Foa_Content_of_CDC-RFA-GH-24-0097.pdf

Centers for Disease Control and Prevention

Center for Global Health

Strengthening Laboratory Capacity and Quality for HIV Diagnosis, Care, Treatment, and Monitoring in Malawi under the President's Emergency Plan for AIDS Relief (PEPFAR)

CDC-RFA-GH-24-0097

02/05/2024

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-24-0097. 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:

Strengthening Laboratory Capacity and Quality for HIV Diagnosis, Care, Treatment, and Monitoring in Malawi 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-24-0097

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):

2. Due Date for Applications:

02/05/2024 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 As Malawi strives to reach HIV epidemic control, there is a need to improve and sustain achievements in the national laboratory systems. Technical assistance (TA) to the Ministry of Health (MOH) will ensure universal diagnostics access and address public health system gaps.

For sustainability, MOH’s public health laboratory capabilities will be strengthened for governance and ownership, National Reference Laboratories (NRL) capacity will be built for surveillance and outbreak responses, and the HIV laboratory program will be integrated into broader disease areas.

Priorities include scaling up patient-centered approaches to identify and address challenges of low viral load coverage (VLC) and suppression in different age groups and populations, point of care testing (POCT) laboratories for integrated multi-disease tests, and rapid testing continuous quality improvement (RTCQI) to achieve national certification. Other priorities include improving access for advanced HIV disease (AHD) and pre-exposure prophylaxis (PrEP) tests, conducting regular diagnostic network optimization to ensure efficiencies and testing accessibility, increasing utilization of high throughput instruments in conventional molecular laboratories to improve VLC, improving biosafety and waste management, preparing additional laboratories for International Organization for Standardization (ISO) accreditations, and extending the external quality assessment (EQA) program to multiple testing parameters.

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 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:

$8,375,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $8,375,000. 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 According to the Malawi Population-based HIV Impact Assessment 2020-2021, Malawi has made remarkable achievements by attaining 88-98-97 of the UNAIDS 95-95-95 targets towards epidemic control. The country needs to address overall systemic challenges to sustain and improve gains. Malawi has weak laboratory systems, affecting the quality of testing and patient management. Due to a limited number of health facilities in the country, people living with HIV (PLHIV), including priority populations (PP), have difficulties in accessing diagnostic and treatment monitoring services. The laboratory services are affected by weak infrastructure, slow implementation of quality management systems (QMS), inefficient supply chain systems, and an inadequate number of qualified laboratory workers. VLC has been consistently below 70%, and the gap in children under 5 years of age and other PP is significant. The overall VL test turnaround time (TAT) in conventional molecular laboratories is above 30 days, resulting in delayed patient management. NRL in the Public Health Institute of Malawi (PHIM) does not have adequate capacity to conduct surveillance and respond to emerging and re-emerging diseases that affect PLHIV. Any improved laboratory capacity should be integrated into the general public health response per current PEPFAR guidance.

This NOFO aims to continue to assist the MOH in strengthening the laboratory systems and to tackle structural and political barriers. TA should be provided to MOH on the development and implementation of policies and strategic plans. To improve the quality of laboratory services and sustain laboratory accreditation efforts, this NOFO aims to support establishing a national accreditation body and ancillary equipment calibration center. To sustain the preparedness of the national laboratory public health systems and laboratory networks, PHIM capacity should be built with modern technologies, training, and infrastructure.

To ensure accessibility for accurate and timely testing for HIV and TB, this NOFO aims to support laboratories on infrastructure improvement, equipment management, and availability of commodities/reagents, as well as develop workforce capacity and establish appropriate biosafety systems. Integrated and multi-disease testing should be enhanced at POCT and conventional molecular laboratories. VLC should be improved through intensive demand creation and an optimized diagnostic network. Closing equity gaps among PP, providing training to health care workers, transitioning to an all-inclusive pricing service agreement with suppliers, and scaling up the integration of the Electronic Medical Records (EMR) with the Laboratory Information Management System (LIMS) should also be used to improve VLC.

To support patient-centered services, standard and innovative CQI initiatives should be scaled up to all testing laboratories. Efforts should continue to achieve and maintain ISO15189 accreditation for multiple scopes of tests. Stepwise Process for Improving Quality for Point of Care Testing should be rolled out for instrument-based and rapid diagnostics tests. HIV RTCQI should be scaled up to ensure all testing points are certified by the Medical Council of Malawi and enhanced by training test providers using the Extension for Community Health Outcome platform. The EQA program should be maintained and scaled up for VL, Early Infant Diagnosis (EID), TB, AHD, and PrEP tests. To sustain the EQA program, local proficiency panels, production should be strengthened in the NRL.

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 For the past 20 years, PEPFAR, through CDC and CDC-funded implementing partners, has collaborated with the MOH to strengthen Malawi’s laboratory systems. PEPFAR has played a significant role in improving access to HIV diagnostics and treatment monitoring services across the 28 districts. This NOFO is expected to continue the progress made under the last NOFO (CDC-RFA-GH19-1910), which should lead to further laboratory system strengthening.

Currently, the country has 14 centrally located conventional molecular and 80 POCT laboratories with multi-disease testing capacities. The conventional molecular laboratories test most (99%) of the VL samples. To provide consistent services, PEPFAR supports training laboratory staff to run tests and deploying trained laboratory technologists and data clerks to enhance testing quality. PEPFAR also supports improving infrastructure for a suitable working environment, providing ancillary equipment, including regular calibration and preventive maintenance, supporting a LIMS for timely result return and data capturing, and supplying reagents and commodities during shortages to minimize service interruptions.

To improve access to HIV and TB tests, the sample referral system is fully funded by PEPFAR.

790 facilities and testing laboratories are networked in a hub and spoke model. To enhance access to testing and to maximize instrument utilization, 65 laboratories with GeneXpert devices provide multiplex testing for EID, TB, targeted VL, HPV, and SARS-CoV-2 tests. To improve VLC, the country has a policy to test VL samples from PP using GeneXpert platforms. To enhance electronic information transfer from anti-retroviral therapy (ART) clinics to hubs and testing molecular laboratories, LIMS and Electronic Medical Records System (EMRS) are being integrated to minimize missing results and the TAT. LIMS is being extended to monitor the overall laboratory stock management from end to end. Laboratories receive training on appropriate waste management, and innovative liquid and solid waste management is being introduced.

Diagnostics network optimization is being finalized for appropriate resource utilization across the VL, EID, and TB testing cascades. The capacity of each laboratory in the network will be optimized depending on the workload, availability of human resources, and equipment utilization. To create an efficient sample referral system, the distance between sample referring facilities to testing laboratories is being optimized. To increase VLC above 95%, PEPFAR supports data clerks in ART clinics, hubs, and molecular laboratories. Old molecular platforms were replaced with new and high throughput platforms to minimize service interruptions and reduce TATs. To avoid wastage of reagents and supplies, long-lasting backup power was provided to very high VL testing molecular laboratories. Using the gold standard, plasma sample for VL testing is being scaled up to reach up to 70% by the end of 2025.

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.

CQI was provided at all levels of the testing network. 24 laboratories underwent Strengthening Laboratory Management Towards Accreditation (SLMTA) and Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) in preparation for ISO15189 accreditation. 9 laboratories achieved and maintained their ISO15189 accreditation status, and the plan is to prepare additional laboratories, including the NRL, for ISO1518 and ISO17043 accreditations, respectively. HIV RTCQI was rolled out in 775 testing points within 672 facilities. A baseline assessment was conducted using the Stepwise Process for Improving the Quality of HIV RT checklist at the beginning of the enrollment, and 249 of the testing points scored a level 4. Of the 249 testing points, 152 were certified by the Medical Council of Malawi.

Enhanced interface between clinical and laboratory services has improved tracking of VL and EID testing progress.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-Term Outcomes Intermediate Outcomes

Long-Term Outcomes

Strategy 1:

Scale-up multi-disease and integrated diagnosis and treatment monitoring services across the country

Strategy 2:

Strengthen biosafety, biosecurity, and waste management measures and systems at all levels of laboratory networks

Strategy 3:

Strengthen MOH capacity to coordinate and oversee national diagnostic services

Strategy 4: Scale-up of CQI in conventional laboratories and POCT services

Increased adequate use of laboratory equipment in both conventional and POCT sites

Increased capacity of laboratory staff to conduct genomic sequencing

Reduced risk of staff to potential hazards and sample contamination by improving physical laboratory infrastructure

Improved staff skills and workflow of liquid and solid waste management and laboratory biorepository capacity at all levels

Improved capacity of Health Technical Services Support (HTSS) Department at MOH to coordinate and integrate laboratory systems

Increased access and uptake of

SLMTA/SLIPTA

Improved quality, reliability, and timeliness of testing services at all levels of laboratories

Increased viral suppression coverage

Improved genomic data analysis and pharmacovigilance

Improved biosafety, biorepository, biosecurity, and waste management at all levels

Improved adherence to national laboratory guidelines and standard operating procedures (SOP) at MOH and testing laboratories

Increased ISO accredited laboratories and nationally certified testing sites

Reduced HIV transmission, mortality, and morbidity

Improved TB case detection and treatment among PLHIV

Improved pathogen detection during outbreak and pandemic responses

i. Purpose The purpose of this NOFO is to improve and sustain PEPFAR’s laboratory investments through the Malawi MOH. Specifically, produce timely and multi-disease testing services; test 95% of VL, EID, TB, PrEP, and AHD samples and dispatch results on time; optimize the diagnostic network; enhance appropriate biosafety and waste management; obtain ISO15189/ISO17043

Strategies and Activities

Short-Term Outcomes Intermediate Outcomes

Long-Term Outcomes enrollment and processes

Improved access and uptake of EQA program and national certifications accreditations in testing and proficiency panel producing laboratories; enroll PEPFAR priority tests into the EQA program with a 90% pass rate; and expand HIV RTCQI activities for national certification.

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 adequate use of laboratory equipment in both conventional and POCT sites o Laboratory equipment refers to molecular platforms for multi-disease testing. The adequate use includes human resources capacity, laboratory infrastructure optimization proper equipment, and commodities management.

o Conventional molecular laboratory refers to laboratories with high throughput molecular platforms with a pre-determined testing capacity. These laboratories are expected to monitor the utilization of each platform according to a pre-specified utilization rate.

• Increased capacity of laboratory staff to conduct genomic sequencing

• Reduced risk of staff to potential hazards and sample contamination by improving physical laboratory infrastructure o Physical laboratory infrastructure refers to adequate space, consistent power and water supply, and a conducive working environment.

• Improved staff skills and workflow of liquid and solid waste management, and laboratory biorepository capacity at all levels

• Improved capacity of HTSS Department at MOH to coordinate and integrate laboratory systems o Health Technical Services Support-Diagnostics (HTSS-D) capacity needs to be built on central coordination and integration of laboratory programs; this will minimize duplication of efforts and improve efficient utilization of limited resources.

• Increased access and uptake of SLMTA/SLIPTA enrollment and processes o SLMTA/SLIPTA program is the framework to implement cost-effective and sustainable QMS which leads to ISO accreditation.

• Improved access and uptake of EQA program and national certifications o EQA program ensures accuracy and reliability of laboratory results. Proficiency

Testing (PT) program is the most common EQA method that provides evidence of laboratory competence to customers and accreditation bodies.

o POCT platforms are deployed in laboratory and non-laboratory settings. Non-laboratory professionals conduct testing in the non-laboratory settings and appropriate training and quality assurance systems need to be implemented.

o Laboratories have POCT platforms that are used for multi-disease testing and equipment utilization and TAT need to be monitored based on the pre-specified targets.

Intermediate Outcomes:

• Improved quality, reliability, and timeliness of testing services at all levels of laboratories

• Increased viral suppression coverage o All PLHIV are expected to have annual VL samples collected, tested, and results returned to the facility for appropriate patient management.

• Improved genomic data analysis and pharmacovigilance

• Improved biosafety, biorepository, biosecurity, and waste management at all levels o Appropriate biosafety equipment, materials, infrastructure, and training need to be in place to reduce exposure of staff, work environment, and community from potentially infectious organisms, toxins, and biological hazards.

o Standard biorepository system builds capacity to collect, process, and store biological specimens for enhanced surveillance.

o Appropriate waste management is key at all levels of the laboratory network; this includes proper handling and disposal of solid and liquid waste within and outside a laboratory.

• Improved adherence to national laboratory guidelines and SOP at MOH and testing laboratories

• Increased ISO accredited laboratories and nationally certified testing sites o CQI initiatives are stepwise quality improvement approaches to implement QMS in HIV and TB diagnostic services in conventional and POC testing facilities.

Long-Term Outcomes:

• Improved pathogen detection during outbreak and pandemic responses o Improved pathogen detection includes laboratories having the appropriate biosafety levels, modern technologies, infrastructure, and well-trained staff.

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: Scale-up multi-disease and integrated diagnosis and treatment monitoring services across the country

• Support expansion of optimized diagnostic capacities across priority diseases that affect PLHIV, including HIV/TB, HPV, SARS-CoV-2, and other emerging diseases through utilization of conventional and POCT platforms

• Support the scale-up of HIV VL and EID coverage through timely testing and return of results

• Enhance VL testing on POCT platforms for PP; pediatrics, key populations, adolescent girls, pregnant and breast-feeding women

• Scale up Creatinine and Hepatitis B testing capacities for PrEP services

• Strengthen the capacity of NRL at PHIM for emerging and re-emerging disease surveillance, investigation, and response

• Improve pathogen genomic sequencing capacity for emerging and re-emerging diseases at NRL

Strategy 2: Strengthen biosafety, biosecurity, and waste management measures and systems at all levels of laboratory networks

• Improve laboratory infrastructure to increase biosafety and appropriate workflow

• Support the scale-up of liquid and solid waste management systems using innovative strategies

• Strengthen and sustain biosecurity and biorepository at all levels of laboratory networks

Strategy 3: Strengthen MOH capacity to coordinate and oversee national diagnostic services

• Develop and implement national laboratory policies, strategies, and guidelines to strengthen HTSS-D capacity

• Expand HTSS-D capacity to monitor supply chain activities

• Support HTSS-D capacity to develop a standardized supportive supervision program to oversee the performance of laboratories and POCT sites

• Ensure district health offices’ laboratory activities are aligned with the MOH decentralization strategy so they can conduct supervision, review meetings, mentorship, training, and PT program management

• Advance data collection, analysis, and interpretation at all laboratory network systems for evidence-based decision-making

• Strengthen a tiered, integrated laboratory network to support diagnostics

• Strengthen human resource competencies for efficient service delivery across various levels of the health system

• Strengthen commodity utilization to ensure uninterrupted access to high-quality diagnostic services

• Implement strong monitoring and evaluation system at HTSS-D to optimize the national referral network; this includes improving data capturing, reporting, analyzing, and interpretation systems

• Promote competent, flexible, and efficient workforce at all levels of the laboratory network by building MOH, District and laboratory management staff leadership skills

• Ensure the NRL at PHIM conduct regular evaluation and verification of new and existing test methods; this enhances the capacity of the laboratories to respond to emerging and re-emerging public health threats impacting PLHIV

Strategy 4: Scale-up of CQI in conventional laboratories and POCT services

• Expand SLMTA/SLIPTA and ISO15189 accreditation in conventional molecular laboratories and near POCT facilities

• Support NRL to attain ISO17043 accreditation

• Support MOH to establish a local ISO accreditation body

• Scale up HIV RT and other POCT CQI

• Support the scale up of EQA to HIV, TB, CD4, Hematology, Chemistry, Microbiology and other PEPFAR-supported tests

• Support NRL capacity for local PT panels production e.g., HIV EID, VL, Cryptococcal

Antigen screening, Lateral Flow urine TB-Lipoarabinomannan (LF TB-LAM), TB molecular, TB culture, Syphilis RT, Hepatitis, and other tests

• Establish a local laboratory equipment calibration center for ancillary equipment and support its accreditation to ISO17025

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-funded health system strengthening and service delivery implementing partners, HIV surveillance, EMRS and LIMS, Sample Transport and Human Resource for Health (HRH) partners. In addition, the recipient(s) will be expected to collaborate with the Malawi Department of HIV and Aids and PHIM. These collaborations will ensure capacity building at various levels and enable sustainability. The CDC Malawi country office will assist the recipient(s) in connecting with other partners working in this area and the recipient(s) will be expected to ensure work is not duplicative but complementary and supportive to other work funded by CDC and other partners. The recipient(s) will likely work specifically with CDC Malawi’s Health Systems Strengthening Branch, Health Epidemiology and Strategic Information Branch, Health Services Branch, and Grants Management Branch.

b. With organizations not funded by CDC:

The recipient(s) will be expected to collaborate with other PEPFAR United States government (USG) agencies (USAID, Department of Defense, and State Department) that are supporting health system strengthening and HIV/TB service delivery programs.

Additionally, collaboration will be expected with other MOH departments (ex. HTSS-D, Quality Management Department [QMD]); the Global Fund Project Implementation unit (PIU); non- USG supported partners; international organizations implementing laboratory programs; and regulatory bodies including Medical Council of Malawi.

2. Population(s) of Focus

The populations of focus for this NOFO include the general population of men, women, and children in Malawi, as well as PLHIV. Other populations of focus include the MOH HIV Test Services and laboratory staff, and staff in NRL within PHIM.

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 $8,375,000 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: Additional Activities and Emerging Health Issues (buffer component).

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

To ensure continuous quality improvement and monitoring of the program at large, CDC expects that the routine performance data is reviewed, cleaned, and used for program management. To this effect, the recipient(s) should hold regular quarterly 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 10% of funds should be allocated for monitoring activities and 5% of funds should be used for evaluation activities. These are estimates for the total funding over the 5-year project.

PERFORMANCE MONITORING

Currently, reporting on PEPFAR monitoring, evaluation, and reporting (MER) indicators is not applicable to the scope of this NOFO, although that is subject to change in future project years.

Some custom (non-MER) indicators, targets, and reporting frequencies corresponding to Year 1 to 5 of the NOFO are shown below. The applicant should also propose additional relevant custom 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.

Non-MER: Additional Performance Measures (Custom Indicators)

Applicants should include additional custom performance measures to monitor achievement of outcomes not directly measured by PEPFAR (MER) indicators. These 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.

• District Hub laboratories:

o Percentage of VL and EID samples logged into EID/VL LIMS, and dispatched to testing laboratories [Target: 98%; Reporting Frequency: Quarterly] o Average TAT from sample draw from patient at requesting facility to dispatch to testing laboratories for VL and EID samples [Target: 5 days; Reporting Frequency: Quarterly] o Percentage of EID and VL results received from testing laboratories and dispatched to requesting facilities [Target: 100%; Reporting Frequency:

Quarterly] o Average TAT for VL and EID from result receipt from testing laboratory to dispatch to requesting facilities [Target: 3 days; Reporting Frequency: Quarterly]

• Near POCT GeneXpert laboratories:

o Percentage of EID and targeted VL samples tested and dispatched with valid results [Target: 95%; Reporting Frequency: Quarterly] o Average TAT from sample draw from patient to result dispatch to requesting facility [Target: <7 days; Reporting Frequency: Quarterly] o Percentage of instrument utilization at POCT laboratories [Target: 80%;

Reporting Frequency: Quarterly]

• POCT m-PIMA sites:

o Percentage of EID/VL samples tested and released with valid results within the requesting facility [Target: 95%; Reporting Frequency: Quarterly] o Average TAT for EID/VL samples from sample draw from infants/patients to result return within the requesting facility [Target: 1 day; Reporting Frequency:

Quarterly]

•…