Revised Foa_Content_of_CDC-RFA-GH-24-0099.pdf

Centers for Disease Control and Prevention

Center for Global Health

Strengthening Local and Government Capacity in Mozambique Through Technical Assistance and HIV Service Delivery Support in Zambézia Province in Addition to Targeted National

Health Information Systems Strengthening under PEPFAR

CDC-RFA-GH-24-0099

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-24-0099. 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 Local and Government Capacity in Mozambique Through Technical Assistance and HIV Service Delivery Support in Zambézia Province in Addition to Targeted National Health Information Systems Strengthening under 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 1: Questions and Answers (Q&A), Application Due Date Extension, 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 19th, 2024 (2/19/2024) to February 20th, 2024 (2/20/2024).

• 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-24-0099

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 This NOFO aims to provide technical assistance (TA) and service delivery support for integrated HIV/AIDS prevention, care, and treatment programs in the Zambézia Province of Mozambique while providing TA for specific gaps in data quality and utilization, and opportunities to strengthen health information systems (HIS) throughout the province and country. In particular, this NOFO aims to provide 1) targeted TA to the Government of Mozambique (GM) to strengthen data collection and use for continuous HIV/AIDS program improvement, and 2) TA to the Serviço Provincial de Saúde (SPS) of Zambézia Province and/or other local or government organizations to successfully implement and monitor their increasing service delivery program responsibilities, as these are gradually transitioned from clinical partners to GM.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards https://www.grants.gov/

The expected number of awards is 1-3.

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:

$13,000,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $13,000,000. The expected number of awards is 1-3. 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 One of the key strategic pillars of PEPFAR’s strategic direction focuses on ensuring the long-term sustainability of the HIV response through strengthened government, civil society, and local partner capabilities to lead and manage HIV/TB programs currently supported by PEPFAR.

The Zambézia Province is estimated to be the second most populated province in Mozambique and has the highest absolute burden of HIV in the country, with an estimated 490,000+ people living with HIV (PLHIV) as of fiscal year 2024 (FY24). CDC currently funds the provincial government in Zambézia through the SPS to support HIV/TB services; however, most comprehensive direct service delivery (DSD) for HIV prevention, and for over 85% of PLHIV on HIV treatment, has been provided by a majority of international non-governmental implementing partners (IP). In FY24, a pilot program began to graduate select sites and districts from comprehensive IP support to SPS responsibility, aiming to significantly scale-up the transition in scope and geography over subsequent years. This NOFO aims to provide technical and organizational capacity building and assistance to the SPS of Zambézia and other local government entities to successfully absorb graduated sites and districts, and ensure successful implementation, monitoring, reporting and continuous quality improvement as their responsibilities increase. In addition, this NOFO aims to provide ongoing support for any component of DSD program implementation that cannot be immediately absorbed by the GM including, but not limited to the hiring, management, and support of lay and data entry staff.

To achieve and sustain epidemic control, PEPFAR also supports the GM in strengthening the collection, analysis, and use of data for improved epidemic monitoring, program implementation, and patient-level clinical management. The National HIV Program within the Mozambican Ministry of Health (MOH) has made strides in improving HIV monitoring and evaluation (M&E) through HIS used for HIV and TB. While these systems have been successfully harmonized, upgraded, and centralized, effort is required to increase coverage, support government adoption, and ensure integration with other national HIS initiatives. This NOFO seeks to support the provision of targeted TA to the MOH at the central and provincial levels to optimize, improve health system operations for adaptive, proactive, and strategic responses to the evolving landscape of HIV challenges in Mozambique.

This NOFO aims to augment existing HIS solutions, focusing on integration, scalability, and sustainability. With the recent harmonization and centralization of the existing Electronic Patient Tracking System (EPTS) for use at PEPFAR-supported DSD site, the MOH has begun to engage in official broader-scale adoption of this platform for reporting purposes. In line with these new developments, the NOFO aims to improve data quality through innovative methods, (e.g., implementation of tools for patient de-duplication and support for health information exchanges).

Integrating existing systems (e.g., EPTS) into the wider national HIS ecosystem allows for more advanced modules, seamless data sharing, and enhanced data quality and analytics. Collaborating extensively with MOH and other stakeholders will foster the evolution and adoption of national HIS benchmarks, to create a cohesive data-driven environment. Finally, addressing human resource gaps by enabling MOH officials and healthcare professionals with the tools and training to effectively use the enhanced HIS will bolster HIS capacity.

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 nationals 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 CDC currently provides comprehensive HIV and TB services at the provincial, district, and DSD site levels through comprehensive clinical partners and, to a smaller degree, provincial governments. District government entities have also been funded through sub-agreements with prime partners. CDC has been increasingly funding provincial governments to support the PEPFAR-funded HIV/TB portfolio through activities such as training, workshops, supportive supervision visits, and QI activities. However, there is room to grow in terms of organizational and financial capacity to deliver, monitor, report on, and continually improve upon services at the level currently provided by much larger non-governmental IPs, who have historically received the bulk of PEPFAR program investments, in order to equitably achieve provincial level HIV targets, set jointly by the MOH and PEPFAR, and to ultimately reach and maintain HIV epidemic control. Additionally, some critical activities are not currently able to be supported by the Mozambican government, including the hiring of lay and data entry staff who provide HIV testing, prevention, treatment, and M&E services that are essential for PEPFAR program success. As CDC increasingly shifts site, activity, and programmatic responsibilities to GM, building on the past work of other clinical partners in line with CDC/PEPFAR goals for program sustainability and localization, this NOFO will provide targeted TA, capacity-building, and supplemental staffing support to GM partners as necessary to ensure that these transitions are successful.

This NOFO seeks to build upon increased interest and collaboration with the MOH on integrated approaches to HIS and surveillance, to amplify its impact, particularly concerning the management of emerging public health threats. The use of systems like Open MRS EPTS remains central to CDC’s strategy, bolstered by innovative modules addressing emerging health threats.

This NOFO seeks to support the Mozambique MOH for high-quality, sustainable implementation of HIS solutions, with EPTS remaining central to CDC‘s approach, necessitating agile modifications in line with PEPFAR and MOH policy dynamics, governed by rigorous project management and phased transitioning to MOH. Building on existing interoperability standards, the HIS strategy will ensure seamless data sharing and integration between EPTS and other systems. Capacity building and ownership transition activities will focus on integrating MOH personnel into core HIS functions with a proficient MOH, empowered with skills ranging from project management to software development, leading HIS initiatives with minimal external aid.

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

This NOFO aims to move beyond mere system implementation to fostering an environment where Mozambique stands autonomous, with robust systems and skilled personnel, ready to tackle future health challenges head-on.

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: Provide TA and support the Mozambique MOH to optimize and scale HIS solutions to improve service delivery and evidence-based decision-making for HIV, TB, and other emerging disease programs for national and provincial-level public health officials

Strategy 2: Support the transition and sustainment of PEPFAR-supported HIV programmatic management, service delivery, and M&E to provincial and other government entities in line with the overall vision for country-led, sustainable, and localized programming, through targeted TA and DSD support

Increased integration and efficiency of HIS solutions for HIV/TB program management

Increased oversight of national technical working groups (TWG) in the development of HIS standards by MOH

Increased capacity of MOH staff to use HIS solutions for monitoring, evaluation, and reporting quality data

Increased capability of technical, managerial, financial, and programmatic human resources at provincial, district, and site level

Sustained HIV and TB prevention and treatment service

Increased compliance with national Health Information Management Systems (HIS) standards and policies

Increased HIS management capacity of MOH staff

Increased use of quality HIS data to inform program improvement by government officials

Increased integration of HIV HIS solutions into the national health data ecosystem

Increased capacity of technical, managerial, financial, and programmatic human resources at the provincial, district, and site level

Sustained country ownership of

HIS

Increased ownership of national TWG in the development of HIS standards by MOH

Increased high-quality

PEPFAR-

supported HIV service delivery provided by provincial and local governments

Increased capacity of MOH to detect, investigate, and respond to emerging public health threats for all

Strategies and Activities

Short-Term Outcomes

Intermediate Outcomes

Long-Term Outcomes delivery at transitioned or graduated sites

Increased availability of quality HIS data to inform program improvement by government officials

Increased successful transfer of PEPFAR-supported program and site management, implementation, and monitoring to provincial and local government populations affected by HIV

i. Purpose The purpose of this NOFO is to provide TA and DSD support for integrated HIV prevention, care, and treatment programs in Zambézia Province, Mozambique, while strengthening HIS throughout the province and country. This NOFO aims to strengthen local capacity in Mozambique through 1) TA to SPS Zambézia and/or other local or government organizations to successfully implement and monitor service delivery program responsibilities as these are gradually transitioned from clinical partners to GM, and 2) Targeted TA to GM to strengthen data collection and use for continuous program improvement.

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 integration and efficiency of HIS solutions for HIV/TB program management o Integration and efficiency of HIS solutions includes but is not limited to interoperability of HIV/TB HIS solutions with other existing and emergent national information systems; enhanced data accessibility and management for timely decision-making in HIV/TB programs

• Increased oversight of national TWG in the development of HIS standards by MOH

• Increased capacity of MOH staff to use HIS solutions for monitoring, evaluation, and reporting quality data

• Increased capability of technical, managerial, financial, and programmatic human resources at provincial, district, and site level

• Sustained HIV and TB prevention and treatment service delivery at transitioned or graduated sites o HIV/TB prevention and treatment service delivery for adults, children, adolescents and pregnant and breast-feeding women may include, but is not limited to, targeted HIV case-finding through an optimal mix of nationally endorsed modalities; linkage to optimized HIV treatment regimens; viral load monitoring and results-based care; offer of differentiated models of service delivery and psychosocial support; combination prevention programming through use of condoms, pre- and post-exposure prophylaxis, voluntary male medical circumcision, and gender-based violence services; and special programming for key and vulnerable populations, adolescent girls and young women, and patients with advanced HIV disease or comorbidities (including TB and cervical cancer screening, prevention and treatment)

• Increased availability of quality HIS data to inform program improvement by government officials o Quality HIS data may include, but is not limited to, approaches to examining data accuracy, consistency, completeness, and relevance of data, such as implementation of solutions to deduplicate patients and prevent duplication in the future; streamlined data collection tools preventing data entry errors; optimized data quality controls; and enhanced data collection mechanisms

Intermediate Outcomes:

• Increased compliance with national HIMS standards and policies

• Increased HIS management capacity of MOH staff

• Increased use of quality HIS data to inform program improvement by government officials o Use of quality HIS data may include, but is not limited to, centralized data repositories; user-appropriate dashboards and visualization tools; decision support systems; healthcare analytics and reporting tools

• Increased integration of HIV HIS solutions into the national health data ecosystem o Integration of HIS solutions may include but is not limited to Health information exchanges (HIEs); interoperability standards and platforms; and population health management tools o National health data ecosystem may include, but is not limited to, public health registries; surveillance databases; pharmacy and prescription databases; data analytics and AI platforms; and telemedicine platforms

• Increased capacity of technical, managerial, financial, and programmatic human resources at the provincial, district, and site level

• Increased successful transfer of PEPFAR-supported program and site management, implementation, and monitoring to provincial and local government

Long-Term Outcomes:

• Sustained country ownership of HIS

• Increased ownership of national TWG in the development of HIS standards by MOH

• Increased high-quality PEPFAR-supported HIV and TB service delivery provided by provincial and local governments

• Increased capacity of MOH to detect, investigate, and respond to emerging public health threats for all populations affected by HIV

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: Provide TA and support the Mozambique MOH to optimize and scale HIS solutions to improve service delivery and evidence-based decision-making for HIV, TB, and other emerging disease programs for national and provincial level public health officials

• Build upon existing HIS structures by incorporating novel modules, ensuring data quality, strengthening security, privacy, and confidentiality, bolstering analytics, and accelerating the transition to MOH ownership; innovations may be initially piloted in Zambezia province to assess scalability

• Prioritize the seamless integration of PEPFAR HIS systems with existing and emergent systems, leveraging global open-source interoperability norms

• Enhance collaboration with MOH and relevant stakeholders, fostering the evolution and adoption of national HIS standards

• Institutionalize robust project management methodologies across all HIS development activities, promoting meticulous documentation and standard adoption

• Support capacity-building initiative aimed at amplifying health informatics expertise among MOH officials, healthcare professionals, and HIS stakeholders

• Enrich MOH personnel's competencies in project management, software development, systems support, and data analytics, ensuring they are adept at leveraging HIS utilities.

• Drive consensus through consistent engagement, such as workshops, brainstorming sessions, and system evaluations

• Distill and propagate pivotal informatics techniques, cementing a structured project management method to optimize information systems and data utility

Strategy 2: Support the transition and sustainment of PEPFAR-supported HIV programmatic management, service delivery, and M&E to provincial and other government entities in line with the overall vision for country-led, sustainable, and localized programming, through targeted TA and DSD support

• Provide organizational capacity building and targeted technical assistance to the provincial and other government entities to assume greater HIV/TB program and financial responsibility through close and ongoing mentorship and sharing of best practices

• Support expansion of site and program graduation to the SPS through targeted and evidence-based technical support to ensure that the quality of HIV service delivery is maintained, and to help course-correct based on problems identified during the program/service delivery transition process

• Hire and manage lay and data entry staff required for successful PEPFAR-supported programming as DSD responsibility for select sites is graduated to the provincial government from a non-governmental organization, and support mid- to longer-term absorption once the Government of Mozambique (GM) community cadres mechanisms are in place

• Perform joint data reviews, and site monitoring and supervision with the provincial government and other local government entities to identify and act upon successes and challenges, and to strengthen their technical capacity to perform these activities successfully and independently

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 other CDC-funded facility and community-based implementing partners providing comprehensive HIV prevention and treatment service delivery in Zambézia Province and/or elsewhere in Mozambique to achieve NOFO goals. The recipient(s) is expected to collaborate with, and support program management capacity of, government entities at the provincial, district and site levels. The recipient(s) will also be expected to collaborate with the Mozambican MOH, which is funded centrally through CDC.

b. With organizations not funded by CDC:

The recipient(s) will be expected to collaborate with other PEPFAR-funded organizations such as those funded to provide community services in Zambézia through USAID and/or civil society.

The recipient(s) will also be expected to collaborate with non-CDC funded Ministries, international and national civil society, as well as international donors such as the Global Fund, World Bank and their implementing partners, and local organizations that have a role in achieving the NOFO goals and objectives.

2. Population(s) of Focus The population(s) of focus for this NOFO include government staff at the provincial, district and site level who will be targeted for technical assistance and capacity building, as will multi-level government staff that utilize or guide development of health information systems. Additional populations of focus include PLHIV and populations who are at high risk of HIV and TB infection or severe disease, including children, adolescents and youth, key populations, and men.

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 $13,000,000 with the below listed components:

• Component 1: COP Q1 Targets/Activities;

• Component 2: COP Q2 Targets/Activities;

• Component 3: COP Q3 Targets/Activities;

• Component 4: COP Q4 Targets/Activities;

• Component 5: COP Additional Targets/Activities.

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 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, a minimum of 3% of funds should be allocated for monitoring activities and 2% of funds should be used for evaluation activities. These are estimates for the total funding over the 5-year project.

PERFORMANCE MONITORING

At this time, 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 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.

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.

Non-MER: Additional Performance Measures (Custom Indicators)

Applicants should propose custom performance measures to monitor the achievement of outcomes. 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.

• Percent M&E implemented corrective action plans with written performance improvement recommendations based on MER indicators reported by SPS from graduated sites [Target: 80%; Reporting Frequency: Quarterly]

• Number of problems identified and resolved from the corrective action plans for graduated sites [Target: 10; Reporting Frequency: Quarterly]

• Percent SME provincial TA or supervision visits with written performance improvement recommendations at each visit and documented follow-up based on MER indicator review [Target: 80%; Reporting Frequency: Quarterly]

• Percent of provincial QI/QA plan approved and adopted for graduated facilities [Target:

100%; Reporting Frequency: Quarterly]

• Percent of graduated facilities reporting data to PEPFAR by SPS monthly [Target: 100%;

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

• Percent completeness of data for HIV indicators for graduated facilities [Target: 100%;

Reporting Frequency: Quarterly]

• Number of graduated or otherwise supported sites with reported deficiencies in performance per MER, quality improvement, or other routinely collected indicators that receive on-site quality improvement interventions supported by the applicant [Target: 3;

Reporting Frequency: Quarterly]

• Percent of HIS releases with no defects [Target: 20%; Reporting frequency: Annually]

• Number of HIS policies developed [Target: 1; Reporting frequency: Annually]

• Number of HIS policies updated [Target: 1; Reporting frequency: Annually]

• Number of policy documents on HIS solutions (e.g., integration, interoperability, information exchange) developed in collaboration with the government of Mozambique within the first year of award [Target: 1; Reporting frequency: Annually]

• Number of HIS systems fully transitioned to the MOH within the first year of award [Target: 1; Reporting frequency: Annually]

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

Evaluation

The evaluation topics below are examples of areas that the…