RFA-GH21-003.pdf

Centers for Disease Control and Prevention

Center for Global Health Extramural Research Program Office

Advancing Public Health Research in Kenya

RFA-GH-21-003

Application Due Date: 02/15/2021

Advancing Public Health Research in Kenya

RFA-GH-21-003

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Center for Global Health National Center for Emerging and Zoonotic Infectious Diseases National Center for Health Statistics National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention National Center for Immunization and Respiratory Diseases Notice of Funding Opportunity (NOFO) Title Advancing Public Health Research in Kenya Activity Code

U01

Notice of Funding Opportunity Type Reissue of RFA-GH-16-006 Agency Notice of Funding Opportunity Number

RFA-GH-21-003

Assistance Listings (CFDA) Number(s) 93.326 Category of Funding Activity:

Health NOFO Purpose The purpose of this notice of funding opportunity is to conduct and/or facilitate CDC-initiated epidemiologic studies and surveillance, clinical research, clinical trials, laboratory, and operations research on infectious diseases, non-communicable diseases, and environmental health in Kenya to better understand disease burden, risk factors, and effective interventions to influence policy and decrease morbidity and mortality. To accomplish these goals, the Center for Global Health also seeks to further strengthen national capacity in Kenyan institutions to effectively manage physical infrastructure and assets and improve fiscal oversight of USG-funded research at CDC-supported research sites.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-21-003, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/15/2021

Application Due Date: 02/15/2021

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 04/01/2021

Secondary Review: 06/01/2021

Estimated Start Date: 09/30/2021

Expiration Date: 02/16/2021 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 15 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose: The purpose of this notice of funding opportunity is to conduct and/or facilitate epidemiologic studies and surveillance, clinical research, clinical trials, laboratory, and operations research on infectious diseases to include emerging infectious diseases like COVID- 19, non-communicable diseases, and environmental health in Kenya to better understand disease burden, risk factors, and effective interventions to influence policy and decrease morbidity and mortality. To accomplish these goals, the CDC/Center for Global Health also seeks to further strengthen national capacity in Kenyan institutions to effectively manage physical infrastructure and assets and improve fiscal oversight of USG-funded research at CDC-supported research sites.

To improve the quality, oversight and conduct of collaborative research in Kenya and ensure CDC’s long-standing effort to build capacity in both researchers and institutions, this NOFO utilizes the following structure of cores and categories:

I. Research Core

1. Category 1: Population-based health and demographic surveillance

2. Category 2: Epidemiologic and laboratory research, and implementation science

3. Category 3: Clinical research

II. Administrative Core

1. Category 1: Research coordination and administration

2. Category 2: Laboratory research administration

The outcomes of the award will include further understanding of the infectious and non-communicable disease burden and validation of effective interventions, influencing national and global policy changes.

• Mechanism of Support: Cooperative Agreement

• Funds Available and Anticipated Number of Awards. Awards issued under this

NOFO are contingent upon availability of funds. The total number of awards is anticipated to be 1.

• Budget and Period of Performance. Total Year 1 budget is $15,000,000 (inclusive of indirect costs). Year 1 budget under the two Cores is detailed below:

• I. Research Core - $11,750,000 o Category 1. Population-based health and demographic surveillance - $4,825,000 o Category 2. Epidemiologic and laboratory research, and implementation science

- $6,075,000 Priority area 2A: Influenza and respiratory pathogens - $2,550,000 Priority area 2B: Malaria - $1,700,000 Priority area 2C: HIV & TB - $400,000

Priority area 2D: Other health research - $925,000 Outcome 2D.1: NCD - $100,000 Outcome 2D.2: Zoonotic diseases - $675,000 Outcome 2D.3: NTD - $50,000 Outcome 2D.4: VPD - $100,000

Priority Area 2E: Laboratory science and research - $500,000 o Category 3. Clinical research - $850,000

• II. Administrative Core - $3,250,000 o Category 1: Research coordination and administration - $2,000,000 o Category 2: Laboratory research administration - $1,250,000

The estimated total funds available for the entire project period is $75,000,000. The project period will run from September 30, 2021 to September 29, 2026.

• Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information” of this announcement.

• Eligible Institutions/Organizations: Institutions/organizations listed in Section III.1 are eligible to

• Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to

• Number of PDs/PIs: There will only be one (1) qualified PD/PI for each application.

Applications may include more than one PI; however, the first PI listed on the application will be the contact PI for all correspondences. Any additional PIs are permitted but would be referred or should be listed as Co-PIs. Consortia (Consortium of institutions) are invited to apply. A consortium is defined as a formal agreement whereby one PI and institution is named as lead and may partner with other institutions to implement the award. The lead recipient must perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. The PD/PI of the award must be from the lead recipient. Consortium agreements are considered subawards for the purposes of this award. The consortium agreement must be in effect at the time of application submission.

• Number of Applications: An eligible institution must apply for, and submit, a separate application for each of the core and categories outlined in the Application Submission section II, and the ‘Application Package Summary Table’. An eligible institution can only apply once for each core and category.

• Application Type: New

• Special Date(s):

Letter of Intent Due Date: January 15th, 2021.

Application Due Date: February15th, 2021.

A pre-application conference call will be held on November 10th , 2020 at 10am EST to provide details of this NOFO and the application submission process. Call-in information for this conference call is as follows: 1-888-780-9654. Information shared during the call, questions and answers provided, along with any changes and updates, will be added as an amendment to the NOFO and will be posted on www.grants.gov within a reasonable time.

• Application Materials: See Section IV.1 for application

• Hearing Impaired: Telecommunications for the hearing impaired are available at:

TTY: 1-888-232-6348.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Public Health Service Act, Section 301(a) [42 USC 2419a, as amended], Section 307 [42 USC 242L, as amended], Section 307 [42 USC 242l], as amended, Section 301(a) [42 USC 214(a)], and Section 318(k)(2) [42 USC 247(b)k2d], as well as the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123) and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, 2020 P.L. 116-136

1. Background and Purpose The overarching objectives of the NOFO are; 1) to further understand the infectious and non-communicable disease burden and to evaluate effective interventions that may lead to national and global policy recommendations, through facilitating, conducting and supporting research and strengthening surveillance systems to better understand the population-level burden and epidemiology of communicable and non-communicable diseases of public health concern in Kenya.

2) to support the research agenda and ultimately the public health impact the this NOFO it also aims to strengthening the business and research administration capacity at key Kenyan research institutions, including systems, structures and personnel development. 3) to improve and expand the content and quality of research conducted in Kenya and ensure CDC’s long-standing effort to build capacity in both researchers and institutions. This NOFO utilizes the following structure:

I. Research Core

Category 1. Population-based health and demographic surveillance

Category 2. Epidemiologic and laboratory research, and implementation science

Category 3. Clinical Research

II. Administrative Core

Category 1. Research coordination and administration

Category 2. Laboratory research administration

Purpose

The purpose of this notice of funding opportunity is two-fold:

1. To conduct and/or facilitate epidemiologic studies and surveillance, clinical research, clinical trials, laboratory, and operations research on infectious diseases, non-communicable diseases, and environmental health in Kenya to better understand disease burden, risk factors, and effective interventions to influence policy and decrease morbidity and mortality, and

2. To strengthen national capacity in Kenyan institutions to effectively manage physical infrastructure and assets and improve fiscal oversight of USG-funded research at CDC-supported research sites.

CDC’s mission is to protect and promote health in Kenya and the region through collaboration on science, policy, and evidence-based public health actions, thereby improving global health security. Kenya is one of the leading countries in Africa for public health research, detection and monitoring of infectious diseases of humans and animals, and is home to a range of endemic, emerging and re-emerging infectious agents, as well as rising rates of non-communicable diseases (NCDs). The high burden of HIV/AIDS, malaria, and tuberculosis results in substantial morbidity and mortality in many areas and can compound the impact of other infectious and non-communicable comorbidities. Threats to environmental health including varying/variable climate factors and microbial, toxic, and environmental hazards, coupled with gaps in infrastructure and sanitation, compromise the safety of air, food, and water in Kenya. NCDs, injuries and tobacco use also pose a significant and increasing public health burden in Kenya that require further assessment and strategies for prevention and control.

Background

CDC works in close partnership with the government of Kenya and other local, national and international partners to improve the understanding and prevention of morbidity and mortality related to disease, injury or environmental factors in Kenya and to improve its health systems and epidemiological and laboratory capacity to study diseases and their prevention.

Strengthening public health capacity in partner countries for public health science, surveillance, laboratory expertise and implementation of prevention measures and rapid response to disease threats through collaborative efforts will impact the health and well-being of people around the world, advancing health equity.

Public health surveillance, clinical and laboratory research programs in any setting require the support of well-organized and effective financial and research administration systems to conduct research and secure future funding. The overall impact of multi-stakeholder research agendas is also dependent on administrative support to effectively manage and coordinate stakeholder activities and ensure structures are in place for efficient coordination and communication. Strengthening the business and research administration capacity at key Kenyan research institutions, including systems, structures and personnel development will support sustainable public health surveillance and research.

Healthy People 2030 and other National Strategic Priorities

• This NOFO supports the Healthy People 2030 initiative through the global health goals to:

• Increase the number of individuals trained globally to prevent, detect, or respond to public health threats

• Increase the number of globally important public health events that are monitored and reported, and

• Increase laboratory diagnostic testing capacity, surveillance, and reporting globally (https://health.gov/healthypeople/objectives-and-data/browse-objectives/global-health).

Public Health Impact This NOFO can provide a positive health impact through the conduct of excellent public health science research on infectious and non-infectious diseases that can guide stakeholders to prioritizing resources and implementing policies to mitigate the impact of health threats.

Through better understanding of present disease threats, earlier detection of new and emerging diseases, and rapid application of existing, novel and expanded prevention and treatment measures, morbidity and mortality can be lowered and global security increased.

Kenya is home to 45 million people not only at increased risk of severe disease from common diseases, but also emerging and re-emerging infectious diseases, including but not limited to HIV/AIDS, tuberculosis, malaria, viral hemorrhagic fevers, zoonotic infections, and other diseases with pandemic potential. Understanding the spectrum of etiologies of clinical syndromes and risk factors for infection and severe disease is key to detecting novel pathogens and important changes in microbiologic and epidemiologic features of common pathogens.

Increasing the understanding of the range of pathogens and their epidemiology, and the capacity to address pressing public health needs with science, will result in a resource that is available regionally and globally to prevent, detect, and respond to public health events of international concern.

Relevant Work CDC along with other stakeholders/partners, has collaborated for more than 40 years with the Kenya Medical Research Institute (KEMRI) on the epidemiology and control of infectious diseases, non-communicable diseases, and injury. Investments have been used to build local capacity and infrastructure for large scale epidemiologic studies and clinical research trials, and to build laboratory capacity including lab accreditation, quality assurance, biosafety and infection control practices across infectious and non-communicable disease and injury areas (https://www.cdc.gov/malaria/malaria_worldwide/cdc_activities/kenya.html and https ://www.cdc.gov/globalhealth/countries/kenya/).

Population-based surveillance and health research

A large Health and Demographic Surveillance System (HDSS) in Siaya, Kisumu, and Nairobi Counties provides a foundational population-based research ?platform? on which additional epidemiologic research, clinical research, and implementation science studies have been layered. The HDSS also functions as a platform for the Gates Foundation funded Child Health and Mortality Surveillance (CHAMPS) study, in which the CDC collaborates with other implementing partners to investigate detailed causes of death in under-5?s. The HDSS has been utilized as a data and intervention platform to address emerging threats such as COVID-19 and have been utilized for seminal trials and interventions in malaria, HIV, influenza, rotavirus, and tuberculosis, which have influenced national and global policy change.

The Population-based Infectious Disease Surveillance (PBIDS) project is nested in the HDSS in Siaya and Nairobi and provides critical assessments of the link between community health practices and clinical presentation of disease in health facilities. The importance of this surveillance platform became apparent when the first COVID-19 infection in Kibera, Nairobi was detected through PBIDS.

Kenya has a generalized HIV epidemic with an estimated national adult HIV prevalence of 4.9%, annual adult incidence of 0.14%, and approximately 1.5 million persons living with HIV (PLHIV). CDC technical teams have also collaborated with the Government of Kenya to plan and execute implementation of research activities, surveys and surveillance with national and subnational governmental entities, including for example, MOH, NASCOP, National Public Health Laboratory Services (NPHLS) and Kenya Medical Research Institute (KEMRI). Other collaborators have included both PEPFAR and non-PEFAR implementing partners, local universities and other institutions.

Since 2015 the US CDC in collaboration with KEMRI has supported a maternal-child cohort in Siaya County that seeks to estimate the burden of influenza-associated respiratory illness in mothers and among their infants (born to mothers with and without influenza infection during pregnancy), and later expanding to evaluate both the immune response to influenza vaccine comparing and the level of vaccine-induced influenza antibody transfer to infants. Recently, with the emergence of SARS-CoV-2, this work has expanded to include estimating the percent of SARS-CoV-2 infections during pregnancy, describing the clinical presentation and severe outcomes associated with SARS-CoV-2 infection among pregnant women and their infants, and evaluating the level of infection-induced SARS-CoV-2 antibody transfer to infants stratified by underlying medical conditions (HIV-infection, malaria). In addition, CDC has been working to assess the impact and implications of adding seasonal influenza vaccinations to routine immunization programs in Kenya. More information about this work can be found at: https ://www.cdc.gov/flu/pdf/international/program/DIA-AnnualRept2016-2017.pdf .

The epidemiology and burden of non-communicable diseases (NCDs) in Kenya has not been fully quantified. As the COVID-19 pandemic has demonstrated, NCDs can interact substantially with infectious diseases and result in worse health outcomes than either would produce alone. CDC?s NCD research is in its nascent stage, with plans to integrate NCD assessments into the HDSS and provide the Government of Kenya with data to inform interventions addressing lifestyle factors that increase the population burden of NCDs.

Clinical Trials in HIV, TB and other infectious diseases

CDC, along with other partners have worked with KEMRI to establish, maintain, and operate the Clinical Research Unit in Kisumu. This research unit also functions as the Kisumu Clinical Research (Kisumu CRS) site under the Emory-CDC Clinical Trials Unit. The CRS has participated in numerous HIV and TB clinical research trials under globally renowned HIV research networks, many of which have influenced HIV prevention and treatment interventions globally over the last three decades. The Kisumu CRS is now poised to expand into additional infectious disease research in the coming decade.

Laboratory science and research

CDC has also established and supported HIV and other infectious disease research laboratories in collaboration with KEMRI. In addition to staffing, laboratory funding has supported procurement of state-of-the-art equipment, equipment maintenance and supplies, quality control processes, training, local and international travel, telecommunications, logistics and lab accreditation at international standards. CDC has also supported research activities in the laboratory to develop and validate diagnostic tests in HIV, TB and other areas. Capacity building and support to laboratory science and research is critical to the sustainability of a high quality, reliable, diagnostic laboratory research platform. This includes ensuring appropriate cost-allocation methods are implemented for tests conducted in the laboratories, and subsequent utilization of those allocations for their intended purposes, such as life cycle management of equipment.

2. Approach Collaborative public health research utilizing strong data and laboratory platforms will inform interventions, policy, capacity development and information sharing for the Government of Kenya and other key stakeholders.

An eligible institution must apply for each Core and Category listed below by submitting separate applications with specific titles, as outlined in the Application Submission section II.

Each application must include an SF424 R&R, a separate research plan, budget, and strategy to address each priority area. All applications submitted by an eligible institution must name the same, single lead Principal Investigator/Principal Director (PI/PD), along with all key staff responsible for programmatic oversight.

If an application is submitted by a consortium, details regarding the consortium agreement must be provided, including the management structure. The lead entity of the consortium has overall responsibility for the management plan.

Overall Management Plan

An overall management plan must be included as part of the Administrative Core application package as outlined in the Application Submission section II. The overall management plan must address the entire 5-year project period, as well as address the overall management plan for each Core and Category listed below. The overall management plan must address all categories, priority areas, outcomes and objectives listed below. The plan must describe how the applicant will manage common resources and address any potential overlap of costs and activities. The plan should name the principal investigator or other key staff responsible for overall programmatic oversight.

Applicants are expected to apply for the entire project period, with specific focus on required objectives in Year 1.

This notice of funding opportunity consists of the following sections:

THE RESEARCH CORE consists of three research categories:

1. Population-based health and demographic surveillance

2. Epidemiologic and laboratory research and implementation science

3. Clinical research

THE ADMINISTRATIVE CORE consists of two administrative categories:

1. Research coordination and administration

2. Laboratory research administration

Details for each core are below:

I. RESEARCH CORE

Category 1: Population-based Health and Demographic Surveillance

There are three priority areas (PA) under this category. Applicants must apply for Priority Area 1A and must address all the objectives under Outcome 1A.1. Additional priority areas are optional.

The duration of proposed projects may be between 1 to 5 years but should not exceed the 5-year project period.

Year 1 budget for Category 1: $4,825,000

Priority Area 1A: Health and demographic surveillance

Outcome 1A.1. Improved population health and demographic surveillance systems across Kenya for infectious and non-communicable diseases, including zoonotic and vaccine preventable diseases.

Objectives:

1. To develop, and/or expand and maintain one or more surveillance systems in Kenya combining population-based, community- and facility-based, demographic, morbidity and mortality surveillance and verbal autopsy, including hardware, software, human resources and data storage and management

2. To develop, and/or expand and maintain sentinel surveillance systems for diseases including but not limited to HIV, TB, respiratory disease, malaria, other febrile illness, enteric disease, hepatitis, meningitis and other vaccine-preventable diseases

3. To conduct additional population-based sub-studies on infectious and/or non-communicable diseases or health challenges, including those related to varying/variable climate factors, injury and mortality.

Priority Area 1B: National and sub-national health surveys

Outcome 1B.1. Robust national data on health issues of interest are collected, analyzed and disseminated

Objective:

1. To provide technical collaboration and direct implementation support to the national and subnational GOK and partners for general and key population-based and clinic-based surveys and surveillance in protocol development, tools development, training, data collection, data analysis, and dissemination.

Priority Area 1C: Impact of varying/variable climate factors and urbanization on health

Outcome 1C.1. Improved understanding of the effect of varying/variable climate factors and urbanization on health in Kenya

Objectives:

1. To evaluate increased intensity of precipitation events and the impact of flooding on water quality, including the introduction of microbial, chemical, pesticide, soil, and other non-point source runoff into rivers, lakes, or other water sources

2. To measure the degree to which flooding leads to increased prevalence of waterborne diseases in affected populations, and evaluate whether increases in minimum and maximum temperatures lead to increased geographic ranges of existing waterborne and vector-borne diseases, and through which mechanisms/pathways, during and following extreme events

3. To conduct feasibility and scalability assessments of adaptation strategies available to support Kenyans? adaptation to varying/variable climate factors health impacts.

Category 2: Epidemiologic and Laboratory Research and Implementation Science

There are five priority areas under this category.

Applicants must apply for all priority areas, with the following exceptions:

For Priority Area 2A, applicants must address all objectives under Outcome 2A.1. Other outcomes and objectives are optional.

For Priority Area 2D and 2E, applicants must address all outcomes.

Projects should not exceed the 5-year project period but can be anywhere from 1 year to 5 years.

The budget below is only for the first year.

Year 1 budget for Category 2: $6,075,000 ? this is the total budget for this category and breakdown per PA noted below.

• Priority Area 2A: $2,550,000

• Priority Area 2B: $1,700,000

• Priority Area 2C: $400,000

• Priority Area 2D: $925,000 o Outcome 2D.1: $100,000 o Outcome 2D.2: $675,000 o Outcome 2D.3: $50,000 o Outcome 2D.4: $100,000

• Priority Area 2E: $500,000

Priority Area 2A: Influenza and Respiratory Pathogens

Year 1 budget for Priority Area 2A: $2,550,000

Outcome 2A.1. To better understand the disease burden of influenza and other respiratory pathogens nationally and among groups at increased risk of influenza complications to guide targeted public health interventions

Objectives:

1. To maintain a maternal and child cohort for active surveillance to assess disease burden, mortality and the relative contribution of influenza, SARS-CoV2, and other infections during pregnancy to the health of mothers, newborns, birth outcomes (e.g., pre-term delivery, low-birth weight), and child growth development

2. To determine and better understand the etiologies, disease and mortality burden of influenza and other respiratory pathogens nationally and among groups at increased risk of influenza complications to guide targeted public health interventions

3. To conduct surveillance for human respiratory pathogens including but not limited to avian and human influenza, SARS-CoV-2 in Kenya, maintaining an archive of study and surveillance specimens to answer additional questions of public health importance related to respiratory diseases

4. To assess efficacy/effectiveness, immunogenicity and impact of vaccines, treatments, and non-pharmaceutical interventions (NPIs) and other control measures to reduce the burden of influenza disease and COVID-19 among high-risk and vulnerable populations, using quantitative and/or qualitative methods.

Outcome 2A.2. A better understanding of the cost, effectiveness and feasibility of introducing respiratory disease control strategies

Objectives:

1. To research and/or assess effectiveness of respiratory disease control strategies, newly introduced vaccines, investigational new drugs and delivery modalities

2. To evaluate cost effectiveness and viability of introducing influenza or other respiratory vaccination programs in Kenya.

Priority Area 2B: Malaria

Year 1 budget for Priority Area 2B: $1,700,000

Outcome 2B.1. Availability of robust, near real-time data for the monitoring of malaria transmission, utilization of prevention and treatment interventions, drug efficacy and resistance

Objectives:

1. To conduct entomological surveillance, including but not limited to insecticide resistance and outdoor transmission, composition and behavior of malaria disease vectors

2. To monitor or measure use, coverage, efficacy and effectiveness of known and newly proven interventions (e.g., ITNs, IPTp, IRS, CM, malaria vaccine). This includes monitoring antimalarial drug efficacy/resistance both in-vivo and in-vitro.

Outcome 2B.2: Clinical and Operational research result in the development and/or feasibility assessments of new malaria prevention and treatment tools

Objectives:

1. To conduct epidemiological and/or clinical research on the development or assessment of new or existing tools for transmission and/or morbidity reduction, including, but not limited to vector control tools, pharmaceuticals, vaccines, and population-based strategies or campaigns

2. To conduct operational research, including but not limited to social-cultural research aimed at improving uptake of known/proven malaria control strategies to accelerate progress towards malaria elimination in western Kenya, and testing new tools/interventions to further reduce malaria transmission with the ultimate goal of malaria elimination.

Priority Area 2C: HIV and Tuberculosis

Year 1 budget for Priority Area 2C: $400,000

Outcome 2C.1. Improved understanding of the changing epidemiology of HIV and TB, with data to support innovative interventions

Objectives:

1. To facilitate or conduct research and surveillance to understand the changing epidemiology of HIV and/or TB

2. To facilitate or conduct research on the effectiveness and acceptability of new and/or improved prevention, care and treatment interventions for HIV, TB, STI and other related diseases, including but not limited to biomedical, behavioral and structural interventions.

Outcome 2C.2.: Robust national-level research data exists to guide changes in the HIV response

Objective:

1. To facilitate or conduct quantitative and qualitative studies, surveys and surveillance with national and subnational GOK entities, including for example, MOH, NASCOP, National Public Health Laboratory Services (NPHLS) and Kenya Medical Research Institute (KEMRI), non-governmental organizations, local universities and other institutions.

Priority Area 2D: Other Health Research

Year 1 budget for Outcome 2D.1: $100,000

Year 1 budget for Outcome 2D.2: $675,000

Year 1 budget for Outcome 2D.3: $50,000

Year 1 budget for Outcome 2D.4: $100,000

Outcome 2D.1. Noncommunicable Disease (NCD) burden, mortality and related data is available to provide guidance to the Government of Kenya on developing NCD-specific services.

In this research NOFO, NCDs investigated may include, but are not limited to: Cancer, hypertension, diabetes and cardiovascular disease. Here they are referred to individually and collectively as ?NCD? or ?NCDs?.

Objectives:

1. To develop baseline data for NCD and infectious disease comorbidity burden, using innovative surveillance techniques, leveraging existing surveillance platforms

2. To develop pilot studies which demonstrate novel approaches for the prevention, diagnosis, treatment, and control of NCDs, including lifestyle, behavioral and/or biomedical approaches that address the primary risk factors for NCDs

Outcome 2D.2. Development of a scientific base to advance the multi-sectoral One Health platform, which cuts across human, animal and environmental health.

Objectives:

1. To conduct research on human/animal interactions to advance epidemiologic understanding zoonotic diseases including human-animal transmission dynamics, antimicrobial resistance patterns, effective interventions, and environmental factors influencing zoonotic diseases

2. To longitudinally investigate antimicrobial resistance, antibiotic use, and antibiotic seeking behavior at healthcare facilities in low-income communities, including prospective and/or retrospective analysis of environmental, vaccine-related, and other factors.

3. To evaluate light infrastructure and behavioral/managerial improvements of public sanitation facilities

4. To evaluate surface water contamination (biological and physio-chemical, e.g. fecal microbes, metals, pH, turbidity, conductivity, total dissolved solids) in lakes and rivers

Outcome 2D.3. Improved understanding of the impact of NTDs on health and their role as comorbid infections with other infectious and non-communicable diseases.

Objectives:

1. To evaluate the impact of NTDs on susceptibility to other infections such as malaria and

HIV

2. To measure the effectiveness and impact of control interventions for NTDs including mass drug administration (MDA), intermediate host control approaches, sanitation, and other methods of transmission reduction

3. To conduct operational research to assess the efficacy/ effectiveness of NTD control tools including diagnosis and improvement routinely collected surveillance data

Outcome 2D.4. Improved understanding of the burden of other vaccine-preventable diseases (VPDs) and the socio-cultural and political factors which affect access to vaccinations

Objectives:

1. To estimate disease burden of groups at increased risk of vaccine preventable diseases (VPDs) to guide targeted public health interventions including, but not limited to, vaccination

2. To assess efficacy/effectiveness, immunogenicity and impact of vaccines, coverage, schedules, treatments and other interventions to reduce burden of VPDs

3. To conduct socio-cultural and behavioral research on knowledge, attitudes, and practices related to VPDs

4. To conduct research on the immunization information systems, social mobilization, communications, equity, coverage, and quality of immunization service delivery, including identifying barriers to vaccination in high-risk groups

Priority Area 2E: Laboratory Science & Research

There is one outcome under this priority area. Applicants must address all the objectives under Outcome 2E.1.

Year 1 Budget: $500,000

Outcome 2E.1: Laboratory-based research on new and/or improved assays and equipment is conducted in Kenya, contributing to the global body of knowledge.

Objectives:

1. To conduct laboratory-related research that is related to epidemiology, prevention, management and treatment of infectious and non-communicable diseases in Kenya

2. To evaluate the operational utility of reference laboratory-based and handheld antibody multiplex approaches for NTDs, other (parasitic, bacterial and viral) infectious agents, and vaccine coverage surveys

3. To improve knowledge of new laboratory technologies, diagnostic systems and clinical models with quality, timeliness and accuracy of lab data

Category 3: Clinical Research

Priority Area 3A: Clinical Research Capacity Building and Conduct of High Impact Clinical Research

There are two outcomes under this category. Applicants must apply for Outcome 3A.1 and address both objectives. Applying to additional outcomes is optional.

Year 1 Budget for Category 3: $850,000

Outcome 3A.1: High-impact HIV prevention clinical research contributes to improved global policy and practices

Objectives:

1. To conduct clinical research on HIV prevention and infectious diseases while continually ensuring the ability of Kenyan staff to plan, develop, implement and evaluate clinical research trials

2. To create a standardized system of integrated epidemiologic and science-based support for clinical trials

Outcome 3A.2: High-impact prevention and treatment clinical research contributes to improved global policy and practices.

Objective:

1. To conduct clinical research aimed at reducing morbidity and mortality from infectious and non-communicable diseases

II. ADMINISTRATIVE CORE

Applicants must apply and be funded for the administrative core to be funded for research core categories. The Administrative Core application package consists of the administrative core categories and must include the overall management plan.

The key objectives under the Administrative core are focused on Research and Laboratory, with budgets noted as below:

Year 1 budget for Administrative Core: $3,250,000

• Year 1 budget for Category 1: $2,000,000

• Year 1 budget for Category 2: $1,250,000

Category 1. Research Coordination and Administration- $2,000,000

Outcome 1A: Well-managed finances in a well-organized business administration system can effectively support multi-stakeholder research in Kenya.

Objectives:

1. To coordinate and collaborate with local and international stakeholders and donors engaged in health research in Kenya to further strengthen the Kenya research portfolio.

This would include partnering with KEMRI and/or other Kenyan institutions engaged in health research.

2. In collaboration with KEMRI, to support development of life cycle management of physical assets through improved cost allocation plans and utilization of said plans

3. To strengthen organizational effectiveness of local partners to manage and maintain shared infrastructure and staff bu building capacity to capture and delineate costs

4. To ensure local researchers can successfully apply for, and manage, research funding by training, mentoring and otherwise supporting Kenyan researchers to develop and implement research protocols, secure funding for research, and disseminate research results

5. To train and mentor on epidemiology activities that are central and most relevant to sustainable scientific work in Kenya

6. To ensure all local stakeholders have the administrative and research expertise needed to sustain high impact health research in Kenya

7. To provide routine research portfolio updates to stakeholders

8. To ensure all research ethics procedures are followed to the satisfaction of all internal review boards (IRBs)

9. To provide fiduciary oversight for subawards; review, monitor and confirm cost allocation

10. To ensure integration of physical and data (HDSS or other) systems costs into routine costing of campus operations

Category 2. Research Laboratory Administration - $1,250,000

Outcome 2A: Self-sustaining and highly functional state-of-the-art research laboratories play a key role in supporting clinical, epidemiological and operational research in Kenya

Objectives:

1. To deliver high quality laboratory technical services and training in support of health research

2. To improve cost allocation on laboratory testing fees and utilization of this fees to monitor equipment performance, maintenance and service, and supply chain

3. To support and develop laboratory platforms for etiologic investigation, evaluation of novel diagnostic assays and point-of-care diagnostics for faster and easier detection and characterization of pathogens

4. To maintain optimal and timely accreditation standards and ongoing quality assurance processes including participation in all external quality assurance for tests conducted in the laboratory

5. To ensure the research laboratories develop and maintain an integrated system that includes data management, ethics, human subjects? protections, protocol development and monitoring, and commodity supply chain processes in the laboratory

6. To identify gaps in knowledge and skills for key researchers collaborating with CDC and the recipient, and create an annual training plan to help address these gaps

7. To increase research laboratory staff knowledge of data management systems, ethics, quality control, human subjects? protection, protocol development and compliance

8. To improve research laboratory staff knowledge of new laboratory technologies, diagnostic systems and clinical models with improved quality, timeliness and accuracy of laboratory data

Summary Table of Required and Optional Outcomes

Core Category Priority Area

Outcome Objectives Required/

Optional

Year 01 Funding ceiling

1A 1A.1 1-3 Required

1B 1B.1 1 Optional

1. Population-based health and demographic surveillance

1C 1C.1 1-3 Optional

$4,825,000

2A.1 1-4 Required2A

2A.2 1-2 Optional

$2,550,000

2B.1 1-2 Required

I. Research

2. Epidemiologic and laboratory research, and implementation science

2B

2B.2 1-2 Required

$1,700,000

2C.1 1-2 Required2C

2C.2 1 Required

$400,000

2D.1 1-2 Required $100,000

2D.2 1-4 Required $675,000

2D.3 1-3 Required $50,000

2D

2D.4 1-4 Required $100,000

2E 2E.1 1-3 Required $500,000

3A.1 1-2 Required3. Clinical research 3A

3A.2 1 Optional

$850,000

1. Research coordination and administration

N/A 1A 1-6 Required $2,000,000II.

Administrative

2. Laboratory research administration

N/A 2A 1-6 Required $1,250,000

Total $15,000,000

Objectives/Outcomes

Target Population As part of a comprehensive global health research funding opportunity, the target populations are as follows:

• Residents of Kenya in counties who have or who are at high risk of, or affected by, infectious and/or non-communicable diseases

• Those living in counties with specific health concerns or where CDC support may be prioritized

Collaboration/Partnerships

• Collaboration with the Kenyan Government, such as the Kenya Ministry of Health and the Kenya Medical Research Institute (KEMRI), is required. An applicant must document this collaboration by submitting a letter of support. Please see Section III.5 - Eligibility Information, Responsiveness for specific submission requirements.

• Collaboration with other CDC implementing partners is required. The recipient must partner with other CDC implementing partners, including non-governmental organizations, educational institutions, Ministries of Health, and other host governmental bodies, including multi-lateral organizations that receive CDC funds. The recipient?s proposal should complement activities already implemented by other CDC-funded organizations. The recipient should ensure their proposed activities are not duplicating activities already implemented by other CDC-funded organizations.

• Collaboration is expected with organizations not funded by CDC: The recipient will be expected to work with other stakeholders in country and at the global level including but not limited to other government entities, non-governmental organizations, universities, civil society, the private sector, and other USG agencies.

Evaluation/Performance Measurement Performance will be continuously monitored during the life of the award, with quarterly meetings held between the recipient and CDC. The recipient will work with CDC and other global partners as appropriate to develop and implement an evaluation plan and performance measures after award. Some examples of potential performance measures for a selection of categories are listed below:

Epidemiologic and Laboratory Research, and Implementation Science

• Number of protocols launched on planned timeline

• Proportion of participants recruited on time

• Proportion of studies completed on time

Clinical Research

• Number of clinical research networks enrolled in

• Number of new clinical research studies added each year

Administrative Core

• Implementation of necessary administrative standard operating procedures

• Number of planned routine meetings with key stakeholders scheduled and completed

• Timely submission of quarterly financial plan with clear cost allocation breakdown

• Timely submission of progress reports and dissemination to key stakeholders

• Number of staff completed human subjects research training

• Number of labs which maintain current levels of lab accreditation

• Number of labs which increase level of lab accreditation

• Number of necessary laboratory standard operating procedures drafted, reviewed and approved

• Number of staff protocol violations

• Implementation and utilization of cost allocation plans for campus management and laboratory services

• Number of commodities stockouts at each research site

• Number of physical assets which exceed their expected life span

• Time from report to repair of physical assets or infrastructure

• Proportion of expected routine maintenance checks conducted on physical assets and intrastructure

Translation Plan Applicant should describe plans for how research and scientific findings will be reported and disseminated (e.g., peer-reviewed journals, scientific presentations, reports, meetings and conferences) and specify how these activities are integrated into the project plan. The translation of findings should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users.

Questions to consider in preparing this section include:

• How will the scientific findings inform the Kenyan government and other stakeholders to introduce public health policy or practice in Kenya?

• How will the project improve or affect the translation of study findings into policy or practice?

• How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public health programs and practices?

• How will the findings advance or guide future scientific efforts or related activities?

• How will the research improve health outcomes?

Section II. Award Information Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $75,000,000

Anticipated Number of Awards: 1

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award ceiling and floor are for the first 12-month budget period only.

Award Ceiling: $15,000,000 Per Budget Period

Award Floor: $0 Per Budget Period Total Period of Performance Length: 5 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/…