ATTACHMENT J.7 COP 18 Gudiance to ART Clinical Implementing Partners.pdf

PEPFAR 2018 Country Operational Plan Guidance for Standard Process Countries

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Table of Contents

1.0 COP BASICS

1.1 Executive Summary

1.2 What is a COP?

1.3 Which Programs Prepare a COP?

1.4 Standard Process COP Timeline

1.5 Required COP Elements Checklist

2.0 PEPFAR'S APPROACH TO PROGRAM PLANNING AND DECISION-MAKING

2.1 Global Overview and Context

2.1.1 What is Epidemic Control?

2.2 PEPFAR’s Role and Response

2.2.1 Seamless Planning, Implementation and Learning

2.2.2 Defining Program Goals to Accelerate Epidemic Control

2.2.3 Increasing Engagement with Faith-Based Organizations

2.2.4 Overcoming Barriers to Epidemic Control

2.2.5 Realigning Headquarters to Better Support the Field

2.3 Coordination and Strategic Communication with External Partners during COP Planning

2.3.1 Host Country Governments

2.3.2 Multilateral and Private Sector Partner Engagement

2.3.3 Active Engagement with Community and Civil Society

2.3.4 Stigma, Discrimination, Violence and Human Rights

2.3.5 Coordination among U.S. Government Agencies

3.0 PLANNING STEPS FOR STANDARD PROCESS

3.1 Planning Step 1: Review the Current Program Context and Budget

3.2 Planning Step 2: Identify Specific Barriers, Define Solutions to Key Barriers Based on In-country Analysis of Data on Performance, Consider Management and Monitoring

3.2.1 Triangulate Program, Financial and Quality Data

3.2.2 Examine Potential Solution(s) for Overcoming Barriers

3.2.3 Discuss Needed Programmatic and Structural Adjustments

3.2.4 Discuss Adjustments Needed to Implementing Partner Workplans to Incorporate Identified Activities

3.2.5 Discuss Monitoring and Management of Solutions to Ensure Programs are Implemented Effectively and with Fidelity

3.3 Planning Step 3: Set Preliminary Budgets, Targets, and above-site activities

3.3.1 Set Preliminary Budget

3.3.2 Setting Targets for Accelerated Epidemic Control in Priority Locations and Populations

3.3.3 Prioritize activities in Table 6

3.4 Planning Step 4: Interrogate, Adjust, Examine and Align Preliminary Budgets and Targets with the Strategic Plan

3.5 Planning Step 5: Finalize SNU and IM Targets and Budgets

3.6 Planning Step 6: Develop Detailed Site-Level Targets

3.6.1 Allocate Targets by Site

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3.6.2 Provide narratives for strategic objectives

3.7 Planning Step 7: Finalize and Submit COP

3.7.1 Develop Annual Workplans and Targets

4.0 COP ELEMENTS

4.1 Chief of Mission Submission Letter

4.2 Strategic Direction Summary

4.3 Indicators and Targets

4.3.1 Site and Sub-national Level Targets

4.3.2 Implementing Mechanism Level Indicators and Targets: Required for all IMs

4.3.3 PEPFAR Technical Area Summary Indicators and Targets

4.3.4 Host Country Indicators and Targets

4.4 Implementing Mechanism Information

4.4.1 Prime Partner Name

4.4.2 Mechanism Details

4.4.3 Government to Government Partnerships

4.4.4 Funding Agency

4.4.5 Procurement Type

4.4.6 Implementing Mechanism Name

4.4.7 HQ Mechanism ID, Agreement Number, and Field Tracking Number

4.4.8 Agreement Timeframe

4.4.9 TBD Mechanisms

4.4.10 New Mechanism

4.4.11 Construction/Renovation

4.4.12 Motor Vehicles, including All Transport Vehicles

4.4.13 Prime Partners

4.4.14 Definitions

4.4.15 Funding Sources / Accounts

4.4.16 Cross-Cutting Budget Attributions and Definitions

4.4.17 Strategic Objective Table

4.4.18 Public Private Partnerships

5.0 COP PLANNING LEVELS AND APPLIED PIPELINE

5.1. COP 18 Planning

5.1.1 COP Planning Levels

5.1.2 Applied Pipeline

5.2 Budget Code Definitions

5.2.1 Care & Treatment

5.2.1.1 HBHC- Adult Care and Support

5.2.1.2 HVCT- HIV Testing Services

5.2.1.3 HVTB- TB/HIV

5.2.1.4 PDCS- Pediatric Care and Support

5.2.1.5 HTXD- ARV Drugs

5.2.1.6 HTXS- Adult Treatment

5.2.1.7 PDTX- Pediatric Treatment

5.2.2 Prevention

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5.2.2.1 HMBL- Blood Safety

5.2.2.2 HMIN- Injection Safety

5.2.2.3 MTCT- Prevention of Mother to Child Transmission

5.2.2.4 HVAB/Y

5.2.2.5 HVOP – Other Sexual Prevention

5.2.2.6 IDUP- Injecting and Non Injecting Drug Use

5.2.2.7 CIRC- Voluntary Medical Male Circumcision

5.2.3 Orphans and Vulnerable Children

5.2.3.1 HKID- Orphans and Vulnerable Children

5.2.4 Health Systems Strengthening

5.2.4.1 OHSS- Health Systems Strengthening

5.2.4.2 HLAB- Laboratory Infrastructure

5.2.4.3 HVSI- Strategic Information

5.3 Mandatory Earmarks

5.3.1 Orphans and Vulnerable Children

5.3.2 Care and Treatment Budgetary Requirements and Considerations

5.4 Other Budgetary Considerations

5.4.1 Water and Gender-Based Violence (GBV)

5.4.2 Tuberculosis

5.4.3 Food and Nutrition

5.4.4 Budget Code (AB/Y) Reporting Requirement

5.4.5 Strategic Information

5.5 Single Partner Funding Limit

5.5.1 Exceptions to the Single Partner Funding Limit

5.5.2 Single Partner Limit Justification

5.6 Justifications

5.7 Implementation of Protecting Life in Global Health Assistance in PEPFAR Programs

6.0 U.S. GOVERNMENT MANAGEMENT AND OPERATIONS (M&O)

6.1 Interagency M&O

6.1.1 PEPFAR Staffing Footprint and Organizational Structure Analysis, Expectations and

Recommendations

6.1.2 Strategic Direction Summary Requirement

6.2 Staffing and Level of Effort Data

6.2.1 Who to Include in the Database

6.2.2 Staffing Data Field Instructions and Definitions

6.2.3 Capturing Staff Time Instructions

6.2.4 Attribution of Staffing-Related CODB to Technical Areas

6.3 OU Functional and Agency Management Charts

6.4 Cost of Doing Business Worksheet

6.4.1 Cost of Doing Business Categories

6.5 U.S. Government Office Space and Housing Renovation

6.6 Peace Corps Volunteers

7.0 TEMPLATES, TOOLS AND COP SUBMISSION

8.0 OTHER ELEMENTS

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8.1 Acronyms and Abbreviations

8.2 Small Grants Program

8.2.1 Proposed Parameters and Application Process

8.3 Construction and Renovation of Laboratories

8.4 Technical Assistance Available for Global Fund Activities

8.5 PEPFAR SharePoint Contacts and Help Information

8.6 Inventory of PEPFAR-funded Surveys and Surveillance Activities

8.7 Inventory of all PEPFAR-funded Evaluation and Research

9.0 APPENDIX

9.1 New or Updated Technical Guidance

9.1.1 PEPFAR Support of CD4 Testing

9.1.2 Transition to TLD as Preferred ART for Adults & Adolescents (>= 10 years old and body weight

>= 30 kg.)

9.1.3 Prevention in Adolescent Girls and Young Women

9.1.4 Prevention for Adolescents Ages 9-14

9.1.5 PrEP Targeting and Programming

9.1.6 Market-based Approaches for Condoms and Lubricants

9.1.7 Voluntary Partner Notification/Index-Patient Testing

9.1.8 Provider-initiated Testing and Counseling

9.1.9 HIV Self-Testing

9.1.10 Birth Testing and Point-of-Care Infant Testing

9.1.11 Lab Instrument Mapping and Optimization

9.1.12 Presumptive Tuberculosis Guidance

9.1.13 Tuberculosis Preventive Therapy

9.1.14 Key Populations HIV Service Package

9.1.15 Mother-Infant Cohort Monitoring

9.1.16 Dried Blood Spots for Increased Access to Routine Viral Load Monitoring

9.1.17 Sustainable Financing

9.1.18 Legal & Policy Environment

9.1.19 HRH Salary and Surge Hiring Guidance

9.1.20 Task Sharing

9.1.21 Bringing Interventions to Scale

9.2 Quality and Partner Management Guidance

9.2.1 Quality Management for Epidemic Control (QMEC)

9.2.2 HIV Rapid Testing Continuous Quality Improvement

9.2.3 Laboratory Continuous Quality Improvement

9.2.4. Partner Management

9.3 Data Use-related Guidance

9.3.1 Triangulation of Demographic, Epidemiologic and National/Regional Program Data to the Lowest

SNU

9.3.2 Site Yield and Volume Analysis for HTS, PMTCT and Treatment

9.3.3 HIV Case Findings by Age, Sex, Modality and Geographic Location

9.3.4 Analyzing Cost Per Positive

9.3.5 Reviewing Financial Performance and Program Data by Implementing Mechanism

9.3.6 Reviewing How the National Response is Funded and Implemented

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9.3.7 Prioritizing Populations and Locations

9.4 Monitoring and Target-Related Guidance

9.4.1 Site Improvement Through Monitoring System (SIMS)

9.4.2 Setting Targets for Accelerated Epidemic Control in Priority Locations and Populations

9.4.3 Setting Benchmarks for Above Service Delivery

9.4.4 Recommended Process for Establishing and Entering Targets

9.4.5 Standardized Health and Exchanges Data Surveillance for HIV Epidemic Control

9.4.6 Biobehavioral Surveys

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1.0 COP BASICS

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1.1 Executive Summary

PEPFAR’s focus on sustainable control of the HIV epidemic is paying big dividends. The latest

PEPFAR Population-based HIV Impact Assessment (PHIA) data show that seven African countries are making progress towards controlling their HIV/AIDS epidemics, with key gaps identified—especially among the first 90, knowing your status, which among over 15 year olds ranges from 85% to 52%. Adherence to and the effectiveness of treatment results across all countries with viral load suppression ranges from 83% to 92%. Resistance to first line drugs has been less than predicted. However, progress is not even and should be comprehensively addressed, from treatment coverage in children, to viral load suppression in adolescents, to missing men, especially under 35 years, old, and to clinical cascades in key populations, that lag behind all other groups. We need policies to address these key issues, which must be overcome to realize epidemic control

Figure 1.1.1 Progress to 90/90/90 in Adults

Source: PEPFAR PHIA; Note: Those treated are shown as a percent of those aware of their HIV status; those virally suppressed are shown as a percent of those treated.

Building on this progress, at the 2017 United Nations General Assembly, United States (U.S.)

Secretary of State Rex Tillerson launched the PEPFAR Strategy for Accelerating HIV/AIDS

Epidemic Control (2017-2020). The Strategy reaffirms the U.S. government’s leadership and

FY2018 Country Operational Plan Guidance for Standard Countries Page 8 of 333 commitment, through PEPFAR, to support HIV/AIDS efforts in more than 50 countries, ensuring access to services by all populations, including KP and other vulnerable groups. The Strategy also sets a course for accelerated PEPFAR implementation in a subset of 13 high-burden countries with the greatest potential to achieve HIV/AIDS epidemic control by 2020, providing provides a roadmap for progress and impact, and ensures PEPFAR contribution to achievement of the 2030 Sustainable Development Goals.

PEPFAR’s focus on sustainable epidemic control began in 2014, when PEPFAR programs pivoted to a data-driven approach that strategically focuses on geographic areas and populations where HIV/AIDS is most prevalent. With this approach, PEPFAR, in collaboration with host country governments and communities, will achieve the greatest impact. With those pivots now completed, the Country Operational Plan (COP) for Fiscal Year (FY) 2018 (COP 18) focuses on progress in implementation and ensuring resources are focused on overcoming key barriers and achieving even greater impact.

For COP 18, all PEPFAR teams will continue to work toward 90/90/90 across all genders; by age groups, including children (under 15), youth (15-19 and 20-24) and adults (25 and over);

and by male and female risk groups. By focusing on specific populations, countries should be able to achieve 95/95/95 at the national level across all populations. Triangulation of both survey data, when available, (such as PHIA) and program data will be essential to understanding programming and ensuring accurate reporting. Building on program experience over the past two years, the COP 18 strategy emphasizes:

Continuing to focus on finding the people and populations we have been missing, getting them on treatment and retaining them. To successfully address challenges in reaching sustained levels of epidemic control, it is critical that operating units (OUs) routinely assess data to understand which populations (gender, age, risk groups) are being missed or are tailing the clinical cascade, identify evidence-based short- and long-term solutions appropriate to reaching those populations, implement those solutions according to standards (i.e. with fidelity), and take the solutions to scale1. Reducing

1 Fidelity indicates that all key elements of the intervention are in place and standards of success and quality are adhered to at all times. At scale indicates that the intervention is no longer a pilot, but is being implemented outside of pilot sites/geographic areas and ultimately across PEPFAR priority locations.

FY2018 Country Operational Plan Guidance for Standard Countries Page 9 of 333 stigma and discrimination against key populations (KP) will increase access to essential prevention and treatment services.

Continuing to focus on prevention among children and adolescents, including programming focused on preventing sexual violence and preventing HIV through avoiding sexual risk among 9 to 14 year olds (i.e. preventing sexual violence and any form of coercive/forced/non-consensual sex in the community, preventing early sexual debut, supporting healthy choices, and helping communities and families to surround these youth with support and education – all these activities must be grounded in evidence-based prevention programming) and integrating these approaches with orphans and vulnerable children (OVC) programs; and identifying, reaching and retaining children and adolescents living with HIV.

Increasing program impact and outcomes by:

o Implementing activities with fidelity and at scale.

o Ensuring implementing partner workplans are aligned with PEPFAR program planning, target setting, budgeting processes and strategies.

o Engaging in meaningful dialog with implementing partners throughout the year for continuous, real-time improvements.

o Collaborating with the leadership and Implementation Subject Matter Experts (ISMEs) in the Epidemic Control Teams (ECTs), discussed in Section 2.2.5, to identify and scale up impactful and efficient standard practices and new innovations to address persistent gaps.

Ensuring ‘above service delivery’ activities are mapped to key barriers and achieving measurable outcomes related to reaching epidemic control by reviewing and using documented outcomes from implementation of COP 17 Table 6, Sustainability Index and

Dashboard (SID) 3.0 results, and other contextual information.

Ensuring outcomes at the national level by systematically incorporating feedback from a variety of PEPFAR stakeholders (i.e., civil society, community organizations, multilateral organizations, and partner governments) into PEPFAR-funded activities and services. Early and meaningful engagement with stakeholders will help ensure that programs are grounded in reality; stakeholders provide valuable insights that improve the impact and accountability of programs.

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Working with and implementing activities through indigenous partners, including 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 increase program sustainability.

In a continued effort to make the COP planning process more streamlined so that time can be spent on partner dialog for workplan development and target setting, COP 18:

Retains the Strategic and Technical Alignment for Results (STAR) and standard processes from COP 17 planning.

Updates the Datapack to include automated entry of site-level targets from Data Pack analysis.

Key modifications to COP 18 include:

Replacement of the PEPFAR Budget Allocation Calculator (PBAC) with the Funding Allocation to Strategy Tool (FAST), a comprehensive planning and budgeting process based on short— and long-term solutions and outcomes that will help ensure that workplans and finances optimize PEPFAR investments.

o The PBAC will no longer be used in the COP budgeting process, as it consolidated and estimated the budget per target and did not allow for budgeting for specific activities the partner was performing.

o To support this process, following the COP 18 development and approval process, PEPFAR teams will be required to submit COP 18 implementing partner workplans.

Prioritizing implementation of solutions that bring innovations or actualize scaling of verified successful small-scale approaches or activities.

o In support of this priority, the PEPFAR Technical Considerations document, included with the guidance for COP 17, has evolved into a new PEPFAR Solutions Platform.

Promoting development and implementation of quality management programs at the facility and community levels to systematically improve partner performance and health outcomes.

Applying greater efficiencies and effectiveness in program activities, including the adoption of tenofovir/lamivudine/dolutegravir (TLD) as the first and second line anti-retroviral (ARV) treatment for adolescents (>= 10 years old and body weight >= 30 kg.) and adults and the use of laboratory instrument mapping and optimization

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Extending the PEPFAR Monitoring, Evaluation and Reporting (MER) age requirement to five-year age bands for achievement of 90/90/90 to better understand the epidemiologic and health-related differences within and among age ranges.

Including documentation for all proposed evaluations, surveys and research, inclusive of those funded by headquarters, in COP 18 for approval.

As the COP 18 process is implemented, comments and suggestions for how to further improve our program and approaches continue to be most welcome and encouraged.

1.2 What is a COP?

The COP2 documents U.S. government annual investments linked to specific results in the global fight against HIV/AIDS to ensure every U.S. dollar is maximally focused and traceable for impact. It is the basis for approval of annual U.S. government bilateral HIV/AIDS funding in most partner countries. The COP also serves as a source for Congressional Notifications; a tool for allocation and tracking of budget and targets; an annual strategic plan for U.S. government-funded global HIV/AIDS activities; and the coordination platform with the Global Fund to Fight

AIDS, Tuberculosis and Malaria (Global Fund) to ensure elimination of duplication. Data from the COP are essential to complying with PEPFAR’s commitment to transparency and accountability to all stakeholders.

1.3 Which Programs Prepare a COP?

COP 18 will continue to utilize the two separate planning and submission processes first introduced in COP 17, a “standard” process completed annually and a “STAR” process, completed in a two-year cycle based on performance. These separate processes allow for refined tools, requirements, and processes that better align with the programs and priorities of the individual PEPFAR programs. PEPFAR teams receiving $5 million or more in annual

2 Throughout this document, the term ‘COP(s)’ includes Regional Operating Plans (ROPs) except as specified, and the term ‘country teams’ includes regional teams for programs completing a ROP.

FY2018 Country Operational Plan Guidance for Standard Countries Page 12 of 333 combined PEPFAR funding will prepare their COP 18 or Regional Operational Plan (ROP) 18 using either the standard process, described in this document, or the second year of the STAR

Process, described in separate forthcoming STAR process guidance. These STAR process countries will be engaged individually.

Bilateral programs required to complete a COP 18 using the standard process described in this guidance document include:

Botswana, Burundi, Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Haiti, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Rwanda, South

Africa, South Sudan, Swaziland, Tanzania, Uganda, Ukraine, Vietnam, Zambia and

Zimbabwe.

Regional and bilateral programs required to complete a ROP/COP 18 using the STAR Process, described in a separate guidance document, include:

Regional Programs: Asia Regional Program (China, Laos, Thailand), Caribbean (Barbados, Guyana, Jamaica, Suriname, Trinidad & Tobago), Central America (El Salvador, Guatemala, Honduras, Nicaragua and Panama) and Central Asia (Kazakhstan, Kyrgyz Republic, Republic of Tajikistan).

Bilateral Programs: Angola, Burma, Cambodia, Dominican Republic, Ghana, India, Indonesia and Papua New Guinea

PEPFAR programs receiving less than $5 million in PEPFAR funding are not required to complete a COP or ROP. These programs will account for PEPFAR HIV/AIDS resources through the preparation of a Foreign Assistance Operational Plan (F-OP) and funding for them is still under development. The Office of U.S. Foreign Assistance Resources (F) at the

Department of State coordinates the development of the F-OP. The U.S. Centers for Disease

Control (CDC) programs in countries/regions that do not prepare COPs will account for their resources through CDC Country or Regional Assistance Plans.

1.4 Standard Process COP Timeline

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Standard Process COP 18 Guidance Release Date: January 18, 2018

All COP 18 guidance documents will be released on January 18, 2018.

In-country COP Planning Meetings: Week of January 29, 2018 at the latest

No later than the week of January 29, 2018, all PEPFAR programs using the standard process are expected to host an in-country strategic planning retreat with their local stakeholders to analyze new data, discuss performance, and reach consensus on the proposed COP 18 direction. Key elements of this retreat include:

1) Building on the review of FY 17 Quarter 4 (Q4) and Annual Program Review (APR) 17 program results and key analyses to highlight programmatic successes, needs and gaps. This review is to ensure all participants share an understanding of key programmatic data, achievements and gaps, and must include the presentation of:

a. A summary of the areas highlighted in the PEPFAR Oversight and Accountability

Response (POART) FY17 Q4 Corrective Action Summary (CAS), including data from the site improvement monitoring system (SIMS) and the Sustainability Index

Dashboard (SID) 2.0.

b. Analyses conducted on the current geographic and population priorities to determine whether these should be reviewed and revised to include new areas/populations for saturation.

c. Sex and age band analyses to highlight gaps in services between males and females and adults and children.

d. Analyses of current performance and financial data, including outlay data, at the national, district, and partner levels that can inform proposed COP 18 national, district, and partner level targets and budgets.

2) In-depth dialog about technical approaches, specific interventions and other solutions needed to accelerate epidemic control. Discussions must:

a. Include the identification of specific activities and solutions that address gaps in effective implementation and populations reached.

b. Utilize information from COP 17 partner workplans and strategic objectives to review partner performance, discuss successes and challenges, and determine areas for continued investment, areas requiring revision and updates and areas needing new strategies and solutions or realignment of partners.

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3) Discussions focused on monitoring and management to ensure programs are implemented effectively and with fidelity, specifically highlighting strategies for partner and quality management. These discussions must prioritize and emphasize:

a. The use of data inputs from the MER, SIMS, SID, annual and quarterly outlays, and other sources to monitor progress.

b. The identification and development of comprehensive data inputs to monitor and manage partner performance in an open and transparent manner.

c. Development of quality management programs, through Quality Management for

Epidemic Control (QMEC), located at service delivery points (above-service delivery or at-site) to improve health outcomes and partner performance (See Appendix 9.2.1).

4) A consensus on the proposed strategy for COP 18, including national, district, and partner level targets and budgets.

During this period, PEPFAR teams should also consider building on regular and meaningful dialog with implementing partners by hosting an implementing partner meeting to review data and discuss the proposed COP 18 direction.

COP 18 Regional Planning Meetings: February 19-23, 2018, or February 25-March 1, 2018, each country will attend one of two five-day COP 18 Regional Planning Meetings (RPM) in

Johannesburg, South Africa, replacing the former DC Management Meetings (DCMM). The goal of these meetings, involving PEPFAR field and headquarters teams, host country leadership, local and headquarters community and civil society representatives, and multilateral stakeholders, is to identify and agree on critical solutions and effective means of operationalizing them to advance each country’s ability to accelerate epidemic control. Key outputs from the meeting will be partner level budgets, targets, and management solutions.

COP 18 Submission: March 15, 2018 or March 22, 2018

Consistent with previous COP processes, all standard process countries will have three weeks following the conclusion of the RPM to submit their final COP 18 in all indicated systems or tools.

In-person COP 18 Approval Meetings: April 10-13, 2018 or April 17-20, 2018

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Four-day in-person COP 18 Approval Meetings will be held in Washington, DC. During these meetings, PEPFAR field and headquarters teams, host country leadership and headquarters stakeholders will come together to review and present the final COP 18 plan for final approval.

The COP 18 Standard Process Timeline is summarized in Figure 1.4.1, below.

Figure 1.4.1

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1.5 Required COP Elements Checklist

Detailed Standard COP 18 Elements and Supplemental Document* Checklist

COP Element Requirement

System of Completion / Tool / Template*

(location of tool/template)

DRAFT

required for

Regional Planning Meeting

Data Pack All OUs Tool

(SharePoint: OU HQ Collaboration page)

Yes

FAST All OUs Tool

(SharePoint: OU HQ Collaboration page)

Yes

Table 6 Excel Template All OUs

Template (SharePoint: COP18 page)

Yes

Laboratory Instrument Mapping and Optimization Tool

All OUs Template (SharePoint: COP18 page)

Yes

TLD Forecast Tool All OUs Tool (SharePoint: COP18 page)

Yes

TLD Transition Plan All OUs Template (SharePoint: COP18 page)

Yes

Evaluation Inventory All OUs Yes: COP and/or HOP resources that are proposed for new or are currently invested in ongoing evaluations

No: COP or HOP resources are not funding ongoing or proposed for new evaluations

DATIM (final submission)

Template (RPM) (SharePoint: COP18 page)

Yes

Research Inventory All OUs Yes: COP and/or HOP resources that are proposed for new or are currently invested in ongoing research projects that do not fall under the Evaluation Inventory as described in

ESOP 3.0

No: COP or HOP resources are not funding ongoing or proposed for new research or all research is captured in the Evaluation Inventory

Template

Yes

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Surveillance Inventory All OUs Yes: COP and/or HOP resources that are proposed for new or are currently invested in ongoing surveillance activities

No: COP or HOP resources are not funding ongoing or proposed for new surveillance activities

DATIM (final submission)

Template (RPM)

Yes

Strategic Direction Summary

(SDS)

All OUs Template

(SharePoint: COP18 page) No

Disaggregate Target Tool All OUs

Tool (SharePoint: COP18 page)

No

Targets

All OUs DATIM No

OU/National Level PSNU Level Mechanism Level Site-Level Implementation and Planning Attributes

Implementing Mechanism (IM) Details:

All OUs

FACTS Info No

Partner Name All IMs G2G check-box and managing agency

As Applicable

Funding Agency All IMs Procurement Type All IMs IM Name All IMs Mechanism ID All IMs Agreement Timeframe All IMs TBD check-box As applicable New IM check-box As applicable Agreement Number All non-TBD IMs Construction/Renovation check-box and construction/renovation plans

As applicable

Motor Vehicles check-box and numbers

As applicable

Funding Source allocations, including applied pipeline

All IMs

Budget Code allocations As applicable Crosscutting Allocations As applicable

Crosscutting Allocation:

Gender Activity Checklist

Required if Gender-GBV or Gender Equality allocation

Crosscutting Allocation: Key Populations Checklist

Required if Key Populations allocation

Management & Operations: All OUs Agency Cost of Doing Business, including applied pipeline All Agencies with CODB costs FACTS Info

No

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FACTS Info Staffing Data Module

All Agencies with staff FACTS Info

Agency functional staff charts All Agencies with staff No Template Chief of Mission Letter All OUs No Template No COP18 CSO Matrix All OUs Template

(SharePoint: OU HQ Collaboration page)

No

Laboratory Construction or Renovation Project Plan Supplemental

All OUs Yes: PEPFAR funding proposed for laboratory construction in COP 18 at

BSL-3 and BSL-2 lab No: PEPFAR not funding laboratory construction in COP 18 at BSL-3 or BSL-2

No Template No

Justification for partner funding All OUs Yes: Single partner budget exceeds 8 percent of PEPFAR budget

No: No partner exceeds 8 percent of PEPFAR budget

No Template No

*All supplemental documents (requirements that are not completed through data entry within FACTS

Info or DATIM) are submitted within the documents library in FACTS Info.

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2.0 PEPFAR'S APPROACH TO PROGRAM

PLANNING AND DECISION-MAKING

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COP 18 is grounded in the epidemiologic impact framework laid out in COP 15 and retains the same program goals for accelerating epidemic control as COP 17. COP 18 builds on new data to adjust approaches, places increased emphasis on identifying and addressing key barriers, and highlights the importance of implementing basic essential practices with fidelity and at scale. COP 18 continues to require consultations with stakeholders throughout the COP development process and demands that

COP planning consider issues of stigma, discrimination and human rights.

2.1 Global Overview and Context

We are at a historic moment in the global HIV/AIDS response: We have the opportunity to change the very course of the pandemic by controlling it, without a vaccine or a cure.

Controlling the pandemic will lay the groundwork for eliminating or eradicating HIV, which we hope will be possible through future scientific breakthroughs, including a functional cure and even an effective vaccine.

Data in Figure 2.1.1 show seven African countries making progress towards control of their epidemics.

Figure 2.1.1 Progress Towards 90/90/90 in Adults

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Source: PEPFAR PHIA; Note: Those treated are shown as a percent of those aware of their HIV status; those virally surpressed are shown as a percent of those treated.

Countries like Swaziland, Lesotho and Zimbabwe are making amazing progress across the three 90s. Countries like Tanzania will need to triangulate the PHIA anti-retroviral therapy (ART) coverage and viral suppression results with program data to understand differences between the data sources to strengthen the routine data and take appropriate program action. Progress is not linearly related to historic resources; continued attentiveness to progress, addressing gaps in real time, and critical policies are necessary to ensure effective implementation.

As illustrated in Figure 2.1.2, tremendous progress has been made testing and treating women, but there are still significant gaps in our ability to reach men, adolescent girls and young women

(AGYW), children, key populations, and other critical groups with successful combination prevention and treatment interventions. Reaching these populations at a level of intensity that will lead to epidemic control is a key challenge for the global HIV community and will require concentrated effort and continued innovation. Also the figure shows that in some countries women’s awareness of HIV status and testing is under 70%. Teams must critically evaluate and address this discrepancy.

Figure 2.1.2 Progress towards 90/90/90 among Females >=15 years

Source: PEPFAR PHIA

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Significant effort has been placed on reaching men with effective HIV prevention through the scale up of voluntary medical male circumcision (VMMC). The global emphasis on 14 priority countries in eastern and southern Africa with high levels of HIV prevalence and low levels of male circumcision resulted in approximately 14.5 million voluntary medical male circumcisions performed in those 14 countries between 2008 and 2016.3 PEPFAR alone supported more than

15.2 million VMMC procedures between fiscal year 2008 and 2017, thereby exceeding the ambitious goal set forward at the 2015 United Nations General Assembly Sustainable

Development Summit of 13 million PEPFAR-funded VMMCs by more than two million. In FY 17, PEPFAR supported 3.38 million VMMC procedures, 46% in the 15-29 age groups for optimal impact on the epidemic.

Because adolescent girls and young women are a population that still requires critical attention, the Determined, Resilient, AIDS-Free, Mentored, and Safe (DREAMS) Partnership will continue to provide a holistic and layered approach to address the multidimensional circumstances placing young women at increased risk of contracting HIV. As PEPFAR announced on World

AIDS Day 2017, in the 10 African countries (63 districts) implementing PEPFAR’s pioneering

DREAMS public-private partnership, the majority (65% or 41) of the highest HIV-burden districts achieved a decline in new diagnoses among adolescent girls and young women ages 15-24 by more than 25% since 2015, including 14 districts that had a decline of greater than 40%4.

Importantly, new diagnoses declined in nearly all DREAMS intervention districts. DREAMS activities will continue to be integrated into PEPFAR’s country operational plans and to focus on adolescent girls and youth based on groundbreaking research and evidence-based tools.

Through the current DREAMS programming, we have also seen a gap in addressing the critical issues in 9-14 year olds that put them at risk, including sexual violence prevention. DREAMS investments must continue and increase as the most effective interventions are defined from the current program.

The payoff from this effort is great. Achieving and sustaining epidemic control will stem the global pandemic, reduce the disease burden on communities and health systems, decrease the

3 Blind Spot, UNAIDS, 2017 4 PEPFAR 2017 Annual Reported Results, http://www.pepfar.gov/documents/organization/276321.pdf

FY2018 Country Operational Plan Guidance for Standard Countries Page 23 of 333 future costs of care and treatment, and enhance economic stability in resource-constrained settings by increasing the productive potential of people living in these areas.

2.1.1 What is Epidemic Control?

For the sake of global monitoring, PEPFAR defines national HIV epidemic control as that point at which the total number of new infections falls below the total number of deaths from all causes among HIV-infected individuals5 (the classic R0 to Ri approach to infectious diseases).

Figure 2.1.3, below, shows the relationship in trends of all-cause mortality among people living with HIV (PLHIV) and new HIV infections in Swaziland and highlights the time at which the number of new infections is expected to fall below the number of deaths among PLHIV, if the programmatic achievements remain on track, based on the most recent PHIA data. Swaziland has seen a greater than 40% decline in new infection rates in just five years due to dramatic increases in PEPFAR resources to the country. This definition of epidemic control does not suggest near-term elimination or eradication of HIV as may be possible with other infectious diseases, but rather suggests a decline of HIV-infected persons in a population, achieved through the reduction of new HIV infections when mortality among PLHIV is steady or declining, consistent with natural aging. Critically, however, a country will not be able to maintain epidemic control if program efforts are not sufficiently sustained and new infections are allowed to rebound or death rates to increase. Continued focus on VMMC, condoms, PrEP, elimination of new pediatric HIV infections, and DREAMS activities to accelerate prevention are essential components to controlling the pandemic. Thus, emphasis will be placed throughout this guidance on optimizing program and systems investments to support, achieve and sustain epidemic control.

5 PEPFAR Strategy for Accelerating Epidemic Control, 2017-2020.

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Figure 2.1.3 Swaziland-Pathway to Reaching Epidemic Control

Source: PEPFAR Strategy for Accelerating Epidemic Control, 2017-2020, Based on 2017 UNAIDS Spectrum Estimates and Global Reporting

We are excited about Swaziland’s accomplishments from 2011 to 2016. The Government of

Swaziland’s leadership and commitment, along with PEPFAR resources ($375,000,000) and

Global Fund resources ($64 million) have had substantial impact.

Figure 2.1.4 illustrates progress toward epidemic control by showing the absolute number of new HIV infections and all-cause deaths among PLHIV in the 13 countries highlighted in the new PEPFAR Strategy for 2017-2020. Both measures – new HIV infections and all-cause deaths among PLHIV – are modeled by UNAIDS using the most recent available population and program data inputs.

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Figure 2.1.4

Source: PEPFAR Strategy for Accelerating Epidemic Control, 2017-2020, Based on 2017 UNAIDS Spectrum Estimates and Global Reporting

To operationalize pathways to epidemic control, UNAIDS pronounced, countries endorsed, and

PEPFAR supports, global 90/90/90 targets for 2020 with 95/95/95 targets for 2030 through specific program actions to diagnose persons infected with HIV, provide life-saving ARV therapy for PLHIV, and support retention and adherence to ensure HIV viral suppression. Also a key part of UNAIDS global strategy and complementary to the 90/90/90 program efforts are evidence-based HIV prevention programs, including VMMC and PEPFAR DREAMS. This programming and related targets readily translate into program action, promote accountability for program advancement toward epidemic control, demand attention to both quality and outcomes of HIV programs, and promote equity by closing program gaps for all communities and populations. Achievement of these programmatic targets by 2030 is expected to contribute to epidemic control through an estimated 90% reduction in HIV incidence and 80% reduction in all-cause mortality globally.6

Given the dynamic and intersecting nature of all of these factors, attention must be paid to community and network dynamics that increase or decrease new HIV Infections and increase or reduce morbidity and mortality among PLHIV. Further, paramount to achieving and sustaining

6 UNAIDS 90/90/90 strategy, http://www.unaids.org/en/resources/documents/2017/90-90-90

FY2018 Country Operational Plan Guidance for Standard Countries Page 26 of 333 epidemic control is the strength of populations, communities, and programs to understand and respond to local epidemic dynamics.

2.2 PEPFAR’s Role and Response

At the 2017 United Nations General Assembly, U.S. Secretary of State Rex Tillerson launched the PEPFAR Strategy for Accelerating HIV/AIDS Epidemic Control (2017-2020). The Strategy reaffirms the U.S. government’s leadership and commitment, through PEPFAR, to support

HIV/AIDS efforts in more than 50 countries, ensuring access to services by all populations, including the most vulnerable and at-risk groups.

As in past years, PEPFAR’s overall goal for COP 18 is to accelerate progress toward epidemic control in all countries. During COPs 15, 16 and 17, significant emphasis was placed on using data to develop strategic plans that were appropriately focused on the locations and populations with the highest burden of HIV disease. In COP 18, the emphasis is on optimally implementing and managing evidence-based solutions to achieve greater impact by better aligning planning, implementation, management and resources. COP 18 recognizes that we are already on the path to epidemic control—and focuses on refining the key pathways to accelerating progress and documenting impact.

2.2.1 Seamless Planning, Implementation and Learning

To achieve greater impact with its programming, over the past years PEPFAR has moved toward a seamless planning, learning and implementation process, as illustrated in Figure 2.2.1, POART reviews, results reporting, SIMS, PHIAs, and other data streams all provide critical, up-to-date information that allow country teams, with support from headquarters and in consultation with stakeholders, to proactively plan, implement, manage, learn and make incremental, real time changes to program for greater impact and effectiveness. The continuous use of data to improve program knowledge and action means that the COP process, rather than being an extensive yearly reset, provides an annual opportunity for country teams to deliberately step back for a higher-level review to identify where programmatic adjustments or changes are needed. We have made progress, for example, in using detailed program site-level data for real-

FY2018 Country Operational Plan Guidance for Standard Countries Page 27 of 333 time evaluation of sites with greater than 50% men compared to women new on treatment, recognizing their substantially lower coverage. Site-level data must be used to find the sites with evidence of enrolling men and children < 15 years old on treatment, analyze their successes, and articulate their solutions for wider implementation. Additionally, sites that have greater than

75% linkage of key populations to testing and treatment should be identified, investigated, and translated across the program to scale.

Figure 2.2.1 PEPFAR’s Seamless Planning, Learning and Implementation Process

Each country team, in consultation with stakeholders, will review country contexts and budget, including priority geographic areas and populations and Global Fund investment, to validate that the investment priorities agreed upon in COP 17 are correct. Teams will use the information generated by the FY 17 program implementation cycle (annual program results), FY 17 Quarter

3 and Quarter 4 POART analysis and discussions related to site and above service delivery achievements, and data from other sources to identify gaps in reaching epidemic control by age bands, sex and priority sub-national unit (PSNU). This information and analyses will lead to the identification of efficient and effective solutions required to address the gaps and key barriers that are inhibiting progress toward epidemic control.

COP 18 will focus on translating solutions into full scale implementation, using program data analysis to ensure that implementing mechanism programmatic activities, targets and budgets are aligned accordingly. Site-level targets will be developed before finalizing and submitting the

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COP. Country teams will engage stakeholders early and continuously through their COP planning process, including conducting an in-country strategic planning retreat with stakeholders to review country results and data, identify achievements and gaps, and discuss COP 18 strategic objectives, budgets, targets, solutions, and priority locations to reach agreement on the overall COP 18 strategic direction.

As during the POART process, during COP 18 planning, country teams must answer:

Are PEPFAR programmatic investments achieving the anticipated results?

Where has there been successful implementation? Where have solutions been taken to scale? What led to success?

Where have there been problems? What are the barriers?

Are there issues related to quality and/or scale?

How can lessons from successful implementation be expanded and applied in areas with less success?

Is the PEPFAR budget aligned with the programmatic goals and implementation plans?

Are programs being designed in a way that ensures impact, but affordable enough that local entities can eventually take them on?

2.2.2 Defining Program Goals to Accelerate Epidemic Control

For COP 18, the five PROGRAM GOALS HAVE REMAINED CONSTANT FROM COP 17.

However, in COP 18 the STRATEGIES TO REACH THESE GOALS HAVE EVOLVED based on current implementation experience and PHIA data, when relevant.

1. Focus programming and budgeting to achieve epidemic control across all genders, ages and risk groups.

2. Scale-up evidence-informed combination prevention and treatment interventions.

3. Ensure the availability and use of high quality data for program planning, monitoring and implementation.

4. Promote shared responsibility for reaching and sustaining epidemic control.

5. Partner performance management and quality assurance.

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Goal 1: Focus programming and budgeting to achieve epidemic control.

Programming

Data coming from the PHIA highlight important geographic and population differences that are central to the planning process. Carefully examining the HIV cascades by age group (by age band, children and adult) and sex will identify areas where gaps or barriers exist and where solutions are needed. Solutions may be found at specific sites within the country that can be taken to scale. Figure 2.2.2, below, highlights the difference in progress among adults and adolescents in six high-burden countries.

Figure 2.2.2

Source: PEPFAR PHIA

In every country, adolescents are 10-20% less aware of their status than adults over 24 years old. In the majority of countries, less than 50% of adolescents are tested and viral suppression rates are 10% lower than viral suppression rates for adults over 24 years old. This is a critical gap that must be immediately addressed.

Budget

PEPFAR resources must be strategically allocated to achieve epidemic control. Country teams need to consider several factors as they allocate funds to strategic objectives:

FY2018 Country Operational Plan Guidance for Standard Countries Page 30 of 333

What is the “right” balance between funding for above service delivery vs. direct service activities and between funding at site level vs. above site level?

What level of funding is required to optimally implement a given approach with fidelity and to scale?

How can non-PEPFAR resources, especially host country government and Global Fund resources, be leveraged to enhance PEPFAR investments?

Goal 2: Scale-up evidence-informed combination prevention and treatment interventions.

After thirty plus years of work in the HIV field, a solid evidence base confirms that certain combination prevention and treatment interventions work. As stated by Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the U.S. National

Institutes of Health, “PEPFAR has all the tools it needs to control the HIV/AIDS epidemic, it needs to identify how to effectively implement and scale the tools.”

The figure below demonstrates the impact of treatment on HIV prevention in Swaziland, where testing and treatment coverage increased from 23% in 2011 to 61% in 2016. PEPFAR started supporting VMMC in Swaziland in 2010 with nearly 20,000 VMMC supported to over of 97,000 through 2016 getting to 27% VMMC coverage. Such evidence-based strategies must be implemented and consistently scaled in all countries where they are relevant.

Two critical elements are evident from the graphic: new infections have decreased significantly in 18-30 year olds, as demonstrated by the decreased prevalence in young people, and older

HIV positive clients are thriving on ART, with increases in prevalence in 35-49 year olds.

Decreasing new infections by another 40% in the next four years (2016-2020) will bring the epidemic to a steady state and epidemic control.

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Figure 2.2.3 Declines in HIV prevalence in Women Under 30

Source: Swaziland HIV Incidence Measurement Survey 1 (2011) and 2 (2016-2017)

Being able to scale such activities with fidelity involves knowing the country context and adapting implementation, as necessary; engaging in collaborative planning with stakeholders;

designing activities with affordability in mind; sharing successes and challenges across implementing partners; integrating quality and scale into partner workplans; and continuously assessing, monitoring and managing to make real-time course corrections.

Goal 3: Ensure the availability and use of high quality data for program planning, monitoring and implementation.

The availability and routine use of high-quality data is a critical component of epidemic control.

HIV incidence, prevalence, and AIDS-associated mortality among PLHIV, and other key indicators are essential for monitoring national responses to the epidemic. Unfortunately, these data are often unavailable, lacking detail, or too dated to inform short-term program decisions.

Using PEPFAR and national program data to triangulate with available published survey and surveillance data can help to bridge this gap.

To address these issues, PEPFAR is working with host country governments and other stakeholders to improve the frequency, level of disaggregation and…