SITUATION ANALYSIS TOOLKIT
STEP 1: DATA COLLECTION
PURPOSE AND USE
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.
Situation Analysis Toolkit: 3 Steps
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. Working concurrently in three countries and allowing time for document collection, compilation, review and revision OPTIONS was able to complete the three step process in three- four months.
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 .
STEP 1: DATA COLLECTION
This document is a tool for data collection. Questions guide in-country data and information-gathering in a structured and efficient way using secondary research, interviews, meetings, and other communication. The resulting findings from this research can be packaged in several ways (e.g., through the Situation Analysis Summary and/or the Implementation Planning Framework that are also provided as templates).
The questions included here are organized along a simplified “value chain” that charts what is needed for country introduction of Oral PrEP through five major stages: (1) Planning and Budgeting, (2) Supply Chain Management, (3) PrEP Delivery Platforms, (4) Individual Uptake, and (5) Effective Use and Monitoring.
Contents
The questions included here are in three sections:
· Section One: Context
These questions provide an overview of the key stakeholders for PrEP, the key questions/considerations about PrEP, and the ongoing research and activities related to PrEP. This section may be completed last, pulling up from details in other sections of this document.
· Section Two: Value Chain Research
These questions identify key actors, challenges and opportunities at each point along the value chain. These questions help countries map the recent, ongoing, upcoming, and needed resources and activities related to the introduction of PrEP.
· Section Three: Target Population Data
These questions gather information on potential target populations for PrEP use and further details on the ongoing research and modelling taking place in-country.
Process
Gathering this information requires a combination of secondary and primary research. Documents such as national strategic plans for HIV/AIDS, national HIV behavioural and other health surveys, PEPFAR country documents, AIDSInfoOnline.org, and PrEPWatch.org have been immensely helpful in conducting situation analyses. Interviews with relevant experts and stakeholders are needed to augment this research and to understand the most current context and information on PrEP.
SECTION ONE: CONTEXT
Name(s) (of those completing this portion of the situation analysis)Organization(s) coordinating situation analysis
Country
Data collection approach
Who are the key regional or national stakeholders relevant for effective scale-up of PrEP in your country?
Who are the key global stakeholders relevant for effective scale-up of PrEP in your country?
What are the biggest questions or concerns on the minds of these stakeholders?
What efforts (e.g., PrEP demonstration projects, other research, modelling, working groups) are underway to answer these questions?
SECTION TWO: VALUE CHAIN
The next section provides a template for collection of qualitative data along the value chain. The aim of this data collection is to identify key assets and bottlenecks for introduction and scale-up of PrEP.
In order to make this analysis as robust and comprehensive as possible it is structured along the components of the value chain for PrEP (see graphic below).
Value Chain Outline
The section below includes a table for each component of the value chain in the graphic above. Each table includes several questions each with several columns:
· One space to collect information (“response”)
· One space to note your level of certainty in that response (high-moderate-low). This will enable you to capture your or others’ hypotheses and refine on an ongoing basis, as opposed to waiting until you have absolute certainty.
· One space to capture the source of your information (e.g., individuals or secondary sources)
PLANNING AND BUDGETING
Cost-effectiveness and impact analysesQuestions / Response / Certainty / Source
What is the current thinking on the cost-effectiveness and impact of PrEP as part of a comprehensive combination approach to HIV prevention? / Level of certainty
What are other considerations? / Leave blank if none
What analyses have already been conducted or will be conducted? / See Section 3, Table 2
Target populations quantification and profiling
Questions / Response / Certainty / Source
To what extent have decisions about target populations been made? / Level of certainty
What is the expected outcome for PrEP (if ongoing process)? / Level of certainty
What stakeholders are involved currently or will need to be involved in planning? / Level of certainty
What is the expected timeline? What are relevant key milestones? / Level of certainty
What are other considerations? / Leave blank if none
What data already exists? / See Section 3, Table 1
Inclusion of PrEP and female-controlled methods in national HIV plans
Questions / Response / Certainty / Source
To what extent is PrEP already included in national HIV plans?
What is expected for PrEP (if ongoing process)?
Is planning for PrEP expected to fall within HIV prevention or HIV treatment? / Level of certainty
What stakeholders are involved currently or will need to be involved in planning? / Level of certainty
What is the expected timeline to develop a plan? What are relevant key milestones? / Level of certainty
What are other considerations? / Leave blank if none
Timeline and Plan for PrEP Introduction
Questions / Response / Certainty / Source
To what extent has a timeline and plan for PrEP introduction already been developed?
What stakeholders are involved currently or will need to be involved in planning? / Level of certainty
What is the expected timeline to develop a plan and timeline for introduction? What are relevant key milestones? / Level of certainty
What are other considerations? / Leave blank if none
National government budgeting for HIV prevention and treatment
Questions / Response / Certainty / Source
To what extent is PrEP already included in government budgets?
Is budgeting for PrEP expected to fall within HIV prevention or HIV treatment? / Level of certainty
What stakeholders are currently or should be involved in the budgeting process (if different from planning)? / Level of certainty
What is the expected timeline to develop a budget for PrEP scale-up? What are relevant key milestones? / Level of certainty
What are other considerations? / Leave blank if none
Global stakeholder budgeting for HIV prevention and treatment
Questions / Response / Certainty / Source
What global funders have / are expected to commit(ted) funding for PrEP scale-up?
What is the expected timeline for decisions? What are relevant key milestones? / Level of certainty
What are other considerations? / Leave blank if none
SUPPLY CHAIN MANAGEMENT
Product Registration with National AuthoritiesQuestions / Response / Certainty / Source
What is the current situation?
What is the expected outcome for PrEP (if ongoing process)? / Level of certainty
Who is involved / will be involved in the registration process? / Level of certainty
What is the expected timeline? What are relevant key milestones? / Level of certainty
To what extent will registration be a barrier to effective scale-up of PrEP provision? / Choose an item / Level of certainty
Why? What specific challenges do you anticipate? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What opportunities do you see that could overcome these barriers, or facilitate progress? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What are other considerations? / Leave blank if none
Demand and supply forecasting
Questions / Response / Certainty / Source
To what extent will supply/demand forecasting be different for PrEP than for ARVs? How will it differ? / Level of certainty
Who is expected to manage forecasting for PrEP? / Level of certainty
What is the expected timeline/frequency for PrEP forecasting? / Level of certainty
To what extent will this activity be a barrier to effective scale-up of PrEP provision? / Choose an item / Level of certainty
Why? What specific challenges do you anticipate? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What opportunities do you see that could overcome these barriers, or facilitate progress? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What are other considerations? / Leave blank if none
What analyses have already or will be conducted? / See Section 3, Table 2
Supplier identification, price negotiation, and purchase contract establishment
Questions / Response / Certainty / Source
To what extent will the procurement process for PrEP differ from the existing process for ARVs? How will it differ? / Level of certainty
Who is expected to manage this process for PrEP? / Level of certainty
What is the expected timeline? What are relevant key milestones? / Level of certainty
To what extent will this activity be a barrier to effective scale-up of PrEP provision? / Choose an item / Level of certainty
Why? What specific challenges do you anticipate? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What opportunities do you see that could overcome these barriers, or facilitate progress? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What are other considerations? / Leave blank if none
Financing mechanisms for purchase of PrEP
Questions / Response / Certainty / Source
How do you expect the purchase of PrEP will be financed? / Level of certainty
To what extent will there be sufficient financing for purchase of PrEP? / Choose an item. / Level of certainty
Why? What specific challenges do you anticipate? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What opportunities do you see that could overcome these barriers, or facilitate progress? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What are other considerations? / Leave blank if none
Distribution plan to reach target populations with PrEP
Questions / Response / Certainty / Source
What is the expected planning process for distribution of PrEP? / Level of certainty
Who is / will be involved in developing distribution plans? / Level of certainty
What is the expected timeline? What are relevant key milestones? / Level of certainty
What are other considerations? / Leave blank if none
What data already exists? / See Section 3, Table 1
Safe and timely distribution to key PrEP delivery points
Questions / Response / Certainty / Source
To what extent will PrEP be distributed through existing mechanisms used to distribute ARVs? What might be different? / Level of certainty
To what extent will safe distribution be a barrier to effective scale-up of PrEP? / Choose an item / Level of certainty
Why? What specific challenges do you anticipate? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What opportunities do you see that could overcome these barriers, or facilitate progress? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What are other considerations? / Leave blank if none
Quality assurance guidelines and regulations
Questions / Response / Certainty / Source
Please note any additional considerations on guidelines for distribution of PrEP that you feel are relevant.
PREP DELIVERY PLATFORMS
Issuance of Standard Treatment Guidelines for PrEPQuestions / Response / Certainty / Source
What is the current situation?
What is the expected outcome for PrEP (if ongoing process)? / Level of certainty
Who will issue treatment guidelines? Who influences these decisions? / Level of certainty
What is the expected timeline? What are relevant key milestones? / Level of certainty
To what extent will this activity be a barrier to effective scale-up of PrEP provision? / Choose an item / Level of certainty
Why? What specific challenges do you anticipate? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What opportunities do you see that could overcome these barriers, or facilitate progress? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What are other considerations? / Leave blank if none
Organizational ability to deliver PrEP services
Questions / Response / Certainty / Source
To what extent do the healthcare facilities that reach target populations have capacity to deliver PrEP? / See Section 3, Table 1 / Level of certainty
How is this expected to change in the next 1-3 years? / Level of certainty
What stakeholders are / will build health system capacity to deliver PrEP? / Level of certainty
What are key milestones to consider? / Level of certainty
To what extent will healthcare capacity be a barrier to effective scale-up of PrEP? / Choose an item / Level of certainty
Why? What specific challenges do you anticipate? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What opportunities do you see that could overcome these barriers, or facilitate progress? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What are other considerations? / Leave blank if none
Plan to reach and support healthcare workers
Questions / Response / Certainty / Source
What types of HCWs will be able to prescribe / dispense PrEP? / Level of certainty
To what extent is there a plan for how HCWs will be trained to deliver PrEP?
Is it expected that HCWs who do not currently prescribe ARVs will be prescribing PrEP? If so, what additional support is planned for them? / Level of certainty
What stakeholders are involved currently or will need to be involved in planning for HCW training? / Level of certainty
What are key milestones to consider to reach HCWs? / Level of certainty
What are other considerations? / Leave blank if none
What analyses have already been conducted? / See Section 3, Table 2
HCW awareness, ability and willingness to prescribe PrEP to target populations
Questions / Response / Certainty / Source
To what extent are HCWs aware, able and willing to prescribe PrEP when it becomes available? / Level of certainty
To what extent have tools to help potential clients and HCW understand who should use PrEP been created? / Level of certainty
What stakeholders are currently or will need to be involved in training/ preparing HCWs to deliver PrEP? / Level of certainty
What is the expected timeline? What are relevant key milestones to reach HCWs? / Level of certainty
To what extent will HCW capacity be a barrier to effective scale-up of PrEP? / Choose an item / Level of certainty
Why? What specific challenges do you anticipate? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What opportunities do you see that could overcome these barriers, or facilitate progress? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What are other considerations? / Leave blank if none
Funding for capacity to prescribe and dispense PrEP
Questions / Response / Certainty / Source
To what extent will there be sufficient funding to build needed healthcare capacity? / Choose an item. / Level of certainty
Why? What specific challenges do you anticipate? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What opportunities do you see that could overcome these barriers, or facilitate progress? / Leave blank if answer to previous question is 1 or 2 / Level of certainty
What are other considerations? / Leave blank if none