7200AA19APS00001_Amd_000010 signed.pdf

Date issued: February 4, 2025

Subject: Amendment #000010 to Annual Program Statement:

7200AA19APS00001

TB Local Organizations Network Project (LON)

Dear Prospective Applicants:

Pursuant to Agency Notice dated January 28, 2025, Subj: USAID’s Implementation of the Funding Pause for Foreign Assistance Programs, the purpose of this Amendment is to inform all qualified applicants that no applications will be accepted at this time and that a subsequent amendment will be issued to either resume or close this Annual Program Statement (APS).

Sincerely, Abibou Oussantidja Agreement Officer Office of Acquisition and Assistance

Federal Agency Name: United States Agency for International

Development (USAID)

Funding Opportunity Title: Local Organizations Network Project (LON)

Announcement Type: Annual Program Statement (APS)

Funding Opportunity Number: 7200AA19APS00001

Amendment #000010

Catalog of Federal Domestic Assistance (CFDA) Number: 98.001

Issuance Date: January 29, 2019

End Date: September 30, 2029 (Suspended)

Deadline for Questions Please refer to subsequent programmatic and country-specific Addenda for all applicable deadlines.

Deadline for Submission of Concept Papers): Please refer to subsequent programmatic and

Deadline for submitting Full Application: Please refer to subsequent programmatic and

**PLEASE NOTE:

The APS is an umbrella funding opportunity, and establishes the overall purpose, criteria, process, and rationale for this activity. In addition to the umbrella APS, USAID will subsequently express specific programmatic and geographic priorities through individual, country-specific Addenda which will solicit Concept Paper submissions. Such Addenda will be issued on an as-needed basis, to reflect the particular programmatic or geographic focus of a USAID Mission, or B/IO. This approach will ensure that specific Addenda reflect the objectives and nuances of each unique environment, and that USAID Missions or B/IOs are in a position to review and issue awards for those applications.

Interested eligible local organizations should refer to forthcoming Addenda and follow the specific instructions and submission deadlines therein, in order to tailor Concept Paper submissions to the specific requests of the Agency. Concept Papers should not be submitted in response to this umbrella APS, but only in response to subsequent Addenda which will provide the specific instructions and deadlines including funding ceilings.

To Interested Applicants:

The United States Agency for International Development (USAID) seeks concept papers from qualified applicants. This Annual Program Statement (APS) publicizes the intention of the United States Government (USG), as represented by the USAID, Bureau for Global Health (GH), to fund one or multiple awards to address TB diagnosis, treatment, and prevention needs, addressing stigma and discrimination, while using locally generated solutions that tailor USAID’s TB response to patients and communities.

This APS provides prospective applicants with a fair opportunity to develop and submit competitive applications to USAID for potential funding. Applicants will first submit a Concept Paper in response to a specific Addendum to the APS that will be reviewed for responsiveness to the purpose of the APS and Addendum. Concept Papers will be evaluated against the merit review provided in the Addendum. Applicants who are successful in the Concept Paper stage will be invited to join a co-creation process. Following the co-creation process, selected applicants (individual organizations and/or consortia developed during co-creation) may be invited to proceed with award development, the content and format to be provided in greater detail by the Agreement Officer.

Publishing this APS does not commit USAID to make any awards. USAID also reserves the right to not conduct a co-creation process and/or award development process with the applicants successful at concept paper stage. If/when there are changes to the APS or an Addendum, this APS will be amended with appropriate information.

Sincerely, Gerald T. Smith Agreement Officer Office of Acquisition and Assistance

TABLE OF CONTENTS

“SECTION A: PROGRAM DESCRIPTION 5

SECTION B – FEDERAL AWARD INFORMATION 21

SECTION C – ELIGIBILITY INFORMATION 24

SECTION D – CONCEPT PAPER SUBMISSION INFORMATION 26

SECTION E – CONCEPT PAPER MERIT REVIEW INFORMATION 31

SECTION F – FEDERAL AWARD AND ADMINISTRATION INFORMATION 31

“SECTION A: PROGRAM DESCRIPTION

This funding opportunity is authorized under the Foreign Assistance Act (FAA) of 1961, as amended. Resulting award(s) will be subject to 2 CFR 200 – Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, and USAID’s supplement, 2 CFR 700, as well as the additional requirements found in Section F.

1. Introduction

The Tuberculosis Local Organizations Network (LON) is a key component of the USAID Global Accelerator to End Tuberculosis Plus. USAID’s investments are most successful when they are coupled and aligned with strong commitments from other governments and partners. To accelerate action, LON will leverage additional resources from countries, private sector partners, and other local organizations in order to meet the USAID Global TB Strategy for 2023-2030 to reach, detect, and enroll on treatment at least 90% of the estimated drug-sensitive (DS) and drug resistant (DR) TB cases and successfully and appropriately treat 90% of those individuals in TB priority countries. LON will focus on the countries with high burdens of TB in which USAID already has existing partnerships, and where the Agency could reprogram funds to better align with local communities and partners to deliver performance-based results towards the global target. This is a change in approach to ensure USAID is fighting to end TB effectively and efficiently. LON will focus on locally generated solutions that tailor USAID’s TB response to patients and communities to address the diagnosis, treatment, and prevention needs, addressing stigma and discrimination. It will engage and leverage civil society, private sector, communities, including faith-based partners by partnering directly with local entities within TB priority countries to provide accessible services, resulting in increased diagnosis and treatment success rates.

2. Program Background

Problem statement

Measured by the number of people who die each year, tuberculosis (TB) is one of the world’s deadliest infectious diseases. Transmitted through the air and primarily targeting the lungs, this disease caused by a bacterial infection claims more than 4,300 lives every day, or 1.6 million lives every year1. In terms of cases, the best estimates for 2022 are that there were 10.5 million new TB cases (of which 6.3% were among HIV-positive people), of which 5.8 million were among men, 3.5 million among women and 1.2 million among children. Overall, 88% of cases were adults and 12% children. Worldwide 1.7 billion people are infected with Mycobacterium tuberculosis (Mtb) referred to as latent TB infection, the bacterium that causes TB, comprising a source of the illness that must be addressed if we are to be successful in ending the disease2.

1 The Economist; Global Tuberculosis Report 2022, World Health Organization 2 The Global Burden of Latent Tuberculosis Infection: A Re-estimation Using Mathematical Modelling; Rein M. G. J.

Houben and Peter J. Dodd

The gap between the number of people who developed active TB and the number of people actually diagnosed and reported widened substantially in 2021; it is estimated that about 4.2 million TB cases went undetected and/or unreported. The COVID-19 pandemic disrupted access to TB detection services, reversing years of progress in closing the gap between 2012 and 2019.

The number of new TB case notifications in 2021, 6.4 million, takes the world back to 2016 notification levels. This issue extends to children as well; out of the 20 million people treated for TB from 2018 to 2020 (representing 50% of the UNHLM target), 1.4 million were under 15 years (or only 41% of the 3.5 million child sub-target was achieved).

After two years of COVID-19-related disruptions to TB prevention, diagnosis, and treatment efforts, 2023 had the highest number of people diagnosed and started on treatment since the beginning of the disease’s global monitoring in 1995– due in part to concerted efforts to recover from the pandemic’s devastating global impact. In 2022, global case notifications increased over the previous year, with 7.5 million, or 70%, of estimated incident cases diagnosed and started on treatment. This was a 16% increase in notifications from 2021 and a five percent increase as compared to 2019. TB mortality decreased by seven percent in 2022 compared to 2021 and was two percent lower compared to 2019, before the onset of COVID-19.

However, much work remains to achieve the Sustainable Development Agenda and USAID’s Global TB Strategy goals of ending TB as a major public health threat by 2030. Many individuals with TB are not appropriately diagnosed, despite a growing increase in the availability of rapid molecular tests. In 2022, only 63% of reported TB cases were bacteriologically confirmed (similar to 2021), and only 47% of individuals with notified cases were tested with World Health Organization (WHO)-recommended rapid molecular tests (a 24% increase from 2021).

Individuals infected with latent TB infection (LTBI) are vulnerable to progression to active TB disease and may begin to experience symptoms such as chronic cough, fever, weight loss, and fatigue. HIV/AIDS, diabetes, malnutrition, and other illnesses can make a person more vulnerable to TB illness, and some populations, such as prisoners, miners, and slum dwellers, are more vulnerable to both infection and disease, given their crowded living and working conditions and often precarious health status. Although men are more likely to be infected with TB, women are more likely to develop active TB disease and experience symptoms associated with the illness. TB is one of the leading causes of death among women worldwide. In addition to the burden of mortality, there is some evidence that TB during pregnancy leads to complications for both mothers and infants.

The economic burden of TB at the household level is significant. In addition to the immediate loss of income and productivity for the household member who is sick, other family members may be pulled temporarily out of work and/or school in order to provide care. In many places, families must pay for daily or weekly transport to a health facility even if TB diagnosis and treatment are available free of charge. At the national level, it is estimated that some countries lose from four to seven percent of gross domestic product due to TB. TB disproportionately affects the poor and worsens conditions of poverty: 95% of TB cases are in developing countries, and crowded living conditions, poor ventilation, and lack of access to clean water and sanitation all contribute to an increased susceptibility to TB. Societies that have experienced broad socioeconomic development have seen a substantial reduction in TB incidence and mortality rates. Poverty alleviation has historically contributed the most to the reduction in TB rates in countries that now have a low TB burden. However, economic growth alone is not a guarantee for a rapid decline in TB cases and deaths. Unequal wealth distribution, with large parts of the population left behind, leaves fertile ground for a sustained TB burden.

In other regions, most notably Eastern Europe and Central Asia, drug resistance has grown steadily during the last decade, and globally, there were 410,000 estimated incident cases of drug resistant TB (DR-TB) in 2022. This is largely a result of increased transmission of drug-resistant forms of TB or clinical and programmatic mismanagement of drug susceptible TB, for example, where drugs are of low quality, providers do not prescribe the proper regimen, and/or patients do not receive support to ensure they take the full six months of treatment. DR-TB is much more difficult to diagnose and treat, requiring specialized laboratory expertise and infrastructure and long duration regimens of rather expensive, toxic medications. Of those with DR-TB 175,650 people (43%) were notified globally in 2022.

The HIV epidemic continues to drive the spread of TB in sub-Saharan Africa where about 40 percent of all TB patients are also infected with HIV. People with TB/HIV co-infection often have different symptoms and are more difficult to diagnose with the standard tests used throughout the world. When they are diagnosed with both TB and HIV, they may have to visit more than one clinic to receive care for both illnesses. Globally in 2017, 60 percent of notified TB patients had a documented HIV test result, a 23-fold increase in testing coverage since 2004.

In the African Region where the burden of HIV-associated TB is highest, 86 percent of TB patients had a documented HIV test result. The proportion of known HIV-positive TB patients on antiretroviral therapy (ART) was 85 percent globally.

USAID TB Portfolio

The United States Agency for International Development (USAID) is the largest bilateral donor globally in tuberculosis (TB) diagnosis, treatment and prevention efforts and leads the U.S.

Government’s international efforts through bilateral support to 24 countries with high burdens of TB. The Agency is appropriated approximately $400 million each year to implement the USAID Global TB Strategy 2023-2030 in 24 priority TB countries.

Guided by USAID’s Global TB Strategy, 2023-2030, and in cooperation with Ministries of Health, USAID provides bilateral assistance in 24 countries with high burdens of TB. In addition, by leveraging the USG’s contribution to the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), USAID supports the successful implementation of TB grants and provides targeted technical assistance to an additional 32 countries. USAID works with WHO, the Stop TB Partnership, the Global Fund Secretariat and Principal Recipients, other USG departments and agencies, local and civil society partners, local non-government organizations, faith-based organizations, affected communities, and the private sector and other key country, regional and global stakeholders to achieve the Global Plan to End TB 2023-2030, End TB Strategy, and the United Nations High-Level Meeting (UNHLM) on TB targets. In each country, USAID closely coordinates with a wide range of multi-sectoral TB partners to support the achievement of each country’s National TB Strategic Plan (NSP). USAID also works with these stakeholders to enhance investment in the development, introduction, and scale-up of new tools to find, treat, and prevent TB/DR-TB and to strengthen primary health care (PHC) systems to improve access to TB services for all, as well as the overall service delivery platform.

Launched in 2023, USAID’s Global Accelerator to End TB Plus applies a localization approach to increase commitment and leverage collaboration from governments, civil society, and the private sector to accelerate countries’ progress in reaching the global targets. The Accelerator aims to drive countries’ progress by strengthening partnerships with Ministries of Health, through joint development of partnership statements and country Roadmaps, as well as with the private sector and other partners; improving the sustainability of technical support through embedded advisors to build National TB Programs’ technical expertise; increasing locally generated solutions by partnering directly with local organizations; and driving innovation and leveraging resources through targeted interventions including securing partner resources, matching funds, and price reductions. USAID’s TB program is leading in the implementation of the Agency’s Local Capacity Strengthening Policy, which guides investments in local actors. To go beyond direct support and build the next cadre of TB local partners, USAID has helped improve the organizational, management, and technical capabilities of 115 local partners (110 local non-governmental organizations and five local government entities) through TB programming efforts as of 2022. As part of the Agency’s localization efforts and the UNHLM commitment, the Bureau for Global Health announced the target of allocating 60 percent of its TB country level funding directly to local partners by 2027.

USAID TB funds support 24 high-priority countries and five regions through a variety of centrally managed and bilateral cooperative agreements, grants, and contracts.

The Bureau for Global Health’s Office of Infectious Disease Tuberculosis Division (GH/ID/TB) team manages a comprehensive portfolio of TB activities and partners including:

● Health Systems for TB (HS4TB): Launched in 2020, USAID’s Health Systems for

Tuberculosis (HS4TB) project supports high TB burden countries with financing and governance strategies, tools, and approaches to achieve TB elimination goals.

● SMART4TB Supporting, Mobilizing, and Accelerating Research for Tuberculosis

Elimination (SMART4TB) will design and implement research studies with local partners to identify effective person-centered methods for finding, treating, and preventing TB;

strengthen local capacity to conduct high-quality research; and engage communities to build demand for new interventions, drive policy change, and improve implementation of new and existing interventions to reach the End TB targets.

● Tuberculosis Implementation Framework Agreement (TIFA) works with National TB

Programs and other local entities in up to 24 USAID TB priority countries to develop and negotiate TB commitment grants (TCGs), contracts, or other awards to strengthen National TB Programs in managing their national response and accelerate TB eradication efforts.

● Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) The U.S. government has been the largest donor to the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) since 2002. Close coordination with the Global Fund is an integral part of the USG Global TB Strategy. Global Fund TB grants and USAID bilateral TB work plans are complementary in filling financial gaps identified in the National TB Program strategic plan.

● Stop TB Partnership (STP) As a Stop TB Partnership (STP) member, USAID provides funding and technical assistance to more than 40 countries to strengthen the implementation of the Stop TB Strategy and support the expansion of the Partnership’s mission through advocacy, communication and social mobilization, delivery of health services, research and development, and community engagement. USAID supports the STP through grant funding focused on supporting the Global TB Drug Facility (GDF) and technical activities of the Partnership Secretariat including global communications; advocacy, communication, and social mobilization; building national partnerships; and the Challenge Facility for Civil Society.

● TB Alliance is focused on supporting trials of promising new anti-TB medicines and activities to accelerate the availability of pediatric TB drug formulations.

● World Health Organization USAID provides funding, through a grant with the WHO Global

TB Program, to several WHO TB initiatives and works closely with WHO and country partners to implement TB prevention, diagnostic and treatment protocols.

● LEAP Local Africa: Embedding technical advisors The Long-term Exceptional Technical

Assistance Project (LEAP) Local Africa is a five-year fellowship program that strengthens national infectious disease programs by empowering host governments to lead and manage key aspects of their infectious disease portfolios as well as improve coordination between infectious disease program stakeholders involved in the country and the host government.

● LEAP Global: Embedding technical advisors The Long-term Exceptional technical

Assistance (LEAP Global) supports development of effectively managed national infectious disease programs in USAID-supported countries by embedding technical advisors and subject matter experts into the national programs.

● TB Local Organization Network Mental Health Asia and Africa are three-year (2023 - 2026)

USAID-funded activities designed to identify the potentials for integrating mental health services and TB services in Indonesia, Cambodia, and the Philippines, through the TB MIND activity), and in South Africa, Uganda, Tanzania, and Zambia, through the TB COMMIT activity. The activities will develop initial frameworks for collaborative care to improve TB care outcomes.

3. LON Purpose

The purpose of the TB LON project is to support the prevention, care, and treatment of TB in USAID TB priority countries. LON, a key component of the USAID TB Portfolio, will partner with local stakeholders and implement locally generated solutions focusing on country empowerment and accountability to improve TB services and leverage additional resources in USAID priority TB countries. LON will build on the capacity and available resources of local institutions to achieve maximum impact and effectiveness of national TB programs. By partnering directly with local institutions and organizations to implement locally generated solutions, LON will maximize the potential impact of USAID resources to make sustainable improvements in TB services by shifting accountability and ownership to local stakeholders.

The international community is committed to significantly reducing the burden of TB globally and preventing as many deaths from TB as possible. This will be accomplished by rapidly detecting all TB cases, especially in vulnerable populations, and ensuring prompt and appropriate treatment. The prevention, diagnosis, and treatment of TB is one of the key priorities of USAID’s Global TB Strategy for 2023-2030 as well as the United Nations High Level (UNHLM) meeting on TB. By the end of 2030, USAID strives to reach, detect, and enroll on treatment at least 90% of the estimated DS and DR-TB cases and successfully and appropriately treat 90% of those individuals in priority TB countries. To achieve these goals, it is necessary to develop new tools and approaches through research and innovation, implement sound and impactful interventions, and strengthen the systems that utilize these advances to be both resilient and sustainable. LON will contribute to these goals and targets by empowering civil society, private sector service delivery providers, faith-based organizations, and other key local stakeholders to contribute to the fight against TB.

USAID continues to work with foreign governments in USAID priority TB countries to develop ambitious and realistic National TB Strategic Plans to set targets and establish priority interventions based on the unique context of the TB burden in each country. LON will draw on the existing capacity of local civil society organizations, faith-based organizations, academic institutions, private sector service delivery providers, and other local organizations – much of which has been strengthened through previous and existing USAID TB interventions – and continue to build this capacity by partnering directly with these local entities. By partnering with local entities, and by structuring the awards through an Annual Program Statement (APS) process of co-creation, USAID expects that the resulting agreements will include numerous new partnerships with local institutions that have not previously partnered with USAID. Creating new partnerships with local entities will expand opportunities to utilize innovative approaches to address the challenge of TB.

4. Technical, Strategic and Geographic Areas of Emphasis

USAID’s Global TB Strategy is organized by the following strategic objectives:

(1) REACH: Maximize the detection of all forms of TB in all individuals of all ages. Reaching every person with TB is foundational to USAID’s vision of a TB-free world and requires universal access to the most accurate tools to screen and diagnose individuals for TB.

REACH includes a broad range of interventions along the patient pathway to care, starting with activities that occur before a person accesses TB testing and continuing through all the steps required to confirm (or reject) a diagnosis of TB. These activities may take place at the household, community and/or facility level. Five key priorities described below and based on international guidance and best practices will help direct USAID strategic and technical design and implementation of activities under the REACH Objective towards achieving USAID’s targets of 90% of incident TB and DR-TB cases diagnosed and initiated on treatment.

(2) CURE: Empower all individuals diagnosed with TB to complete treatment and be cured.

Three key priorities listed in this Objective will ensure that USAID programming focuses on key aspects of TB cascade delivery and considers international recommendations and best practices. Treatment initiation and successful completion is one of the critical indicators both for the national TB programs as well as for USAID and other donors. In the UNHLM targets for 2028, 90% of people detected with TB have to be enrolled in appropriate care. USAID’s strategic framework for the 2023-2030 strategy calls for 90% of incident TB and DR-TB cases to be diagnosed and initiated on treatment.

(3) PREVENT: Stop the spread of new infections and progression from infection to active TB disease. Prolonged exposure to DS and DR-TB such as occurs in communities, households, and congregate settings results in high transmission rates of TB infection and active TB disease. Depending on the definition of contacts and the methods used to diagnose the index case, Contact investigation is a high yield active case finding strategy to identify persons with TB earlier in the course of their disease as well as an important opportunity to find contacts with TB infection who will benefit most from TPT. A WHO guideline review found a yield of 3.4% (95% CI: 2.9,3.8) among contacts of bacteriologically confirmed (bac+) index cases, 3.9% (95% CI: 2.5, 5.4) among contacts <5 years old, 3.7% (95% CI: 2.4, 5.3) among MDR/XDR contacts, and 11.6% (95% CI: 8.2,15.4) among contacts who were also HIV infected. TBCI also provides an opportunity when IGRA or TST testing is available to identify persons with TBI who would benefit from TPT and avoid unnecessary treatment for contacts who are uninfected. However, TBI diagnostic testing should not be an obstacle to providing TPT when they are not available. WHO recommends systematic screening of all household and other close contacts of pulmonary TB disease. Contact investigations should always be done for: 1) bacteriologically confirmed pulmonary TB, 2) persons presumed or diagnosed with DR-TB, and 3) all children who are clinically diagnosed or bacteriologically confirmed to identify the ‘source case’ (reverse contact investigation) [WHO, Sec.2.4.1, pg17]. Contact investigation for clinically diagnosed TB cases should also be considered and encouraged especially when access to molecular diagnostics is limited (see also REACH Priority #1).

(4) INNOVATE: Research, develop, introduce, and scale-up new tools and approaches to combat TB. Robust efforts are needed to sustain and improve on the gains made to date, and to address persistent challenges that have led to uneven progress in the fight against TB. The USAID Global TB Strategy 2023 - 2030 results framework demands that major technological breakthroughs are needed and prioritizes a multisectoral approach to developing and equitably disseminating the most appropriate medical and programmatic innovations diagnosing, treating, and preventing TB. Countries’ policies should respond to the needs of individuals and health care systems, to ensure that innovations address both health and non-health determinants of TB, are affordable and accessible, and can be made available sustainably. In promoting TB research, there is a need for mechanisms that steer innovation towards sustainable, ethically acceptable, and socially desirable interventions, communicated effectively in the affected communities working with community and civil society organizations.

(5) SUSTAIN: Build country-owned TB health systems, led by local partners, that accelerate progress and support pandemic preparedness USAID’s TB programs strive to improve the capacity of country health systems to respond to the TB epidemic through its surveillance, prevention, diagnosis, care, and treatment activities. This work, while focused on TB, also strengthens health systems, and has shown great potential as a versatile platform, particularly for airborne and respiratory diseases. In the wake of COVID-19, countries continue to rely on TB infrastructure, expertise, political commitment, and partnerships to respond to a range of communicable and non- communicable diseases, particularly airborne diseases. Innovations in approaches and tools to the screening and detection of TB also provide expanded opportunities to leverage the platform to more rapidly identify a broader range of communicable and non-communicable diseases and to facilitate referral to appropriate clinical, supportive, and social services. The TB platform also offers an opportunity to identify the presence of health issues and social determinants that predispose individuals to both TB infection and disease, and to link individuals to related services, such as those that promote nutrition and address co-morbidities like diabetes. USAID efforts to strengthen TB supply chain management and surveillance systems are a core component of USAID TB programs; this work supports broader supply chain and surveillance networks while building stronger TB networks in-country.

To achieve specific TB goals and overarching TB outcomes, it is critical to outline how health system reforms will have a substantial impact on TB-specific indicators. One critical step is to include all of the components of the TB program in insurance, social protection, and sustainable financing mechanisms to help prevent catastrophic costs and further impoverishment of individuals with or at risk of TB. Efforts in this area would need to build on broader reforms in the health system to achieve specific outcomes for TB.

In addition to efforts geared to improving TB programs and the broader health system, sustainability is inextricably tied to expanding the role of local partners and constituencies, including local organizations, civil society groups, and affected individuals and communities to understand the context–political, social, and economic–in which these programs function, and bring this perspective to identifying resources, developing people-centered responses, and monitoring and assessing impact. Ensuring that local partners and those from affected communities and civil society direct and lead USAID-supported programs helps promote programs that are seen as, and truly are, “of the community” rather than foisted on it, which in turn leads to involvement, commitment, and ownership, and eventually, greater likelihood of integration and support by local governments long after external support has ended.

Despite the broad variation in each of the above technical considerations among the USAID priority TB countries, the overarching goal for LON is to create and sustain country empowerment and accountability. Through direct partnership with local civil society and private sector service delivery providers, LON is a key component of the USAID TB portfolio.

As specified by subsequent Addenda, LON activities are expected to be conducted in one or more of the USAID TB priority countries (Afghanistan, Bangladesh, Burma, Cambodia, Democratic Republic of Congo, Ethiopia, India, Indonesia, Kenya, Kyrgyzstan, Malawi, Mozambique, Nigeria, Pakistan, Philippines, South Africa, Tajikistan, Tanzania, Uganda, Ukraine, Uzbekistan, Vietnam, Zambia, and Zimbabwe) and regional platforms (Central Asia and East Africa). LON awards will partner directly with organizations based in the USAID TB priority countries.

5. Localization

USAID is redoubling our commitment to shift more leadership for priority setting, project design, implementation, and measuring results to the people and institutions with the capabilities and credibility to drive change in their own countries and communities. Localization is the set of internal reforms, actions, and behavior changes USAID is undertaking to ensure our work puts local actors in the lead, strengthens local systems, and is responsive to local communities.

The foundational assumption of LON is that empowerment of local stakeholders by supporting locally generated and driven interventions with a framework of accountability will result in sustainable achievements that will far outlast the period and level of USAID investment.

LON will partner with local entities, including civil society, faith-based organizations, and private sector service delivery providers to build local organizational and technical capacity and to sustain results long after the life of the project. Under LON, USAID will partner directly with an array of new and local partners to implement locally generated, context-specific solutions, focus on the scale up of new technologies with proven results to improve case detection and treatment outcomes, and utilize new approaches to empower local stakeholders. LON uses innovative, co-creative design structures to leverage increasingly iterative, agile, and accountable approaches to address TB challenges.

6. Strategic Objectives and Outcomes

All LON activities will aim to fulfill the main purpose and achieve the stated goals by contributing to one or more of the project’s four intermediate results (IRs):

IR 1: Improved access to high-quality, person-centered TB, DR-TB, and TB/HIV services.

IR 2: TB service delivery platforms strengthened.

IR 3: TB disease transmission and progression reduced.

IR 4: TB research and innovations accelerated with improved impact on program implementation.

IR 1: Improved access to high-quality, person-centered TB, DR-TB, and TB/HIV service

● Enabling environment: TB services must be tailored to the needs of individuals and their communities. TB care has evolved to embrace a person-centered approach that is focused on meeting the individual needs of each person so that they are able to access timely, quality diagnosis, care, and treatment in a supportive environment that is based on respect for patient autonomy, physical comfort, and psychosocial support. Individuals receiving TB treatment face months of therapy; those requiring treatment for DR-TB not only face months of therapy but toxic and often painful regimens. Person-centered care has been shown to reduce stigma and increase patient satisfaction as well as treatment adherence.

Improved access will be achieved through interventions to support an enabling environment that promotes the identification of all individuals with symptoms associated with TB; rapid, accurate evaluation for and diagnosis of TB (including universal Drug Susceptibility Testing (DST); and early initiation and successful completion of optimal TB treatment. Person-centered care and treatment put the individual at the center of all activities and strives to meet their specific needs. It requires an on-going and in-depth partnership between healthcare providers and individuals and their family and community to identify and address the full range of individual needs and preferences. TB care and treatment services should also include access and referral to supportive services such as counseling, social services, nutrition, and income-generating activities.

● Enhanced services for the prevention, detection, and treatment of MDR-TB: The magnitude of the MDR-TB burden continues to outpace the scale-up of interventions.

Focused attention is needed on all forms of MDR-TB so that the gains made in TB over past decades are not wasted. Now is the time to ensure that quality and appropriate treatment models with palliative care and private sector involvement are developed and rolled out in countries with the greatest burden of MDR-TB. In recent years, more efficacious DR-TB regimens containing new drugs and requiring shorter treatment periods have been approved by WHO and introduced in a growing number of countries.

USAID’s role has been critical in ensuring free access to one of the new drugs, bedaquiline, through its donation agreement with the manufacturer (Janssen). The rapid scale up of shorter regimens and new drugs is urgently needed to ensure an effective public health response.

IR 2: TB service delivery platforms strengthened.

● Strengthened TB service delivery systems: TB services are implemented and delivered at all levels of the health system, from the primary to tertiary. The national health system is the platform through which TB prevention, diagnosis, and treatment activities are introduced, expanded, and strengthened. It is, therefore, clear that the quality of this system has a direct impact on the provision of high-quality, person-centered TB services.

Although this project is not intended to address entire health systems, our efforts focus on strengthening key service delivery platforms for TB service delivery. We will assist countries to identify populations at high risk of TB and support improvements to the health settings in which they seek care. This will require a multi-sectoral approach and engagement of a range of partners including not only traditional government health agencies, but also affected communities and community organizations and the private sector – for-profit and non-profit. Through these partnerships, the project will focus on strengthening financing for TB services (including health insurance schemes), drug policy and management, monitoring and evaluation systems, and human resources. A strong backbone of core systems must be in place to support the overall TB program, including a comprehensive and functional logistics plan for quality drugs and other commodities with no stock-outs; a monitoring and evaluation system for quality data; and strong institutional, health care worker and lay worker capacity building. Countries will need strong platforms to introduce and scale up new diagnostics, drugs, and vaccines as they become available. These platforms also include systems for improving access to and services for global health security/antimicrobial resistance (AMR) and infectious diseases.

● Engaging the private health sector: USAID partners with the private sector and affected communities to expand their engagement in the delivery of TB services. Across our bilateral TB programs, USAID enables providers outside the government system, such as faith-based organizations, to care for patients as recommended by national guidelines, and to facilitate their inclusion in local planning activities.

IR 3: TB disease transmission and progression reduced.

● Expanded access to prevention services: USAID programs work to prevent both the transmission of TB from one person to another, and the progression from latent TB infection (LTBI) to active TB disease in those who become infected. Access to early diagnosis and quality treatment is one of the best ways to prevent the transmission of active TB disease, as well as the development of MDR-TB. In addition, TB Preventive Therapy (TPT), a critical intervention, particularly for contacts of individuals with active TB disease and PLHIV, is being expanded in countries. Until a vaccine that prevents infection and/or progression to active disease is available, the project will support early and effective TB diagnosis and treatment as the primary focus of TB prevention efforts.

Still, the project will support a range of prevention activities, including strengthening targeted screening for active TB among high-risk individuals and groups; improving infection control interventions to prevent transmission in congregate settings; and screening for and treatment of LTBI to reduce the risk of progression to active TB among individuals with or at greatest risk to develop TB.

IR 4: TB research and innovations accelerated with improved impact on program

● Accelerated research and innovation: Global progress in the development and introduction of new tools and approaches for TB has been slow. New drugs, diagnostics, tools are not yet widely available and further progress requires continued support of fundamental research for the development of new tools and approaches for detecting, treating, and preventing TB, and augmented efforts to improve program impact and introduction of new tools through operational and implementation research. The project will support the development, introduction, and implementation of shorter, less toxic, and more effective treatment regimens for drug-susceptible TB and DR-TB in adults and children; collaborate with national and international partners, including WHO, on the introduction of new drugs for adults and children into existing or new treatment regimens approved at the national level; promote the evaluation of biomarkers to diagnose TB infection and TB disease and to monitor disease progression and treatment outcomes;

support studies to evaluate the accuracy and feasibility of promising diagnostic tools for TB and DR-TB in adults and children with an emphasis on point-of-care products;

evaluate the programmatic impact of new tools; examine the effectiveness of new and existing treatment regimens for LTBI; and, support the development of TB vaccines to prevent TB disease.

● Improved and expanded data use and communications: Improved analysis of data for decision-making is critical to ensure effective and efficient program implementation.

Communication about TB is important to raise awareness and education. There is a need for a strategic plan to ensure effective communication on TB as a disease as well as USAID’s TB program. Strategic counsel on ways and methods to incorporate comprehensive communication at various levels will be addressed.

All LON activities will emphasize consistent and effective utilization of data for purposes of design, adaptation, quality assurance, and context-appropriate scaling, and development of future National TB Strategic Plans, with particular attention to improving transparency, access to data, and application of evidence-based practices among practitioners and decision makers at country, regional, and global levels. Overall key indicators for success will be an increase in the number of TB and MDR-TB) cases diagnosed and put on treatment, and the number of cases successfully treated. USAID will evaluate these indicators both in the public and private sector, and in other targeted and key populations. Other priority indicators will focus on the strength of systems, like the laboratory and diagnostic networks, drug management, and data quality; and the prevention of transmission both for infection and disease. In terms of the implementation approach, a strong emphasis will be placed on ‘outside of the box thinking’, adopting innovations from other health and non-health sectors, and translating these into TB operations.

LON will significantly contribute to USAID Global Health’s (GH) strategic health priority of “combating infectious diseases.” The proposed activities of this TB project will further the effectiveness and efficiency of TB programs; provide technical leadership in responding to new global health challenges; partner strategically with a wide range of actors, including interagency partners (Centers for Disease Control and Prevention (CDC), Office of the US Global AIDS Coordinator (OGAC), National Institutes of Health and the Global Fund); accelerate the development and application of innovation, science, and technology, including new TB diagnostics and drugs; scale up evidence-based, equitable, and locally adapted health solutions;

strengthen local health system capacity to support partner countries’ leadership of health policies, strategies, and actions; and, work efficiently and be effective stewards of public trust and resources.

7. Gender Integration in LON

Gender equality and women’s empowerment are essential for achieving USAID’s development goals. The USAID Gender Equality and Female Empowerment Policy advances equality between women and men, boys, and girls, and empowers women and girls to participate fully in and benefit from development activities, through the integration of gender in the entire project cycle -- from project design and implementation to monitoring and evaluation. This integrated approach focuses on achieving three overarching outcomes: 1) Reducing gender disparities in access to, control over and benefit from resources, wealth, opportunities, and services – economic, social, political, and cultural; 2) Reducing gender-based violence and mitigating its harmful effects on individuals and communities, so that all people can live healthy and productive lives; and 3) Increasing the capability of women and girls to realize their rights, determine their life outcomes, and influence decision making in households, communities, and societies.

The activities under LON will contribute to the first listed outcome by reducing gender disparities in access to and benefit from TB care and treatment services. Activities may also contribute to the third listed outcome by increasing the capability of women and girls to realize their right to seek healthcare services and to influence decision making regarding health care.

Furthermore, as gendered barriers may prevent men and boys from seeking and benefitting from services, activities will work to transform negative masculinities and address other barriers that impact men and boys.

Summary of Findings from Existing Gender Analyses and Assessments

Gender impacts how TB is experienced; to be most effective, TB programs need to take this into consideration at all stages of programming -- planning, implementation, monitoring, and evaluation -- and at all points along the health/illness continuum: risk factors, exposure, knowledge, access to services, diagnosis, treatment, support, and recovery. Globally, men have higher rates of TB than women. Men are commonly thought to be more at risk for TB due to both physical and behavioral reasons. However, in some societies, women have quite high rates, likely due to restricted access to healthcare. In addition, women with HIV are at high risk for TB.

Research has also shown that men, on average, delay seeking care more than women and also have lower treatment success rates.

Analysis of Key Gender Issues

Access to and Control Over Assets and Resources

Access to and control over assets and resources can vary by gender as well as by ethnicity, religion, geography, socioeconomic status, education, source of livelihood and other factors.

Control over family assets varies by community and family. In some societies, women often have less control over use of family assets than men, which can impede health-seeking behavior.

Women may also have less access than men to financial services, such as banking services. In some areas, especially where women are less educated than men, women may have less access to health information which results in less knowledge and awareness of TB.

Access to healthcare, as defined by WHO, consists of three components: physical accessibility, financial affordability, and acceptability. Physical accessibility includes not only distance and physical location, but also opening hours and other factors. Those in rural areas, both men and women, often face barriers in accessing services due to cost or length of travel. In some communities, women may need permission from a husband or male relative to travel or may need an escort to accompany them, for either cultural or safety reasons. Physical access can also be difficult if the individual is employed in any type of seasonal work or must travel for work.

Both men and women may experience difficulties accessing health care services due to opening hours and conflicts with work or other responsibilities.

Financial affordability can be a barrier to accessing health care for all those with limited financial assets or for those with limited control over assets, including children and youth. Even though TB testing and treatment is free in many countries, knowledge of that fact may be limited, the cost of travel may be prohibitive, or the opportunity cost related to missing work (formal or informal) may impede healthcare seeking.

Acceptability “captures people’s willingness to seek services” and “is low when patients perceive services to be ineffective or when social and cultural factors such as language or the age, sex, ethnicity or religion of the health provider discourage them from seeking services.”3 Men and women may be reluctant to seek care from a provider of the opposite sex. Men may be reluctant to access services they perceive as being targeted toward women and children, or in facilities where they feel unwelcome and uncomfortable due to their gender. Transgender individuals may face significant barriers due to insensitivity or lack of awareness on the part of the provider, or due to outright discrimination or ridicule. All genders experience stigma regarding TB, and this can also be a barrier to accessing health care. Men in particular may be constrained by socially and culturally defined notions of masculinity which may also constitute a barrier to accessing services.

3 Evans, David B et al. “Universal health coverage and universal access.” Bulletin of the World Health Organization vol. 91,8 (2013): 546-546A. doi:10.2471/BLT.13.125450

Laws, Policies, Regulations, and Institutional Practices

Laws, policies, and regulations should uphold the right of all genders, including transgendered individuals, to get tested and treated for TB free of charge.