Amendment 01 to Addendum 04 - TB Program Integration of Mental Health.pdf

AMENDMENT 01

TO THE CALL FOR CONCEPT PAPERS

Tuberculosis (TB) Program integration of mental health care to improve quality of TB patient care Under Existing

TB LOCAL ORGANIZATIONS NETWORK (LON) ANNUAL PROGRAM

STATEMENT

APS No.: 7200AA19APS00001

ADDENDUM 04

The purpose of the amendment is to extend the date to submit questions from interested parties from January 6, 2022 to January 19, 2022. Please refer to Attachment 1 for details, all changes are highlighted in yellow for easy reference.

Please note that there are no plans to extend the closing date for concept paper submissions at this time, so please plan accordingly.

List of Attachment:

Attachment 1: Amendment 01 to ADDENDUM 04 - Tuberculosis (TB) Program integration of mental health care to improve quality of TB patient care under Existing TB LOCAL ORGANIZATIONS NETWORK (LON) ANNUAL PROGRAM STATEMENT, APS No.: 7200AA19APS00001.

/s/ 01/05/2022

Imran Mahmud Agreement Officer

Attachment 1: Amendment 01

U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT

ANNOUNCEMENT

CALL FOR CONCEPT PAPERS

ADDENDUM 04

Tuberculosis (TB) Program integration of mental health care to improve quality of TB patient care

Under Existing

TB LOCAL ORGANIZATIONS NETWORK (LON) ANNUAL PROGRAM

STATEMENT

APS No.: 7200AA19APS00001

ISSUANCE DATE: December 21, 2022

CLOSING DATE OF QUESTIONS: January 19, 2022

CLOSING DATE OF CONCEPT PAPERS: February 27, 2022

PLEASE NOTE: This is an Addendum to an existing announcement. All interested organizations should carefully review both this addendum AND Amendment 5 to the full umbrella announcement, which can be found here: Important information contained in the full umbrella APS is not repeated in this specific Addendum.

This program is authorized in accordance with Part 1 of the Foreign Assistance Act of 1961, as amended. Through this Addendum to the TB Local Organizations Network (LON) Annual Program Statement (APS) No. 7200AA19APS00001, the U.S. Agency for International Development (USAID) seeks to capitalize on the expertise, ingenuity, and passion of local organizations that have specific interests and competencies to advance opportunities for developing a regional capacity building framework making effort to increase knowledge, skills, establish methodology and infrastructure needed to implement and sustain evidence-based, culturally appropriate model(s) for mental health management integrated into tuberculosis service.

Geographic Focus: USAID anticipates receiving multiple-countries’ Concept Papers from local entities from the 23 TB priority countries which can be linked to any particular geographical region within these countries.

USAID anticipates funding multiple awards, cooperative agreements and/or grants in the amount not to exceed $500,000 covering a three-year implementation period. However, actual funding amounts are subject to availability of funds and appropriate approvals. Publishing this Annex does not commit USAID to make any awards. USAID also reserves the right not to follow a co-creation process and request full application from the successful applicants at the concept paper stage.

Unless otherwise stated herein, all terms and conditions of the LON APS apply.

I. Problem Statement

Tuberculosis (TB) remains a significant cause of the global disease burden, especially among disadvantaged populations. In 2019, approximately 10 million people developed clinical TB disease, of whom about half a million new cases were rifampicin resistant. A total of 1.4 million people died from TB in 2019 (including 208,000 people with HIV)1. People with tuberculosis are at a greater risk of developing mental health conditions, often suffering from depression and anxiety as they adjust to their diagnosis and adapt to living with a long-lasting complex treatment accompanied with numerous side effects. Mental illnesses may have a high comorbidity rate among people suffering from TB2, possibly with multidirectional relationships. Mental and substance use disorders increase risk factors to TB disease progression, such as tobacco smoking and poor nutrition, often compounded by additional conditions such as diabetes and HIV infection.

In addition, treatment for TB itself can cause a wide range of side-effects on the central nervous system, including depression, nervousness, euphoria, hallucinations, and psychosis. The COVID- 19 pandemic and subsequent virus transmission mitigation activities imposed by social distancing measures, lockdown, and an unprecedented economic crisis resulted in high rates of unemployment have not only had a significant impact on TB programs but have also threatened mental health of patients, their families, and health care workers. With increased attention on the mental health outcomes on vulnerable groups and general populations3, there are growing calls regarding the need to integrate mental health programs into COVID-19 response and TB recovery plans. Building a resilient and comprehensive TB care system would help to ensure more robust pandemic preparedness, including scaling up of mental health support and services, and would also deliver greater progress in TB control programs.

Limited reliable data on the prevalence of mental health problems in patients with tuberculosis are available and there is no country with a targeted epidemiological surveillance system in place actively tracking mental health of TB patients. Similarly, data on human resources for mental health represents estimates. Mostly, information has been reported by single studies or systematic reviews of existing publications. For example, studies conducted in Pakistan, Ethiopia, and Nigeria have placed prevalence estimates for comorbid TB and depression/anxiety between 46% and 54%4. Several prevalence studies reporting mean depression and anxiety rates of 46% -- 72%

1 WHO Global TB Report 2020, https://www.who.int/teams/global-tuberculosis-programme/data 2 Doherty AM, Kelly J, McDonald C, O'Dywer AM, Keane J, Cooney J. A review of the interplay between tuberculosis and mental health. Gen Hosp Psychiatry. 2013;35(4):398–406 3 https://unsdg.un.org/resources/policy-brief-covid-19-and-need-action-mental-health 4 Ambaw F, Mayston R, Hanlon C, et al. Burden and presentation of depression among newly diagnosed individuals with TB in primary care settings in Ethiopia. BMC Psychiatry 2017; 17(1): 57. 9.

Ige OM and Lasebikan VO. Prevalence of depression in tuberculosis patients in comparison with non-tuberculosis family contacts visiting the DOTS clinic in a Nigerian tertiary care hospital and its correlation with disease pattern. Ment Health Fam Med 2011; 8(4): 235–241 establish the need to address mental disorders in TB care5. The average estimated prevalence of alcohol use disorders (AUD) in tuberculosis patients was 30% (the prevalence of AUD in tuberculosis patients was higher in Asia and Europe -- 37% than the prevalence in the US and Africa -- 24%)6.

Mental disorders in TB patients come with substantial risks, such as decreased quality of life, non-compliance and prolonged treatment, and an increased risk of developing drug resistance, all of which contribute to poorer treatment outcomes7.

Identifying mental health issues among people living with tuberculosis is critical; however, far too often those individuals go undiagnosed and untreated. People may not want to reveal their psychological state to health-care workers for fear of stigma and discrimination and health-care workers may not have the skills or training to detect psychological symptoms or may fail to take the necessary action for further assessment, management, and referral if symptoms are detected.

Stigma is seen to play a huge role in the experience of illness by TB patients, and it is believed that most TB patients even after full recovery from the illness feel the disease can never be completely cured8.

Despite growing recognition that mental health services should be integrated into tuberculosis care, substantial constraints to integration exist in low- and middle-income countries. These include competing national TB program priorities, deficiency of specialist human resources, and limitations to decentralization of TB services. There is also little practical guidance on how planning and implementation for integrated mental health services can be achieved. Currently, very few tuberculosis services are systematically addressing mental health issues. Nevertheless, in a survey of 26 National Tuberculosis Program (NTP) managers, 92% were somewhat or very receptive to incorporating a mental health component into their program9.

Prevention, testing, treatment, and care services must meet the complex medical, psychological, and social needs of people affected by tuberculosis and mental health issues, which can be best managed through integrated programs (“coordinated programs”, “collaborative programs”).

Integrated approaches need to be across sectors and involve social, legal, clinical care, and educational services engaging local communities and should aim to improve patient outcomes, be cost effective, and reduce stigma related to mental health.

Key Components of TB care-Mental Health integration

5 I. H. AmyBender, I. Hyman, and S. Guruge, “Exploring tuberculosis, mental health, and immigrant health through a syndemic approach,” CERIS Final Report, 2011.

6 Necho, M., Tsehay, M., Seid, M. et al. Prevalence and associated factors for alcohol use disorder among tuberculosis patients: a systematic review and meta-analysis study. Subst Abuse Treat Prev Policy 16, 2 (2021). https://doi.org/10.1186/s13011-020-00335-w 7 Peddireddy V. Quality of life, psychological interventions and treatment outcome in tuberculosis patients: the Indian scenario. Front Psychol 2016; 7: 1664 8 N. H. Long, E. Johansson, V. K. Diwan, and A. Winkvist, “Fear and social isolation as consequences of tuberculosis in Vietnam: a gender analysis,” Health Policy, vol. 58, no. 1, pp. 69–81, 2001

9 Sweetland AC, Galea J, Shin SS, Driver C, Dlodlo RA, Karpati A, Wainberg ML. Integrating tuberculosis and mental health services: global receptivity of national tuberculosis program directors. Int J Tuberc Lung Dis. 2019 May 1;23(5):600-605. doi: 10.5588/ijtld.18.0530. PMID:

31097069; PMCID: PMC6558966.9.

CASE FINDING, SCREENING, AND REFERRAL TO CARE: This entails incorporating steps to develop methods and systems for identifying TB patients with behavioral/mental health conditions, assessing their symptoms, and meaningfully developing mental health assistance plan that would include evidence-based targeted psychological and/or pharmacological treatment according to the specific care pathway for the identified condition.

USE OF A MULTI-DISCIPLINARY PROFESSIONAL TEAM: Involves specialists in the mental care team vary depending on a level of integration with the main goal to optimize contact between TB care providers and behavioral health specialists (any providers with specialized behavioral/mental health training), to facilitate care planning and communication about patients.

ONGOING CARE MANAGEMENT: ongoing and proactive follow-up of TB patients starting from TB diagnosis and during treatment is essential to eliminating fragmentation and engaging patients in their care. While tools used for tracking may vary, ongoing longitudinal assessment and communication with patients, including a focus on both physical and behavioral health, are important aspects of an integrated approach.

CULTURALLY ADAPTED SELF-MANAGEMENT SUPPORT: beyond a simple focus on treatment monitoring and adherence, self-management mental health support encompasses an exchange of information that helps patients (and their families) understand their behavioral health condition and promotes shared decision making between patients and TB care providers. Some tools (e.g., motivational interviewing) can be utilized to promote patient self-management through effective culturally appropriate communication.

INFORMATION TRACKING AND EXCHANGE AMONG PROVIDERS: development of multiple methods of information sharing, both formal and informal, and possibly tools for electronically tracking and coordinating information (e.g., formal patient registries or shared electronic records systems), as well as protocols for when and how information is exchanged.

LINKAGES WITH COMMUNITY/SOCIAL SERVICES: effective integrated mental health care models would address the key social determinants of health fostering effective linkages to supportive social services and to community organizations and resources for maintaining support after TB treatment.

II. Purpose

The proposed activities will address programmatic challenges for integration of early identification, accurate diagnosis, and effective management of mental health (anxiety and depression) and substance use conditions into TB care. This activity aligns with Intermediate Result 1 and Intermediate Result 2 of the APS whereby there is improved access to high-quality, person-centered TB, DR-TB and TB/HIV services and TB platforms strengthened across multiple countries.

The importance of mental health care integration into TB clinical management has not been questioned. However, it is less clear how to accomplish that at scale, given the varying types of TB care practices in different countries, resource limitations, and complexity of models for integrating medical and behavioral care. USAID seeks to fill that gap by advancing regional capacity building in development and optimization of integrated mental health practices into TB services. The capacity building framework should guide the development of new and/or complement and support current Mental Health/TB initiatives in the targeted region ensuring systematic and strategic approach in operations, monitoring & evaluation, and policy impact.

The activities under this Addendum will aim to achieve the stated goals by contributing to the following LON APS intermediate results:

IR 1: Improved access to integrated, high-quality, person-centered TB, DR-TB, and TB/HIV services across multiple (a region) countries IR 2: TB service delivery (particularly mental health) platforms strengthened across multiple (a region) countries IR4: TB research and innovations accelerated with improved impact on program implementation across multiple (a region) countries

Through this Addendum, USAID seeks Concept Papers (CPs) to achieve the following objectives:

1. The project will provide programmatic oversight, technical guidance, and performance monitoring within the capacity building framework in development and implementation of innovative model(s) of mental health management practices into TB care. Services will ensure coordination of practices and meet the various needs of TB patients with mental health conditions (with main concentration on anxiety, depression, and alcohol use disorders)

2. The project will provide technical expertise and build workforce capacity for the effective and efficient implementation of clinical, structural, and operational components of the integrated Mental Health/TB model(s) establishing relationship between the intervention(s) and targeted outcome(s), feasibility to implement and scale-up the proposed model of service, and acceptability of patients, medical personnel, and community

3. The project will leverage the experience and information published as well as maintain the strong involvement of community-based resources as key components of TB patient’s recovery and after-treatment well-being

4. The project will promote collaboration between National Governments (National TB Program

- NTPs) and other local stakeholders developing recommendations, training modules, scaling-up successful interventions, and participating in the national policy development process.

III. Eligibility Information

The Addendum targets local entities with tuberculosis and mental health interventions development and programmatic implementation capacity, to work together with the National TB Programs, USAID TB Division (Washington), USAID Country Missions, and local and international mental health experts to achieve the objectives described above as well as to address challenges in scaling-up the novel interventions. Local non-governmental entities are eligible to submit a Concept paper in response to this Addendum. USAID welcomes concept papers from organizations which have not previously received financial assistance from USAID as well as from local non-governmental organizations which have received USAID funding.

For-profit organizations can apply, however the recipient/recipients may not earn or keep any profit resulting from the award as per 2 CFR 200, Subpart E, Cost Principles.

Only local organizations as defined below are eligible for the award. USAID defines a “local entity” as a corporation, a nonprofit organization, or another body of persons that:

(1) Is legally organized under the laws of; and

(2) Has as its principal place of business or operations in; and

(3) Is majority owned by individuals who are citizens or lawful permanent residents of; and

(4) Is managed by a governing body the majority of who are citizens or lawful permanent residents of the country receiving assistance.

For purposes of this section, ‘majority owned’ and ‘managed by’ include, without limitation, beneficiary interests and the power, either directly or indirectly, whether exercised or exercisable, to control the election, appointment, or tenure of the organization’s managers or a majority of the organization’s governing body by any means.

The recipients must be responsible entities and must have the necessary organizational experience, accounting, operational controls and technical skills, or ability to obtain them in order to achieve the objectives of the project and comply with the terms and conditions of the award.

Concept papers from organizations that do not meet the above eligibility criteria will not be reviewed and evaluated. Individuals are not eligible to apply for this APS.

USAID strongly encourages concept papers from potential new partners to the US government who meet the above eligibility requirements. Such organizations are advised that they will be required to undergo a Pre-Award Responsibility Determination - a pre-award survey to determine fiscal responsibility (i.e. whether the prospective recipient has the necessary organization, experience, accounting and operational controls, and technical skills – or ability to obtain them – in order to achieve the objectives of the project and comply with the terms and conditions of the award).

IV. Concept Paper Template and Submission

Presented Concept Papers (CPs) should include the following key elements for development of a regional capacity building framework to support multiple countries efforts and strategies for integration of mental health delivery model(s) into tuberculosis continuum of care:

● The CP should reflect an understanding of healthcare networks and in particular TB clinical systems and environment in which the novel mental health model will be introduced with appreciation of the regional epidemiological background. The structure of the countries’ tuberculosis care system (specifically, inpatient vs outpatient DR-TB management, geographical variations, and TB/HIV integration) should be reviewed.

● The CP should outline the overall capacity building strategy and objectives for the proposed project:

o the approach should combine the needs of TB care personnel/community workers (improving the performance of staff delivering the mental health assessment and case management according to defined competencies and requirements), organizational (improving the performance of internal TB care and primary health services organizational systems leading to stronger collaboration and referral practices around mental health issues with the ability to adapt and continue to develop over time), and health system/policy (improving the external environment in which organizations, caregivers, and patients function, including structures allowing organizations to interact, local policies and standards that must be adhered to), o specific capacity building priorities should be determined by the expected effect on TB outcomes and quality of life impacts, o describe current or new partnerships with national government, local organizations and other stakeholders that will support the strategy o provide evidence that appropriate capacity and infrastructure are in place or will be established to support adequate performance of the proposed activities

● The CP should propose a basic framework for evaluation and monitoring qualitative and quantitative parameters:

o the capacity building outputs and outcomes and what indicators will be used to measure these, o quality standards determined at the o countries’ level based on input from a collaborative process with host countries and other stakeholders, including USAID teams, o recognizing the heterogeneity of TB country programs and contexts, the applicants are encouraged to use a selection of indicators to monitor change over time in capacity building efforts supporting future independent implementation of Mental Health/TB integrated services

● The CP should demonstrate the capacity to conduct the project successfully: leadership experience in the development and implementation of TB activities at targeted countries, data collection and analysis, and prepare reports and manuscripts. Applicants could provide examples of previous projects and publications, describe management capacity to ensure quality of the program results, accountability for carrying out the proposed activities, and critical mass of personnel with technical skills in TB and Mental Health.

● The CP should propose a plan for introduction of novel approaches involving NTP leadership and core USAID TB Division and Country Missions and provide recommendations to lead the scale-up process on national level identifying barriers to successful integration and what would be expected barriers to sustainability.

V. Additional Considerations

Prior to submitting a CP, applicants should ensure that submissions are in line with the Global TB Accelerator business model. Successful CP will also align closely with the broader priorities of USAID10. USAID has been especially interested in promoting new partnerships with local entities.

The applicant should have an interest and possess capacity to lead the work within the region

10 https://www.usaid.gov/global-health/health-areas/tuberculosis across multiple countries, possibly complementing and strengthening TB control projects implemented by other local entities.

As USAID and implementing partners will make every effort to increase the sustainability of Mental Health/TB activities and results, the relationship between capacity building and development outputs, outcomes, and impact is very important. The concept paper may include plans for an additional data analysis: a qualitative study of trends in patient and medical personnel preferences for management of mental health issues, health economic evaluation, analysis of TB treatment adherence, and possibly TB treatment outcomes.

Applicants should commit to a collaborative effort with the NTPs, USAID Country Missions, and USAID/Washington in the proposed implementation strategy and anticipate that the proposed implementation strategy will be adjusted based on input from the partners.

USAID’s preference is to receive CP that cover multiple countries or have a regional approach, however, USAID will accept single country CP. The intermediate results, key elements and intended achievements remain technically the same, and would be applicable to a single country rather than a multitude of countries.

VI. Application and Review Process

USAID Regional Offices and Country Missions are responsible for the review process and management of any awards issued under this Addendum.

Concept Papers, Full Applications, and supervision of any awards issued under this Addendum will be managed in accordance with the process described in the umbrella LON APS announcement. Information provided in the Concept Paper Template described in the umbrella LON announcement should address the objectives and criteria presented herein.

General Instructions

The Concept Paper must be specific, complete, presented concisely and written in English. The Concept Paper must demonstrate the Applicant’s capabilities and expertise with respect to achieving the objectives.

Based on the activities proposed by the Applicant, the proposed award size and duration must be specified in the Concept Paper. Proposed award duration can be less than or up to 3 years.

All Concept Papers must be submitted by the closing date listed on page 1 of this Addendum.

Submissions received after the specified closing date will not be eligible for review.

Excluding the cover page described below, the Concept Paper must not exceed five (5) pages, using Times New Roman 12-point font, on standard 8.5” x 11” sized paper, and single spaced with no less than one-inch margins and pages numbered consecutively. 10 - point font can be used for graphs and charts. Any pages submitted beyond the five-page limit will not be evaluated.

Additional documentation, such as annexes, charts and graphs that exceed the five pages will not be reviewed. USAID will not review any information provided in links in the Concept Paper.

The Concept Paper must be submitted in PDF format.

USAID TB LON CONCEPT PAPER TEMPLATE

A. Cover Page – to the extent possible or applicable, please complete the following questions below: [Note that #1-10 shall be submitted as a cover page, not included in the five-page limit for the Concept Paper.]

1. Proposed Activity Name/Title: __________________________________________

2. USAID Funding Priority/Strategic Objective/Intermediate Result: ___________________

3. Proposed Period of Performance (i.e., start date and end date): ________________

4. Overall Estimate of Funding Requested (in USDs, up to 500,000): ______________

5. Applicant Organization Name: __________________________________________

6. Applicant Contact Person (name, title, phone, email): ________________________

7. Full Address for Applicant Organization: _________________________________

8. Type of Organization (e.g., non-US, multilateral, private, for-profit, non-profit) date of incorporation, etc.): ____________________________________________________

9. Name(s) of Partner(s) (Applicants that are Implementing Partners will name Resource Partner(s) (if any) here): __________________________________________

10. DUNS number if available: _________________________________

11. Country of performance: _________________________________

B. Concept Introduction: (approximately ½ page)

Describe programmatic challenges the project will address including practical issues relevant to building capacity for planning and implementation of the TB/Mental Health integrated model in the region. Clarify implementation considerations: whether the activities are operationally feasible, and whether they can be conducted in a manner that maintains program integrity minimizing risk of harm and adequately addressing the interests of NTPs, patients, and funders.

C. Beneficiaries: (approximately ½ page) Describe the types of benefits the intervention will produce and the types and range of people who will benefit from this intervention. Was the concept designed with the end-user input? Has it or can it be adapted to reach both women and men? How can the concept be scaled up to reach more people?

D. Geographic Location: (approximately ½ page) In what region and countries are you proposing to operate? Describe key elements of and actors in the value chain or intervention in the countries in which you propose to work. What are the biggest challenges and opportunities?

E. Intervention approach: (approximately 1½ pages)

1. Proposed intervention(s) description: briefly describe scope and strategic considerations for the project and main program components: 1) building capacity framework development, 2) regional technical assistance, 3) continuous quality improvement and sustainability for local organizations, and 4) monitoring and evaluation support.

2. Epidemiological data (population demographics, disease burden, geography) can help to estimate the potential magnitude and distribution of activities as well as some limitations including gender-specific interventions adaptation and concerns.

3. The CP should include a short description of the proposed Theory of Change.

4. The applicant should illustrate a timeline for planning, initiating, and rolling-up the activities.

5. The concept paper should demonstrate current knowledge of the primary challenges related to the project implementation and a strong understanding of barriers to achieving the project purpose.

F. Intervention results: (approximately 1 page) As specifically as possible, describe the anticipated outputs, outcomes, results and/or impact of the proposed intervention. What are the key quantifiable metrics related to your project’s performance or expected performance?

G. Partner roles: (approximately ½ page) If applicable, describe and define the role of any other entities in the partnership. This must include a description of how roles will be divided and managed efficiently.

H. Applicant capacity: (approximately ½ page) Describe organizational capacity – programmatic implementations and technical skills, managerial, financial, administrative, monitoring and evaluation.

Concept paper e-mail submissions must include the APS number, Addendum Title, and applicant’s name in the subject line.

Concept Papers must be submitted to LON@usaid.gov).

VII. Evaluation Criteria

Concept Papers and subsequent Full Applications to this Addendum will be assessed according to this evaluation criteria. Overview of Merit Review criteria have been outlined in the umbrella LON APS announcement. The following technical criteria are listed in descending order of importance, and will be considered when reviewing concept papers:

A. The degree to which the Concept Paper proposes a technically sound and programmatically feasible implementation plan, realistic goals and objectives, efficient methodology to achieve outcomes, and demonstrates a strong understanding of limitations and opportunities related to the operational elements and future recommendations.

B. The degree to which the proposed objectives align with the priorities of the health care networks in the region and the proposed countries, including feasibility to implement and scale-up the proposed model of service and engagement with the appropriate expertise and stakeholders.

C. The degree to which the proposed activities have theoretical and practical significance in terms of global regulatory environment and national strategy to end tuberculosis.

D. The degree to which the concept paper demonstrates institutional capability, financial management capacity, and relevant technical expertise needed to achieve the proposed results.

Note: This Addendum serves primarily to outline the goals and priorities of USAID in making an award under the LON APS. More comprehensive information regarding the application and review processes (including Concept Paper submission, co-creation, Full Application, and Evaluation stages) can be found in the umbrella LON APS, located here.

Applicants are advised to refer extensively to both documents in preparing Concept Notes.

VIII. Questions and Further Assistance

Questions regarding the substance and objectives of this Addendum should be directed to LON@usaid.gov.

[END OF AMENDMENT 01 TO THE ADDENDUM NO. 04 TO LON APS]