Creating Policies, Plans and Budgets

A step-by-step framework for planning the introduction of PrEP

value chain graphic

For PrEP to have impact, programs need to be well designed and resourced. The first step involves answering questions such as: who is at highest risk for HIV infection and to whom will PrEP be targeted? How much will this cost? Where will resources for prevention investments come from? Then, this information can shape national guidelines and policies on PrEP.

Estimate Cost and Impact

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

Oral PrEP Specific Materials

Modelling Summary | PrEP and microbicide modelling study literature review

Cost-Effectiveness and Impact Studies

Cost-Effectiveness Studies

Sample PrEP Impact Studies

Dapivirine Ring Specific Resources
Several modeling efforts have demonstrated the potential impact, and in some cases the cost and cost-effectiveness, of a monthly dapivirine ring.

Regulatory Approval

Biomedical HIV prevention products take various paths to regulatory approval, and in examining the experience of oral PrEP (both Truvada and Descovy) and the dapivirine vaginal ring these differences are highlighted.

Oral PrEP Specific Resources

In 2012, the US FDA approved the use of TDF/FTC (brand name Truvada) for HIV prevention in all populations, and WHO guidance was developed based on data from randomized controlled trials of TDF/FTC and TDF (a generic option). Similarly, F/TAF (brand name Descovy) was approved by the FDA in October 2019, as safe and effective HIV prevention option for cisgender men and transgender women. However, due to a lack of data in cisgender women, additional data will be needed before use of F/TAF is approved for this group.

Dapivirine Ring Specific Resources

Five action areas to support ring introduction

IPM, the ring’s developer, applied to the European Medicines Agency (EMA) for review of the ring under Article 58. This procedure allows the EMA, in cooperation with the World Health Organization (WHO), to provide a scientific opinion on the safety, efficacy and quality of medicines that would be marketed exclusively outside of the European Union—specifically in low- and middle-income countries—for diseases of major public health interest.

In July of 2020, the EMA gave a positive scientific opinion on the public health benefits of the ring for use by women in low- and middle-income countries outside of the European Union. The positive opinion also said there should be a commitment to do a post-authorization efficacy study. This study would enroll cisgender women aged 18-25 to better understand efficacy, and to complement existing data on potential drug resistance. The EMA’s positive opinion helps move the ring from a research product to a real tool that women can use.

In November 2020, the WHO prequalified the ring, which involves evaluating whether a medicine meets global standards for quality, safety and efficacy. Many African national regulatory agencies consider WHO prequalification as they review new products.

In March 2021, the WHO released new clinical recommendations on HIV prevention which included detailed guidance for the ring as an additional prevention choice for women at substantial risk of HIV infection as part of a combination prevention package. This followed an initial announcement in January 2021 where the WHO recommended the ring as an additional HIV prevention option for women at substantial risk for acquiring HIV.

IPM submitted the ring to the US FDA for regulatory review in early 2021. IPM is also applying for the ring to be reviewed by countries in sub-Saharan Africa, where women face persistently high HIV risk. Initial regulatory submissions are planned for Eswatini, Kenya, Lesotho, Malawi, Rwanda, South Africa, Tanzania, Uganda, Zambia and Zimbabwe. For the latest information, visit IPM’s website.

For many countries, an opinion from a stringent regulatory authority such as the EMA along with WHO guidelines and prequalification will help advance national-level regulatory decision-making. For more information on the regulatory process, access the Dapivirine Ring Market Introduction Considerations deck.

Demonstration Planning

Understanding country-level questions and interest in any biomedical HIV prevention product is a critical part of planning. For this reason, strategic design and implementation of demonstration projects in-country are a critical first step to bringing a product to market.

Oral PrEP Specific Resources
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.

Dapivirine Ring Specific Resources
For the ring, learning from the introduction of and experiences with HIV prevention products or other types of vaginal rings and family planning products can also inform planning.

Identify Priority Populations

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

Establish a Technical Working Group (TWG)

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

Create an Implementation Plan and Timeline

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.

Oral PrEP Specific Resources

Country Implementation Plans

Interactive Oral PrEP Implementation Timelines

Dapivirine Ring Specific Resources

The Dapivirine Ring Global Action Plan is a living document that will serve as a consolidated map that describes current and planned activities at the global level to support ring introduction. Its primary objective is to support coordination across partners for the planning, funding and introduction of the dapivirine ring in Africa in the context of combination prevention, including oral PrEP and integrated service delivery.

Develop Policies and Guidelines

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

PrEP Ring Guidelines

These are customizable, adaptable guidelines that align with the World Health Organization (WHO) guidance and recommendations for implementation of the monthly dapivirine vaginal ring as HIV pre-exposure prophylaxis (PrEP).


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.

Oral PrEP Specific Resources
National policies and guidelines from a number of countries are available here.

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.


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.

Post-Exposure Prophylaxis (PEP) Policy Synthesis Brief

This brief aims to summarise the PEP policy landscape, illustrate how to address policy and implementation barriers, and recommend ways to increase access to and uptake of PEP as part of HIV prevention. While it focuses on countries within the MOSAIC consortium, the findings are applicable across the HIV prevention landscape and can be used by ministries of health, implementing partners, providers, and potential PEP users alike to better inform and expand access to PEP and aptly elevate this underutilized prevention method.

Engage the Private Sector

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

Ring Specific Resources

PrEP Ring Template Guidelines

These are customizable, adaptable guidelines that align with the World Health Organization (WHO) guidance and recommendations for implementation of the monthly dapivirine vaginal ring as HIV pre-exposure prophylaxis (PrEP).

Help Desk

Need answers? The PrEPWatch Help Desk provides support for all your questions related to PrEP implementation and planning.

Last updated on January 19, 2022.