Tanzania CDC-RFA-JG-25-0095 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 25, 2025

Implement and sustain a comprehensive response to HIV and technical assistance to strengthen the capacity of regional authorities in the United Republic of Tanzania under the President's Emergency Plan for AIDS Relief

(PEPFAR)

Opportunity number: CDC-RFA-JG-25-0095

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 33

Get registered 34

Questions 35

Step 3: Prepare Your Application 36

Application contents and format 37

Step 4: Learn About Review and Award 47

Application review 48

Award notices 55

Step 5: Submit Your Application 56

Application submission and deadlines 57

Application checklist 59

Step 6: Learn What Happens After Award 61

Post-award requirements and administration 62

Contacts and Support 69

Contents 2

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

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

See Step 2: Get Ready to Apply

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

See Step 2: Get Ready to Apply

Apply by the application due date Applications are due by 11:59 p.m. Eastern Time on February 25, 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:

Implement and sustain a comprehensive response to HIV and technical assistance to strengthen the capacity of regional authorities in the United Republic of Tanzania under the President’s Emergency Plan for AIDS Relief (PEPFAR)

Opportunity number:

CDC-RFA-JG-25-0095

Announcement type:

New

Assistance listing: 93.067 Global AIDS Program

Key dates

Application deadline:

February 25, 2025

Expected award and start date: September 30, 2025

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

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

NOFO.

Summary The NOFO aims to implement and sustain a comprehensive response to HIV/ TB and strengthen the capacity of regional authorities in the United Republic of Tanzania under PEPFAR. The overarching goals of the NOFO include:

• Improving the quality of life for people living with HIV, including key and vulnerable populations.

• Reaching and maintaining the UNAIDS 95-95-95 targets for all subpopulations.

This NOFO aims to achieve these goals by:

• Improving service delivery models.

• Strengthening all health systems while sustaining achieved gains and expanding the HIV/TB response.

• Transformative partnerships that support the management, oversight, reporting, and funding of health facilities (HF).

• Technical assistance and capacity-building services to strengthen the ability of local and regional government agencies and partners to implement and sustain a comprehensive response to HIV/TB.

Activities outlined in the NOFO are expected to support assigned administrative regions to develop, adapt, and implement monitoring and evaluation (M&E) tools. These M&E tools will be used to:

• Identify and address disparities in health outcomes and service gaps.

• Address health equity.

• Improve programmatic service delivery.

• Make informed evidence-based decisions.

Step 1: Review the Opportunity 5

Additionally, activities and funding should be streamlined to facilitate an optimized delivery of HIV/TB services and coordination across different stakeholders in each region.

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $50,000,000 This is the expected total Year 1 funding for all awards made under this

NOFO.

Expected number of awards: 1-4 The number of awards is subject to available funds and program priorities.

Exact amounts for each award under this NOFO will be determined upon award.

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

Funding strategy

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

You may not request more than this amount.

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

• Availability of funds.

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

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

Component funding

Overview

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

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

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

Step 1: Review the Opportunity 6

Setting up components

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

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

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

◦ Component 1: COP Q1 Targets and Activities.

◦ Component 2: COP Q2 Targets and Activities.

◦ Component 3: COP Q3 Targets and Activities.

◦ Component 4: COP Q4 Targets and Activities.

◦ Component 5: COP Additional Targets and Activities.

◦ 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 Tanzania.

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 This NOFO focuses on facility and community-based approaches in response to HIV in Tanzania. Currently, CDC supports HIV services through PEPFAR in 11 administrative regions of mainland Tanzania and the semi-autonomous islands of Zanzibar.

• Dar es Salaam.

• Geita.

• Kagera.

• Kigoma.

• Mara.

• Mwanza.

• Pwani.

• Shinyanga.

• Simiyu.

• Tabora.

• Tanga.

• Zanzibar.

These 11 regions and Zanzibar account for approximately 55% of the projected 1.6 million people living with HIV in Tanzania. This NOFO supports activities across supported regions, subject to funding availability and changes in assigned regions based on performance or epidemiologic data.

In 2023, there were approximately 60,000 estimated new cases of HIV among those aged 15 years and older and approximately 1,548,000 adults living with

HIV.

HIV prevalence among adults aged 15 years and older was 4.5% in Mainland Tanzania and 0.4% in Zanzibar. In Mainland Tanzania regions, HIV prevalence ranged from 1.7% in Kigoma to 12.7% in Njombe. The prevalence of HIV was higher among women (5.6%) than among men (3.0%). HIV incidence was also higher among women (0.24%) compared to men (0.11%).

The overall population viral load (VL) suppression is estimated at 78% and regional differences range from 65% (Tabora) to 93.5% (Tanga).

Step 1: Review the Opportunity 10

Progress has been made to reduce vertical transmission to 6.9%, but work remains in this area. Progress on the UNAIDS 95 targets in Tanzania for adults has also been positive but continued focus is needed:

• 82.7% of people living with HIV know their status.

• 97.9% know their status and are receiving HIV treatment.

• 94.3% of those on treatment have achieved VL suppression.

To achieve epidemic control and strengthen Tanzania’s capacity to implement an effective response to HIV and reduce or eliminate disparities, a combination of prevention and treatment interventions is needed.

Successful approaches for this NOFO will:

• Provide support to accelerate and sustain evidence-based HIV prevention and treatment.

• Align systems-level activities towards building a resilient health system.

• Reduce disparities among subpopulations across the HIV care continuum, including:

◦ Identification and prompt linkage to ART for people living with HIV.

◦ Continuity of treatment.

◦ Achievement and maintenance of VL suppression.

• Integrate non-communicable diseases (NCD), mental health care and cervical cancer prevention and treatment into the HIV care continuum.

• Sustain program gains while strengthening the capacity of Regional/ Council Health Management Teams (R/CHMTs) to implement an effective response to HIV.

Priority activities for this NOFO include:

• Offering highly effective, targeted HIV prevention services and interventions to persons at risk of acquiring HIV in the general and focus populations of the NOFO.

• Contributing to building capacity at the subnational level to implement the program and strengthen public health security.

• Implementing customized, innovative approaches for:

◦ Targeted case-finding modalities.

◦ Linkage to case management.

◦ Triple elimination of vertical transmission of HIV, syphilis, and hepatitis.

◦ TB case finding and TB preventative treatment (TPT).

Step 1: Review the Opportunity 11

◦ Multi-month dispensing (MMD).

◦ Workforce training.

◦ Differentiated service delivery models (DSDM).

◦ VL testing and adherence support.

◦ Optimization of ART regimens.

◦ Management of NCDs.

◦ Voluntary medical male circumcision (VMMC).

◦ Scale-up of pre-exposure prophylaxis (PrEP).

• Using routinely collected and analyzed data along with community-led monitoring to inform continuous quality improvement (CQI) efforts.

Specific outcomes of this NOFO include:

• Reducing new infections and the treatment coverage gap, especially among focus populations.

• Achieving and maintaining the UNAIDS 95 targets for epidemic control.

All efforts will respond to Tanzania’s fifth National Multisectoral Strategic Framework on HIV and AIDS, the fifth Health Sector Strategic Plan, the fifth Health Sector HIV Strategic Plan, and priorities of the National AIDS, STIs, and Hepatitis Control Program and R/CHMT. Systems-level activities will be aligned with the national public health security agenda and cross-cutting activities led by other CDC partners and other United States government agencies conducting PEPFAR-supported activities in Tanzania.

Purpose The purpose of this NOFO is to provide targeted support to accelerate and sustain evidence-based HIV prevention and treatment program implementation at both the facility and community level.

This NOFO also aims to align systems level activities towards ending HIV as a public health threat and strengthening the capacity of local authorities in implementing and sustaining a comprehensive response to HIV/TB in selected regions in the United Republic of Tanzania.

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. Provide targeted support to accelerate and sustain evidence-based, comprehensive HIV/ TB program implementation in assigned CDC-supported regions.

Strategy 2. Scale up innovative, effective interventions for HIV prevention and treatment services for all focus populations.

Strategy 3. Build the capacity of the HIV/TB program to sustain programmatic gains and respond to the changing HIV epidemic.

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

Improved identification of people living with HIV in supported regions.*

Increased timely linkage of people living with HIV to HIV/ TB treatment services.*

Increased linkage of focus populations to appropriate HIV/TB prevention services.*

Improved capacity of supported facilities to implement stigma-free, comprehensive HIV/TB services.*

Increased use of comprehensive HIV services by all focus populations.*

Increased VL coverage for people living with

HIV.*

Sustained timely linkage of people living with HIV to HIV/ TB treatment services.*

Increased adherence to treatment by people living with

HIV.*

Increased retention of focus populations in appropriate comprehensive HIV services.*

Reduced new HIV infections in supported regions.*

Reduced morbidity and mortality for people living with

HIV.*

Reduced HIV transmission in all focus populations.*

Increased durable VL suppression for people living with

HIV.*

Improved capacity of regional staff in supported regions to implement the HIV/TB program.

Improved resilience of health system to

Step 1: Review the Opportunity 13

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes

Strategy 4:

Strengthen the subnational health system using high-quality data, M&E, and CQI approaches to create a sustainable and integrated health system.

Increased capacity of program staff to implement M&E systems for data quality, surveillance, and CQI.*

Reduced gaps in treatment coverage for all focus populations.*

Increased use of high-quality data by program staff at subnational level for M&E of HIV/TB program and to inform program improvement.* respond to changes in the HIV epidemic.

Increased efficiency of HIV/TB program implementation through use of high-quality data and evaluation findings.

Additional information on outcomes in the logic model:

• Stigma-free, comprehensive HIV services include, but is not limited to:

◦ Prevention

▪ Medication-assisted therapy (MAT)

⁃ PrEP, post-exposure prophylaxis.

⁃ VMMC.

⁃ Cervical cancer screening.

⁃ TPT.

⁃ Prevention of mother-to-child transmission (PMTCT).

⁃ Vaccination.

⁃ Infection prevention and control (IPC) measures, etc.

◦ Testing

▪ HIV testing services (HTS).

▪ HIV self-testing (HIVST)

▪ Early infant diagnosis (EID).

▪ Universal birth testing, etc.

◦ Care and treatment

▪ NCDs.

▪ Sexually transmitted infections.

▪ ART.

▪ VLS.

Step 1: Review the Opportunity 14

▪ MMD.

▪ Advanced HIV disease (AHD).

▪ Mental health care.

▪ Adherence support, etc.

• Program staff includes, but is not limited to:

◦ Facility healthcare workers.

◦ Community health workers.

◦ Implementing partner staff.

◦ Local authority personnel.

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

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

Strategy 1: Provide targeted support to accelerate and sustain evidence-based, comprehensive HIV/TB program implementation in assigned CDC-supported regions.

Required activities

• Accelerate targeted case-finding modalities, including:

◦ Index testing.

◦ Social network testing.

◦ Provider-initiated testing and counseling (PITC).

◦ Targeted community testing.

◦ HIVST.

• Provide supportive supervision, mentoring, and training to health care workers (HCWs) and counselors to enable them to offer high-quality HTS targeted and tailored to various sub-populations.

• Provide and/or ensure availability of tools and equipment to enable high-quality HTS to target subpopulations.

• Expand HIV recent infection surveillance to identify patterns of recent infections across councils in supported regions and subpopulation groups and triangulate with other epidemiologic data.

Step 1: Review the Opportunity 15

Strategy 2: Scale up innovative, effective interventions for HIV prevention and treatment services for all focus populations.

Required activities

• Mentor and strengthen coordination of appropriate personnel to provide linkage case management services for newly diagnosed people living with

HIV.

• Enhance and accelerate prevention interventions using technology and digital platforms for services such as:

◦ Basic education.

◦ The distribution of condoms.

◦ HIVST kits.

◦ Medication adherence.

◦ Service directories.

◦ Referrals.

◦ Linkages to preventive services and more.

• Support stigma and discrimination reduction programs and structural interventions, including community-led monitoring activities.

• Support GOT to quickly approve implementation of innovative HIV prevention and treatment interventions (such as CAB-LA and lenacapavir injections) based on evidence.

• Provide technical assistance and capacity-building services to R/CHMTs, the Ministry of Health (MOH), and other national government bodies and at the subnational level to transition and sustain VMMC program activities.

• Build awareness among R/CHMTs, MOH, and other partners about systemic and structural barriers that may exist throughout the HIV response continuum. In addition, awareness should be built around evidence-based approaches for effectively reducing or eliminating those barriers so that all populations may have access to care without stigma, judgment, or discrimination. This especially includes populations experiencing health disparities, unique needs, and barriers.

Step 1: Review the Opportunity 16

Strategy 3: Build the capacity of the HIV/TB program to sustain programmatic gains and respond to the changing HIV epidemic.

Required activities

• Provide uninterrupted, effective ART to people living with HIV and support adoption of initiatives to improve continuity of care among people living with HIV.

• Accelerate coverage and quality of DSDM and innovations in DSDM.

• Scale up MMD to subpopulations with unmet needs.

• Strengthen the integration of HIV and TB screening prevention, diagnostic, and treatment services.

• Improve and accelerate the quality of TB screening.

• Strengthen integration of cervical cancer prevention, detection, and management.

• Scale up identification and management of all people living with HIV and AHD and expand death audits and use of death audit findings.

• Strengthen gender-based violence prevention, screening, and clinical post-violence response services.

• Scale up integration of NCD services into HIV care and treatment services.

• Scale up implementation of HIV drug resistance testing and accelerate Enhanced Adherence Counselling quality assurance activities.

• Strengthen linkage between facility and orphan and vulnerable children services.

• Collaborate with partners to plan, implement, and monitor an array of training, technical assistance and capacity building programs addressing the needs of Tanzania’s public health workforce, including but not limited to HCWs, epidemiologists and other staff.

• Mentor HCWs at facilities and community settings to provide comprehensive and high-quality prevention and treatment services to all focus populations.

• Mentor HCWs at facilities on comprehensive PMTCT services, including triple elimination of mother-to-child transmission of HIV, Syphilis, and Hepatitis B.

• Scale up and sustain maternal retesting, PrEP, and HIVST in reproductive and child health settings.

Step 1: Review the Opportunity 17

• Support universal birth testing, ensure availability of treatment for neonates, and strengthen and scale up initiatives that will improve access to early infant diagnosis (EID).

• Support the use of technology to improve tracking of mother-baby pairs.

• Provide and/or support a lean system of sample (VL, dried blood spot, TB, and CD4) referral and results utilization for optimal care of people living with HIV.

• Train laboratory staff and other HCWs on quality sample collection and biosafety principles.

Strategy 4: Strengthen the subnational health system using high-quality data, M&E, and CQI approaches to create a sustainable and integrated health system.

Required activities

• Provide and/or ensure the availability of M&E tools and necessary equipment to enable reporting and monitoring of high-quality HIV prevention and treatment services as HIV/AIDS service delivery gets integrated into overall health system.

• Support and implement at scale unique identification of people living with HIV.

• Mentor facility staff to use existing data systems and databases to monitor performance in real-time and support quality improvement approaches to improve program outcomes.

• Provide and/or ensure the availability of supply chain data to support program data quality improvement and avoid stockouts, low-stock levels, and treatment interruptions.

• Support implementation of community-led monitoring at scale to inform improvements across all program areas and facilitate overall data use.

• Identify and support drivers for joint responsibility and accountability with regional authority and accelerate the integration of HIV service delivery into existing subnational health systems.

• Expand regional capabilities on infection prevention and control and emergency response.

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.

Step 1: Review the Opportunity 18

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 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.

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

Step 1: Review the Opportunity 19 https://www.state.gov/reports-pepfar/ https://www.state.gov/wp-content/uploads/2022/09/PEPFAR-Strategic-Direction_FINAL.pdf https://www.state.gov/wp-content/uploads/2022/09/PEPFAR-Strategic-Direction_FINAL.pdf

• 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:

• Children.

• Adolescent boys and girls.

• Young men and women.

• Men.

• Pregnant women.

• Breastfeeding mothers and their infants.

• Key, vulnerable, and other at-risk populations.

• People living with HIV.

• And regional local authorities and staff under the regional authorities in CDC-supported regions of Tanzania.

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.

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/

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:

• GOT and government institutions.

• Central and local government entities involved in the supported activities.

• CDC-funded implementing partners and organizations, CDC service delivery implementing partners, and above site partners operating in the same location or providing services in Tanzania.

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

• Other United States government agencies and non-CDC-funded partners conducting PEPFAR-supported activities in Tanzania.

• Bilateral organizations and other development partners in the country.

• Civil society organizations and faith-based organizations.

• Private sector.

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

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

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

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

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

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

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

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

Step 1: Review the Opportunity 22

MER reporting in the MER Guidance and resource materials, available at DATIM’s MER Indicator Reference Guides.

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

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

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

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

Prevention:

• KP_MAT: Number of people who inject drugs (PWID) on medication-assisted therapy (MAT) for at least 6 months. [Target: 4,645; Reporting Frequency: Annual]

• KP_PREV: Number of key populations reached at least once with individual and/or small group-level HIV primary or secondary prevention interventions designed for the target population. [Target: 81,550;

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:

262,552; 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: 190,046; Reporting Frequency: Quarterly]

• PP_PREV: Number of priority populations (PP) reached with the standardized, evidence-based intervention(s) required that are designed to promote the adoption of HIV prevention behaviors and service uptake.

[Target: 983,281; Reporting Frequency: Semi-Annual]

Testing:

• CXCA_SCRN: Number of women living with HIV on ART screened for cervical cancer. [Target: 138,936; Reporting Frequency: Semi-Annual]

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

Step 1: Review the Opportunity 23 https://help.datim.org/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

• HTS_INDEX: Number of individuals who were identified and tested using Index testing services and received their results. [Target: 227,197;

Reporting Frequency: Quarterly]

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

1,692,975; 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: 99%; Reporting Frequency: Quarterly]

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

Treatment:

• 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:

95%; Reporting Frequency: Semi-Annual]

• 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]

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

Viral Suppression:

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

[Target: 95%; Reporting Frequency: Quarterly]

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

• SAME DAY INITIATION: Proportion of eligible clients who were initiated on ART within 7 days of HIV diagnosis. [Target: 99.5%; Reporting Frequency: Monthly]

• 6+ MONTH DISPENSING: Proportion of eligible clients who received 6 months of ARVs at their most recent appointment. [Target: 97%;

Reporting Frequency: Monthly]

Step 1: Review the Opportunity 24

• PEDIATRIC ART: Proportion of pediatric clients on first-line ART who are receiving a preferred ART regimen. [Target: 99%; Reporting Frequency:

Monthly]

• TPT ACHIEVEMENT: Proportion of eligible clients who have completed TPT in the past or were receiving TPT at their last visit. [Target: 99%;

Reporting Frequency: Monthly]

• EARLY RETENTION: Proportion of clients initiated on ART (TX_NEW) from the prior month who are still on ART at the end of the reporting month.

[Target: 99.5%; Reporting Frequency: Monthly]

• EID 2 MONTHS: Proportion of infants born to HIV-positive women two months prior to the reporting period who had an EID sample collected by two months of age. [Target: 98%; 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.

• Efficiency of HIV case identification strategies to reach the hardest-to-reach subpopulations: process evaluation.

• Continuity of treatment among subpopulations: outcome evaluation.

• Readiness of the local regional authority to implement comprehensive HIV program and sustaining the gains: 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.

Step 1: Review the Opportunity 25

• 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.

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.

Step 1: Review the Opportunity 26

• 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.

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.

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

Step 1: Review the Opportunity 27 https://www.cdc.gov/grants/additional-requirements/ar-25.html

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

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

• Archival and long-term data preservation plans.

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

In addition to the other requirements listed, also include:

• Cybersecurity plans.

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

• 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 28

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 29 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 to purchase furniture or equipment.

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

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

dollars.

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

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Satisfactory progress in meeting your project’s objectives.

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

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

◦ Funding more applicants.

◦ Extending the period of performance.

◦ Awarding supplemental funding.

See also program-specific limitations.

Unallowable costs You may not use funds for:

• Research.

• Clinical care, except as allowed by law.

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

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

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

Step 1: Review the Opportunity 30 https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=13f24ea1f961f5f0d14b87ec1b39b25f&term_occur=999&term_src=Title:45:Chapter:A:Subchapter:A:Part:75:Subpart:E:Subjgrp:39:75.440

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

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

◦ See Anti-Lobbying Restrictions for CDC Recipients.

• Needle exchange programs.

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

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

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

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

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

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

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

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