Foa_Content_of_CDC-RFA-GH-24-0070.pdf

Centers for Disease Control and Prevention

Center for Global Health

Building an Effective, Robust and Sustainable Integrated Sample Transportation System in Cameroon under the President's Emergency Plan for AIDS Relief (PEPFAR)

CDC-RFA-GH-24-0070

02/17/2024

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- GH-24-0070. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Building an Effective, Robust and Sustainable Integrated Sample Transportation System in Cameroon under the President's Emergency Plan for AIDS Relief (PEPFAR) C. Announcement Type: New - Type 1:

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For purposes of this NOFO, research is defined as set forth in 45 CFR 75.2 and, for further clarity, as set forth in 42 CFR 52.2 (see eCFR :: 45 CFR 75.2 -- Definitions and https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR- 2007-title42-vol1-sec52-2.pdf. In addition, for purposes of research involving human subjects and available exceptions for public health activities, please see 45 CFR 46.102(l) (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section- 46.102#p-46.102(l)).

Applicants should note that a Letter of Intent (LOI) is not requested or required as part of the application for this NOFO or for any CDC PEPFAR FY24 NOFO. Applicants should not submit LOIs.

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH-24-0070

https://www.grants.gov/ https://www.grants.gov/ https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l)

E. Assistance Listings Number:

93.067 F. Dates:

1. Due Date for Letter of Intent (LOI):

12/04/2023

2. Due Date for Applications:

02/17/2024 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph This NOFO will support an integrated laboratory sample referral and transport system for HIV, TB, and other emerging public health concerns. It seeks to ensure optimal turnaround time of results, provide improved quality laboratory testing services for clients supported by PEFPAR, promote sustainability of an optimized diagnostic network, and strengthen laboratory health systems in Cameroon. Routine viral load (VL) monitoring continues to be scaled up across the country to reach all eligible clients on treatment, considering alternate specimen collection modalities, such as dried blood spots (DBS), and cold chain infrastructure. Monitoring key quality performance indicators of the developed and implemented national integrated sample referral system will be critical. To aid with monitoring turnaround time, sample quality, and effective use of the implemented system, laboratory information systems (LIS) will also be strengthened at high-volume testing sites to maximize impact. Through this NOFO, national capacity will be strengthened for transportation and referral of samples for laboratory testing services and return of results for HIV, TB, and emerging infectious diseases. This NOFO will also support tailored laboratory waste management strategies and transport networks for the safe and efficient transport of waste generated from molecular testing reference laboratories for safe disposal and to minimize environmental impact.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards The expected number of awards is 1.

d. Total Period of Performance Funding:

$0 https://www.grants.gov/

The Approximate Project Period of Performance Funding/Estimated Total Funding for the Total 5 year Project Period is None. The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for years 2-5 will be set at continuation.

e. Average One Year Award Amount:

$3,000,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $3,000,000. The expected number of awards is 1. Exact amounts for each award under this NOFO will be determined at the time of award. Applicants are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount.

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

September 30, 2024

h. Cost Sharing and / or Matching Requirements:

No Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview An efficient integrated specimen referral and transport system is critical for early disease detection, clinical monitoring, and timely reporting by laboratory networks. Current programs are implementing siloed, multiple, and ad hoc sample transport systems (STS). Most of these STS are partner-driven and disease specific, leading to duplicated efforts. Equipment placement is decentralized and although several laboratory network mappings have been conducted, laboratory testing decisions are not based on them. This has led to long turn-around times (TATs) and delays in critical decisions for care and treatment options.

Major focus areas for the HIV epidemic response include improving performance indicators for early infant diagnosis (EID), VL, and TB. Samples for VL, EID and TB rely on referral and transport networks for diagnosis. Diagnostic capacities are not equal across the laboratory-tiered system in PEPFAR-supported sites. Samples collected at district health facilities are shipped to reference laboratories for testing, and results are returned for clinical decisions. Sub-optimal performance for VL, EID, and TB are partly due to a non-functional STS that has led to high sample rejection rates and longer TAT for results, impacting PEPFAR program indicators and hindering efforts to reach epidemic control.

The recipient will support the Ministry of Public Health (MOH) to build an effective and sustainable STS at national and sub-national levels based on international standards and best practices. The NOFO will build the capacity of MOH staff and other key stakeholders on sample packaging, storage, and shipment, including biosafety/biosecurity measures. The recipient will support the procurement and distribution of sample transport materials respecting triple packaging. Additionally, the recipient will provide technical assistance for the development and implementation of a system for monitoring and tracking to ensure specimen integrity and quality.

The recipient will also provide guidance and support for cold chain maintenance at all points and in developing and implementing standard operating procedures (SOPs), guidelines, tools, and job aids for sample transport at national and sub-national levels. Moreover, the recipient will support mentorship activities to MOH and other key stakeholders to conduct site evaluations and supportive supervision with continuous quality improvement (CQI) initiatives. Other areas of support will include developing quality controls and assurance strategies, guiding efforts aimed at strengthening systems for sample tracking/monitoring, including enhancing sample transportation data collection, analysis, and reporting for informed decision-making, and leveraging the sample transport model to support laboratory waste collection, transport, and management.

Through this NOFO, an STS will be established as part of sustainable public health systems strengthening resulting in increased volume of specimens collected and tested over time; shorter TAT of results for clinical decision-making and fewer patient visits to health facilities; faster ART initiation or regimen change for patients as results are returned more promptly and consistently; and reduced specimen rejections in the reference laboratories. Efficient STS will encourage decentralization of services as more health facilities offer ART services. An efficient STS will equally improve TB service delivery and outcomes since in standalone PEPFAR-supported HIV sites without TB diagnostic and treatment centers, patients are often referred to other sites.

b. Statutory Authorities This program is authorized under Public Law 108-25 (the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003) [22 U.S.C. 7601, et seq.] and Public Law 110-293 (the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008), and Public Law 113-56 (PEPFAR Stewardship and Oversight Act of 2013).

The President’s Emergency Plan for AIDS Relief (PEPFAR) has called for immediate, comprehensive and evidence-based action to turn the tide of global HIV/AIDS. The overarching purpose of this NOFO is to fund activities to prevent or control disease or injury and improve health, or to improve a public health program or service.

c. Healthy People 2030 N/A

d. Other National Public Health Priorities and Strategies Under the leadership of the Global Health Security and Diplomacy Bureau (GHSD Bureau), as part of PEPFAR, the U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (HHS/CDC) works in partnership with host country governments and other key partners to assess the needs of each country and design a customized program of assistance that fits within the host nation's strategic plan in a manner consistent with the purposes of this NOFO. Goals and priorities include the following:

• Reducing the prevention and treatment gaps for adolescent girls and young women (AGYW), children, and key populations (KPs);

• Strengthening national and local programmatic, financial, and community leadership;

• Designing new partnerships with key private, public, and multi sector entities that can complement existing programs and expand reach;

• Utilizing the PEPFAR platform for broader disease surveillance and public health programming, consistent with the PEPFAR legislative and funding authority;

• Investing in the scale-up of cutting edge behavioral and implementation science to bend the curve on new infections;

• Improving the care and treatment of HIV/AIDS, sexually transmitted infections (STIs), and related opportunistic infections by improving STI management; enhancing laboratory diagnostic capacity and the care and treatment of opportunistic infections; interventions for intercurrent diseases impacting HIV infected patients including tuberculosis (TB); and initiating programs to provide anti-retroviral therapy (ART);

• Strengthening the capacity of countries to collect, use, and share surveillance data and manage national HIV/AIDS programs by expanding HIV/STI/TB surveillance programs and strengthening laboratory support for surveillance, diagnosis, treatment, disease monitoring, and HIV screening for blood safety; and

• Developing, validating, and/or evaluating public health programs to inform, improve, and target appropriate interventions, as related to the prevention, care and treatment of HIV/AIDS, TB, and opportunistic infections.

In an effort to ensure maximum cost efficiencies and program effectiveness, HHS/CDC also supports coordination with and among relevant partners. Recipients may be requested to participate in the following programmatic activities:

• Scale-up evidence-based programs to identify and close the major HIV gaps among AGYW, children, and KPs;

• Increase impact through strategic coordination and integration;

• Strengthen and leverage key multilateral organizations, global health partnerships, and private sector engagement;

• Encourage country ownership and invest in country-led plans, putting our national and local partners in the lead and actively enabling their growth through design of the program at all phases;

• Build sustainability through investments in health systems;

• Enhance health equity and reduce disparities in access to and uptake of HIV services;

• Improve performance metrics, monitoring and evaluation and the quality of related data;

and

• Promote research, development, and innovation to develop a body of knowledge, enhance awareness and increase the skills and abilities of stakeholders (research is not supported by this NOFO).

PEPFAR defines national HIV epidemic control as the point at which the number of new infections falls below the declining number of deaths among people living with HIV (PLHIV).

This definition of epidemic control does not suggest near-term elimination or eradication of HIV as may be possible with other infectious diseases, but rather suggests a decline of HIV-infected persons in a population, achieved through the reduction of new HIV infections when mortality among PLHIV is steady or declining, consistent with natural aging. Critically, however, a country will not be able to maintain epidemic control if program efforts are not sufficiently sustained and new infections are allowed to rebound or death rates to increase.

In addition to the specific activities listed in the Strategies and Activities section of this NOFO, all CDC PEPFAR cooperative agreements resulting from this NOFO may address the following activities, where and when appropriate, that focus U.S. government resources and activities toward achieving and sustaining the HIV/AIDS epidemic:

• Optimize HIV testing and treatment strategies to reach undiagnosed populations living with HIV, especially young adults, men, and KP. These strategies may include or build upon traditional methods and activities related to outbreak detection, investigation, and response, including efforts to reduce or remove evidenced barriers to services such as stigma and discrimination and inequitable gender norms. Responding to recent infections or ongoing patterns of transmission will be prioritized.

• Focus on prevention among children, adolescents, young adults, and members of vulnerable and key populations.

• Support surveillance activities and programs, along with information systems, that improve understanding of HIV epidemiology, help identify inequities and remaining gaps (e.g., societal impediments to HIV services), and inform future programming.

• Support efforts to maintain quality for laboratory systems and activities, including diagnostics and viral load measurement.

• Actively use epidemiologic, program, and financial/cost data to ensure implementation of high quality, cost-effective programs to improve partner performance and increase epidemiologic impact.

• Support country-led, sustainable programming by working with and implementing activities through local partners, including faith communities and faith-based organizations (FBOs), HIV network organizations and community-based organizations (CBOs) directly servicing communities and populations at-risk and most affected by HIV to build local capacity.

• Strengthen programmatic, financial, and community contributions by partner governments in the HIV/AIDS response.

• Support activities, interventions, and programs (e.g., including those intended to reduce or remove evidenced societal impediments to services such as stigma, discrimination, and inequitable gender norms) to find, treat, and prevent TB among PLHIV and to identify and treat HIV among people infected with TB.

• Support efforts to prevent, detect, respond, and treat infectious and non-infectious diseases that impact PLHIV and populations affected by HIV.

Any activities outside of HIV or TB activities will be consistent with the direction set forth in PEPFAR’s Five-Year Strategy, PEPFAR’s annual Country/Regional Operational Plan (COP/ROP) Guidance, annual COPs/ROPs, or other similar forthcoming strategy, guidance, or planning documents as may be consistent with applicable law.

Geographic prioritization may change over the course of the period of performance based on the burden of disease and changing program and PEPFAR priorities.

If the scope of activities to be conducted by the recipient(s) of funds under this NOFO includes work with KP, the recipient(s) will be expected to collaborate with KP organizations in the design and delivery of appropriate optimal and quality HIV services to KP.

Any Personally Identifiable Information (PII) collected for continuity of service provision should be managed in a manner that ultimately protects individual-level data to the extent allowed by applicable law.

In addition, PEPFAR is committed to protecting children from abuse, exploitation, and neglect in order to decrease their vulnerability to HIV/AIDS. Consistent with underlying authorities, PEPFAR seeks to ensure that children and youth obtaining services through PEPFAR programming are also protected from abuse, exploitation, and neglect in CDC PEPFAR-supported programs. To that end, because activities to be funded under this NOFO may involve children or personnel coming into contact with children, Recipients of CDC PEPFAR funds agree to ensure compliance with host country and local child welfare and protection legislation or international standards, whichever gives greater protection, and with U.S. law, where applicable. Further, Recipients of CDC PEPFAR funding are strongly encouraged to: 1) have in place policies and procedures that prohibit recipient personnel from engaging in child abuse, exploitation, or neglect; 2) consider child safeguarding in project planning and implementation to determine potential risks to children that are associated with project activities and operations; 3) apply measures to reduce the risk of child abuse, exploitation, or neglect, including, but not limited to, limiting unsupervised interactions with children; prohibiting exposure to pornography; and complying with applicable laws, regulations, or customs regarding the photographing, filming, or other image-generating activities of children; 4) promote child-safe screening procedures for personnel, particularly personnel whose work brings them in direct contact with children; and 5) have a process for ensuring that personnel and others recognize child abuse, exploitation, or neglect, report allegations, investigate and manage allegations, and take appropriate action in response to such allegations. It is also strongly encouraged that Recipients include the above provisions in any applicable code of conduct for its personnel implementing PEPFAR-funded activities.

In its work with partners, CDC seeks to help control HIV epidemics and to achieve and maintain low levels of HIV incidence and mortality. Now and in the future, viable, capable, durable, and successful local partners will play an important role in achieving and sustaining control of national HIV epidemics. To that end, CDC strongly encourages direct applications from local organizations (i.e., institutions located, registered, and managed in the country and/or sub-region where work occurs and led by national of that country and/or sub-region). U.S.-based partners working in international settings also offer unique capabilities and will continue to make important contributions. Partnerships between local organizations and U.S.-based organizations may also offer benefits and are encouraged in such cases.

This NOFO is only for non-research activities supported by CDC. Recipients may not use funds for research. Certain activities that may require human subjects review due to institutional requirements but that are generally considered not to constitute research (e.g., formative assessments, surveys, disease surveillance, program monitoring and evaluation, field evaluation of diagnostic tests, etc.) may be funded through this mechanism. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102

e. Relevant Work Lower-tiered laboratories in PEPFAR-supported sites lack the capacity and resources to conduct molecular confirmatory testing for HIV. VL, EID, and TB samples rely on referral systems for diagnosis., in some PEPFAR-supported sites, motorbikes pick up VL, EID, and TB samples from health facilities and transport them to reference testing laboratories. Alternatively, healthcare workers pick up and hand-carry samples for referral through commercial transportation systems.

Despite efforts to improve the existing system, challenges with coordination between collecting health facilities and reference laboratories are negatively impacting program performance for VL, EID, and TB. In addition, untrained staff and inappropriate material resources for proper packaging, labeling, monitoring/tracking, and storage of samples are affecting sample quality and integrity. Delays in sample pick up, safety issues, and increased TAT for test results are among other challenges.

In the Country Operational Plan 2023 (COP23), a major focus for PEPFAR Cameroon is improving on VL, EID, and TB program performance. A harmonized, integrated, efficient, and functional sample referral/transport system will enhance coordination, ensure necessary resources are in place to preserve sample integrity, quality, and biosafety and reduce TAT for test results — an uptrend in VL, EID and TB indicator performance.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short Term Outcomes

Intermediate Outcomes Long Term Outcomes https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102

i. Purpose The purpose of this NOFO is for the recipient to implement the STS which in turn supports MOH by implementing an effective, integrated, and sustainable STS in Cameroon aimed at

Strategy 1:

Implement an integrated STS to optimize diagnosis and treatment monitoring for HIV, TB, other co-infections, and emerging infections

Strategy 2:

Strengthen biosafety, biosecurity, and logistics capacity for sample referral to ensure quality and integrity of samples

Strategy 3:

Establish data systems and monitoring and evaluation capacity at all sample transportation levels including specimen referring facilities, hubs, and conventional laboratories that are complimentary to other systems to track, manage and evaluate sample transport

Reduced result turnaround time to facility and people living with HIV (PLHIV) and TB

Improved VL coverage for all

PLHIV

Increased volume of quality samples collected and tested at reference laboratories

Increased human resource capacity to support STS

Improved real-time tracking and management of samples and results

Improved identification and ratification of transport challenges

Improved sample transport data collection, analysis, and reporting

Reduced visits to health facility for lab results by clients

Sustained VL coverage for all PLHIV

Increased use of laboratory results in a timely manner by clinicians

Improved efficiency and utilization of resources

Improved standardization and integration of transport system

Improved efficiency, timely referral, and delivery of samples

Increased engagement with all partners to ensure synergy of entire logistic processes

Improved sample collection quality, integrity packaging, and transport biosafety

Improved quality of diagnostic testing through proper handling of specimens and results

Increased access to diagnostic testing, improved timeliness of test and results for clients

Improved timely diagnosis, treatment, linkage, and monitoring of PLHIV to HIV care and ART services

Improved intensified case finding and TB treatment among TB/HIV co-infected patients

Increased coverage, adherence, retention, and viral load suppression (VLS) of PLHIV on ART

Improved laboratory network systems

Improved services for HIV, TB, co-morbidities, and emerging infectious disease services

Sustained national, integrated STS

Improved, sustained monitoring of sample transportation

Sustained synergy of laboratory processes among all partners improving sample referrals/transport networks and reducing high sample rejection rates and diagnostic TAT. It is meant to complement the existing STS and provide a stepwise approach for harmonizing and scaling up an optimized STS in Cameroon.

ii. Outcomes CDC may require or allow applicants to propose additional related project period outcomes other than those identified in the NOFO.

Short-Term Outcomes:

• Reduced result turnaround time to facility and PLHIV and TB

• Increased volume of quality samples collected and tested at reference laboratories

• Increased human resource capacity to support STS

• Improved real-time tracking and management of samples and results

• Improved identification and ratification of transport challenges

• Improved sample transport data collection, analysis, and reporting

Intermediate Outcomes:

• Reduced visits to health facility for lab results by clients

• Increased use of laboratory results in a timely manner by clinicians

• Improved efficiency and utilization of resources

• Improved standardization and integration of transport system

• Improved efficiency, timely referral, and delivery of samples

• Increased engagement with all partners to ensure synergy of entire logistic processes

• Improved sample collection quality, integrity packaging, and transport biosafety

• Improved quality of diagnostic testing through proper handling of specimens and results

• Increased access to diagnostic testing, improved timeliness of test and results for clients

Long-Term Outcomes:

• Improved timely diagnosis, treatment, linkage and monitoring of PLHIV to HIV care and treatment services

• Improved intensified case finding and TB treatment among TB/HIV co-infected patients

• Increased coverage, adherence, retention, and VLS of PLHIV on ART

• Improved laboratory network systems

• Improved services for HIV, TB, co-morbidities, and emerging infectious disease services

• Sustained national, integrated STS

• Improved, sustained monitoring of sample transportation

• Sustained synergy of laboratory processes among all partners

iii. Strategies and Activities CDC may require or allow applicants to propose additional related strategies and activities other than those identified in the NOFO to achieve the expected Outcomes.

Strategy 1: Implement an integrated STS to support diagnosis and treatment monitoring for HIV, TB, other co-infections, and emerging infections

• Implement a stepwise approach to transform existing STS into a robust and integrated sample referral network of key disease areas to support efficient and optimized sample movement and result delivery that can be scaled up over time

• Build STS capacity to adapt and accommodate emerging and re-emerging infections, including during public health emergencies

• Procure and distribute appropriate materials/equipment (e.g., triple packaging materials, cold chain, tracking devices, temperature monitoring, etc.) in a standardized manner to ensure sample integrity, sample packaging, biosafety, and biosecurity

Strategy 2: Strengthen biosafety, biosecurity, and logistics capacity for sample referral to ensure the quality and integrity of samples

• Train, mentor, and coach facility, laboratory staff and drivers on guidelines and SOPs including sample packaging, biosafety, and biosecurity. Provide SOPs and guideline to drivers routinely

• Conduct cascaded training, mentorship, and coaching that complements the prioritization of training for sites

• Conduct site evaluations to assess the outcome of practical training and provide supportive supervision and targeted capacity improvement plans

• Collaborate with the Government of the Republic of Cameroon and other key stakeholders to support sample transport activities

• Conduct and support waste transportation and disposal services from laboratories

Strategy 3: Establish data systems and monitoring and evaluation capacity throughout the whole sample transport process including specimen referring facilities, hubs, and conventional laboratories that are complimentary to other systems to track, manage and evaluate sample transport

• Develop a standardized monitoring and evaluation plan for integrated sample transport

• Develop a platform with key stakeholders for reporting, monitoring, coordinating specimen transport

• Develop and monitor key performance indicators regularly, including but not limited to sample tracking and results return rates

• Identify and mitigate gaps, bottlenecks, barriers continuously in STS in real-time or near real-time

• Implement and evaluate an integrated system for regularly tracking, managing, and confirming sample collection, accuracy, and receipt

• Review specimen referral network and optimize laboratory capacity at conventional and point-of-care testing laboratories to support new technologies

• Develop and implement an efficient plan for replacement of supplies and equipment

• Evaluate existing specimen electronic data collection and analysis tools

• Collaborate with stakeholders to ensure efficient utilization of sample transportation electronic data

In furtherance of the underlying purposes of this NOFO, Recipient is expected to provide copies of and/or access to all data, software, tools, training materials, guidelines, and systems developed under this NOFO to Ministry of Health and other relevant stakeholders, including HHS/CDC, for appropriate use consistent with underlying authorities.

1. Collaborations

a. With other CDC projects and CDC-funded organizations:

The recipient will be expected to collaborate with CDC-funded implementing partners through PEPFAR, GHSA, and other relevant CDC-supported initiatives (WHO/UNAIDS/UNICEF mechanisms).

b. With organizations not funded by CDC:

The recipient will be expected to collaborate with, including but not limited to, the Department of Pharmacy, Medicines and Laboratory (DPML), Department for the Control of Diseases, Epidemics and Pandemics (DLMEP), National Public Health Lab (NPHL), National Veterinary Laboratory (LANAVET), and Military Research Center (CRESAR), and other implementing partners funded through the President’s Malaria Initiative (PMI), Global Health Security Agenda (GHSA), and Global Fund.

2. Population(s) of Focus The direct/primary beneficiary populations are PLHIV and TB across Cameroon, including priority populations such as children, adolescent boys and girls, pregnant and breast-feeding women (PBFW) and their partners, and key populations, whose biological samples will be timely transported and tested with results reported back for clinical decision-making and patient monitoring. Secondary beneficiaries include healthcare workers, laboratorians, and other clinical personnel who will benefit from relevant capacity strengthening efforts through trainings, supportive supervision, and other technical assistance.

This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of race, color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy) or other constitutionally protected statuses.

a. Health Disparities The goal of health equity is for everyone to have a fair and just opportunity to attain their highest level of health. Achieving this requires focused and ongoing societal efforts to address historical and contemporary injustices; overcome economic, social, and other obstacles to health and healthcare; and eliminate preventable health disparities.

Broadly defined, social determinants of health are non-medical factors that influence health outcomes. They are the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life. These forces (e.g., racism, climate) and systems include economic policies and systems, development agendas, social norms, social policies, and political systems. See content below and in other sections (e.g., Approach, Collaborations, Populations of Focus) for information on how this specific NOFO affects social determinants of health.

A health disparity is a preventable difference in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by populations that have been socially, economically, geographically, and environmentally disadvantaged. Health disparities are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these diseases and conditions.

In an effort to assure that activities funded through this NOFO (1) affirm and advance, as appropriate, the role of health equity and an equitable, diverse, and inclusive workforce as core principles, and (2) advance the reduction of stigma and discrimination through the promotion, consistent with applicable laws, of civil and human rights to improve the health outcomes of persons at risk of, or living with, HIV and/or TB infection, CDC PEPFAR awards resulting from this NOFO may address the following activities, where and when appropriate:

• Community involvement in the design, implementation, and monitoring of HIV and TB services.

• Training for implementing partners involved in the design, implementation, and/or monitoring of activities on stigma, discrimination, gender equitable norms, human rights, and community engagement to minimize the likelihood for activities to unintentionally increase stigma and discrimination directed towards PLHIV, people with TB, and other

KP.

• Programs to address evidenced health disparities and social barriers (e.g., HIV-related stigma) to HIV and TB services.

• Use of data to monitor disparities and implement strategies to improve access, service use, and outcomes.

iv. Funding Strategy Applicants to this NOFO are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount. Applications must not exceed this amount.

Component Funding: It is required that all PEPFAR-funded cooperative agreements be formulated for component funding. A component is a discrete set of activities with an associated budget. CDC will use component funding to provide funding for activities proposed in an application that received merit review but were not selected for funding in the initial award (i.e., at the onset of budget period 1) but may be funded at a later point in the budget period as programmatically necessary and as funding becomes available. Please review the following key points about component funding:

• Component funding must be setup at the time of the application. While preparing the application, applicants should review the expectations listed in the NOFO for Year 1 activities and group them under the anticipated components listed below. Only activities planned for Year 1 should be grouped into components; applicants do not need to group activities in the high-level plan for the subsequent years 2-5 of the award into components. Funding amounts and components for years 2-5 will be determined at continuation.

• Each component must be a discrete set of activities with an associated budget.

Distinguishable component budget narratives are required. Setting up components based on time (i.e., quarterly) is an appropriate distinction of activities, provided activities are clearly outlined.

• Applicants should submit the anticipated components on an SF-424A form as part of their application which shows all components for the budget period. The amounts should exactly match what is being requested for funding. Each component has its own approved amount and cannot be funded above the established amount. The combined total of all components must total the requested amount.

• If more than 4 components are proposed, multiple SF-424As will be needed. Applicants may include the first 4 components on one SF-424A form and the remaining components on a second SF-424A form. Applicants may download additional SF-424A forms and upload them as PDFs under “Budget Narrative Attachment Form” or “Other Attachments Form.” These should be clearly labeled for easy identification and included in the Table of Contents for the entire submission.

• If possible, applicants are encouraged to submit a separate budget justification for each component, but it is not a requirement. Applicants will not be deemed incomplete if separate budget justifications are not provided with the submission. A separate budget justification will ultimately be required for all components that are funded.

• Any component that is not funded at the time of a new award may be deemed “Approved but Unfunded (ABU)”. There is no guarantee that all components will be funded in a budget period as ABU components are subject to the availability of funds and the underlying legal authority for the work.

o Components may not be awarded in order. All ABU components are eligible to receive funding once (and if) funds become available.

o If funding becomes available, multiple components can be funded through the same funding action (single NOA).

o If funding is awarded for an amount less than the ABU component approved amount, it is not possible to fund the difference at a later time. Components can only be funded once.

• If, during the funding confirmation, the Program Office approves a budget that differs from what was submitted at the time of application (reflected in the budget markup), a revised budget may be required in addition to the technical review responses. If required, the revised budget is due within thirty (30) days of the start of the budget period. If required, technical review responses will also be due within thirty (30) days of the start of the budget period and must be submitted separately from revised budget applications.

Future funding for ABU components will not be awarded until a revised budget, if required, is submitted and approved by CDC.

• Once components are awarded, funds cannot be redirected between components.

However, funds may be redirected within a component between object class categories.

It is critical to ensure accountability, transparency, and programmatic performance of all U.S.

taxpayer dollars. When developing the annual work plan, please be advised that the annual COP/ROP guidance requires that CDC take decisive action if an implementing partner is underperforming programmatically during any quarter of a fiscal year.

Applicants are encouraged to consider the following in the development of their budgets and budget narratives:

For Year 1, CDC anticipates an Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award of $3,000,000 with the below listed components:

• Component 1: COP Q1 Targets/Activities;

• Component 2: COP Q2 Targets/Activities;

• Component 3: COP Q3 Targets/Activities;

• Component 4: COP Q4 Targets/Activities;

• Component 5: COP Additional Targets/Activities;

• Component 6: Emerging Public Health Priorities.

Applicants must specify a descriptive title for each corresponding column shown on the SF- 424A, followed by the total (cumulative) in the column to the far right of the SF-424A.

Applicants are encouraged to use the components listed above, but may propose alternative budget components so long as the general component funding guidance is followed.

Funding provided under this NOFO is subject to the availability of funds. The total number of years for which federal support has been programmatically approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. All future year funding will be based on satisfactory programmatic progress and the availability of funds.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

CDC expects that the routine performance data is reviewed, cleaned, and used for program management. To this effect, the recipient should hold regular review meetings to discuss performance and use data in program quality improvement activities.

The recipient should allocate funds made available under this NOFO for both evaluation activities and performance monitoring. While the final funding amount will be agreed upon by both CDC and the recipient, a minimum of 10% of funds should be allocated for monitoring activities and 3% of funds should be used for evaluation activities. These are estimates for the total funding over the 5-year project.

PERFORMANCE MONITORING

Some anticipated PEPFAR (MER) and non-MER indicators, targets, and reporting frequencies corresponding to Year 1 of the NOFO are shown below. Applicants should also propose any additional relevant PEPFAR MER and non-MER indicators as part of their initial Evaluation and Performance Measurement Strategy.

Applicants should note that these may be adjusted, or new targets and indicators may be identified in subsequent years based on implementation of HIV/AIDS epidemic control strategies and program priorities. Any gaps or unmet needs not fulfilled in the first year may affect the targets of the subsequent years.

Unless otherwise indicated, the reporting periods for MER indicators will mirror the PEPFAR MER indicator reporting frequency (quarterly, semi-annually, and annually). Additional information regarding MER reporting is included in the MER Guidance and resource materials, available at the following link (copy/paste into web browser to access):

https://datim.zendesk.com/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides.

PEPFAR MER Process and Outcome Measures:

• HTS_TST: Number of individuals who received HIV Testing Services (HTS) and received their test results [Target: 372,102; Reporting Frequency: Quarterly]

• HTS_INDEX: Number of individuals who were identified and tested using index testing services and received their results [Target: 56,831; Reporting Frequency: Quarterly]

• LAB_PTCQI: Number of PEPFAR-supported laboratory-based testing and/or Point-of- Care Testing (POCT) sites engaged in continuous quality Improvement (CQI) and proficiency testing (PT) activities. [Target: 661; Reporting Frequency: Annual]

Non-MER: Additional Performance Measures (Custom Indicators)

Applicants should propose additional custom performance measures to monitor achievement of outcomes not directly measured by PEPFAR (MER) indicators. Custom indicators should include process and outcome measures directly correlated with the logic model. Below are examples of additional process and outcome measures for the strategies/activities and outcomes previously discussed in the logic model and associated sections.

• Percentage of quality samples collected from facilities disaggregated by facility: [Target:

70%; Reporting Frequency: Quarterly]

• Percentage of quality samples delivered to reference laboratory within 1 month: [Target:

70%; Reporting Frequency: Quarterly]

• Percentage of samples collected from reference laboratory post testing within 2 weeks:

[Target: 70%; Reporting Frequency: Quarterly]

• Percentage of samples rejected in reference laboratories [Target: 20%; Reporting Frequency: Quarterly]

• Percentage of test results returned to the facilities within 2 weeks disaggregated by facility and test result: [Target: 65%; Reporting Frequency: Quarterly]

• Percentage of patients with multiple visits to facilities for test results: [Target: 40%;

Reporting Frequency: Quarterly] https://datim.zendesk.com/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

• Percentage of facility and laboratory staff trained on SOPs and guidelines to transport samples: [Target: 90%; Reporting Frequency: Quarterly]

• Percentage of facilities correctly prepared specimens for transport [Target: 90%;

Reporting Frequency: Quarterly]

• Number of partners collaborating throughout the logistics process: [Target: 3; Reporting Frequency: Annual]

• Percentage of patients diagnosed within 3 months from test result receipt: [Target: 70%;

Reporting Frequency: Quarterly]

• Percentage of patients linked to ART services with 1 week from positive test result receipt: [Target: 70%; Reporting Frequency: Quarterly]

Data Sources for MER and Custom Indicators: Data sources may include registers, tally sheets, electronic and paper patient records, quarterly progress reports, surveillance and survey reports, and other program monitoring tools.

Evaluation

The evaluation topics below are examples of areas that the recipient may be expected to answer through process or outcome evaluation(s). Applicants should include at least 1, but no more than 3 potential evaluation topic areas. Recipients will be expected to conduct a mid-term and/or end-year evaluation.

Sample Evaluation Topics:

• Assessment of Sample Transportation Logistics Process (Process evaluation)

• Efficiency and Effectiveness of Integrated Sample Transportation System (Outcome evaluation)

Evaluation Data Sources: Data sources may include registers, tally sheets, electronic and paper patient records, recipient progress reports, focus groups, in-depth interviews, surveys, and other program monitoring tools.

Dissemination of Evaluation Results: Dissemination channels may include local and international conferences and forum abstract presentations, conference poster displays, manuscripts, bulletins, reports, presentations to technical working groups and stakeholder meetings, and other approved products in print and electronic media. The primary intended users of evaluation results and findings will be the wider program stakeholders. All evaluation reports will be publicly available on PEPFAR resource sites. CDC and stakeholders will use overall evaluation findings during the five-year NOFO period to share and implement key recommendations to strengthen program implementation and effectiveness, sustainability, and continued program improvement upon completion of the award.

Evaluations and strategy should align with national, PEPFAR, and agency requirements and priorities, and will be reviewed and may require approval as part of the COP/ROP. As such, the example evaluation topics listed in this NOFO may be amended based on feedback from the GHSD Bureau during the annual COP/ROP review process.

ii. Applicant Evaluation and Performance Measurement Plan

Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

• How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement, including, as applicable to the award, how findings will contribute to reducing or eliminating health disparities and inequities.

• How key program partners will participate in the evaluation and performance measurement planning processes.

• Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant).

• How evaluation findings will be disseminated to communities and populations of interest in a manner that is suitable to their needs.

• Plans for updating the Data Management Plan (DMP) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data;

data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additional-requirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, the applicant should be directed to:

• Describe the type of evaluations (i.e., process, outcome, or both).

• Describe key evaluation questions to be addressed by these evaluations.

• Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

Applicants should submit their initial data management plan (DMP) as part of their initial evaluation and performance measurement plan (EPMP). This should include cybersecurity plans and information about how PII will be protected when collected, stored, in transit, and in use. In addition, the initial DMP should include a description about how data will be de-identified in intermediate and final data sets.