full NOFO GH20-2059.pdf

Centers for Disease Control and Prevention

Center for Global Health

Namibia Mechanism for Public Health Assistance, Capacity, and Technical Support II (NAM-

PHACTS II) under the President's Emergency Plan for AIDS Relief (PEPFAR)

CDC-RFA-GH20-2059

Application Due Date: 03/08/2020

Namibia Mechanism for Public Health Assistance, Capacity, and Technical Support II (NAM- PHACTS II) under the President's Emergency Plan for AIDS Relief (PEPFAR)

CDC-RFA-GH20-2059

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- GH20-2059. 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:

Namibia Mechanism for Public Health Assistance, Capacity, and Technical Support II (NAM- PHACTS II) under the President's Emergency Plan for AIDS Relief (PEPFAR)

C. Announcement Type: New - Type 1

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For 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:

CDC-RFA-GH20-2059

E. Assistance Listings (CFDA) Number:

93.067 Additional CFDA Number: 93.947

F. Dates:

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

2. Due Date for Applications: 03/08/2020, 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:

Namibia achieved 94-96-95 of the 95-95-95 goals by the end of 2018. This NOFO will strengthen the Namibian HIV program to achieve sustained epidemic control. Namibia has a shortage of qualified health workers and health system managers, posing a major challenge for attainment of sustainable epidemic control. This NOFO provides technical and service delivery assistance to the Ministry of Health and Social Services (MoHSS) and other Namibian public health institutions to increase the capacity for a locally-led response to achieve and sustain HIV epidemic control. This will be achieved by providing technical support and capacity building for scaling up targeted case finding strategies (index testing, refined provider-initiated testing, recency testing); improving linkage and same-day antiretroviral therapy (ART) initiation among newly diagnosed clients; expanding services for retention, adherence to ART, and viral load (VL) suppression (community adherence groups/ART, multi-month scripting, patient tracing, optimizing antiretroviral medicine (ARV) regimens); preventing new infections through targeted outreach and medical interventions for those most at risk; expanding Tuberculosis (TB) preventive therapy (TPT) and expanding TB diagnostics and treatment;

providing cervical cancer screening (CCS), treatment, and referral for women living with HIV (WLHIV); increasing indigenous partner capacity and expertise; and providing systems investments to achieve sustained epidemic control.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

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

d. Total Period of Performance Funding: $0 The Approximate Project Period of Performance Funding/Estimated Total Funding for the Total 5 year Project Period is None. The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for years 2-5 will be set at continuation.

e. Average One Year Award Amount: $16,000,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $16,000,000. The expected number of awards is 1-2.

Exact amounts for each award under this NOFO will be determined at the time of award.

Applicants are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount.

f. Total Period of Performance Length: 5

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

Namibia has a generalized HIV epidemic, with 10% of the general population living with HIV.

The disease remains the leading cause of death among adults and the sixth-leading cause among children under five years of age. Among adults (>25 years of age), women bear a disproportionate burden of the HIV epidemic, with a prevalence of 19.8% compared to 14.9% for men. With Namibia estimated to have achieved 94-96-95 of the 95-95-95 goals by the end of

2018, this NOFO is designed to take a deeper look at what needs to be strengthened to fully evolve the program in order to achieve sustained epidemic control in Namibia. Namibia is challenged by a shortage of qualified health care workers and health system managers. The lack of capacity affects the quality and accessibility of health services provided in the public sector, posing a major challenge for the attainment of sustainable epidemic control in Namibia.

The overarching goals for this NOFO are to provide technical and service delivery assistance directly to the MoHSS and other key Namibian public health institutions to increase the capacity for a locally-led public health response to achieve and sustain HIV epidemic control. These goals will be achieved by providing technical support and capacity building for scaling up and expanding targeted case finding strategies (index testing, refined provider-initiated testing and counseling, recency testing); improving fidelity of linkage and same day ART initiation among newly HIV diagnosed clients; expanding services for retention and adherence to ART through differentiated care models (DCM) (community adherence groups, community-based ART, multi-month scripting, patient tracing); quality improvement (QI) interventions supporting achievement of VL coverage and suppression among all population groups with optimal ARV regimens;

preventing new infections through targeted outreach and medical interventions for priority populations (PP); expanding TPT for all eligible people living with HIV (PLHIV) and expanding TB diagnostics and treatment; providing CCS, treatment, and referral for WLHIV; increasing indigenous partner capacity and expertise; and providing systems investments to ensure that Namibian institutions can sustainably maintain epidemic control by 2020 and beyond.

The approach to Technical Assistance (TA) will include: 1) strengthening national and decentralized capacity of the MoHSS to provide service delivery and high-impact in-service, on-the-job, and mentorship training/support to health care workers and managers; 2) providing TA to the national and decentralized levels of MoHSS for the development, implementation, supervision, and monitoring of high-quality clinical services, including for HIV/AIDS, TB, other communicable diseases, and primary health care services; and 3) integrating quality management practices at the site and above-site (national, regional, district) levels for sustained epidemic control. This includes development and implementation of MoHSS-level policies and practices that ensure quality HIV services are delivered at the site and above site levels, and ultimately contribute to better health outcomes.

The long-term goals of this NOFO are to reduce HIV incidence, reduce HIV-related morbidity and mortality, improve quality of HIV care, improve quality of life for PLHIV, and develop a sustainable model of human resources for health (HRH) for epidemic control.

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.

This program is authorized under Section 307 of the Public Health Service Act [42 USC 242/], as amended and Section 301(a) of the Public Health Service Act [42 USC 241(a)], as amended.

c. Healthy People 2030

N/A

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/cdc-policy-disti nguishing-public-health-research-nonresearch.pdf

e. Relevant Work

This NOFO builds on the activities successfully implemented under the first NOFO (CDC-RFA- GH15-1615), “Namibia Mechanism for Public Health Assistance, Capacity, and Technical Support (NAM-PHACTS) under the President’s Emergency Plan for AIDS Relief (PEPFAR)” 2015-2020. Namibia has been accelerating progress towards HIV epidemic control, and by September 2019 over 110% of the estimated 203,396 PLHIV in Namibia are expected to be on ART. New HIV infections have halved since 2004, and life expectancy increased by 8 years from 56 in 2005 to 64 in 2016 (World Bank). The Government of the Republic of Namibia’s (GRN)’s leadership has also resulted in Namibia achieving high HIV treatment and prevention of mother-to child transmission (PMTCT) coverage levels, and rapidly adopting new international guidelines and best practices.

Under the previous mechanism, CDC supported Namibia to rapidly implement a robust HIV response which accelerated the progress towards attaining the 95-95-95 goals. Based on the most recent HIV estimates, Namibia now stands at 94-96-95, placing the country at the cusp of achieving epidemic control targets almost 10 years ahead of time. These achievements are to a great extent due to the success of the NAM-PHACTS mechanism. NAM-PHACTSII will build upon the successes of the NAM-PHACTS mechanism. This NOFO will focus on achieving and sustaining epidemic control through innovative approaches to implementation, quality monitoring, training and mentoring, and system investments for a sustained HIV response.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

i. Purpose

The purpose of this NOFO is to provide TA to strengthen individual and institutional capacity within the health system in Namibia for the development and execution of high-impact, evidence-based public health interventions that will lead to Namibia achieving and sustaining the 95-95-95 targets established by UNAIDS: 95% of PLHIV know their HIV status, 95% of people diagnosed with HIV infection are receiving ART, and 95% of people receiving ART treatment have achieved viral suppression. Overall, morbidity, mortality, and HIV incidence at the population level will be reduced.

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 HIV case identification, recency testing, and data reporting for previously undiagnosed PLHIV Improved linkage and same-day ART among newly-diagnosed PLHIV Increased ART coverage, retention, adherence, and VL suppression among PLHIV Improved VL testing coverage and suppression for PLHIV on ART Increased proportion of PLHIV who completed TPT Improve TB diagnostics and treatment for all eligible persons Increased CCS and treatment among WLHIV Increased uptake of HIV prevention services Increased data-driven allocation of government-funded HRH

Intermediate Outcomes

Increased knowledge of HIV status among PLHIV Increased capacity and timeliness for locally-led public health response to transmission hotspots Increased VL suppression among PLHIV Increased tracking and follow-up of patients with non-suppressed VL Reduced incidence of TB disease among PLHIV Reduced incidence of cervical cancer among WLHIV Reduction in new pediatric HIV infections

Long-Term Outcomes:

Improved quality of HIV care by providers trained by recipient(s) Sustained model of HRH for epidemic control Reduced HRH donor dependency

iii. Strategies and Activities

Provide TA to MoHSS for delivering quality clinical services

Strategy should strengthen national and decentralized capacity of the MoHSS to provide service delivery and high-impact in-service, on-the-job, and mentorship training/support to health care workers and managers.

Strategy should provide TA to the national and decentralized levels of MoHSS for the development, implementation, supervision, and monitoring of high-quality clinical services, including for HIV/AIDS, TB, other communicable diseases, and primary health care services.

Expand high-yield targeted HIV case identification strategies

Effective approaches for facility-based index testing recently diagnosed HIV positives and patients on ART without viral suppression should be developed.

Strategies should support optimization of Provider-Initiated Testing (PITC) among Antenatal Care (ANC)/sexually transmitted infection (STI)/family planning attendees, persons with presumptive TB, out-patient primary health clinics and in-patient hospital wards.

Strategies should support recency testing of all newly-identified positives and reporting of data for early public health responses to HIV transmission hotspots.

Improve fidelity of linkage and same day ART initiation among newly HIV diagnosed clients

Specific approaches to initiating ART on the same day as HIV diagnosis should be identified to lead to better patient outcomes.

Proposed activities should lead to increased ART coverage and improved quality of care.

Expand services in priority sites for retention and adherence to ART through DCMs

Proposed models of care should focus on improving retention and adherence. Suggested activities include systematic monitoring of retention in HIV care for all patients, routine ART adherence monitoring, and patient education for support for medication adherence.

Strategies should include support differentiated service delivery models such as community adherence groups, community-based ART, multi-month scripting.

Strategies should include strategies to strengthen tracing of defaulters and tracking of outcomes.

Expand VL coverage and suppression for all PLHIV on ART through QI initiatives

Provide models of care to improve VL coverage and VL suppression, especially among children/adolescents.

Strategies should include strategies to strengthen prescribing of optimal ARV regimens for all populations (infants, children, adults, TB co-infected, 2nd line, salvage).

Expand TPT for all eligible PLHIV and expand TB diagnostics and treatment

Activities should focus on identifying, initiating, supporting full completion, and documentation of TPT in all eligible PLHIV.

Optimize diagnosis and treatment of TB disease to prevent TB-related mortality.

Activities should be proposed which support attaining high quality TB screening coverage in PLHIV.

Provide CCS of WLHIV through screen and treat

Strategies and activities should focus on providing CCS at ART clinics for HIV infected women between 20-50 years of age.

Expand HIV prevention services for PP through evidence-based interventions

PMTCT: Activities and strategies should focus on 1) the prevention of infections among reproductive age groups; 2) case finding, timely ART initiation, optimal retention and adherence, and monitoring VL suppression in pregnant and breastfeeding women; and 3) provision of effective infant ARV prophylaxis, cohort monitoring, and timely/regular HIV tests for children identified to be at risk.

PrEP: Activities and strategies should support the continued rollout of PrEP for high risk populations including discordant couples, pregnant and breastfeeding women, adolescent girls and young women, and key and PP.

PEP: Activities and strategies should support the expansion of the availability and use of PEP for sexual risk exposure (including post violence) and occupational exposures.

Activities should include training of health care workers and continued support for the development of monitoring and evaluation tools.

Comprehensive Prevention Services: Activities and strategic should include risk reduction education and counseling, condom promotion, VMMC, evidence based HIV and Gender Based Violence prevention programs for high PP as well as structural interventions to reduce vulnerability to HIV infection. Specific activities include training for health care workers and continued monitoring and evaluation.

Implement a phased, multi-year strategy to transition core HRH functions to the GRN

Education and training to increase HRH capacity in the public health sector Increased allocation of government HRH based on up-to-date HRH data and epidemiologic priority

Activities may change during the project period based on programmatic need.

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(s) will be expected to collaborate with the Namibian MOHSS and/or other local institutions on all activities at both the national as well as subnational levels. The recipient(s) will also be expected to collaborate with CDC-funded multilateral partners, including WHO, UNICEF, and UNAIDS. The recipient(s) will also be expected to collaborate with CDC-funded recipients in each of the funded regions as per the partner area of expertise. The CDC Namibia Country office will assist the recipient(s) in connecting with other recipients working in this area and the recipient(s) will ensure work is not duplicative but complimentary and supportive to other work funded by CDC.

b. With organizations not funded by CDC:

The recipient(s) will be expected to collaborate with other U.S. Government (USG) PEPFAR implementing partners (IPs), civil society organizations, multilateral partners including but not limited to the Global Fund, and other stakeholders. Additionally, the recipient(s) will be expected to collaborate with all stakeholders implementing TB/HIV related programs in the priority regions to create synergy in achieving the goals and objectives outlined in this NOFO, as well as realizing the spirit of one national response framework, one national coordinating authority, and one national M&E system. Other expected collaborators include the Namibian police, local/regional councilors, Ministry of Education, Ministry of Gender Equality and Child Welfare, non-governmental organizations (NGOs), churches, and traditional leaders.

2. Target Populations

Activities implemented in the NOFO will target HIV-infected children, men, and women between the ages of 15 to 49 years of age in selected regions of Namibia according to strategic needs. The recipient(s) will focus on activities targeting specific PP (or subgroups), including women of reproductive age, HIV-exposed children under 15 years old, children and adolescents, and men.

PP and regions may change during the project period based on programmatic need.

a. Health Disparities

N/A

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 $16,000,000 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 non-COP Targets

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

Recipient(s) should allocate funds made available under this NOFO for both evaluation activities and performance monitoring. While the final funding amount will be agreed upon by both CDC and the recipient(s), a minimum of 10% for monitoring activities and evaluation.

PERFORMANCE MONITORING

Performance measures may include both PEPFAR (MER) and non-MER indicators. Recipient(s) will be responsible for reporting on but not limited to the indicators listed below; applicants 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 reporting is included in the PEPFAR MER 2.0 (V2.3) guidance.

PEPFAR (MER) Process and Outcome Measures:

Quarterly:

o HTS_TST (including HTS_TST_POS) - Number of individuals who received

HIV Testing Services (HTS) and received their test results [Target: 50,000] o TX_NEW - Number of adults and children newly enrolled on antiretroviral therapy (ART) [Target: 11,000] o TX_CURR - Number of adults and children currently receiving antiretroviral therapy (ART) [Target: 125,000] o PMTCT_EID – Percentage of infants born to HIV-positive women who received a first virologic HIV test (sample collected) by 12 months of age [Target: 1,000] o PrEP_New – Number of individuals who have been newly enrolled on (oral) antiretroviral pre-exposure prophylaxis (PrEP) to prevent HIV infection in the reporting period [Target: 5,000] o TB_Prev - The number of ART patients who completed a standard course of TB preventive therapy within the semiannual reporting period TB_ART (N&D) [Target:N-39,000, D-45,000] o TB_STAT (including TB_STAT_POS) - Percentage of new and relapse TB cases with documented HIV status [Target: 100%]

Semi-Annually:

o TX_TB - The proportion of ART patients screened for TB in the semiannual reporting period who are receiving TB treatment [Target: 95%] o TB_Prev - The number of ART patients who completed a standard course of TB preventive therapy within the semiannual reporting period [Target: 6,000]

Annually:

o TX_ML - Number of ART patients with no clinical contact since their last expected contact [Target: <100] o TX_PVLS (N&D) - Percentage of ART patients with a VL result documented in the medical record and/or laboratory information systems (LIS) within the past 12 months with a suppressed VL (<1000 copies/ml) [Target: 95%]

Host Country Indicators:

o PMTCT_ARV_Nat - Percentage of HIV-positive pregnant women who received antiretroviral medicine (ARV) during pregnancy to reduce the risk of mother-to-child transmission [Target: 95%] o PMTCT_Stat_Nat - Percentage of pregnant women with known HIV status [Target: 95%] o TX_Curr_Nat - Percentage of adults and children receiving antiretroviral therapy [Target: 95%] o Diagnosed_Nat - The percentage of adults and children living with HIV who know their status (have been diagnosed) [Target: 95%] o VL_Suppression_Nat - Percentage of people living with HIV on ART with a suppressed VL [Target: 95%]

Non-MER: Additional Performance Measures (Custom Indicators)

Applicants should propose additional custom performance measures to monitor achievement of outcomes not directly measured by PEPFAR (MER) indicators. Custom indicators should include process and outcome measures directly correlated with the logic model. 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 discusses in the logic model and associated narrative sections.

Proportion of patients identified through index case testing [Target: 50%; monthly reporting] Percentage of patients initiated on ART same day of HIV diagnosis [Target: 90%;

monthly reporting] Percentage of stable patients enrolled in Multi-Month Dispensing (MMD) [Target: 95%;

monthly reporting]

Data Sources for MER and Custom Indicators:

Routinely collected data from the Electronic Patient Management System (ePMS), Electronic Dispensing Tool (EDT), Electronic TB Register (ETR), PMTCT-Tracker (P- Tracker), District Health Information System (DHIS) and MEDITECH laboratory system and patient interviews.

Paper-based tools include Patient Care Booklets, ART Registers, TB Registers, VL Registers.

Dissemination of Monitoring Results:

Potential performance monitoring data will be disseminated through written reports, online and in-person presentations, and/or professional conferences. Potential audiences include MoHSS across levels and other key stakeholders. Written reports will be made available in electronic and paper formats; webinars will be hosted via online video conferencing software and archived for future use. Presentations will be given at in-person meetings and archived for future use.

EVALUATION

This NOFO provides technical and service delivery assistance to the MoHSS and other Namibian public health institutions to increase the capacity for a locally-led response to achieve and sustain HIV epidemic control. The potential evaluation topics below are examples of what the recipient(s) may be expected to answer through evaluation(s). Applicants should include at least 1, but no more than 3 potential evaluation questions. The applicant should consider the following areas when developing evaluation questions:

Sample Evaluation Topics:

Progress toward 95-95-95 target for epidemic control as a result of the NOFO activities (outcome evaluation should be proposed)

Human resources efficiency, effectiveness, and utilization to support and sustain CDC supported districts as a result of activities carried out in this NOFO (process evaluation should be proposed)

Data sources: Data sources to evaluate efforts include, but are not limited to current and recommended M&E policies, procedures, tools, program planning and implementation documents, patient and program records, MoHSS staff, and community partners. These include:

NAMPHIA survey Analysis of routinely collected data from the Electronic Patient Management System (ePMS), Electronic Dispensing Tool (EDT), Electronic TB Register (ETR), PMTCT- Tracker (P-Tracker), District Health Information System (DHIS) and MEDITECH laboratory system and patient interviews.

Rapid HRH assessments and desk review of HRH documents

Dissemination of Evaluation Results:

Potential performance monitoring data will be disseminated through written reports, online and in-person presentations, and/or professional conferences. Potential audiences include MoHSS across levels and other key stakeholders. Written reports will be made available in electronic and paper formats; webinars will be hosted via online video conferencing software and archived for future use. Presentations will be given at in-person meetings and archived for future use. All evaluation reports will be publicly available on PEPFAR resource sites. CDC and stakeholders will use overall evaluation findings during the five-year NOFO period to share and implement key recommendations to strengthen program implementation and effectiveness, sustainability, and continued program improvement upon completion of the award.

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

Applicants should submit the following materials in their appendix:

Statement of Experience (maximum 3 pages) demonstrating organizational capacity to address the requirements of the NOFO and specifically in the following areas:

o Capacity in ensuring HIV program quality in high HIV/TB burden areas within the sub-Saharan Africa region o Experience in rapid scale-up in HIV testing, care and treatment service delivery o Technical experience and expertise in clinical care o Experience of the proposed key senior staff in working with the Namibia HIV response o Experience in establishing functional working relationships with Ministries of

Health for purposes of providing HIV Program TA CVs/Resumes for key personnel, including but not limited to the Principal Investigator (PI), Business Official, Care & Treatment Lead, and M&E Lead Job Descriptions for key personnel, including but not limited to those listed above Organizational Chart (maximum 1 page) Financial Management Statement (maximum 1 page) that describes the following:

o Systems and procedures used to manage funds o Procurement procedures o Previous experience managing budgets greater than $5 million per annum

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

d. Work Plan

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 headquarters. Evaluations can be process, outcome, or economic.

A. Process Evaluation: measures how the intervention was delivered, what worked/did not, differences between the intended population and the population served, and access to the intervention.

B. Outcome Evaluation: determines effects of intervention in target population(s) (e.g., change in knowledge, attitudes, behavior, capacity, etc.).

C. Economic Evaluation: justifies the investment, and determines the efficiency and economic impact of interventions.

19. Supply the recipient with protocols for related evaluations.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism: U2G

3. Fiscal…