type:

New

Assistance listing:

93.067 Global AIDS

Program

Key dates

Application deadline:

February 19, 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 aims to enhance comprehensive HIV and TB services and systems in high-burden areas of Namibia by supporting facility- and community-based service delivery for HIV, TB, and associated comorbidities.

You will support the Ministry of Health and Social Services (MOHSS) in overseeing and monitoring government-led programs, including quality management, mentorship, monitoring and evaluation, surveillance through routine data, and public health response.

Comprehensive support includes:

• Enhanced HIV service delivery for adult and pediatric patients.

• Strengthened TB prevention, diagnosis, and treatment.

• Elimination of mother-to-child transmission.

• Improved cervical cancer prevention, screening, and treatment.

• Established site-level supply chain monitoring, including:

◦ Laboratory systems strengthening.

◦ Human resources for health (HRH).

• Enhanced differentiated service delivery (DSD) models.

• Strengthened surveillance of routine HIV, TB, and associated comorbidities.

• Improved MOHSS health information systems (HIS) use.

Step 1: Review the Opportunity 5

Expected outcomes include:

• Decreased HIV and TB incidence.

• Improved government health data quality, access, and use.

• Efficient resource mobilization, particularly financial, HRH, and supply chain with an optimized workforce.

• Consistent availability of critical commodities at site level.

• Full DSD model implementation.

• Enhanced host government capacity to respond to HIV, TB, and related health threats.

• Strengthened government capacity to sustain the response.

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $15,000,000 This is the expected total Year 1 funding for all awards made under this

NOFO.

Expected number of awards: 1-3 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.

Step 1: Review the Opportunity 6

Component funding

Overview

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

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

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

Setting up components

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

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

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

◦ Component 1: COP Quarter 1 Targets and Activities.

◦ Component 2: COP Quarter 2 Targets and Activities.

◦ Component 3: COP Quarter 3 Targets and Activities.

◦ Component 4: COP Quarter 4 Targets and Activities.

◦ Component 5: COP Additional Targets and Activities.

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

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

• Budget narrative

• Component funding instructions for SF-424A

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

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

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

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

• Is submitted after the deadline.

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

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

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

• Is not in English.

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

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

See the application checklist to understand your application requirements.

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

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

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

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

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

Program description Background overview and related work The HIV epidemic in Namibia: progress and remaining gaps The HIV epidemic in Namibia is generalized, with an estimated 10% prevalence among the general population. Namibia is at 93-95-98 of the Joint United Nationals Programme on HIV/AIDS (UNAIDS) 95-95-95 targets, it’s one of the first high-burden countries to approach epidemic control.

Yet, challenges remain:

• There are continued gaps in HIV diagnosis and viral load suppression (VLS) among children and men aged 20-30 years.

• The latest models show a slight increase in deaths among people living with HIV, driven by COVID-19 and TB co-infections.

• Among adults over 25, women bear a disproportionate burden, with a 19% prevalence compared to a 13% prevalence for men.

The status of TB in Namibia Namibia has the 11th highest incidence rate of TB in the world, 450 per 100,000, with approximately 25% of cases undiagnosed. Also, Namibia has:

• 75% estimated TB treatment coverage.

• 30% of TB patients are also living with HIV.

• TB remains the leading infectious disease cause of death, including among people living with HIV.

• Large gaps still exist in TB case diagnosis (approximately 25%), particularly among children.

• Drug-resistant TB remains a concern among vulnerable populations.

Closing gaps in Namibia’s response to HIV and TB As Namibia moves towards epidemic control, this NOFO is designed to strengthen programs, ensure their sustainability, and close remaining program gaps.

We recognize the years of investment and leadership the Namibian government has taken to build strong collaborations among implementing

Step 1: Review the Opportunity 10 partners, civil service organizations, multilateral agencies, and other stakeholders.

Goals and expected activities This NOFO aims to use targeted and innovative approaches to prevent new infections, retain people in care, reduce mortality rates, and strengthen the health system while providing person-centered, high-quality health services.

To achieve these goals, we will expect you to:

• Provide technical support and capacity building to address case-finding gaps and reach priority populations.

• Improve integrated TB case finding through active screening in facility and community settings and ensure continuous access to molecular diagnostics.

• Carry out the MOHSS quality management strategy and expand continuous quality improvement collaboratives to sustain program gains across the HIV/TB cascade.

• Optimize antiretroviral therapy (ART) regimens and achieve undetectable viral load (VL) in over 95% of all sub-populations.

• Increase prevention measures, including pre-exposure prophylaxis (PrEP), among focus populations.

• Optimize laboratory network and reduce turnaround time to modernize laboratory testing platforms.

• Support MOHSS’s quality management strategy, including improving data quality, access, and use, and automating processes to streamline data entry, processing, and analysis.

• Ensure ongoing availability of commodities at the facility and community level.

• Support ongoing improvement to MOHSS organizational effectiveness.

• Use a data-driven approach to optimize HRH and increase government capacity to share responsibility for HRH planning and management.

• Expand systems investments to ensure Namibian institutions can sustainably end HIV and TB as public health threats by 2030.

The long-term goals of this NOFO are to:

• Enable the government of Namibia to lead and oversee the public health response to HIV/TB.

• Strengthen the Namibian health system to reduce HIV and TB incidence.

• Reduce HIV- and TB- related morbidity and mortality.

Step 1: Review the Opportunity 11

• Improve the quality of HIV and TB care.

• Improve the quality of life for people living with HIV and those diagnosed with TB.

Purpose The purpose of this NOFO is to:

• Develop innovative approaches to prevent new HIV/TB infections.

• Identify cases not yet enrolled in care.

• Keep people in care.

• Reduce mortality rates.

• Improve the use of data for public health action.

• Build efficient health systems.

• Provide person-centered, high-quality health services in Namibia.

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 12

Table: Strategies and outcomes

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes

Strategy 1: Implement innovative and optimized HIV/TB case-finding strategies and ensure linkage to appropriate services.

Strategy 2:

Strengthen continuity of HIV/TB care for adults and pediatrics, including focus populations.

Strategy 3:

Strengthen quality management systems and continuous quality improvement initiatives.

Strategy 4:

Strengthen strategic information systems for a sustained HIV/TB response.

Strategy 5: Improve HRH planning and management to ensure a prepared health workforce able to sustain the HIV/TB response.

Increased use of HIV/ TB case-finding strategies by program staff.*

Increased timely linkage to HIV/TB services for newly diagnosed people living with HIV.*

Increased capacity of program staff to monitor program quality.*

Increased access to HIV/TB services for focus populations.*

Increased capacity of stakeholders at all levels to access high-quality data.*

Increased use of data to inform program implementation.*

Increased use of data for evidence-based

HRH

implementation.*

Increased job alignment across

HRH.*

Increased capacity of HIV/TB program to find people living with

HIV.*

Increased adherence to treatment for people living with

HIV.*

Increased retention in HIV/TB services for focus populations.*

Increased use of HIV/ TB services by focus populations.*

Increased provision of high-quality HIV/TB services by healthcare workers.*

Increased VL coverage for people living with

HIV.*

Increased use of timely, high-quality data to monitor HIV/ TB response.*

Increased evidence-based allocation of HRH to address programmatic gaps.*

Increased management of HRH through alignment of stakeholder plans.*

Reduced HIV/TB incidence.*

Reduced incidence of HIV/TB-associated comorbidities among focus populations.*

Reduced HIV/TB-related morbidity and mortality.

Increased VLS for people living with

HIV.*

Sustained use of high-quality data for informed programmatic decision-making.

Increased availability of skilled healthcare workers at all levels.*

Increased resiliency of HIV/TB program to meet ongoing public health needs.

Step 1: Review the Opportunity 13

Additional information on logic model outcomes:

• Increased timely linkage to HIV/TB services for newly diagnosed people living with HIV including same-day ART initiation.

• Increased capacity of program staff to monitor program quality includes staff trained and able to use quality management systems and continuous quality improvement initiatives to effectively monitor program quality.

• Increased access to HIV/TB services for focus populations includes prevention services, testing services, and care and treatment services.

• Increased capacity of stakeholders at all levels to access high-quality data, including at the facility, district, regional, and national levels.

• Increased use of data for evidence-based HRH implementation includes using data for policy development and programmatic decision-making for HRH allocation and distribution.

• Increased job alignment across HRH includes alignment between titles and job descriptions for MOHSS and donor-supported HRH.

• Increased adherence to treatment for people living with HIV includes adherence and completion of applicable treatments, such as ART, and TB preventive treatment TPT.

• Increased use of timely, high-quality data to monitor HIV/TB response includes data that uses quality management systems and continuous quality improvement initiatives, monitoring patient outcomes and disease burden.

• Increased evidence-based allocation of HRH to address programmatic gaps includes using high-quality data to monitor disease burden and align HRH to respond.

• Increased management of HRH through alignment of stakeholder plans includes alignment of compensation plans for MOHSS and donor-supported HRH.

• Reduced incidence of HIV/TB-associated comorbidities among focus populations includes cervical cancer.

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

Step 1: Review the Opportunity 14

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

Strategy 1: Implement innovative and optimized HIV/TB case-finding strategies and ensure linkage to appropriate services.

Required activities:

• Offer safe and ethical index testing to all persons newly diagnosed with HIV or those who are virally unsuppressed, including all biological children under 19.

• Optimize provider-initiated testing and counseling to target high-risk groups, including probable TB cases and pregnant and breastfeeding women.

• Improve case finding among men and children / adolescents through a strategic mix of testing modalities.

• Integrate TB and HIV case finding in all healthcare settings, such as clinical facilities and community health posts.

• Ensure timely linkage to care for all diagnosed cases of HIV and TB.

• Ensure that all probable TB cases are promptly referred for clinical evaluation and have specimens collected for molecular testing, and that treatment is initiated as soon as clinically appropriate.

• Scale up use of the latest enhanced TB screening tools recommended by the World Health Organization (WHO), such as digital radiology with use of artificial intelligence.

• Ensure optimization of molecular testing coverage for all probable cases, including appropriate specimen collection for children.

Strategy 2: Strengthen continuity of HIV/TB care for adults and pediatrics, including focus populations.

Required activities:

• Strengthen monitoring of VL and VLS for both adults and children (including pregnant and breastfeeding women).

• Support the implementation of various DSD models, including community adherence groups, particularly family-centered or peer-support models (including adolescent treatment support programs).

• Strengthen collaboration and client referral systems between facilities and community services to enhance continuous care.

Step 1: Review the Opportunity 15

• Support the full implementation of multi-month dispensing (MMD) strategies.

• Optimize of pediatric ART regimens.

• Strengthen the integration of mental health care.

• Strengthen integration of the management of common comorbidities (including hypertension and diabetes mellitus) and sexual/reproductive health into HIV and TB service delivery.

• Carry out facility and community-based efforts to trace and bring back patients who stop their treatment.

• Include activities that address stigma in a measurable way, especially for adolescent girls and boys.

• Support interventions to help men reach the 95-95-95 targets along the cascade of care.

• Support interventions to help pediatric and adolescent patients reach the 95-95-95 targets along the cascade of care.

• Support providing HIV and TB services in the same location to improve diagnosis and treatment and prevent TB-related mortality.

• Prevent and diagnose incident infections during pregnancy and breastfeeding with PrEP and HIV retesting in pregnant and breastfeeding women.

• Scale up facility- and community-based index testing and self-testing in maternal, neonatal, and child health services.

• Carry out facility- and community-based activities to improve ongoing treatment, including access to direct service delivery models like community adherence groups, MMD, family-based models, adolescent peer models, mother-baby follow-up, and tracing services.

• Ensure the optimization of ART regimens and strengthen VL monitoring support.

• Ensure surveillance activities fully track children, adolescents, and pregnant and breastfeeding women across service delivery models.

• Monitor HIV-positive pregnant and breastfeeding women and HIV-exposed infants through the cascade of care, from prevention of mother-to-child transmission (PMTCT) enrollment until the infant’s final outcome.

• Provide cervical cancer screening and treatment for women aged 20 to 50 who are living with HIV using the “screen, triage, and treat” approach.

• Ensure access to treatment services for priority populations, such as children or adolescents living with HIV and HIV-exposed infants.

Step 1: Review the Opportunity 16

• Provide prevention services, including biomedical prevention like PrEP and structural interventions, to reduce vulnerability to HIV infection among priority populations.

• Actively link high-risk priority populations testing negative to prevention services, especially PrEP, and post-exposure prophylaxis.

• Offer regular testing and monitoring for participants in prevention services like PrEP to monitor the impact of key interventions for preventing new infections and maintaining epidemic control.

• Provide TPT to people living with HIV and vulnerable contacts, and actively follow patients on short-course TPT regimens to ensure adherence and monitor for adverse events.

Strategy 3: Strengthen quality management systems and continuous quality improvement initiatives.

Required activities:

• Make sure that clinical mentoring activities are carried out in full in all supported regions and districts.

• Strengthen the MOHSS’s capacity to provide service delivery and high-impact training to healthcare workers and managers at the national and local levels. Training includes in-service, on-the-job, and mentorship.

• Help MOHSS carry out the National Quality Management and Strategic Plan to:

◦ Improve the MOHSS quality management system.

◦ Ensure patient-centered care.

◦ Empower consumers.

◦ Improve patient and healthcare worker safety and clinical practice.

• Provide technical assistance to MOHSS to develop, implement, supervise, and monitor high-quality clinical services at the national and local levels.

Clinical services include HIV, TB, other communicable diseases, and primary health care services.

• Ensure monitoring, reporting, and routine use of quality management and quality improvement data across the health system.

Step 1: Review the Opportunity 17

Strategy 4: Strengthen strategic information systems for a sustained HIV/TB response.

Required activities:

• Improve data quality, including timeliness, completeness, and accuracy, to ensure near real-time availability from relevant HIS.

• Speed up data access for site-level providers, district and regional mentors, and national-level decision-makers so they can work together to discuss program activities with diverse stakeholders.

• Enhance data use for program performance and service quality reviews and improvements.

• Use technology to automate processes and streamline data entry, processing, and analysis.

• Implement service quality assessments, improvements, and assurances.

• Support implementing a national surveillance plan to prepare thematic data review materials for data-driven decision-making.

• Strengthen central, regional, district, facility, and community-level quality management capacity and continuous quality improvement units, including MOHSS clinical and management staff, to monitor HIV/TB program implementation.

• Develop and share information products, such as reports, highlighting key program results, including HIV cascade, using routinely reported data from the national surveillance systems.

Optional activities:

• Help MOHSS develop, implement, and maintain HIS and technological solutions for patient and program management and improvement.

• Help MOHSS develop, implement, and evaluate the country’s eHealth strategies, governance, policies, architecture, and HIS standards.

Strategy 5: Improve HRH planning and management to ensure a prepared health workforce able to sustain the HIV/ TB response.

Required activities:

• Strengthen HRH capacity-building to improve the quality of HIV/TB service delivery.

Step 1: Review the Opportunity 18

◦ Capacity building should include knowledge sharing to ensure healthcare staff can diagnose both HIV/TB in hard-to-reach populations.

• Work with the MOHSS to improve efficient and effective HRH allocation in response to epidemiologic priorities and the country’s disease burden.

• Support MOHSS in improving oversight and evaluations of HRH in facility and community settings and assess if HRH allocation changes result in health outcomes.

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, 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

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/ 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 populations for this NOFO include:

• People (including children, men, and women) who are at increased risk for or are living with HIV and TB in select geographic regions of Namibia according to strategic needs.

Your activities will focus on specific priority populations (or subgroups), including:

• Women of reproductive age.

• HIV-exposed infants.

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

Step 1: Review the Opportunity 20 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

• Children and adolescents.

• Men.

Priority populations and geographic areas may change during the project period based on programmatic needs.

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 21 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:

• Namibia MOHSS, Namibia Institute of Pathology, and other local institutions on all comprehensive clinical activities at national and sub-national levels.

• U.S. government PEPFAR-funded partners, civil society organizations, multilateral partners such as the Global Fund, and other stakeholders.

• Namibian police,local and regional councilors, the Ministry of Education, the Ministry of Gender Equality and Child Welfare, non-governmental organizations, churches, and traditional leaders.

• All stakeholders implementing HIV/TB-related programs in the priority geographic regions:

◦ The 11 high-burden regions in the northern part of Namibia include Khomas, Erongo, Kunene, Otjozondjupa, Oshana, Omusati, Ohangwena, Oshikoto, Kavango West, Kavanago East, and Zambezi.

◦ This is meant to create alignment in achieving NOFO goals and objectives and realize the spirit of one national response framework, coordinating authority, and surveillance system.

• CDC-funded multilateral partners, including WHO, the United Nations International Children’s Emergency Fund, UNAIDS, and CDC-funded recipients in each of the funded geographic areas as per the partner area of expertise.

We will help you connect with other partners working in this area. You should make sure that work complements and supports other work funded by CDC, rather than duplicating efforts.

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

Step 1: Review the Opportunity 22 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 5% for evaluation activities. We will discuss these percentages and finalize them at or after award. These are estimates for the total funding over the 5-year project.

Required performance measures

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

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

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

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

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

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

Step 1: Review the Opportunity 23 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.

• 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:

2,300; 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: 4,000; Reporting Frequency: Quarterly]

• TB_PREV: Proportion of ART patients who started on a standard course of TB Preventive Treatment (TPT) in the previous reporting period who completed therapy. [Target: 90%; Reporting Frequency: Semi-Annual]

• CXCA_SCRN: Number of women living with HIV on ART screened for cervical cancer. [Target: 12,000; Reporting Frequency: Semi-Annual]

• HTS_TST: Number of individuals who received HIV Testing Services (HTS) and received their test results. [Target: 50,000; Reporting Frequency:

Quarterly]

• PMTCT_EID: Percentage of infants born to women living with HIV who received a first virologic HIV test (sample collected) by 12 months of age.

[Target: 100%; Reporting Frequency: Quarterly]

• PMTCT_FO: Percentage of final outcomes among HIV-exposed infants registered in a birth cohort. [Target: 95%; Reporting Frequency: Annual]

• PMTCT_HEI_POS: Number of newly identified infants living with HIV with a positive virologic HIV test result returned in the reporting period, whose diagnostic sample was collected by 12 months of age. [Target: Not Assigned; Reporting Frequency: Quarterly]

• PMTCT_STAT: Percentage of pregnant women with known HIV status at antenatal care (includes those who already knew their HIV status prior to ANC). [Target: 100%; Reporting Frequency: Quarterly]

• TB_STAT: Percentage of new and relapse TB cases with documented HIV status. [Target: 100%; Reporting Frequency: Quarterly]

• CXCA_TX: Percentage of cervical cancer screen-positive women who are living with HIV and on ART eligible for cryotherapy, thermocoagulation or LEEP who received cryotherapy, thermocoagulation or LEEP. [Target: Not Assigned; Reporting Frequency: Semi-Annual]

Step 1: Review the Opportunity 24

• PMTCT_ART: Percentage of pregnant women living with HIV who received ART to reduce the risk of mother-to-child transmission (MTCT) during pregnancy. [Target: 100%; Reporting Frequency: Quarterly]

• TB_ART: Proportion of new and relapsed TB cases living with HIV on ART during TB treatment. [Target: 100%; Reporting Frequency: Annual]

• TX_CURR: Number of adults and children currently receiving antiretroviral therapy (ART). [Target: 106,000; 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_NEW: Number of adults and children newly enrolled on antiretroviral therapy (ART). [Target: 3,500; Reporting Frequency: Quarterly]

• TX_RTT: Number of ART patients who experienced IIT during any previous reporting period, who successfully restarted ARVs within the reporting period and remained on treatment until the end of the reporting period.

[Target: Not Assigned; Reporting Frequency: Quarterly]

• TX_TB: Proportion of ART patients screened for TB in the semiannual reporting period who start TB treatment. [Target: 100%; Reporting Frequency: Semi-Annual]

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

[Target: 98%; 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.

• Proportion of facilities with infection prevention and control standard operating procedures. [Target: 95%; Reporting Frequency: Annual]

• Proportion of eligible people living with HIV prescribed MMD per national guidelines. [Target: 95%; Reporting Frequency: Monthly]

• Proportion of people living with HIV prescribed MMD who are dispensed the amount prescribed. [Target: 95%; Reporting Frequency: Monthly]

• Proportion of people living with HIV who are prescribed and complete TPT. [Target: 95%; Reporting Frequency: Monthly]

Step 1: Review the Opportunity 25

• Number of incident HIV infections among infants. [Target: <1; Reporting Frequency: Monthly]

• Proportion of HIV- and/or TB- related deaths undergoing a mortality audit. [Target: 75%; Reporting Frequency: Monthly]

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

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

• Evaluation of smart integration at specific facilities on retention in treatment and VLS: outcome evaluation.

• Effect of six-month MMD on retention in treatment and VLS: outcome evaluation.

• Effect of TB/HIV integrated screening and testing within outpatient department or primary health care delivery points: 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.

Step 1: Review the Opportunity 26

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

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

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

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

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

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

Methods Describe how you will:

• Collect the performance measures.

• Respond to the evaluation topics.

• Use evaluation findings for continuous program quality improvement.

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

Additionally, explain:

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

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

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

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

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

Step 1: Review the Opportunity 27

Evaluation activities You must carry out specific evaluation activities.

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

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

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

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

Describe:

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

• Key evaluation questions these evaluations will address.

• Other information, such as measures and data sources.

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

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

Submit your initial DMP with your application and include:

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

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

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

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

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

• Archival and long-term data preservation plans.

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

Step 1: Review the Opportunity 28 https://www.cdc.gov/grants/additional-requirements/ar-25.html

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

In addition to the other requirements listed, also include:

• Cybersecurity plans.

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

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

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

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.

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

Step 1: Review the Opportunity 29

Table: Sample format

Activities you will implement

Progress or process measures

From the data, monitoring, and evaluation section.

Relevant period of performance outcomes

From the logic model.

Responsible position or party

Funding component / completion date

Strategy 1:

1.

2.

3.

Strategy 2:

1.

2.

3.

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

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

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

Step 1: Review the Opportunity 30 https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm

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…

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