LON Addendum 01 Ukraine .pdf

U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT

ANNOUNCEMENT

CALL FOR CONCEPT PAPERS

Assessment and implementation of an all-oral, shorter treatment regimen for extensively drug-resistant tuberculosis (XDR-TB) and fluoroquinolone resistant TB in Ukraine

ADDENDUM 01 TO

TB LOCAL ORGANIZATIONS NETWORK (LON) ANNUAL PROGRAM STATEMENT

APS No.: 7200AA19APS00001

CATALOG OF FEDERAL DOMESTIC ASSISTANCE (CFDA) NUMBER: 98.001

ISSUANCE DATE: August 21, 2020 CLOSING DATE FOR QUESTIONS: September 4, 2020 at 5:00PM EDT

CLOSING DATE FOR

SUBMISSION OF CONCEPT PAPERS: September 21, 2020 at 5:00PM EDT

PLEASE NOTE: This is an Addendum to an existing announcement. All interested organizations should carefully review both this addendum AND the full announcement, including all amendments, which can be found: https://www.grants.gov/web/grants/view-opportunity.html?oppId=312434. 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 working in Ukraine that have expertise in performing programmatic operational research in drug resistant tuberculosis treatment.

Subject to the availability of funding, USAID anticipates supporting Grants or Cooperative Agreements of $1,000,000 for a period less than or up to three (3) years. However, actual funding amounts are subject to availability of funds. USAID reserves the right to award multiple awards OR none at all. Unless otherwise stated herein, all terms and conditions of the LON APS apply.

I. Problem Statement and Country Context

The TB epidemic in Ukraine is characterized by widespread drug-resistant forms of tuberculosis (DR-TB), low treatment success rates, and increasing TB/HIV co-infection rates. According to national routine surveillance, in 2019 27.2 % of new TB cases and 42.7 % of previously treated TB cases had RR/MDR-

TB. Detection of MDR-TB cases increased from 5,547 in 2018 to 6,225 in 2019. In 2018, 7,926 cases of MDR-TB initiated second line treatment and 7,506 initiated in 2019.1

There has been improvement in the effectiveness of treatment among XDR-TB patients’ cohort. In the 2016 cohort, the treatment success rate of XDR-TB patients was 37%. This is just marginally below the regional average of 39.1% treatment success rate. However it is much lower than other countries in the region that also have large numbers of XDR-TB patients, namely Azerbaijan, Georgia, and Belarus that all have achieved over 50% treatment success rate of XDR-TB patients by introducing new TB drugs.2

In 2017 Ukraine introduced bedaquiline into the treatment regimens for MDR-TB and XDR-TB through operational research supported by USAID. In 2019, the National TB Program expanded use of bedaquiline throughout the country. All novel TB drugs (Delamanid, Bedaquiline) are registered in Ukraine;

Pretomanid’s registration is under negotiation with the manufacturer. Clinical regulations allow the WHO clinical guidance on implementation of new, shorter treatment regimens for DR-TB as well as implementation of operational research.

New WHO guidelines for treatment of MDR-TB were issued in November 2019, prioritizing all-oral treatment regimens. Strategically Ukraine is moving to implementation of these guidelines and supports implementation of all-oral modified shorter treatment regimen within the WHO operational research. The MOH has also indicated its interest in introducing the BPal regimen by including Pretomanid on the list of drugs that could be procured with the state budget.

COVID-19 Impact The COVID-19 outbreak is having a negative impact on TB case notifications and access TB diagnostics and treatment. The first COVID-19 case in Ukraine was registered on February 29, 2020. Strict quarantine measures were first imposed on March 16, 2020 and have been replaced by adaptive quarantine measures in May 2020. Notification of new and relapsed TB cases in the first quarter of 2020 was 7,094 which is 14.3% less than in the same period of 2019. Notification of TB and HIV co-infection also dropped to 1,147

– 20.4% less than in the same period of 2019. Access to TB services has been limited due to local travel restrictions. In addition, COVID-19 has caused global manufacturing and shipping delays for TB drugs which may lead to a shortage of certain TB drugs in Ukraine. This could further contribute to an increase in drug-resistance forms of TB as patients may experience interruptions in treatment and need to change their treatment regimens.3

National Policy in TB Ukraine’s State Strategy in the area of HIV/AIDS, TB, and Viral Hepatitis was adopted in 2019 and goes until 2030. This strategy has three strategic goals - one of which is the reduction of incidence and mortality from TB. To achieve this goal the Government of Ukraine plans to improve the system of organization and provision of anti-tuberculosis care; ensure effective detection of new cases and prevention of

1 Ukraine Application to GF 2020, Performance Framework

2 WHO, Tuberculosis Epidemiological Review: Ukraine 2019 (draft)

3 Center for Public Health https://www.phc.org.ua/kontrol-zakhvoryuvan/tuberkuloz/statistika-z-tb/analitichno-statistichni-materiali-z-tb development of resistant forms of tuberculosis; and improve the quality and effectiveness of TB treatment.

Implementation of the State Strategy is based on three-year action plans.

The State Strategy for Development of Anti-tuberculosis Care for Population was also adopted in 2019.

The goal of this strategy is to develop by 2023 a new model of prevention, early diagnostics, and provision of medical care for people with TB that meets the needs of the population in medical and public health services. This strategy focuses on implementation of approaches in provision of anti-tuberculosis care, effective anti-tuberculosis preventive measures and improvement TB detection, diagnostics and treatment of TB; optimization of laboratory network; building capacity of human resources; improvement of information system; and implementation of a new financing model.

II. Purpose

In publishing this Addendum, USAID is seeking Concept Papers from eligible local organizations in Ukraine proposing to address the challenges described in section I above by using operational research to implement new drug regimes. The activities under this Addendum will aim to achieve the stated goals by contributing to the following LON APS intermediate result:

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

Through this Addendum, USAID seeks to achieve the following objectives under IR 4:

1. Develop potential solutions for conducting program operational research and measuring efficacy of BPal treatment regimen for XDR-TB patients; using results to inform national DR-TB policy

2. Strengthen local scientific resources that can be used for further evaluation of DR-TB (including XDR-TB) therapies through operational research

3. Promote longer-term collaborative initiatives between the National TB Program and local research organizations, thereby connecting health research and policy-making in Ukraine.

Technical Focus of the Concept Paper

The XDR-TB treatment success rate remains low, necessitating further and more advanced treatment for patients. In December 2019, WHO recommended putting patients with XDR-TB on the BPal treatment regimen under operational research conditions. The introduction of a new, shorter treatment regimen -like BPal - for XDR-TB is highly demanded in Ukraine which has a high prevalence of DR-TB, including

XDR-TB.

Thus, the overall goal of this intervention is to use operational research on the introduction of new treatment regimens for XDR-TB to improve the TB treatment experience and success rates. The suggested geographic focus of the proposed concept is on treatment sites in regions with the high prevalence of XDR-TB and the health infrastructure capable of supporting the implementation of such operational research.

Concept papers should incorporate and address USAID’s guidance on the implementation of treatment options under operational research by establishing and discussing a framework that covers the following aspects:

- Research protocol developed with consideration of national DR-TB diagnostic, treatment, and management strategies, TB epidemiology, programmatic resources, and different patient populations

- Development of an institutional review board (IRB) packages; scientific and ethical approval of a country protocol(s).

- Access to both culture and molecular-based drug susceptibility testing, especially for ruling out fluoroquinolone resistance.

- Implementation of the operational research according to the WHO standards and principles of good clinical practice

- Active pharmacovigilance systems for serious adverse events (SAEs) and adverse drug reactions (ADRs).

- Treatment delivery and adherence component using patient-centered approaches with attention to the social, cultural, and environmental aspects of care and to treatment of comorbid conditions such as HIV, malnutrition, or diabetes.

- Post-treatment monitoring for 12 months to detect relapse or recurrence.4

Additional elements

Applicants should both commit to a collaborative effort with the National TB Program and with USAID/Ukraine on the proposed study and expect that the proposed research plan will be adjusted based on input from all partners.

In most cases, Concept Papers will not need to budget for drug costs as this may be provided by other partners and will be finalized during the co-creation process. However, it is expected that the Concept Paper will demonstrate capacity to facilitate importation of TB drugs into Ukraine and distribution within the country as needed.

III. Eligibility

Organizations are eligible to submit a Concept Paper in response to this Addendum that are local organizations in Ukraine, as defined in Section C of the Amendment #5 to the umbrella APS.

IV. Additional Considerations

Prior to submitting a Concept Paper, applicants should ensure that submissions are in line with the US Government Global TB Strategy. Successful Concept Papers will also align closely with the broader priorities of USAID, including the relevant Country Development Cooperation Strategies (CDCS), the Acquisition and Assistance Strategy, and the Journey to Self-Reliance.

4 USAID Guidance on DR-TB treatment. June 2020 update

USAID is especially interested in promoting new partnerships or projects, as well as existing partnerships that have not been funded by USAID previously.

V. Application and Review Process

USAID/Washington is responsible for the review process and USAID/Ukraine is responsible for the management of any awards issued under this Addendum.

Concept Papers, Full Applications, and management 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 below should address the objectives and criteria presented in Section II above.

Concept Paper Application Content and Template

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 three (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 six (6) 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 six-page limit will not be reviewed.

Additional documentation, such as annexes, charts and graphs that exceed the six 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 #1-11 shall be submitted as a cover page, not included in the six-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):____________________

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 0.5 page) Identify the TB problem you will address, and briefly describe your intervention for tackling this problem. Describe why there is a strategic need for your concept, how it differs from alternatives and any relevant gender specific considerations for the problem or solution.

C. Beneficiaries: (approximately 0.25 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 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 0.25 page) In what location(s) (e.g., province, district, city) are you proposing to operate under this proposed partnership? What are the biggest challenges and opportunities?

E. Intervention approach: (approximately 2 pages) Describe the Project purpose (formulate the research hypothesis, overall goal, and specific objectives). Describe Methodology (research and programmatic components: study design, patient population(s), timeline, etc.). Discuss the requirements and limitations.

F. Intervention results: (approximately 1 page) As specifically as possible, describe anticipated outcomes and how they will be measured.

G. Partner roles: (approximately 0.5 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 0.5 page) Describe organizational capacity – technical, managerial, financial, etc. – to carry out the proposed intervention.

I. Budget (approximately 1 page) Provide summary budget table and brief justifications.

Concept paper e-mail submissions must include the APS number, TB Local Organizations Network in Ukraine, and applicant’s name in the subject line.

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

VI. Merit Review Process for Concept Papers:

All Concept Papers received by the deadline stated in the Addendum cover page will be reviewed for eligibility and compliance with the instructions for submission prior to evaluation against the merit review criteria listed in this section. The Agreement Officer will forward to the Selection Committee (SC) those concept papers that are complete and comply with the instructions for submission. The SC will then conduct a merit review of the concept papers. The final selection of successful concept papers will be determined by the AO. A concept paper is determined to be successful if it receives a “Pass” based on the merit criteria specified in this section. The following criteria will be considered when reviewing concept papers, and are listed in descending order of importance:

A. The degree to which the concept paper proposes scientifically sound research hypothesis, overall goals and objectives, and study design and methodology to achieve outcomes and demonstrates a strong understanding of limitations related to the operational research results and recommendations.

B. The degree to which the proposed research relates to the priorities of the country, is feasible with regards to cost and capacity, and engages the appropriate expertise and stakeholders. Proposed strategies on the results dissemination and who will be the beneficiaries.

C. The degree to which the proposed study has theoretical and practical significance in terms of future sustainability as part of the national TB response.

D. The degree to which the concept paper demonstrates institutional research 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 information regarding the application and review processes (including Concept Paper submission, co-creation, Full Application, and Merit Review Information ) can be found in the Amendment #5 to the umbrella LON APS , located:

https://www.grants.gov/web/grants/view-opportunity.html?oppId=312434.

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

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

Questions regarding the substance and terms of the LON APS umbrella should be directed to LON@usaid.gov using the subject line “Question - LON APS Umbrella”.

[END OF ADDENDUM TO LON APS]