Lesotho CDC-RFA-JG-25-0078 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 20, 2025

Sustaining HIV and TB epidemic control in Lesotho through health system strengthening and technical assistance under the President's Emergency Plan for AIDS Relief (PEPFAR) Opportunity number: CDC-RFA-JG-25-0078

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 36

Get registered 37

Questions 38

Step 3: Prepare Your Application 39

Application contents and format 40

Step 4: Learn About Review and Award 50

Application review 51

Award notices 58

Step 5: Submit Your Application 59

Application submission and deadlines 60

Application checklist 62

Step 6: Learn What Happens After Award 64

Post-award requirements and administration 65

Contacts and Support 72

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 20, 2025.

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

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

Jump to a step

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

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 8

Program description 10

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

Global Health Center

Division of Global HIV and Tuberculosis

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

Have questions?

See Contacts and Support.

Key facts

Opportunity name:

Sustaining HIV and TB epidemic control in Lesotho through health system strengthening and technical assistance under the President’s Emergency Plan for AIDS Relief (PEPFAR)

Opportunity number:

CDC-RFA-JG-25-0078

Announcement type:

New

Assistance listing:

93.067 Global AIDS

Program

Key dates

Application deadline:

February 20, 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 accelerate and sustain HIV epidemic control and reduce TB incidence through interventions to address unmet needs across the clinical cascade in four districts of Lesotho:

• Leribe

• Berea

• Quthing

• Qacha’s Nek

The goal is to attain and sustain the UNAIDS 95-95-95 targets.

We expect you to work with the Lesotho Ministry of Health (MOH) to implement evidence-based interventions and innovative strategies to strengthen the capacity of district health management teams (DHMTs), health facilities, and communities. This increased capacity will improve sustainability and person-centered health service delivery.

Activities under this NOFO include strengthening health systems, continuous quality improvement (CQI), and providing technical assistance (TA) in multiple areas, including:

• Finding cases of HIV and TB.

• HIV care and treatment, including advanced HIV disease (AHD) management.

• Cervical cancer (CxCa) screening.

• Biomedical prevention interventions. For example, elimination of mother-to-child HIV transmission (EMTCT) and pre-exposure prophylaxis (PrEP).

• Preventing, diagnosing, and treating TB.

Step 1: Review the Opportunity 5

• Integrating the management of non-communicable diseases (NCDs) (such as hypertension and mental health challenges) into HIV service delivery.

• Interfacing with laboratory systems.

• Surveillance (for example, recency testing) and data use for program improvement.

Our goals align with the PEPFAR 2030 strategic direction to eliminate the HIV/ AIDS pandemic as a public health threat and strengthen public health systems.

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 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 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 1.

◦ Component 6: COP Additional Targets and Activities 2.

◦ Component 7: 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 Lesotho.

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

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

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

• Is submitted after the deadline.

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

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

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

• Is not in English.

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

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

See the application checklist to understand your application requirements.

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

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

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

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

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

Program description Background overview and related work The state of HIV response in Lesotho There are approximately 270,000 people living with HIV in Lesotho, including 6,400 children (0 to 14 years) and 160,000 women (15 years and older).

Lesotho has made notable gains in life expectancy among people living with

HIV:

• HIV incidence among adults (15 years and older) has sharply decreased from approximately 2.2 per 1,000 in 2010 to 0.5 per 1,000 in 2023. This decrease is due to accelerated prevention and treatment programs.

• In the same period, AIDS-related deaths (all ages) decreased by 45%.

• The Joint United Nations Programme on HIV and AIDS (UNAIDS) Spectrum score card for HIV testing and treatment cascade for all ages was estimated at 95-89-88 in 2023.

Despite the advances made to reach the UNAIDS 95-95-95 targets by 2025, challenges remain, including:

• New infections are still high among females ages 15 to 29.

• Persistent clinical cascade gaps remain, especially for children.

• There are still gaps in delivering services to men ages 25 to 40 and key populations.

This NOFO supports Lesotho’s National AIDS Strategy 2023-2028, which outlines ambitious objectives to reduce new HIV infections by 75% and AIDS-related deaths by 25% by 2028. Lesotho’s strategy aligns with PEPFAR’s strategy to accelerate the response to end the HIV/AIDS pandemic as a public health threat by 2030 while sustainably strengthening public health systems.

This NOFO will also support Lesotho’s TB National Strategic Plan 2023-2028 goals. One goal is to reduce the TB burden by scaling up TB prevention, diagnosis, and care through a people-centered approach. Another is to strengthen structures and support systems for integrated, efficient, and quality TB services.

To align with the PEPFAR’s sustainability goal, this NOFO also aims to strengthen the Government of Lesotho (GOL) and other stakeholders’ ability to support key parts of the country’s health system. These include:

Step 1: Review the Opportunity 10

• Planning and coordination.

• Workforce decentralization through DHMTs.

• Supply chain management.

• Emergency public health response.

Approach If awarded, you will:

• Implement key interventions that support the goals of the UNAIDS 95-95-95 cascades and the World Health Organization (WHO) End TB Strategy.

• Support activities to integrate care for comorbidities and NCDs into service provision for people living with HIV. These activities should use person-centered models of care that leverage PEPFAR investments.

• Focus on high-impact and high-quality HIV and TB prevention services, including targeted HIV testing services and case finding.

• Strengthen facility-based prevention programs for adolescents and young people.

• Deliver services related to early infant diagnosis (EID), EMTCT, PrEP, and facility gender-based violence.

We expect you to collaborate with key prevention partners to make sure that people living with HIV can get holistic, people-centered prevention services.

These services include HIV biomedical interventions as well as community-level social and behavioral science interventions.

We also expect you to strengthen oversight and delivery of quality comprehensive care for HIV and TB. These services should include:

• Opportunistic infections (OIs).

• AHD.

• NCDs such as hypertension, mental health challenges, and diabetes.

• CxCa screening among women living with HIV.

These services should promote person-centered delivery models and reach all populations including:

• Pregnant and breastfeeding women.

• Children and adolescents living with HIV.

• Key populations.

Step 1: Review the Opportunity 11

Previous NOFO This NOFO is a follow-on to CDC-RFA-GH20-2045, which supported:

• Surge strategies for case identification, HIV recent infection surveillance and for addressing treatment interruptions and increasing viral load (VL) testing and coverage

• TB preventive therapy, CxCa screening, and integrating hypertension into HIV services.

• Implementing service delivery approaches, including hiring and placing critical staff in health facilities to carry out activities.

Investments in people-centered service delivery and technical support through the previous NOFO improved the HIV and TB response but did not evenly improve the overall health system. For this new NOFO, you will focus on addressing remaining equity gaps related to the HIV/AIDS epidemic. You will also focus on strengthening the fragile health system by integrating HIV/ TB service delivery into Lesotho-led health systems and programs and by addressing comorbidities impacting people living with HIV.

Purpose The purpose of this NOFO is to:

• Achieve and sustain HIV epidemic control.

• Reduce TB incidence.

• Lower rates of HIV- and TB-related mortality and morbidity.

• Increase early detection, prevention, and control of related public health threats in all supported districts (Leribe, Berea, Quthing and Qacha’s Nek) in Lesotho.

Additionally, the purpose of this NOFO is to sustain the 95-95-95 UNAIDS targets through:

• An improved and resilient health care system.

• Sustained GOL capacity to plan, implement, and monitor high-quality programs to address HIV, TB, and NCDs.

Step 1: Review the Opportunity 12

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

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

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

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

Table: Strategies and outcomes

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes

Strategy 1: Implement innovative, high-impact, high-quality, person-centered HIV and TB case finding and biomedical prevention approaches for priority populations to close clinical cascade gaps.

Strategy 2: Deliver high-impact, high-quality, person-centered, and comprehensive HIV and TB care and treatment and related services to priority populations at specific sites to improve service uptake.

Increased awareness of HIV status among priority populations.*

Improved linkage to care and prevention services for people tested for HIV.*

Increased coverage of HIV, TB, and related services among priority populations.*

Improved capacity of healthcare workers (HCWs) to deliver HIV, TB, and related services to priority populations.*

Increased HIV, TB, and related services uptake among priority populations.*

Increased retention of people living with HIV in care.*

Reduced unmet gaps for 1st 95 for priority populations.*

Reduced vertical transmission of HIV, syphilis, and Hepatitis B among pregnant women.*

Improved TB treatment success rates for co-infected/ TB patients*

Reduced treatment interruptions for people living with

HIV.*

Reduced incidence of HIV and TB.*

Reduced HIV- and TB-related mortality.*

Improved capacity of GOL to sustainably manage HIV, TB, and related programs.

Sustained implementation of quality clinical and community HIV and TB services.

Increased integration of health care services.

Increased coordination between health care services.

Increased sustainable ownership of national

Step 1: Review the Opportunity 13

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes

Strategy 3: Facilitate HIV and TB data use among MOH and other stakeholders for program improvement.

Strategy 4: Build MOH and DHMT’s capacity to manage HIV and TB programs to prepare for program transition and sustainability.

Increased detections of HIV-related comorbidities by healthcare workers.*

Increased retention in services among people living with

HIV.*

Increased viral load suppression (VLS) among people living with HIV.*

Improved reporting of quality data by MOH staff.*

Improved data use by MOH staff for decision making.*

Increased direct financing of HIV and TB program by GOL.*

Improved HIV and TB programs coordinated management at national and sub-national levels.*

Improved implementation fidelity of HIV and TB services, policies, guidelines, and procedures.*

Increased decentralization of HIV and TB program management.*

Increased technical and financial oversight by DHMT of HIV and TB programs.*

HIV and TB response and related programs by GOL.

Additional information on outcomes in the logic model:

• Increased HIV and TB and related services uptake among priority populations includes prevention services, such as:

◦ Pre-exposure prophylaxis (PrEP)

◦ Elimination of mother-to-child transmission (EMTCT)

◦ Early infant diagnosis (EID)

◦ TB preventive treatment (TPT)

Step 1: Review the Opportunity 14

• Related services uptake among priority populations includes:

◦ TB

◦ AHD

◦ EID

◦ NCDs (including mental health challenges)

◦ OIs

• Increased detections of HIV-related comorbidities by HCWs includes but is not limited to:

◦ AHD

◦ TB

◦ CxCa

◦ Other OIs

• Improved reporting of quality data by MOH staff includes, but is not limited to:

◦ Individual-level and aggregate eRegister/District Health Information Systems (DHIS) data.

◦ Surveillance and program data for HIV, TB, mortality, and related public health threats.

• Reduced unmet gaps for 1st 95 for priority populations includes children, adolescents, young people, and men.

• Increased VLS among people living with HIV includes:

◦ Children, adolescents, and young people.

◦ Key populations (Men who have sex with men (MSM), Female sex workers (FSW), Transgender people (TG), people in prisons, people who inject drugs (PWID).

◦ Other priority populations (migrant populations, Men, clients of sex workers).

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.

Step 1: Review the Opportunity 15

Strategy 1: Implement innovative, high-impact, high-quality, person-centered HIV and TB case finding and biomedical prevention approaches for priority populations to close clinical cascade gaps.

Required activities:

• Conduct person-centered, efficient HIV case finding and linkage to treatment and prevention services. Specific activities include:

◦ Provide safe and ethical index case-testing services for all HIV-exposed individuals.

◦ Promote health equity through person-centered approaches to HIV case finding.

◦ Enhance effective case finding for children, adolescents, adult men, and other priority populations in facilities.

• Use recency testing, index, and other strategies to focus case finding and prevention strategies.

• Link priority populations to care and biomedical prevention services, such as post-exposure prophylaxis, PrEP, and EMTCT.

• Scale up TB contact tracing.

• Review and update guidelines for TB screening and diagnosis to make sure that they follow the latest WHO guidance.

• Strengthen collaborations with civil society and community-based organizations to support TB detection, including screening, treatment monitoring, and treatment adherence.

• Implement innovative strategies to enhance diagnosis of TB in children living with HIV.

• Scale-up the use of digital x-rays for TB screening. Scaling up can include tracking the distribution, functionality, and coverage of digital x-rays.

• Provide focus populations with services that are stigma- and discrimination-free, person-centered, and focused on health equity.

• Implement facility-based, person-centered HIV and TB programs for adolescents and young people.

• Implement a harmonized, peer-led, and age-appropriate core package of evidence-based interventions to address equity gaps for adolescent girls and young women and adolescent boys and young men target age bands.

Step 1: Review the Opportunity 16

Strategy 2: Deliver high-impact, high-quality, person-centered, and comprehensive HIV and TB care and treatment and related services to priority populations at specific sites to improve service uptake.

Required activities:

• Implement innovative strategies to keep treatment from getting interrupted, especially among adolescents, young people, and men.

These strategies can include using differentiated service delivery models in facilities and communities.

• Provide a comprehensive package of services, including:

◦ AHD services.

◦ TB treatment.

◦ CxCa screening and treatment.

◦ NCD management.

◦ Mental health and substance abuse services.

• Build capacity of providers to deliver high-quality care, treatment, and management of HIV, TB, and concurrent diseases.

• Design person-centered services that promote health equity and improve health outcomes. Services should be tailored for sub-populations including:

◦ Children.

◦ Adolescent girls and young women.

◦ Adolescent boys and young men.

◦ Adult men.

◦ Key populations.

◦ Priority populations.

• Strengthen EID services and VL monitoring to support EMTCT Strengthen the integration of NCDs, mental health, CxCa screening, and AHD screening into HIV and TB service delivery.

• Strengthen infection prevention and control at facilities and other relevant service points.

◦ Scale up efforts to improve VL coverage. The goal of these efforts is to increase the number of people living with HIV who are on antiretroviral therapy (ART) and who have undetectable VL.

Step 1: Review the Opportunity 17

• Implement activities in support of the Undetectable=Untransmittable campaign

• Provide supportive supervision, mentorship, and TA to strengthen human resources for health (HRH).

Strategy 3: Facilitate HIV and TB data use among MOH and other stakeholders for program improvement.

Required activities:

• Provide TA to key stakeholders in the health sector on using data and implementing the National CQI Frameworks.

• Build capacity of DHMTs to monitor performance and use data to drive program planning and improved service delivery.

• Build capacity of DHMTs to be training and mentorship hubs for CQI.

• Strengthen MOH employees’ data science skills and ability to use MOH information systems (such monitoring and evaluation and case-based surveillance) to make decisions and carry out CQI.

• Use implementation science to assess interventions and scale up effective ones quickly.

• Help facility-based staff use MOH-established laboratory information systems and other monitoring and evaluation tools. Staff should use these tools to track progress and address gaps related to VL testing, EID, and other related HIV and TB testing.

• Strengthen monitoring and reporting of adverse events and collaborate with relevant stakeholders to implement standard site-level pharmacovigilance.

• Strengthen PEPFAR-supported sites’ ability to manage inventory, report consumption, carry out site-level forecasting, and make timely requests for ART commodities.

• Support the use of patient-level electronic health records systems in facilities and communities.

• Support the use of current health information systems (HIS) for disease surveillance and public health programming beyond HIV and TB.

Step 1: Review the Opportunity 18

Strategy 4: Build MOH and DHMTs capacity to manage HIV/ TB programs to prepare for program transition and sustainability.

Required activities:

• Provide TA to healthcare workers to strengthen their knowledge and skills in delivering quality HIV and TB services.

• Support the development or update of the following at the national level:

◦ Policies.

◦ Protocols.

◦ Standard operating procedures.

◦ Clinical prevention and treatment guidelines.

• Provide TA to strengthen workforce planning for HIV- and TB-related services at all levels.

• Build capacity of DHMTs to be training and mentorship hubs for HIV, TB, and related NCDs.

• Build capacity of DHMTs to expand person-centered HIV and TB services in both facilities and communities.

• Help MOH and DHMT staff quantify and order essential medicines, ART, TB, and laboratory commodities in an accurate, timely way.

• Establish and strengthen public-private and multi-sectoral partnerships.

• Build capacity of DHMTs to coordinate and oversee supply chain management, including using an electronic logistics management system.

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

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

Step 1: Review the Opportunity 19

We consider a national HIV epidemic to be under control when:

• The number of HIV-related deaths is declining, and

• The number of new infections is less than the number of deaths.

Controlling the epidemic does not mean that HIV will be eliminated. Instead, it means that the number of people with HIV in the population is decreasing. If new infections or death rates increase, this means the epidemic is no longer under control.

Our work doesn’t end when we reach epidemic control; we must sustain the gains. During your award we may ask you to conduct additional activities to reach and maintain epidemic control, consistent with the scope of this NOFO and the related policies below. This may include:

• Improving prevention, testing, and treatment efforts for HIV/AIDS, TB, sexually transmitted infections (STI), and related opportunistic infections, especially among vulnerable, key, and priority populations as defined in PEPFAR’s annual Country/Regional Operational Plan (COP/ROP) Guidance.

• Promoting sustainable, country-led approaches to managing HIV/AIDS and TB and empowering national and local partners to take the lead in designing and conducting high-quality and cost-effective programs. This could involve forming new partnerships with private, public, local, and multisector entities that can complement and expand the reach of existing programs.

• Improving and expanding laboratory, surveillance, and information systems and using the PEPFAR platform for broader disease surveillance and public health programs in ways that align with PEPFAR goals and initiatives.

• Enhancing efforts to prevent, detect, respond to, and treat other diseases affecting people living with or at risk of HIV.

Related policies If awarded, any activities you conduct must follow the directions in:

• Reimagining PEPFAR’s Strategic Direction: Fulfilling America’s Promise to End the HIV/AIDS Pandemic by 2030.

• PEPFAR’s annual COP/ROP Guidance and approved COPs/ROPs.

• Similar forthcoming strategy, guidance, or planning documents that are consistent with relevant laws.

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

Step 1: Review the Opportunity 20 https://www.state.gov/reports-pepfar/ https://www.state.gov/wp-content/uploads/2022/09/PEPFAR-Strategic-Direction_FINAL.pdf https://www.state.gov/wp-content/uploads/2022/09/PEPFAR-Strategic-Direction_FINAL.pdf https://www.state.gov/reports-pepfar/

Geographic focus The geographic focus of this program may change during the period of performance, based on the burden of disease and changing program and PEPFAR priorities.

Outcomes We expect you to achieve or substantially contribute to the outcomes asterisked ( * ) in the logic model by the end of the five-year period of performance. You will be expected to report on these outcomes.

Focus populations The focus populations for this NOFO include all people affected by the generalized HIV epidemic in the districts of Berea, Leribe, Qacha’s Nek, and Quthing in Lesotho.

The NOFO also focuses on tailoring services for priority populations and key populations while ensuring client confidentiality, patient rights, and non-discrimination.

Specific priority populations include:

• Children.

• Adolescent boys and girls.

• Young people living with HIV.

• Pregnant and breastfeeding women and their male partners.

• Health care workers.

• People in prisons and other closed settings.

If awarded, we expect you to make sure that these populations receive quality services. In your application, explain how you plan to understand and address these populations’ 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.

Step 1: Review the Opportunity 21

• 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.

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 other CDC-funded programs that have a role in achieving the NOFO outcomes. These programs include but are not limited to:

• MOH, including DHMTs, to help districts use MOH policy guidelines to meet the set standards.

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

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

• CDC health management information systems, surveillance, and M&E partners to strengthen electronic reporting systems within supported districts, including:

• DHIS.

• e-Register.

• M&E.

• Clinical CQI initiatives.

• District-led programming.

• HIS.

• Other laboratory partners to deliver patient results more reliably and quickly and make sure that patients can access them.

• Stakeholders involved in community-led monitoring for HIV/TB services.

• Organizations contracted by GOL to deliver healthcare services.

We will also expect you to collaborate with other United Nations agencies and national disease control programs, as well as the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) and other related organizations, including but not limited to:

• Existing community-based organizations, including local civil society organizations and community-based organizations, to sustain epidemic control within the districts. This will improve linkage and access to facility and community HIV services by:

◦ Sharing data.

◦ Profiling the epidemic within the local context.

◦ Dealing with structural and behavioral barriers.

• Supply chain partners funded by the Global Fund and the U.S.

government, to support logistics and supply chain management systems.

• MOH HRH directorate and other HRH partners, to improve human resource management, including staff performance management and using information systems to plan human resources.

• District local governments, including DHMTs, to make sure that integrated annual district work plans do the following:

◦ Align with the 5-year strategic plans.

◦ Use only one district M&E system.

◦ Support district supply chain management to keep HIV- and TB-related products in stock.

• Strategic information partners that are not supported by CDC.

Step 1: Review the Opportunity 23

• Private sector organizations, to capitalize on corporate capacities and investments in program efficiency, effectiveness, and sustained health impact.

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 10% of funds for monitoring activities and 5% for evaluation activities. We will discuss these percentages and finalize them at or after award. These are estimates for the total funding over the 5-year project.

Required performance measures

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

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

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

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

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

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

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

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

• GEND_GBV: Number of people receiving post-gender-based violence (GBV) clinical care based on the minimum package. [Target: 485;

Reporting Frequency: Semi-Annual]

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

4,227; 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: 8,376; Reporting Frequency: Quarterly]

• TB_PREV: Proportion of ART patients who started on a standard course of TPT in the previous reporting period who completed therapy. [Target:

100%; Reporting Frequency: Semi-Annual]

• CXCA_SCRN: Number of women living with HIV on ART screened for cervical cancer. [Target: 11,891; Reporting Frequency: Semi-Annual]

• HTS_INDEX: Number of individuals who were identified and tested using Index testing services and received their results. [Target: 31,334;

Reporting Frequency: Quarterly]

• HTS_RECENT: Number of newly diagnosed persons living with HIV who received testing for recent infection with a documented result during the reporting period. [Target: 2,340; Reporting Frequency: Quarterly]

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

68,126; Reporting Frequency: Quarterly]

• HTS_TST: Number of individuals who received HIV Testing Services (HTS) and received their test results. [Target: 50,831; Reporting Frequency:

Quarterly]

Step 1: Review the Opportunity 25

• 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: 95%; Reporting Frequency: Quarterly]

• PMTCT_FO: Percentage of final outcomes among HIV-exposed infants registered in a birth cohort. [Target: 100%; 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. [Target: 100%; Reporting Frequency: Quarterly]

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

• 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: 95%; Reporting Frequency: Annual]

• TX_CURR: Number of adults and children currently receiving antiretroviral therapy (ART). [Target: 89,586; 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: 3,284; 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 VL result (<1000 copies/ml) documented in the medical or laboratory records/laboratory information systems (LIS) within the past 12 months. [Target: 95%;

Reporting Frequency: Quarterly]

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

Quantitative:

• TX_HIV_HTN: Percentage of people currently on treatment for HIV who have controlled hypertension. [Target: 90%; Reporting Frequency:

Monthly]

• Number of people living with HIV on ART who are screened for hypertension. [Target: 67,067; Reporting Frequency: Monthly]

• Number of people living with HIV initiated on hypertension treatment in the reporting period. [Target: 16,767; Reporting Frequency: Monthly]

• Number of people on hypertension treatment with controlled blood pressure in the reporting period. [Target: 5,830; Reporting Frequency:

Monthly]

• Percentage of people living with HIV who were newly tested and linked to care and treatment within 7 days of their HIV positive diagnosis. [Target:

95%; Reporting Frequency: Monthly]

• Percentage of EID samples processed at point of care sites within 7 days of sample collection [Target: 95%; Reporting Frequency: Monthly]

• Number of established facilities providing competent HIV and TB health services for adolescents. [Target: 10; Reporting Frequency: Monthly]

• Number of established facilities providing competent HIV and TB health services for men [Target: 20; Reporting Frequency: Monthly]

• Percentage of health facilities reporting no stock-out of AHD commodities during the entire reporting period. [Target: 100%; Reporting Frequency:

Monthly]

• Percentage of sites implementing the integrated care clinic model for HIV, TB, and NCDs. [Target: 100%; Reporting Frequency: Monthly]

• Percentage of sites/healthcare workers trained on AHD management.

[Target: 100%; Reporting Frequency: Monthly]

• Percentage of PEPFAR-supported health facilities at eRegister Stage 2 for all HIV and TB indicators. [Target: 100%; Reporting Frequency: Monthly]

• Percentage of women living with HIV on ART who are referred to CxCa services. [Target: 100%; Reporting Frequency: Monthly]

• Percentage of referred women living with HIV on ART who are linked to CxCa services. [Target: 100% Reporting Frequency: Monthly]

Step 1: Review the Opportunity 27

• Percentage of eligible women living with HIV on ART who receive CxCa screening. [Target: 100%; Reporting Frequency: Monthly]

Qualitative:

• The extent to which DHMTs’ reported capacity for performance monitoring and CQI after they receive training, TA, and mentorship.

[Target: Not assigned; Reporting Frequency: Annual]

• The extent to which DHMTs’ reported use of data from MOH information systems to inform decision making. [Target: Not assigned; Reporting Frequency: Annual]

• The extent to which healthcare providers’ reported capacity to deliver high-quality HIV and TB services and related services. [Target: Not assigned; Reporting Frequency: Annual]

• Quality of HIV and TB healthcare provider trainings. [Target: Not assigned; Reporting Frequency: Annual]

• The degree to which supportive supervision, mentorship, and TA activities are delivered. [Target: Not assigned; Reporting Frequency:

Quarterly]

• GOL staff capacity to support key management and technical functions.

[Target: Not assigned; Reporting Frequency: Annual]

• Levels of coordination and management of HIV and TB programs at national and sub-national levels. [Target: Not assigned; Reporting Frequency: Annual]

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 evaluation.

• Determine key factors associated with patient and health system outcomes through implementation of an integrated HIV, TB and NCD service delivery model in Lesotho‘s health system: outcome evaluation.

• Understand the implementation costs of the HIV, TB, and NCD integrated service delivery model: economic evaluation.

Step 1: Review the Opportunity 28

• Degree of client satisfaction with HIV, TB, and NCD integrated service delivery model: outcome evaluation.

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

Dissemination of evaluation results Dissemination channels could include:

• Local and international conferences and forum abstract presentations.

• Conference poster displays.

• Manuscripts.

• Bulletins.

• Reports.

• Presentations to technical working groups and stakeholder meetings.

• Other approved products in print and electronic media.

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

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

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

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

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

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

Step 1: Review the Opportunity 29

Methods Describe how you will:

• Collect the performance measures.

• Respond to the evaluation topics.

• Use evaluation findings for continuous program quality improvement.

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

Additionally, explain:

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

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

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

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

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

Evaluation activities You must carry out specific evaluation activities.

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

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

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

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

Describe:

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

• Key evaluation questions these evaluations will address.

• Other information, such as measures and data sources.

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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…