Creating Policies, Plans and Budgets

Consider exploring the impact of introducing PrEP incrementally to existing prevention programs—and evaluate the cost of this for different populations.

Costing Guidelines and Rollout Analysis

• PrEP Costing Guidelines
• Oral PrEP Introduction Zimbabwe Rollout Analysis
• Oral PrEP Introduction Kenya Rollout Analysis

Modelling Summary | PrEP and microbicide modelling study literature review

• Literature review of studies, reviews and analyses focused on the impact, cost, cost-effectiveness, drug resistance and other parameters of both PrEP and microbicides
• Modeling literature review bibliography

Sample PrEP Cost-Effectiveness Studies

• Comparative effectiveness and cost-effectiveness of antiretroviral therapy and pre-exposure prophylaxis for HIV prevention in South Africa
• Estimating the cost-effectiveness of pre-exposure prophylaxis to reduce HIV-1 and HSV-2 incidence in HIV-serodiscordant couples in South Africa
• What do we know about the cost–effectiveness of HIV preexposure prophylaxis, and is it affordable?

Sample PrEP Impact Studies

• Tailored combination prevention packages and PrEP for young key populations
• Using geospatial modelling to optimize the rollout of antiretroviral-based pre-exposure HIV interventions in Sub-Saharan Africa

Beginning in 2013, the Bill & Melinda Gates Foundation supported seven early oral PrEP demonstration projects. The Prevention Market Manager project aggregated and analyzed the project results to inform oral PrEP rollout and new product demonstration projects. Click here for the findings.

Two companion documents, Lessons from Seven Early Oral PrEP Demonstration Projects and What We Learned About Oral PrEP Delivery from Early Demonstration Projects, are also available.

In this step, you begin to assess which populations should be prioritized for PrEP introduction. This involves understanding the context of the epidemic, the characteristics of end users, and the size of the potential end user population. This is typically an iterative process that starts with collecting and understanding available data before developing new research.

You don’t need all the answers before moving ahead with the next steps for introduction. Now is the time to gather available information and identify gaps. Other questions include whether members of priority populations are willing and likely able to use PrEP consistently and, where applicable, to pay for it.

Identify Priority Populations

• Examples of situational analyses: South Africa, Kenya, Zimbabwe
• Step 2 of the OPTIONS Plan 4 PrEP Toolkit defines scenarios for oral PrEP rollout in different counties/districts or to different populations. The full toolkit is also available.
• Building Evidence to Guide PrEP introduction for Adolescent Girls and Young Women (Population Council, 2016)
• Addressing Gender to Ensure Effective PrEP Introduction

Technical working groups will help drive strategic decision making for PrEP introduction. For guidance on setting up a TWG, click here.

In this step you synthesize the information gathered in the previous activities and use it to develop a road map for when and where PrEP will first be introduced, and how access will scale up over time. This timeline shows PrEP moving from a proof-of-concept to rollout.

Country Implementation Plans

• Implementation Plan for HIV Pre-Exposure Prophylaxis in Zimbabwe 2018-2020
• Framework for the Implementation of Pre-Exposure Prophylaxis in Kenya (2017)

Interactive PrEP Implementation Timelines

• Kenya
• South Africa

PrEP programs are supported by a range of documents. Ensuring you have the needed framework in place is an ongoing process in this initial phase of planning. Things to consider and plan for include guidelines – national-level documents that give a high-level recommendation for how PrEP should be used. Many countries are now including PrEP in their ARV guidelines, that also address how ART should be used in people living with HIV. These guidelines do not provide the detail needed for a program implementer, clinician, or service provider.

Global guidelines

• In June 2016, the WHO issued its consolidated guidelines on the use of antiretrovirals for prevention and treatment. This is the over-arching global document that is guiding country adoption of PrEP and immediate offer of ART.
• For additional related documents developed by WHO, PEPFAR and UNAIDS, click here.

Policies

Policies (also called guidance) offer more specific information about how a country’s PrEP program should look, including eligibility criteria, clinical considerations, components of the minimum package of services that should be associated with PrEP introduction, etc.

National policies and guidelines from a number of countries are available here.

• National Policies and Guidelines
• Clinical Guidelines

Kenya is one example of a country with a range of documents shaping the PrEP policy. These include: the Kenyan HIV Prevention Revolution Roadmap, and Kenya National Strategic Framework (KASF). Specific guidance on how PrEP should be delivered is found in the Guidelines on use of ARV drugs for treating and preventing HIV infections in Kenya – 2016 edition.

OPTIONS Plan 4 PrEP

The Plan 4 PrEP Toolkit supports national planning for the rollout of oral PrEP. Implementers may use all the steps to guide the entire planning process or use specific sections. Policy makers, technical working groups, implementing partners or advocates at the national or sub-national level will find tools informed by experiences in PrEP rollout from South Africa, Kenya and Zimbabwe.

• Plan 4 PrEP Toolkit: Facility Readiness Assessment (OPTIONS 2019)
• Greater Than the Sum of its Parts: Blended finance roadmap for global health (USAID 2019)

Assessment of Opportunities to Deliver Oral PrEP for Women Through Private Sector Health Care (OPTIONS 2017)

• Summary of Research Findings
• Kenya Research Findings
• South Africa Research Findings
• Zimbabwe Research Findings