Situation Analysis Toolkit Step 3: Summary Findings APRIL 2016 This toolkit is designed to help implementers plan for introduction and roll out of oral PrEP. The toolkit enables implementers to 1) catalogue the current situation at the country-level for the introduction of Oral PrEP, 2) identify existing assets and strengths that could be leveraged for PrEP introduction, and 3) highlight gaps in understanding, processes, or resources that will need to be addressed to support successful PrEP introduction. By working through these three steps, implementers will complete a Situation Analysis that can be used to guide planning and preparation for the launch and scale-up of oral PrEP. This toolkit was developed and used by the OPTIONS Consortium to conduct a Situation Analysis to help plan for oral PrEP rollout in Kenya, Zimbabwe and South Africa in 2015/16. OPTIONS and its partners at USAID and PEPFAR are eager to share these tools to help others supporting similar market planning efforts in other countries or for other products. If you have any thoughts, feedback, questions or requests for additional information, please contact Neeraja Bhavaraju at FSG (an OPTIONS consortium member) at Please acknowledge USAID/OPTIONS with use of this

2 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Situation Analysis Toolkit: 3 Steps A Word document that includes a detailed set of questions along the value chain for information collection Document can be used to guide secondary research and as an interview guide for conversations with key stakeholders and experts DATA COLLECTION An Excel file that catalogues ongoing progress, resources, and gaps along the value chain Document can be used to update and organize information for the situation analysis and can serve as a planning tool for in-country stakeholders for a product introduction PrEP PLANNING A PowerPoint file that organizes and presents research findings along the value chain Document can be used to present findings, solicit input from and develop a common understanding with key stakeholders, and advocate for additional research and/or resources where needed SUMMARY FINDINGS 123

3 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Plan developed to implement WHO PrEP guidelines for targeted populations PrEP produced, purchased, and distributed in sufficient quantity to meet projected demand PrEP services delivered by appropriate channels with access to target populations Target populations seek and are able to access PrEP and begin use Target population adheres to PrEP at recommended frequency and for ideal time period PLANNING AND BUDGETING SUPPLY CHAIN MANAGEMENT PREP DELIVERY PLATFORMS INDIVIDUAL UPTAKE EFFECTIVE USE & MONITORING Value Chain for Oral PrEP All of the information collected in the situation analysis is organized along a simplified “value chain” for PrEP introduction. This includes five major stages, noted below: (1) Planning and Budgeting, (2) Supply Chain Management, (3) PrEP Delivery Platforms, (4) Individual Uptake, and (5) Effective Use and Monitoring. Slides 5 – 9 include templates for a set of summary analyses along this value chain. The appendix (slides 11 – 18) includes templates to hold details for each step along the value chain. Value Chain for PrEP

4 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Value Chain Summary Analyses The following slides hold three analyses along the value chain Identifies: Resources, financial and otherwise, that exist in- country to support and accelerate PrEP introduction Gaps in resources that could act as barriers to effective PrEP introduction Key considerations and expected challenges to inform comprehensive in-country planning for PrEP introduction Provides a list of specific factors that need to be in-place to effectively introduce PrEP for each component of the value chain along with progress to-date for each factor Can be used as a project management tool that is updated as progress is made to focus attention and resources to areas not yet underway Details on current situation, key actors, responsibilities, timelines and progress are included in the appendix Outlines key questions along the value chain to inform: In-country discussions and planning Decisions around further investment in modelling, research and analysis efforts

5 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Resources and Gaps for PrEP PLANNING & BUDGETING SUPPLY CHAIN MANAGEMENT PREP DELIVERY PLATFORMS INDIVIDUAL UPTAKE EFFECTIVE USE & MONITORING Expected Strengths Emerging Key Considerations The goal of this section is to understand what factors are likely to be key assets and/or strengths that could enable PrEP introduction along the value chain. List 1-3 expected strengths in each box. The goal of this section is to understand what factors are likely to be key obstacles and/or considerations along the value chain that will need to be addressed if country is moving towards PrEP introduction. List 1-3 emerging obstacles/considerations in each box.

6 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Impact, cost and cost- effectiveness analyses for PrEP as part of comprehensive HIV prevention portfolio Identification and quantification of target populations for PrEP Inclusion of PrEP and female-controlled methods in current or upcoming national HIV prevention plans Timeline and plan for PrEP introduction and scale-up A budget for PrEP roll-out to target populations Sufficient funding to achieve targets Regulatory approval of form(s) of oral PrEP by authorities Establishment of demand and supply forecasting mechanism for PrEP Manufacturer identification and contract negotiation to purchase PrEP Product and packaging design to meet target population needs and preferences Development of distribution plan for PrEP to reach target populations Effective distribution mechanisms to avoid PrEP stock-outs in priority facilities Finalization and dissemination of standard clinical guidelines for prescription and use of PrEP Sufficient infrastructure and human resources to conduct initial HIV tests and prescribe PrEP in priority channels Plan to engage health care workers on PrEP and delivery to target populations (including mitigating stigma) Tools to help potential clients and HCW understand who should use PrEP have been created Sufficient resources to roll-out plans for healthcare worker engagement Clear and informative communications on PrEP for general public audiences Development of demand generation strategies targeted to unique needs of different populations Linkages between HTC, PrEP prescription, and PrEP access to enable PrEP uptake Information for clients on how to effectively use PrEP for all target populations Sufficient resources to roll-out plans for demand generation Established plans to support effective use and regular HIV, creatinine testing that reflect the unique needs of target populations Capacity to provide ongoing HIV and creatinine level testing for PrEP users accessible to target populations Monitoring system to support data collection for ongoing learning (e.g., rate of patients returning for 2nd visit, non-HIV STI rates) PLANNING & BUDGETING SUPPLY CHAIN MANAGEMENT PREP DELIVERY PLATFORMS INDIVIDUAL UPTAKE EFFECTIVE USE & MONITORING Implementation Planning for PrEP Significant progress and/or momentum Early progress Initial conversations ongoing COLOR KEY The goal of this slide is to understand the current state of progress of each of these components (the current version is more specific to Oral PrEP). Update these progress bars to reflect the state in your country as per the color key. Additional detail for each component can be included in the Appendix and in the Implementation Planning Framework (Excel file)

7 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Key Remaining Questions about PrEP What is the incremental cost and impact of adding PrEP to combination prevention for target populations in target geographies? To what extent are target populations willing and able to pay for PrEP? How will the introduction of PrEP be financed? Who will manufacture PrEP? How will it be priced / packaged? What alternatives could be used? How will PrEP procurement and distribution be managed between the national and county levels, particularly for potential channels that are not delivering ARVs? What will be considered “effective use” for each population and how will it be encouraged? To what extent will ongoing testing needs for PrEP users further strain health systems capacity? How will ongoing monitoring be managed? What are the most effective channels to reach target populations with PrEP (e.g., health facilities, community channels)? How will health care workers, including community health workers, be engaged and supported to deliver PrEP? What is the current demand generation strategy for PrEP? How will stigma be addressed both to ensure target populations can effectively access PrEP and to ensure that use by some (e.g., FSW) does not stigmatize PrEP for others (e.g., AGYW)? PLANNING AND BUDGETING SUPPLY CHAIN MANAGEMENT PREP DELIVERY PLATFORMS INDIVIDUAL UPTAKE EFFECTIVE USE & MONITORING The goal of this slide is to identify the remaining key questions about PrEP and its introduction along the value chain. List the key outstanding concerns, information gaps, and unknowns for each section of the value chain.

8 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS National stakeholders Ministry of Health- creates national plans/priorities, and oversees the following HIV-specific divisions National AIDS & HIV Council/Authority- implements strategic plans, coordinates stakeholders, leverages resources, and provides care for PLHIV Other National AIDS &HIV Bodies- oversees policy and guidelines, coordinates technical HIV programming, and capacity-building, performs M&E National technical working groups- provide leadership and strategic guidance for implementation CDC- involved in guideline creation CDC- supplies laboratory capacity support Professional regulators - (Medical Pract. & Dentists Board, Nursing Council)- gives licensure to health providers, and monitors ethical practice of health workers Medicines Regulatory Body- approves all new medications Drug Manufacturer- registered Truvada for prevention in Kenya Medical Supplies Authority- central procurement agency National HIV Laboratory- improves country’s HIV lab capacity Implementers County/Province-level governments- make decisions on planning, funding, procurement/distribution, and health facility capacity-building for PrEP Health care facilities (community-based clinics, key population clinics, comprehensive care clinics, mobile clinics, HTC sites)- provide ARVS and other HIV/AIDS-related services Community based organizations (non-profit, faith-based, advocacy groups)- trusted organizations that can reach target populations with PrEP and generate demand Donors Current donors (PEPFAR, Gates Foundation) Other potential donors (Global Fund, local philanthropic organizations, UNITAID) Key Stakeholders for PrEP Specific organizations will be determined upon national level implementation plans Currently involved Potential/future involvement PLANNING & BUDGETING SUPPLY CHAIN MANAGEMENT PREP DELIVERY PLATFORMS INDIVIDUAL UPTAKE EFFECTIVE USE & MONITORING Specify name and describe current or expected role of stakeholder The goal of this slide is to understand the key stakeholders that are currently involved or could be potentially involved along the PrEP value chain. Examples of types of organization and roles are provided for illustrative purposes only – these will vary across countries.

9 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Timelines for PrEP Introduction Q1, 16Q2, 16Q3, 16Q4, 16Q1, 17Q2, 17Q3, 17Q4, Research Planning/ Implementation Policy Financing The purpose of this slide is to summarize the expected timelines of various ongoing and upcoming activities related to PrEP

10 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS APPENDIX

11 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Appendix: Value Chain Detail The purpose of the following slides is to provide additional detail beyond the summary analyses for the current state, resources and gaps, and stakeholders involved for each component of the value chain found on slides 4 – 8. A sample slide is below. These components and progress indicators are copied from slide 7. This space provide room for a brief description of the current state of each component, including ongoing activities and relevant timelines Specify name and describe current or expected role of stakeholders for the components on the left What are key assets and/or strengths in relation to the activities on the left? What are key obstacles and/or considerations in relation to activities on the left? What are key funding and other resources available/upcoming to enable the activities on the left or others related to this section of the value chain? The Appendix includes 1-2 slides for each piece of the value chain.

12 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Planning & Budgeting Readiness for PrEP Introduction Readiness Factor Progress Cost and impact effectiveness analyses for PrEP have been conducted Target populations are identified, quantified, and product/use preferences are understood PrEP and female- controlled methods are included in current or upcoming national HIV prevention plans A timeline and plan for PrEP introduction and scale-up has been established A budget for PrEP roll-out to target populations is established Sufficient funding has been secured to achieve targets Key Stakeholders Key Strengths and Opportunities Key Emerging Considerations Funding and other resources

13 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Potential Target Populations for PrEP Adolescent girls and young women (AGYW) Sero-discordant couplesFemale Sex Workers (FSW) People Who Inject Drugs (PWID) Men who have sex with men (MSM) Key Indicators Prioritization Questions What messages will be appropriate for encouraging use of PrEP without stigma? Which channels will be effective for PrEP delivery? What additional community support mechanisms need to be in place for PrEP’s effective use? How much demand will there be for PrEP, especially relative to other prevention options in the pipeline? Key Questions for this population(s) regarding PrEP Target populations may vary by country Could include: Size Contribution to new infections Prevalence Current access to HTC or other relevant health services Could include: Inclusion/exclusion as priority population in country’s national HIV plan If PrEP guidelines exist or are under development, inclusion/exclusion of this population as priority for PrEP delivery Demonstration projects working with this population

14 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Supply Chain Management Readiness for PrEP Introduction Readiness Factor Progress A form of PrEP is registered by regulatory authorities An effective demand and supply forecasting mechanism for PrEP is established A contract to purchase PrEP is in place at a price that enables provision of PrEP to target populations Product and packaging reflect needs and preferences of target populations Distribution plan in place to effectively reach target populations Effective distribution mechanisms in- place to avoid PrEP stock-outs in priority facilities Key Stakeholders Key Strengths and Opportunities Key Emerging Considerations Funding and other resources

15 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS PrEP Delivery Platforms Readiness for PrEP Introduction Readiness Factor Progress Standard guidelines have been issued and reflect target population considerations Sufficient HTC infrastructure and human resources in-place to conduct initial HIV tests and prescribe PrEP in priority channels Plan to engage health care workers on PrEP and delivery to target populations (including mitigating stigma) is in-place Sufficient resources exist to roll-out plans for healthcare worker engagement Tools to help potential clients and HCW understand who should use PrEP have been created Key Stakeholders Key Strengths and Opportunities Key Emerging Considerations Funding and other resources

16 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Channel #1Channel #2Channel #3Channel #4 Context Population reach Assets Needs Research Potential PrEP Delivery Channels The purpose of this slide is to collect information on potential PrEP delivery channels to reach target populations to support ongoing planning and to identify areas in need of investment. Could include: information on size, management, geographic distribution Could include: data on number of people accessing services and frequency of access and/or on HIV prevalence/incidence characteristics Include existing assets channel can leverage to effectively deliver PrEP Include investments required for channel to deliver PrEP (e.g., laboratory equipment) List ongoing research efforts related to delivery channel (e.g., demo projects, costing studies)

17 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Individual Uptake Readiness for PrEP Introduction Readiness Factor Progress Demand generation strategies are in place and reflect unique needs of target populations Linkages between HTC, PrEP prescription, and PrEP access enable PrEP uptake Information for clients on how to effectively use PrEP is available for all target populations Sufficient resources to roll-out plans for demand generation have been secured Key Stakeholders Key Strengths and Opportunities Key Emerging Considerations Funding and other resources

18 OPTIONS SITUATION ANALYSIS TOOLKIT | STEP 3 SUMMARY FINDINGS Effective Use & Monitoring Readiness for PrEP Introduction Readiness Factor Progress Plans to support effective use and regular HIV testing have been established and reflect the unique needs of target populations Capacity to provide ongoing HIV, liver, and kidney testing for PrEP users exists within reach of target populations An effective monitoring system is in-place to support data collection for ongoing learning (e.g., rate of patients returning for 2nd visit) Key Stakeholders Key Strengths and Opportunities Key Emerging Considerations Funding and other resources