Revised Foa_Content_of_CDC-RFA-GH-24-0073.pdf

Centers for Disease Control and Prevention

Center for Global Health

Building and Improving Integrated Laboratory Capacity and Quality Services in the Democratic Republic of the Congo (DRC) under the President's Emergency Plan for AIDS Relief (PEPFAR)

CDC-RFA-GH-24-0073

02/20/2024

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-24-0073. 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 and Improving Integrated Laboratory Capacity and Quality Services in the Democratic Republic of the Congo (DRC) 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.

Amendment I: Questions and Answers (Q&A) and Additional Updates 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)

The purpose of this amendment is to include the updates as listed below.

• There was no Q&A for this NOFO.

• This amendment extends the Application Due Date from February 18, 2024 (02/18/2024) to February 20, 2024 (02/20/2024).

• CDC has retired the Risk Assessment Questionnaire Requirement and applicants are no longer required to submit the CDC Risk Questionnaire as part of their NOFO application.

CDC continues to conduct the review of risk posed by applicants described in Phase III Review and may ask for additional information prior to the award based on the results of the review. Risk Questionnaires that are submitted will not be included in this risk review.

• In F. Award Administration Information, 2. Administrative and National Policy Requirements, CDC has added AR-38: Health Information Technology (IT) Interoperability to the list of Organization Specific Administrative Requirements.

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH-24-0073

E. Assistance Listings Number:

93.067 F. Dates:

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

2. Due Date for Applications:

02/20/2024 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 To achieve the Joint United Nations Programme on HIV and AIDS (UNAIDS) 95-95-95 targets in DRC, laboratory and diagnostic networks must be established and operationalized; therefore, this NOFO aims to access quality assured diagnostics and laboratory services which are critical to the effective diagnosis, treatment, and management of HIV and other HIV-related diseases, including TB.

PEPFAR DRC-supported laboratory and integrated diagnostic network strengthening efforts have led to improved access to quality diagnostic and client monitoring services; however, efforts are needed to improve viral load (VL) coverage and suppression and to increase laboratory capacity. The PEPFAR DRC strategy includes continuous quality improvement (CQI) and strengthening the laboratory capacity within the country to reduce HIV/AIDS impact as a public health threat by 2030.

This NOFO will focus on building laboratory capacity and improving the provision of HIV testing activities in all PEPFAR-supported health zones in DRC. Activities will include the implementation of the rapid test continuous quality improvement (RT-CQI) program, scaling up of HIV VL and Infant Virologic Testing/Early Infant Diagnosis (IVT/EID) testing and strengthening of HIV/AIDS the diagnostics capacity and quality management system (QMS).

Applicants should have knowledge of PEPFAR regulations and the ability to work in the DRC context and maintain a presence in-country to meet the needs described in this NOFO.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards The expected number of awards is 1-2.

d. Total Period of Performance Funding:

$0 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:

$3,500,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $3,500,000. The expected number of awards is 1-2. 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 DRC has made progress in scaling up and increasing access to quality-assured conventional services, including HIV rapid testing, EID, detection of HIV-associated TB and HIV VL monitoring. Further scale-up is needed to attain and sustain optimal coverage and access to uninterrupted laboratory and diagnostic services. Scale-up of these services is necessary for reaching epidemic control and making measurable progress toward the UNAIDS’ 95-95-95 targets.

To reach the UNAIDS targets, DRC needs innovative testing technologies, approaches, and country-specific policies and laboratory strategic plans, as well as well-trained and competent laboratory staff. Barriers to achieving the UNAIDS targets include a lack of demand from clinicians for VL testing, a non- sustainable specimen referral system, a non-functional laboratory information management system (LIMS), long turnaround times (TAT) for results, slow progress of EID and VL coverage, lack of access to TB testing using GeneXpert, a limited number of laboratories enrolled in the Stepwise Laboratory Improvement Process Toward Accreditation (SLIPTA) and Strengthening Laboratory Management Toward Accreditation (SLMTA) and that have been accredited, lack of qualified dedicated human resources, and equipment maintenance issues causing disruptions in the laboratory-clinic interface.

This NOFO seeks to ensure access to quality-assured HIV-related laboratory and diagnostic services in PEPFAR DRC-supported provinces through the development of a national tiered public health laboratory network, policies and systems to ensure reliable and accurate diagnostic and treatment monitoring services, a platform to support multi-disease-integration, extending and improving the laboratory QMS, enrolling more laboratories in the Stepwise Process for Improving the Quality of HIV Rapid Testing (SPI- RT) program, strengthening the laboratory network, and improving workforce capacity. At the end of the project period, PEPFAR-supported provinces should achieve:

• Increased access to quality-assured diagnostics and uninterrupted VL and IVT/EID testing services through efficient molecular laboratory networks in line with appropriate DRC-specific policies and laboratory strategic plans implemented at all levels of the clinical and diagnostic networks to achieve 100% VL and IVT/EID testing coverage;

• Increased quality of laboratory services through utilization of QMS and tools (e.g., External Quality Assessment (EQA), SLIPTA and SLMTA Programs, RTCQI, and other

CQI);

• Enhanced utilization of testing results for clinical decision-making leading to improved clinical outcomes for clients with HIV and HIV/AIDS-related infections;

• Strengthened organizational infrastructure with a qualified laboratory workforce that has expertise to support the HIV continuum of care;

• Reduced TAT (<14days for VL and <5 days for EID);

• SLIPTA and International Organization of Standardization (ISO) accreditation standards reached by all laboratories and Point of Care (POC) platforms;

• Establish a reliable sample referral network and transportation to ensure specimens arrive at testing laboratories within the recommended time to maintain their integrity;

• VL scorecards implemented correctly and satisfactory scores for all molecular laboratories;

• A maintenance contract covers all conventional laboratory and POC equipment; and

• Blood samples are available for routine quality controls checks for VL and EID at the molecular laboratory.

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 un-diagnosed 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 This NOFO will build on previous work performed in DRC and lessons learned through the expiring cooperative agreement(CoAg). The previous NOFO, CDC-RFA-GH19-1932, focused on collaborating and partnering with Ministry of Health (MOH) and with local partners to strengthen HIV-related diagnostics and laboratory services in PEPFAR DRC-supported provinces. Lessons learned on previous work include but are not limited to the lack of MoH resources including HRH to sustain laboratory quality services.

The new NOFO will help implement an aggressive scale-up strategy to ensure accurate and timely diagnostics by addressing low access to VL, IVT/EID,and nascent laboratory quality improvement (QI) initiatives. It also aims to ensure complete VL coverage in PEPFAR DRC-supported provinces by optimizing the existing system and strengthening the national laboratory system with a focus on the Lualaba, Haut Katanga, and Kinshasa provinces.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

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

Strategies and Activities

Short-Term Outcomes

Intermediate Outcomes Long-Term Outcomes

Strategy 1:

Implement innovative approaches for quality assurance (QA)/ QI activities in PEPFAR-supported laboratories and Point-of-Care Testing (POCT) sites to strengthen HIV and TB diagnostic testing quality

Strategy 2: Scale-up VL and IVT/EID testing in targeted laboratory network to ensure access to timely quality assured services

Strategy 3: Provide technical assistance (TA) to PEPFAR laboratories for ISO 15189 accreditation

Strategy 4:

Strengthen capacity of laboratory systems at all levels to respond to HIV and other related diseases

Increased capacity of PEPFAR-supported laboratories and POCT sites to adhere to CQI procedures

Increased capacity of PEPFAR-supported laboratory and POCT staff to perform VL and IVT/EID testing

Increased collection, validation, and reporting by PEPFAR-supported laboratories and POCTs

Increased optimization of diagnostic networks

Improved adherence to international laboratory quality standards competency of laboratory leadership to demonstrate effective performance

Increased adherence to CQI procedures by all laboratories and POCT sites

Decreased TAT of VL and EID laboratory results

Decreased rejection rates of VL and EID samples

Increased demand for laboratory services by clinicians, clients, and public health professionals

Increased availability of VL and IVT/EID testing services

Increased availability of high-quality data for monitoring and evaluation (M&E) and surveillance

Improved oversight of organizational operations in PEPFAR laboratories

Increased ownership by MOH of the diagnostic network

Increased capability of laboratories to maintain ISO 15189 accreditation

Sustained quality and efficient laboratory services

Increased use of laboratory services by clinicians, clients, and public health professionals evidence-based decision-making through use of high-quality data and evaluation findings

Sustained oversight of laboratory operations by

MOH

Increased timely detection and response to public health emergencies impacting PLHIV

Strategies and Activities

Short-Term Outcomes

Intermediate Outcomes Long-Term Outcomes

Increased timely detection of early signals for emerging public health threats and other diseases impacting

PLHIV

i. Purpose The purpose of this NOFO is to support and enhance the diagnostic and laboratory capacity to address HIV and TB infections in PEPFAR-supported provinces in DRC. The NOFO will achieve these goals by increasing access to quality-assured HIV-related and diagnostic services, improving laboratory QMS, and strengthening laboratory networks and workforce capacity.

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:

• Increased capacity of PEPFAR-supported laboratories and POCT sites to adhere to CQI procedures o Capacity of laboratories includes but is not limited to laboratory management documentation, HRH, QMS, inventory management (supply chain), equipment maintenance, information systems, laboratory and clinical interface, biosafety and bio-security, and other activities as identified

• Increased capacity of PEPFAR-supported laboratory and POCT staff to perform VL and IVT/EID testing

• Increased collection, validation, and reporting by PEPFAR-supported laboratories and POCTs

• Increased optimization of diagnostic networks o Optimization includes but is not limited to identifying gaps within the current diagnostic network and links between sites and laboratory services and development of innovative sustainable solutions to address the current gaps o Diagnostic networks include but is not limited to sample transportation at all levels, data flow between site, provincial, and national data hubs, clinical and laboratory interface, surveillance, and outbreak response

• Improved adherence to international laboratory quality standards

• Increased competency of laboratory leadership to demonstrate effective performance

Intermediate Outcomes:

• Increased adherence to CQI procedures by all laboratories and POCT sites o Competency standards include but are not limited to HRH certification, proficiency testing (PT), routine training and continuing education

• Decreased TAT of VL and EID laboratory results o TAT is the time from the sample being collected to the time the clinician receives the result

• Decreased rejection rates of VL and EID samples

• Increased demand for laboratory services by clinicians, clients, and public health professionals o Demand for laboratory services includes but is not limited to HIV testing services (HTS), EID, VL, GeneXpertTB testing, Opportunistic infection (OI) test o Public health professionals include health care and non-health care workers at all national and sub-national levels

• Increased availability of VL and IVT/EID testing services

• Increased availability of high-quality data for M&Eand surveillance

• Improved oversight of organizational operations in PEPFAR laboratories

• Increased ownership by MOH of the diagnostic network

• Increased capability of laboratories to maintain ISO 15189 accreditation

• Increased timely detection of early signals for emerging public health threats and other diseases impacting PLHIV

Long-Term Outcomes:

• Sustained quality and efficient laboratory services

• Increased use of laboratory services by clinicians, clients, and public health professionals

• Increased evidence-based decision-making through use of high-quality data and evaluation findings

• Sustained oversight of laboratory operations by MOH

• Increased timely detection and response to public health emergencies impacting PLHIV

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 innovative approaches for QA/QI activities in PEPFAR-supported laboratories and POCT sites to strengthen HIV and TB diagnostic testing quality

• Develop comprehensive QA/QI plan (e.g., routine EQA for HIV and TB, PT, competency testing certification program with pool of in-country auditors and continuing education, RT-CQI program, equipment maintenance and certification plan with local team of engineers, waste management system, etc.)and materials (e.g., job aids, standard operating procedures [SOP], framework documents, web-based dashboard for PT (ePT), etc.) to support laboratory CQI for HIV and TB-related testing

• Collaborate with CDC-DRC to review and refine the developed comprehensive QA/QI plan and other materials

• Implement and maintain comprehensive QA/QI plan and other activities, including routine EQA for HIV and TB, routine PT, competency testing certification program and continuing education, RT-CQI (e.g., training modules, SOP, job aids, etc.)

• Increase uptake of the WHO-AFROSLIPTA and SLMTA Programs, including working with MOH and local partners to continue implementing the SPI-RT program, technology transfer and equipment maintenance

• Work with MOH and local partners to continue implementing RT-CQI program activities, including logbook utilization, lot-release testing, systematizing HIV rapid testing network use and including QA/QI activities, and HRH development through training and certification

Strategy 2: Scale-up VL and IVT/EID testing in targeted laboratory network to ensure access to timely quality assured services

• Develop comprehensive activities to scale up VL and IVT/EID testing

• Collaborate with CDC-DRC to review and refine activities to scale up VL and IVT/EID testing

• Implement VL and IVT/EID testing scale-up activities

• Provide TA, mentoring, and relevant national and international laboratory resources for approximately 9 molecular laboratories, 2,000 HIV testing points, and 20 GeneXpert TB, VL, and EID testing points

• Collaborate with local and international partners to establish and maintain a national laboratory technical working group (TWG) to provide input to support laboratory program development, implementation, and evaluation

• Incorporate VL/EID samples management inventory into the national LMIS (VLSMS)

Strategy 3: Provide TA to PEPFAR laboratories for ISO 15189 accreditation

• Develop capacity building and sustainability plans to achieve and maintain accreditation of PEPFAR laboratories to ISO 15189

• Facilitate capacity building and provide continual mentorship in preparation for ISO 15189 accreditation

• Collaborate with CDC-DRC office and The Government of DRC (GDRC) for selection of accrediting body and application for accreditation

Strategy 4: Strengthen capacity of laboratory systems at all levels to respond to HIV and other related diseases

• Work collaboratively with GDRC, CDC-DRC, DRC PEPFAR partners, and other GDRC donors to establish, maintain, and integrate laboratory networks to strengthen the development and implementation of HIV and other diseases diagnostic policies and procedures

• Build capacity of laboratory and POCT infrastructure, including the acquisition of necessary laboratory equipment, supplies, and other materials

• Develop data QI strategies to address laboratory staffing competency and capacity, support the transition to electronic reporting, and integration of data systems

• Collaborate with CDC-DRC to review and refine laboratory data QI strategies

• Collaborate with GDRC, CDC-DRC, and other implementing partners to implement innovative approaches to increase timeliness and capacity to respond to TB, HIV, and other HIV-related diseases

• Develop and collaborate with CDC-DRC to review, revise, and implement innovative strategies to improve adherence to policies for electronic reporting through the LIMS

• Set up VL-EID molecular laboratory and other laboratory networks by optimizing the diagnostic network and coordinating sample transportation networking from spokes to testing laboratories via hubs

• Expand and increase the utilization of LIMS Viral Load Sample Management System and Viral Load Sample Tracker System (VLSMSand VLSTS) in molecular laboratories, hubs, and spokes

• Support transportation network strengthening activities

• Assess existing sample transportation methods and identify gaps in the country

• Develop innovative strategies to address connectivity and optimization of the network mapping laboratories

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(s) will be expected to collaborate with CDC programs and CDC-funded partners to ensure that all activities are developed in collaboration with PEPFAR-supported laboratory partners, including but not limited to the Division of Global HIV and TB (DGHT), the Division of Parasitic Diseases and Malaria (DPDM), the Division of Global Health Protection (DGHP), and the Global Immunization Division (GID), World Health Organization (WHO), UNAIDS, and other clinical partners to ensure synergies across funding activities and to ensure that all activities are consistent with PEPFAR goals and objectives, WHO normative guidance, national laboratory strategic plans, and other key guidance. The recipient(s) will also be expected to collaborate with the CDC-funded MOH.

b. With organizations not funded by CDC:

The recipient(s) will be expected to collaborate with in-country, regional, and global partners and organizations such as the U.S. Agency for International Development (USAID), Global Fund (GF), World Bank (WB), United Nations International Children’s Emergency Funds (UNICEF), Japan International Cooperation Agency (JICA), Korea International Cooperation Agency (KOICA), and other PEPFAR partners to conduct the activities outlined in the NOFO and to ensure collaboration and synergies across HIV and TB-related diagnostic and clinical activities.

In addition, the recipient(s) will be expected to establish and maintain partnerships and collaborations with non-CDC-funded partner Ministries such as those for the environment, agriculture etc., technical organizations, and other groups to complete the NOFO activities.

2. Population(s) of Focus The population(s) of focus for this NOFO includes people infected, affected, and/or at risk for becoming infected by HIV, TB, STIs, other public health threats, laboratorians, clinical staff, and others who are responsible for the development and implementation of appropriate strategies, partnerships, and collaborations required to support the strengthening of HIV and TB-related or other HIV-related diseases diagnostics, treatment, and management across the clinical cascade in DRC. PEPFAR/DRC-supported provinces may include but are not limited to, Kinshasa, Haut Katanga, and Lualaba.

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 under-performing 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 $3,500,000 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.

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(s) should hold regular review meetings to discuss performance and use data in program quality improvement activities.

The recipient(s) 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(s), a minimum of 5% 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:

• PMTCT_HEI_POS: Number of HIV-infected infants identified in the reporting period,whose diagnostic sample was collected by 12 months of age [Target: Not Assigned; Reporting Frequency: Quarterly] https://datim.zendesk.com/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

• TX_PVLS: Percentage of ART clients with a suppressed viral load (VL) result (<1000 copies/ml) documented in the medical record and/or laboratory information systems (LIS) within the last 12 months [Target: 95%; 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: Not Assigned; Reporting Frequency:

Annually]

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.

• Number of PEPFAR-supported laboratories participating in a CQI program to achieve national accreditation [Target: 9; Reporting Frequency: Annually]

• Percentage of PEPFAR-supported laboratories and testing points with established policies and guidelines to support laboratory quality (Disaggregated by SLIPTA, SLMTA, RTCQI, and other laboratory CQI activities) [Target: 100%; Reporting Frequency: Annually]

• Percentage of audited PEPFAR-supported laboratories that achieve international accreditation [Target: 20%; Reporting Frequency: Annually]

• Percentage of PEPFAR-supported laboratories that have achieved an increase in STAR level (Disaggregated by laboratory) [Target: 50%; Reporting Frequency: Annually]

• Number of tests (HIV Diagnosis) performed by PEPFAR-supported laboratories and testing points [Target: 640,023; Reporting Frequency: Quarterly]

• Number of EID tests performed by PEPFAR-supported laboratories and testing points[Target:3,708; Reporting Frequency: Quarterly]

• Number of HIV VL tests performed by PEPFAR-supported laboratories and testing points (disaggregated by test) [Target: 207,134; Reporting Frequency: Quarterly]

• Number of TB GeneXpert tests performed by PEPFAR-supported laboratories and testing points (disaggregated by test) [Target: 224,803; Reporting Frequency: Quarterly]

• Percentage of PEPFAR-supported laboratories passing PT for HIV serology diagnosis[Target: 100%; Reporting Frequency: Semi-Annually]

• Percentage of PEPFAR-supported laboratories passing PT for EID [Target: 100%;

Reporting Frequency: Semi-Annually]

• Percentage of PEPFAR-supported laboratories passing PT for HIV VL [Target:100%;

Reporting Frequency: Semi-Annually]

• Percentage of PEPFAR-supported laboratories passing PT for TB GeneXpert [Target:100%; Reporting Frequency: Semi-Annually]

• Percentage of laboratories and testing sites with established policies and procedures to ensure and maintain laboratory biosafety, including systems for…