7200AA19APS00001 LON APS - Amendment 1.pdf

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

Catalog of Federal Domestic Assistance (CFDA) Number: 98.001

Issuance Date: January 29, 2019

Deadline for Questions (Round 1): February 20, 2019 5:00 pm Washington DC local time

Deadline for Submission of Concept Papers for First Review Opportunity (Round 1): March 08, 2019

5:00 pm Washington DC local time

Deadline for submitting Full Application: To be provided with notification of Concept Paper “Pass”

Submit Questions and Concept Papers (Round 1) electronically to LON@usaid.gov mailto:LON@usaid.gov

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 that will be reviewed for responsiveness to the purpose of the APS. Concept Papers will be evaluated against the merit review provided in Section E. 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) will be requested to submit a full application, 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 request full applications from the applicants successful at concept paper stage. If/when additional rounds occur; this APS will be amended with appropriate information.

Sincerely, Patricia Bradley Supervisory Agreement Officer Office of Acquisition and Assistance

M/OAA/GH/ID

TABLE OF CONTENTS

SECTION A – Program Description……………………………………………………………...4

SECTION B – Federal Award Information……………………………………………………...20

SECTION C – Eligibility Information…………………………………………………………...23

SECTION D – Concept Paper Submission Information…………………………………………25

SECTION E – Concept Paper Merit Review Information……………………………………….32

SECTION F – Federal Award and Administration Information………………………………...33

SECTION A: PROGRAM DESCRIPTION

This funding opportunity is authorized under the Foreign Assistance Act (FAA) of 1961, as amended. The resulting award 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. 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 UN target of treating 40 million people by 2022. 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 numbers of people who die each year, tuberculosis (TB) is the world’s deadliest infectious disease. Transmitted through the air and primarily targeting the lungs, this disease caused by a bacterial infection claims three lives every minute, or 1.7 million lives every year. In terms of cases, the best estimates for 2017 are that there were 10.0 million new TB cases (including 1.0 million among HIV-positive people), of which 5.8 million were among men, 3.2 million among women and 1.0 million among children. Overall, 90 percent of cases were adults and 10 percent children, and the male: female ratio was 2:1. 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 dedicated to halting TB and reversing the epidemic by 2015, the Sustainable Development Goals (SDGs) have transitioned the focus by including a broader scope of social and economic determinants. Since 2000, the global TB mortality rate has decreased by 42 percent, and incidence has decreased by about 16 percent. However, the global MDG targets of halving TB prevalence and death rates by 2015 have not been met in all regions of the world. Globally, the average rate of decline in the TB incidence rate was 2 percent per year since 2005. This needs to accelerate to 4–5 percent per year by 2020 to achieve the milestones for reductions in cases and deaths set in the End TB Strategy.

Of the estimated 10.0 million new cases in 2017, 6.7 million were actually diagnosed and notified (67 percent) to national authorities. Although the number of cases detected has increased over the past decade, there are still an unacceptably high number of cases not diagnosed or put on treatment every year.

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. Moreover, there are an estimated 10 million children who have lost at least one parent due to TB.

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 percent 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 558,000 estimated incident cases of drug resistant TB (DR-TB) in 2017. 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. The 160,684 drug-resistant TB (DR-TB) cases notified globally in 2017 amount to about 29% of the 558,000 estimated incident cases of DR-TB in 2017. Globally, the 139,114 patients starting second-line DR-TB treatment in 2017 represented about 25% of the incidence estimate.

The US Government (USG), led by USAID, developed a global TB strategy (2015-2019) in response to the Lantos-Hyde Reauthorization Act of 2008. The strategy, closely linked to the

End TB Strategy and the Global Plan to End TB, includes a number of targets to be reached by 2019: 25 percent reduction in TB incidence rate; 90 percent treatment success rate (for drug-susceptible TB); successful treatment of at least 13 million TB patients; and diagnosis and treatment of 360,000 new MDR-TB cases. An additional 200,000 MDR-TB patients are targeted for diagnosis and treatment under the National Action Plan for Combating MDR-TB (National Action Plan or NAP), a five year plan released in 2015.

The NAP builds on existing USG efforts to support the appropriate treatment of more than 16 million TB patients to prevent development of MDR-TB by achieving and maintaining a 90 percent TB treatment success rate. In addition to increased MDR-TB prevention efforts, the NAP proposes increasing the number of individuals initiating MDR-TB treatment in the 10 countries with the highest MDR-TB burden. The NAP is intended to promote greater coordination of USG resources—including domestic, bilateral, and multilateral funding—to reduce the domestic and global risk of MDR-TB, increase the American public’s awareness of the threats posed by MDR-TB, and serve as a call to action to encourage bilateral and multilateral donors, the private sector, and affected countries to increase investments in this critical area of worldwide concern. Investments in research and development will contribute to improved treatment outcomes for individuals with MDR-TB through new tools that are easy to implement in existing health systems, better use of existing and newly licensed TB drugs, an enhanced drug-development pipeline, increased availability of rapid assays for TB diagnosis and drug-susceptibility testing, and improved disease surveillance. These actions will contribute to the prevention of further resistance to TB drugs and significantly reduce the global spread of

MDR-TB.

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.

As we reflect on progress towards the 2019 and beyond targets we have an opportunity to strengthen the USG strategy, revise it to address the current challenges, and design a new TB project to respond to current challenges, future priorities and to achieve self-reliance.

USAID TB Portfolio For 20 years, USAID has been a global leader in combating TB. Support to global and country programs started in 1998 with $10 million and has grown to $261 million currently. 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:

● Challenge TB: A cooperative agreement (2014-2019) focused on providing technical assistance and global technical leadership in 22 countries and two regions, working with National TB Programs to achieve the targets in National TB Strategic Plans and the objectives and milestones of the USG TB Strategy and the National Action Plan to Combat Multi-Drug Resistant TB (MDR-TB).

● TREAT TB: A cooperative agreement (2008-2021) focused on developing and implementing sound TB research through field evaluations of diagnostic tools; clinical trials of priority research questions; and targeted operational research benefitting global, regional, and country TB control efforts.

● TB CARE II: A cooperative agreement (2010-2020) focused on providing technical assistance and global technical leadership on key focus areas, including DR-TB and infection control and prevention. TB CARE II is a key implementing partner in facilitating the achievement of one-, three-, and five-year milestones of the National Action Plan.

● TB Drug Alliance: A cooperative agreement (2008-2022) funding to support trials of promising new anti-TB medicines and activities to accelerate the availability of pediatric TB drug formulations.

● WHO Global TB Program: Grant (2009-2020) funding to support global TB policy development and guidance including: TB monitoring and surveillance and impact measurement; surveillance and management of MDR and Extensively drug-resistant TB (XDR-TB); innovations for intensifying early and complete TB case detection and effective service delivery; technical capacity building for policy adaptation, implementation and service delivery; and the Global Laboratory Initiative.

● Stop TB Partnership: Grant (2015-2022) funding to support the Global TB Drug Facility 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.

● Infectious Disease Detection and Surveillance: A contract (2018-2023) to support the strengthening of disease detection networks and identification of antimicrobial resistance (AMR) in priority infectious diseases, and to improve the quality of real-time surveillance systems for pathogens of greatest public health concern, including AMR and zoonotic diseases.

● STAR: A bureau-wide cooperative agreement (2018-2023) to second technical advisors to key positions within National TB Programs and other strategic positions to address bottlenecks, build capacity within government health systems, and maximize the impact of interventions to improve TB services.

● Control and Prevention of Tuberculosis (CAP-TB): A cooperative agreement (2011- 2021) focused on developing a model for multidrug-resistant tuberculosis to improve rapid detection and treatment outcomes for this disease in Asia. The model is a person-centered, community-driven model to strengthen health systems and TB platforms; target countries include China, Burma, Thailand, and Papua New Guinea.

● TB Data, Impact Assessment, and Communications Hub (TB DIAH): A cooperative agreement (2018-2023) focused on developing a TB data hub that will ensure optimal consolidation and analysis of TB data and the appropriate use of such information to measure and evaluate performance and inform national TB programs (NTP) and USAID portfolio interventions and policies.

3. LON Purpose

The purpose of the TB Local Organizations Network (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’s journey to self-reliance, 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 self-reliance 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 global End TB Strategy has set ambitious goals to reduce TB deaths by 75 percent by 2025 (from 2015 baseline) and reduce incidence rate by 50 percent by 2025. The three pillars of the strategy—Integrated, Person-centered Care and Prevention; Bold Policies and Supportive Systems; and, Intensified Research and Innovations—are closely aligned with USG Global TB Strategy. 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 accountably 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

The global TB situation was much different a decade ago than it is today. Today, the TB epidemic is larger than previously estimated. In 2017, out of the estimated 10.0 million new incident cases, only 6.7 million or 67 percent were notified to national programs. The extension of TB services to identify and treat the 4 million ‘missing cases’ still remains one of the biggest challenges to achieving the END TB Strategy and USG’s Global TB strategy. Global progress depends on major advances in TB prevention and care in the eight countries which accounted for 66 percent of the new cases in 2017. In other countries with higher case detection, there continue to be specific vulnerable and key populations without access to diagnosis or treatment. And in some countries, the gap between rich and poor continues to widen creating additional challenges as overall resources increase but the TB problem remains severe or becomes worse. Additionally, the increasing burden of DR-TB continues to threaten the advances in the fight against TB. While globally we have made important strides to reduce burden and mortality, we need a shift in our TB strategies to react to a changing environment, while maintaining the successes we have achieved. In this regard we analyzed several factors for our focus countries to gauge progress and predict future priorities:

Burden: Many of our focus countries are among the highest-TB-burden countries, including India, South Africa, Indonesia, Bangladesh, Philippines, Ethiopia, the Democratic Republic of the Congo, Nigeria, Mozambique, and Kenya. India alone accounts for 33 percent of the global burden of disease. In these countries, proven and innovative detection and treatment approaches to reach as much of the population as possible need to be scaled up to make an impact on global burden.

TB case detection: A number of countries are still struggling to detect the majority of their TB cases. Growing evidence from prevalence surveys shows that the burden of disease is much higher than previously estimated. In countries such as Nigeria, Zambia, Ghana, Indonesia, Tanzania, Malawi, and Pakistan, the new prevalence results indicate prevalence of two times and higher than previously estimated and case detection rates as low as 17 percent in Nigeria for example. Some of the results also indicate that TB prevalence is systematically higher among men; the epidemic is ‘aging’ in Asia while the picture remains more mixed in Africa (when analyzing age group prevalence); many symptomatic TB cases had sought care prior to detection by survey; high proportion of TB cases are being treated in private and non-public settings. Strategic emphasis on these countries will focus on identifying the population groups of the missing TB cases and developing differentiated approaches to reach them.

Treatment success rate: An indicator of a good TB control program is a high treatment success rate (TSR). Although we have made great strides in this area, especially among the new cases, the TSR among retreatment and DR-TB cases remains low and of great concern. A number of countries are struggling to achieve at least an 85 percent treatment success rate (for new and relapsed cases): e.g., Ukraine (76 percent), Kyrgyzstan (82 percent), Uganda (77 percent), South Sudan (82 percent), Georgia (83 percent), and South Africa (82 percent). The treatment success rate for extensively/multidrug-resistant TB (X/MDR-TB) are even lower, as globally a little more than half of the MDR-TB patients who initiate treatment successfully complete it. Further quality assessments are required to improve treatment success rates and proven interventions such as Directly Observed Treatment (DOT) must be strengthened. The consequences of poor adherence to TB treatment are disastrous, increasing the risk of patient morbidity and mortality, disease relapse, drug-resistance, and transmission of TB. While most programs have long relied upon DOT for TB patients, this monitoring strategy requires greater and more efficient use of currently available resources.

DR-TB burden: DR-TB is becoming an increasing problem for many countries. The emergence and spread of X/MDR-TB pose a significant global threat to health, economic development, and national security, undermining the significant progress made globally and domestically to achieve a world free of TB. In the 10 countries prioritized for the NAP, there were an estimated 364,100 new cases of DR-TB, with 104,340 detected and 86,272 enrolled on treatment. Over 60 percent of all estimated cases in the world are in the NAP countries. These countries fare better than average in terms of detecting DR-TB and putting patients on treatment, but significant challenges remain. In 2017, over 80,000 patients were enrolled on appropriate treatment, which puts these countries on track to reach the 2017 milestone of having at least 30 percent of all estimated DR-TB patients on treatment. In the non-NAP countries, DR-TB interventions will also be scaled up.

Economic/Income groups: Of our priority countries, more than 50 percent are low income, about 40 percent are lower middle income and less than 10 percent are upper middle income. Different strategies are required for countries of different income levels based on resources, need, and burden. Globally, 84 percent of the funding for the TB response currently comes from domestic resources. However, it varies greatly by region and country. The poorest countries still rely on donor funding for much of their basic TB program and have few options for funding, with only 50 percent of the TB funding coming from domestic resources in the non-BRICS (Brazil, Russia, India, China, and South Africa) countries. In these settings we will need to continue comprehensive support for their TB program while helping the country advocate for increased domestic funding of their program. Many of the lower-middle and upper-middle countries are making a progressive shift to increased domestic funding of their basic TB program, although still basic components such as first-line TB drugs are donor dependent. However, these countries have huge “pockets of poverty” and vulnerable TB populations that still need targeted donor funding. And these higher-income countries are the ones with the greatest MDR-TB burdens – which is one area that domestic funding cannot adequately support. Furthermore, interventions need to address the significant out-of-pocket costs for patients and their families.

Combined with loss of income and other economic strains associated with TB, catastrophic costs from TB must be addressed.

Despite the broad variation in each of the above technical consideration 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’s journey to self-reliance.

LON activities will be conducted in 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. Journey to Self-Reliance and Local Partnerships

USAID defines Self-Reliance as a country’s ability to plan, finance, and implement solutions to solve its own development challenges. The Journey to Self-Reliance has been characterized by two mutually reinforcing factors: local capacity and commitment. Commitment is defined as the degree to which a country’s laws, policies, actions, and informal governance mechanisms -- such as cultures and norms -- support progress towards self-reliance. Capacity is defined by a country’s ability to efficiently and effectively manage the human, financial, technical resources it has to meet its public health goals. Effective development partnerships are characterized by a collective shared vision between funders and local actors, common definitions of success, shared contribution of resources, and mutual accountability to communities and beneficiaries.

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 fulfil 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 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 puts 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 a 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.

● Expanded coverage of TB/HIV interventions: TB continues to be the greatest infectious disease killer of people living with HIV (PLHIV). Therefore, we must continue to expand activities to screen all HIV-infected persons for TB and test all confirmed TB patients for HIV. Rolling out innovative diagnostics to detect TB/HIV co-infected persons will be a major component contributing to this result. Ensuring both TB and HIV treatment for co-infected individuals is critical. For those PLHIV who do not have active TB, preventive TB treatment is recommended and remains one of the interventions supported by PEPFAR. The project, working closely with PEPFAR, will facilitate the strengthening of TB/HIV interventions.

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 implementation

● 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, and TB/HIV) 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 self-reliance 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, is comprised 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.

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. Institutional practices should be examined to ensure that all genders feel welcome and receive quality, respectful care.

Gender Roles, Responsibilities and Time Use Gender roles, responsibilities and time use can impact risk factors for TB, exposure to TB, and health seeking behavior. For example, men may be exposed to TB more frequently than women due to time spent in work places (especially mines and factories), time in prison, and time in bars and sports viewing venues. Women may be exposed due to caring for sick individuals more often than men. Men may also be at increased risk of developing TB because they often have higher rates of smoking and drinking alcohol, both risk factors for TB.

Responsibilities and time use can also impact ability of individuals to seek care. Responsibilities such as work and caring for children can make getting to a clinic difficult, especially if the hours are limited, and can impact the likelihood that a patient will adhere to treatment.

Patterns of Power and Decision Making Household level power dynamics can impact women’s and men’s ability to access financial resources, and, ultimately, their ability to take advantage of services available. These power dynamics may also impact who makes decisions about household members seeking healthcare and what type of healthcare is sought. In addition, in order to make effective decisions about their health, both men and women need to be knowledgeable about signs and symptoms of TB, aware of available services, and confident that their needs will be met.

Specific Gender Requirements Activities under LON will include the identification and correction of gender-based inequities in TB service delivery. Partners and staff working with the new TB activities will also seek to understand the underlying reasons for gender-based differences throughout the entire patient pathway, and will seek to apply gender-transformative or gender-sensitive approaches when designing, implementing, monitoring and evaluating activities. Activities shall also assert and uphold the right of all individuals -- men, women, and transgender people -- to quality healthcare services.

Activities under LON will be expected to:

● Gain an understanding of gender relations, the division of labor, and who has access to and control over resources;

● Use participatory processes and include a wide range of female and male stakeholders at the governmental level and from civil society including women’s organizations and gender equality experts;

● Identify barriers to women’s participation;

● Gain an understanding of women’s and men’s health needs and strategic interests and identify opportunities to support them;

● Gain an understanding of the differences in exposure among the genders, identifying settings that may put men as special risk (e.g., mines and prisons);

● Consider the differential impact of the activities on women and men and identify consequences to be addressed.

8. Project Monitoring and Evaluation

LON embraces USAID’s Evaluation Policy in its approach to monitoring, evaluation, and learning. While operational details will be an integral part of the procurement process, the overall approach will consist of the following elements:

● Annual internal performance monitoring with necessary adjustments.

● Performance evaluations of large activities: Sizeable field activities implemented under this award will involve performance evaluations. As these activities are financed through mission buy-ins, precise priorities and arrangements will vary according to country context and mission capacity. However, the project team will include experienced professionals capable of executing performance evaluations if it is not feasible for any given mission to procure this expertise externally. Activity designs and approval processes will prioritize evaluations to ensure that key questions are articulated and appropriate baseline data collected at the outset.

● Impact evaluations of pilot projects and innovative development interventions: In accordance with the evaluation policy, impact evaluations will be conducted for any pilot projects undertaken.