PKG00257998-instructions.pdf

Centers for Disease Control and Prevention

Center for Global Health

Strengthening Federal Ministry of Health Capabilities in Technical Assistance for Service

Delivery and Execution of Core Public Health Functions to Achieve and Sustain HIV Epidemic Control in Ethiopia, under PEPFAR

CDC-RFA-GH20-2030

Application Due Date: 03/27/2020

Strengthening Federal Ministry of Health Capabilities in Technical Assistance for Service

Control in Ethiopia, under PEPFAR

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text 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 Information 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- GH20-2030. 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 Federal Ministry of Health Capabilities in Technical Assistance for Service

Control in Ethiopia, 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 this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

D. Agency Notice of Funding Opportunity Number:

E. Assistance Listings (CFDA) Number:

93.067 Additional CFDA Number: 93.099

93.185 93.318

F. Dates:

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

2. Due Date for Applications: 03/27/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

N/A G. Executive Summary:

1. Summary Paragraph:

This NOFO will enable Ethiopia’s Federal Ministry of Health (FMOH) and affiliated offices and institutions to lead, coordinate, and provide oversight to the national HIV epidemic control program and ensure quality service delivery in all regions for comprehensive HIV prevention, diagnosis, surveillance, care and treatment programs. FMOH will develop and sustain an integrated HIV technical assistance (TA) network at national, regional, and zonal levels and strengthen FMOH’s overall TA coordination function. This NOFO will further the capacity of 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.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html the Government of Ethiopia (GoE) to implement its programs in accordance with PEPFAR goals to attain maximum programmatic impact. As the FMOH for Ethiopia, the Ministry and associated institutions will serve as a national TA provider to all regions and implementing partners, providing leadership and coordination for the national response to sustain HIV epidemic control at the federal level. FMOH, in collaboration with regional health bureaus (RHBs), will regularly monitor the performance of HIV services at public and private health facilities. Additionally, as the FMOH mandate covers all areas of public health in Ethiopia, this NOFO may support other public health system strengthening activities, including but not limited to Global Health Security Agenda (GHSA), immunization, and any other activities of public health importance, in coordination with CDC-Ethiopia. These additional activities are subject to the availability of funds.

a. Eligible Applicants: Single

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 1

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: $5,000,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $5,000,000. The expected number of awards is 1. Exact amounts for each award under this NOFO will be determined at the time of award. Applicants are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount.

f. Total Period of Performance Length: 5

g. Estimated Award Date: 09/30/2020

h. Cost Sharing and / or Matching Requirements: N 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

Part II. Full Text

1. Background

a. Overview Ethiopia has made great progress in improving access to health services and improvements in health outcomes. Ethiopia’s health indicators have improved remarkably in the last two decades.

Millions of new infections and deaths from communicable diseases such as HIV, malaria, TB, and other diseases have been prevented. All this was done while building a health system that can sustain the gains over the long term. A marked improvement has been registered in the availability of health workers, largely due to a massive scale-up of training and education in the last two decades. Despite the impressive progress made, Ethiopia still has high rates of morbidity and mortality from preventable causes. There is also a disparity in uptake and coverage of high impact interventions amongst different regions and population groups.

The 2018 EPHIA shows that Ethiopia is moving closer to HIV epidemic control. As Ethiopia makes progress nationally to reach the UNAID’s 95-95-95 goals (95% of all people living with HIV will know their HIV status, 95% of all people with diagnosed HIV infection will receive sustained antiretroviral therapy (ART), and 95% of all people receiving ART will have viral suppression), the GoE needs to strengthen coordination and core systems to sustain epidemic control, including case finding, maintaining the cohort of persons currently on treatment, and ensuring quality of viral load suppression.

The U.S. Government (USG) collaborates with FMOH in implementing a range of health related activities to improve the capacity of the Ministry, RHBs, Ethiopian Public Health Institute (EPHI), and other GOE institutions to lead and coordinate prevention, control, and response for major health issues. This partnership includes HIV/AIDS, TB/HIV, GHSA, immunization, malaria, and other emerging disease prevention, control, and response efforts.

Under this award, the FMOH will provide overall technical leadership, guidance, resource mobilization, and monitoring and evaluation (M&E) for the transition of services to the existing national health care system to ensure an affordable, manageable, and sustainable comprehensive HIV program as well as monitoring to maintain a standard of care and data quality.

This NOFO is developed to enable FMOH and its affiliated agencies and institutions to lead, coordinate, and provide oversight to the national HIV epidemic control program as well as ensure quality service delivery in all regions for a comprehensive HIV prevention, diagnosis, surveillance, care, and treatment program. FMOH, with the Federal HIV/AIDS Control Program Office (FHAPCO), will develop and sustain an integrated HIV TA network at national, regional, and zonal levels and strengthen FMOH and FHAPCO TA coordination functions. The NOFO will further the capacity of GoE to implement its program in accordance with the goals of PEPFAR to attain maximum programmatic impact. This NOFO will support the FMOH to lead efforts to strengthen core public health functions and services that are critical for sustaining HIV epidemic control and addressing other 21st century health threats. These functions include other public health system strengthening activities for programs under the responsibility of the FMOH. This may include but will not be limited to GHSA, immunization, and/or any other activities of public health importance, in coordination with CDC-Ethiopia. These additional activities are subject to the availability of funds.

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.

Non-PEPFAR funding:

This program is authorized under sections 301(a) and 307 of the Public Health Service Act, as amended [42 U.S.C. §§ 241 and 2421].

This program is also authorized under Sections 317, 317(k)(2), 318 and 318B of the Public Health Service Act (42 U.S.C. Sections 247b, 247b(k)(2) and 247c), as amended; Public Health Service Act, Section 307 as amended [42 U.S.C. §§ 241 and 2421] and Public Health Service Act sections 301(a) and 307, as amended,42 U.S.C. §§ 241 and 242l.

c. Healthy People 2030

d. Other National Public Health Priorities and Strategies Under the leadership of the Office of the U.S. Global AIDS Coordinator (OGAC), as part of the President's Emergency Plan, the U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (HHS/CDC) works with host countries 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 and partnership framework.

HHS/CDC focuses primarily on two or three major program areas in each country. Goals and priorities include the following:

Achieving primary prevention of HIV infection through activities such as expanding confidential counseling and testing programs linked with evidence based behavioral change and building programs to reduce mother-to-child transmission;

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 and use 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 partners and integration of activities that promote Global Health Initiative principles. As such, recipients may be requested to participate in programmatic activities that include the following activities:

Implement a woman- and girl-centered approach;

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;

Build sustainability through investments in health systems;

Improve metrics, monitoring and evaluation; and Promote research, development, and innovation (research is not supported by this

NOFO).

PEPFAR defines national HIV epidemic control as the point at which the total number of new infections falls below the total number of deaths from all causes among HIV-infected individuals (the classic R0 to Ri approach to infectious diseases), with both declining. 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 people living with HIV (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.

Effective December 1, 2018, 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 key populations. These strategies may include or build upon traditional methods and activities related to outbreak detection, investigation, and response. 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, remaining gaps, and informed 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 indigenous partners, including faith communities and faith-based organizations (FBOs), HIV network organizations and community-based organizations directly servicing communities and populations at-risk and most affected by HIV to build local capacity.

Strengthen policy and financial contributions by partner governments in the HIV/AIDS response.

Support activities, interventions, and programs to find, treat, and prevent Tuberculosis (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.

The Epidemic Control language immediately listed above is in effect under this NOFO from December 1, 2018 through the remainder of the project period.

The President’s Emergency Plan for AIDS Relief (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 award 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.

This announcement 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: http://www.cdc.gov/od/science/integrity/docs http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf

/cdc-policy-distinguishing-public-health-research-nonresearch.pdf

e. Relevant Work The USG collaborates with FMOH in implementing a range of health related activities to improve the capacity of the Ministry, RHBs, EPHI, and other GoE institutions to lead and coordinate prevention, control, and response of major health problems of the country. CDC has a long history in supporting and partnering with FMOH, RHBs, and EPHI working to support HIV/AIDS, GHSA, immunization, malaria, and other emerging disease prevention, control, and response activities.

Since 2003, CDC-FMOH partnership has been demonstrated through three NOFOs. The most recent one was under CDC-RFA-GH16-1615 which ended on September 29, 2018. The support improved the FMOH capacity to provide oversight and coordination for the national HIV/AIDS response and the implementation of comprehensive HIV/AIDS program activities.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf

i. Purpose The purpose of this NOFO is to enable FMOH to lead, coordinate, and provide oversight to the national HIV epidemic control program and ensure quality service delivery in all regions for comprehensive HIV program implementation. FMOH will develop and sustain an integrated TA network at national, regional, and zonal levels and strengthen its TA function. The NOFO will support FMOH and its affiliated agencies and institutions to lead and strengthen core public health functions and services that are critical for sustaining HIV epidemic control and addressing other 21st century health threats.

ii. Outcomes Short-Term Outcomes:

Increased knowledge in use of national strategy, plan, and guidelines to facilitate the transition

Improved capacity to mobilize resources by FMOH and RHBs Increased use of transition roadmap at national and regional level to guide the transition process Improved planning, coordination, and management capacity at FMOH and RHBs Improved knowledge and practice in use of new approaches to increase HIV case detection, treatment initiation and retention and viral suppression Improved capacity to conduct site-level HIV program monitoring by FMOH, RHBs, and other implementing partners Improved capacity for timely reporting of MER and custom indicators Increased knowledge and skill in using electronic medical recording system

Intermediate Outcomes:

Improved leadership capacity to manage the transition process Improved efficiency and effectiveness of HIV program management Increased local resource contributions at federal and regional level to maintain quality of

HIV services Increased capacity to deliver and manage quality HIV program and services Improved M&E systems to track changes in the transition process and adjust as required Improved quality of reporting and data use for decision making

Long-Term Outcomes:

Improved quality of HIV services at public, private, and uniform services health facilities

iii. Strategies and Activities Strategy 1: Build capacity of FMOH to lead the transition process and serve as a national TA provider to regions and other local implementing partners including the private sector

Recruit skilled personnel at FMOH to manage HIV program implementation at the federal and regional level

Provide leadership and management training for FMOH and RHB staff Finalize and launch national transition roadmap for use in planning Coordinate and collaborate with RHBs sector offices of FMOH, USG, and other partners to support the national program

Conduct quarterly review meeting with RHBs and other implementing partners to review performance and develop improvement plan

Support RHBs to develop local resource mobilization strategy

Strategy 2: Build capacity of FMOH to plan, coordinate, and manage HIV and TB services at the national federal and regional level to achieve and sustain epidemic control

Strengthen federal and regional capacities to coordinate HIV and TB prevention, care and treatment services

Assist RHBs and private sectors to provide quality training, mentorship, and supervision Adapt new and innovative approaches to improve case finding such as partner services, Social networking strategy (SNS), expanding key population (KP) clinics mainly focusing female sex workers, their sexual partners, linkage, care and treatment, retention and viral suppression

Support RHBs to improve quality clinical and laboratory services Ensure availability of HIV supplies at the sites and regional laboratory Support and facilitate the adherence support and lost to follow up tracing system in public and private health facilities using facility service providers and extension workers

Strategy 3: Strengthen HIV program planning and management at national and regional level

Support Regions to conduct quarterly performance reviews, technical and managerial Conduct bi-annual national program performance reviews engaging all regions, partners, and donors; one of these reviews should be timed in the year so as to strategically guide COP development (e.g. December)

Ensure strategic alignment between GoE, Global Fund, and USG planning processes, in terms of processes, information used, and common goals and objectives

Establish strategic direction for the country and stakeholders from the next 5-year HIV National Strategic Plan (NSP) (2021-2025) to achieve and sustain HIV epidemic control; monitor performance and ensure compliance with the 5-year NSP

Strategy 4: Strengthen M&E system at national, regional, and facility level

Provide support to the RHBs and other transition partners to generate and report quality data for Monitoring, Evaluation, and Reporting (MER) and custom indicator related data for program improvement and decision-making

Strengthen the national HIV/AIDS health management information system at FMOH, support integration of MER indicators into HMIS (DHIS-2) for alignment with PEPFAR DATIM and ultimately, reporting through the national HMIS into DATIM

Support the national M&E system to strengthen data quality assurance (DQA) through training, mentorship, and supervision in collaboration with CDC and implementing partners. Cascade the training to regions and facility level, with special attention provided to emerging regions.

Use data for program improvement and report to the National Level. Build the capacity of FMOH M&E team on MER indicator reporting using DATIM. Support RHBs in the implementation of electronic medical recording at facilities in collaboration with partners.

Work closely work EPHI and implementing partners to support surveys and surveillance such as case-based surveillance

Avail standard operating procedures (SOPs), registers, and guidelines at facilities Conduct regular mentorship and supervision

In furtherance of the underlying purpose of this announcement, Recipient is expected to provide copies 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 for appropriate use. CDC should be provided access consistent with applicable grants regulations.

1. Collaborations

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

The recipient will be expected to collaborate and work closely with other CDC-supported implementing partners, including FMOH agencies and institutions, such as FHAPCO and EPHI, as well as RHBs, uniformed services, non-governmental organizations (NGOs), and international partners working in HIV program coordination, TA provision, training, mentorship, and capacity building activities. This collaboration will focus on program implementation, coordination, technical support and consultation, and is intended to ensure synergy and efficient services toward achieving project outcomes. This is also consistent with the mandate of the FMOH - to provide leadership, coordination, and oversight for all public health efforts in Ethiopia.

b. With organizations not funded by CDC:

The recipient will be expected to collaborate with other USG funded partners (both PEPFAR and non-PEPFAR partners), other bilateral and multilateral organizations, host government organizations, NGOs, and the private sector in planning, coordination, guideline development, capacity building, etc. In all instances, this collaboration is intended to foster harmonization and complementarity of effort. This is also consistent with the mandate of the FMOH - to provide leadership, coordination, and oversight for all public health efforts in Ethiopia.

2. Target Populations The target populations for this NOFO include persons living with HIV, their sexual contacts and biological children, PMTCT clients, TB/HIV/STI clients, KP, persons seeking testing, care and treatment services at public and private health facilities, health care workers, and laboratorians.

a. Health Disparities

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. Applicants should submit the SF-424A as part of their application which shows all components for the budget period and the amounts should exactly match what is being requested for funding. Please note the following key points on component funding:

Component funding must be setup at the time of the application.

Each component must be a discrete set of activities with an associated budget. Setting up components based on time (i.e., quarterly) is an appropriate distinction of activities, provided activities are clearly outlined.

Applicants should submit SF-424As as part of their applications which show all components for the budget period. If more than 4 components exist, multiple SF-424As will be needed.

Any component that is not funded at the time of 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.

If, during the technical review, the program office approves a budget that differs from what was submitted at application (reflected in the budget markup), a revised budget will be required in conjunction with the response to the technical review. This revised budget is due within 30 days of the start of the budget period. Any future components will not be awarded until the revised budget is submitted and approved.

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

Component ceilings cannot change throughout the budget period.

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 $5,000,000 with the following components:

Component 1- COP20 Q1 Targets Component 2- COP20 Q2 Targets Component 3- COP20 Q3 Targets Component 4- COP20 Q4 Targets Component 5- Additional COP20 Targets Component 6- Additional FY21 Funding and Activities

These amounts are subject to approval 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 should hold regular review meetings to discuss performance and use data in program quality improvement activities.

The recipient should allocate funds made available under this NOFO for both evaluation activities and performance monitoring. While the final funding amount will be agreed upon by both CDC and the recipient, a minimum of 2% of funds should be allocated for monitoring activities and 5% of funds used for evaluation activities.

PERFORMANCE MONITORING

Performance measures will include both PEPFAR (MER) and non-MER indicators. The recipient is responsible for reporting on but not limited to the MER indicators listed below; the applicant should propose additional relevant PEPFAR (MER) and non-MER indicators as part of their initial Evaluation and Performance Management Strategy.

Targets and Reporting Frequency Illustrative indicators, targets, and reporting frequencies corresponding to Year 1 of the NOFO are shown below. Unless otherwise indicated, the reporting periods for MER indicators will mirror the PEPFAR MER indicator reporting frequency (quarterly, semi-annually, and annually). Targets and reporting frequencies may be adjusted or new targets 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 will affect the targets of the subsequent years. Additional information regarding MER reporting is included in the PEPFAR MER 2.0 (V2.3) guidance.

PEPFAR (MER) Process and Outcome Measures:

HTS_TST: Number of individuals who received HIV Testing Services (HTS) and received their test results, disaggregated by HIV result [Target: 311,699]

TX_NEW: Number of adults and children newly enrolled on antiretroviral therapy (ART) [Target: 4,862]

TX_CURR: Number of adults and children currently receiving antiretroviral therapy (ART) [Target: 76,152]

PMTCT_EID: Percentage of infants born to HIV-positive women who had a virologic HIV test done within 12 months of birth [Target: 90% of HIV-exposed infants]

TB_PREV: Proportion of ART patients who completed a standard course of TB preventive therapy within the reporting period [Target: 90% of patients who are on ART and clinically indicated]

TX_PVLS: Percentage of ART patients with a viral load result documented in the medical record and/or laboratory information systems (LIS) within the past 12 months with a suppressed viral load (<1000 copies/ml) [Target: 90.2%] o Numerator: Number of adult and pediatric patients on ART with suppressed viral load results (<1,000 copies/ml) documented in the medical records and/or supporting laboratory results within the past 12 months (DSD) [Target: 62,384] o Denominator: Number of adult and pediatric ART patients with a viral load result documented in the patient medical record and /or laboratory records in the past 12 months (DSD) [Target: 69,138]

Non-MER: Additional Performance Measures (Custom Indicators) Additionally, the recipient should ensure availability and monitoring of essential commodities (RTKs, ARVs, OI drugs, and others) with immediate reporting of stock-outs through appropriate channels as well as immediate reporting to CDC-Ethiopia.

The applicant should propose additional custom performance measures to monitor achievement of outcomes not directly measured by PEPFAR (MER) indicators. Custom indicators should include process and outcome measures directly correlated with the logic model. Proposed indicators will be reviewed and refined in the first 6 months of the project period. Below are examples of additional process and outcome measures for the strategies/activities and outcomes previously discussed in the logic model and associated narrative sections.

#/% skilled personnel recruited at the federal and regional level against workplan target (Target: 75, 90%, Annual reporting)

#/% of trainings conducted against workplan target (Target: 30, 90% Biannual reporting) #/% of quarterly joint supportive supervision visits conducted to each of the 11 regions against workplan target (Target: 44, 100%, Quarterly reporting) #/% of regional and national-level performance review meetings conducted against workplan target (Target: 2 per region and national level for a total of 24, 100%, Biannual reporting)

#/% of quarterly programmatic and financial reports submitted to CDC on time (Target:

4, 100%, quarterly reporting)

Data Sources for MER and Custom Indicators: PEPFAR MER indicators data source is HMIS/DHIS 2. In cases where HMIS/DHIS 2 is not adequate to answer monitoring questions, the recipient needs to fill the gap from host government administrative reports and other sources determined by the program. It is the intention of CDC that performance data need to be reviewed, cleaned, and used for program management.

Dissemination of Results: the results of the findings will be disseminated to stakeholders using a variety of channels including written reports, workshops, and publications.

EVALUATION

The potential evaluation questions and/or topics below are examples of what the recipient may be expected to answer through evaluation(s). The applicant should include at least 1, but no more than 3 potential evaluation questions The applicant should consider the following areas when developing evaluation questions for process and/or outcome evaluations:

Sample Topics:

Effectiveness and scalability of the transition from direct service delivery to the national TA model for Ethiopia

Quality of services in regions where USG direct service delivery assistance has stopped, looking at metrics such as incidence of new cases, loss to follow-up/retention in care and treatment, and viral load suppression

Effectiveness of the national M&E system for collecting and reporting site level performance data

Data Sources: Both primary and secondary data sources can be used for the evaluation.

Primary data sources may include interview of patients, health care providers, and health facility administrators as well as focus group discussions. Secondary data sources include review of available data.

Dissemination of Results: The evaluation findings will be disseminated to stakeholders using a variety of channels including reports, through workshops and through publication. CDC and stakeholders will use overall evaluation findings during the five-year NOFO period to share and implement key recommendations to strengthen program implementation and effectiveness, sustainability, and continued program improvement upon completion of the award.

In addition, recipient(s) may be required to conduct a costing analysis or economic evaluation of implemented interventions or activities at the end of project to determine:

Cost and/or unit costs, and cost drivers of interventions or activities Cost-effectiveness of interventions or activities

Evaluations are expected to align with national, PEPFAR, and agency priorities and programmatic gaps, and will be reviewed and approved as part of the Country Operational Plan (COP). As such, the evaluation questions listed in this announcement may be amended based on feedback from OGAC during the annual COP review process.

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

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

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

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

Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans.

For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

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

c. Organizational Capacity of Recipients to Implement the Approach The applicant should submit the following materials in their appendix:

CVs/Resumes highlighting skills and experience related to carrying out the proposal and professional experience referenced in line with organogram for the following key positions:

o Principal Investigator (PI) o Business Official o Technical Area Leads

Job Descriptions for all positions key to the performance of the award, including positions applying less than 100% Level of Effort (LOE) on the award (maximum 1/2 page per job description)

Organizational Chart (organogram) for the project (maximum 1 page): Major focus should be on the staffing structure for the proposed activities and for managing Federal Assistance from the USG in accordance with grants management regulations; however, organizational structure for the wider organization may be included to the extent that it relates to the NOFO project staffing structure. Minimum core functions that need to be supported with dedicated project staff time and included on the Project Organizational Chart include:

o Cooperative Agreement Planning and Management: efficiently coordinate the planning process (action plan and budget) across all relevant technical directorates; work with CDC technical and management personnel to review performance on a quarterly basis, and revise quarterly work plans and associated spend plans, including new or continuation applications, redirections, technical review responses, restriction releases, etc.

o Standardization and process: Develop FMOH-specific project and/or grants management manuals, SOPs, tools, templates, etc.

o Financial management: Identify financing prioritization for activities and funding needs, drawdown money from the U.S. Treasury Payment Management System (PMS), transfer funds to end users for implementations, conduct procurements, track expenditures, establish internal controls, develop payment standards/rates, https://www.cdc.gov/grants/additionalrequirements/ar-25.html reconcile advances, reconcile bank statements with PMS drawdowns and disbursements, etc.

o Compliance: ensures that all stakeholders comply with the rules, regulation of the GoE and donors, especially the terms and conditions applicable to the award.

o Process requests: develop a clear, understandable and feasible process for all aspects project actions such as review requests submitted, check availability of budget and make recommendations o Human resource: Identify staff needs and skill sets, prepare specification, process recruitment to hire the right people on a timely basis and provide orientation o Training: Identify training needs, design training programs and organize them by selecting the right modality, follow-up implementation, create database, conduct post training evaluation, etc.

o Monitoring and supervision: develop a monitoring plan, identify monitoring and tracking tools, schedule supervisions, analyze progress made, etc.

o Procurement: identify procurement need, prepare specifications, initiate procurement, follow-up purchase and delivery, ensure periodic inventory is done, etc.

o Meetings: draft agendas, organize meetings and performance reviews, keep meeting minutes and identify action items, identify best practices and lessons learned, recommend for future improvement, etc.

o Reports: prepare and submit progress reports, financial reports, expenditure, audit reports, etc. to both internal management and CDC o Quality management: Although delivery of products is important, it is equally necessary to ensure quality of product/service through establishing quality control mechanisms, developing quality assurance tools, supervising and coordinating inspection of quality o Documentation: ensure proper documentation is kept in hard copy and electronic forms o Advises management on project selection, priority setting, resource allocation, HR needs, etc.

o Communication: prepares a communication plan, shares information in a transparent manner to all stakeholders within the FMOH, its associated agencies and institutions, to all RHBs, and with PEPFAR, WHO, UNAIDS and other external stakeholders

Financial management statement (maximum 2 pages) that describes the following:

o Systems and procedures used to manage donor funds o Procurement procedures that will support timely execution of assistance and within the performance period of an individual award year o Procedures for obtaining annual audits that meet USG grants regulations A-133 standards o Previous experience managing budgets greater than $1,000,000

Applicants must title these documents in their appendix as follows: “CVs/Resumes,” “Job Descriptions,” “Organizational Chart,” “Financial Statement” and upload it at www.grants.gov.

d. Work Plan http://www.grants.gov/

Applicants must include a work plan that demonstrates how the outcomes, strategies, activities, timelines, and staffing will take place over the course of the award. Applicants must submit a detailed work plan for the first year of the project and a high level plan for the subsequent years.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

f. CDC Program Support to Recipients (THIS SECTION APPLIES ONLY TO

COOPERATIVE AGREEMENTS)

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring. CDC activities for this program include, but are not limited to, the following:

1. Organize an orientation meeting with the recipient for a briefing on applicable U.S.

Government, HHS/CDC, and PEPFAR expectations, regulations, and key management requirements, as well as report formats and contents. The orientation could include meetings with staff from HHS agencies and OGAC.

2. Review and make recommendations as necessary to the process used by the recipient to select key personnel and/or post-award sub-contractors and/or sub-recipients to be involved in the activities performed under this agreement, as part of the PEPFAR COP review and approval process, managed by OGAC.

3. Review and approve recipient’s annual work plan and detailed budget, as part of the

PEPFAR COP review and approval process, managed by OGAC.

4. Review and approve the recipient’s monitoring and evaluation plan, including for compliance with the strategic information guidance established by OGAC.

5. Meet on a regular basis with the recipient to assess expenditures in relation to approved work plan and modify plans as necessary.

6. Meet on a quarterly basis with the recipient to assess quarterly technical and financial progress reports and modify plans as necessary.

7. Meet on an annual basis with the recipient to review annual progress report for each

U.S. Government Fiscal Year, and to review annual work plans and budgets for the subsequent year, as part of the PEPFAR COP review and approval process, managed by

OGAC.

8. Provide technical assistance, as mutually agreed upon, and revise annually during validation of the first and subsequent annual work plans. This could include expert technical assistance and targeted training activities in specialized areas, such as strategic information, project management, and confidential counseling and testing.

9. Provide in-country administrative support to help the recipient meet U.S. Government financial and reporting requirements approved by the Office of Management and Budget

(OMB).

10. Collaborate with the recipient on designing and implementing the activities listed above, including, but not limited to: the provision of technical assistance to develop program activities, data management and analysis, quality assurance, the presentation and possibly publication of program results and findings, and the management and tracking of finances.

11. Provide technical assistance or advice on any data collections on 10 or more people that are planned or conducted by the recipient. All such data collections-- where CDC staff will be or are approving, directing, conducting, managing, or owning data-- must undergo OMB project determinations by CDC and may require OMB Paperwork Reduction Act of 1995 (PRA) clearance prior to the start of the project.

12. Provide consultation and scientific and technical assistance based on appropriate HHS/CDC and OGAC documents to promote the use of best practices known at the time.

13. Assist the recipient in developing and implementing quality-assurance criteria and procedures.

14. Facilitate in-country planning and review meetings for technical assistance activities.

15. Provide technical oversight for all activities under this award.

16. Conduct site visits through the Site Improvement through Monitoring System (SIMS), in compliance with PEPFAR requirements, to monitor and evaluate clinical and community service delivery site capacity to provide high-quality HIV/AIDS services in all program areas and 'above-site' capacity to perform supportive or systemic functions, by assessing and scoring key program area elements of site performance and work with the recipient on identified gaps and continuous quality improvement, which might include more thorough data quality or service quality assessments as indicated.

17. Ensure the recipient’s Evaluation and Performance Measurement Plan is aligned with the strategic information guidance established by OGAC and other HHS/CDC requirements, including PEPFAR’s Monitoring, Evaluation, and Reporting (MER) strategy, PEPFAR’s Evaluation Standards of Practice, and CDC’s Data for Partner

Monitoring Program (DFPM).

18. Provide ethical reviews, as necessary, for evaluation activities, including from

HHS/CDC…