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Creating Policies, Plans and Budgets

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

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 acquisition and to whom will PrEP be targeted? How much will this cost? Where will resources for prevention investments come from? This information can shape national guidelines and policies on PrEP.

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.

Modelling Summary | PrEP & Microbicide Literature Review

Global Guidelines

  • The WHO Consolidated HIV guidelines for prevention, treatment, service delivery & monitoring (July 2021) includes clinical and programmatic recommendations across different ages, populations and settings, bringing together all relevant WHO guidance on HIV produced since 2016. It serves as an update to the previous edition of the consolidated guidelines on HIV.
  • This technical brief (July 2022) on implementation guidance for simplified and differentiated service delivery of PrEP supplements and updates the consolidated guidelines above. The brief aims to support trends towards services becoming demedicalized, simplified, differentiated, digitalized, and integrated to increase uptake and effective use of PrEP.
  • The Consolidated Guidelines on HIV, Viral Hepatitis and STI Prevention, Diagnosis, Treatment and Care for Key Populations (July 2022) present and discuss recommendations on a public health response for five key populations (men who have sex with men, trans and gender diverse people, sex workers, people who inject drugs and people in prisons and other closed settings).
  • This toolkit (July 2022) from the International AIDS Society can be used to support countries to develop and include differentiated PrEP service delivery in their national HIV operational guidance, and includes an editable template and example policies.

Oral PrEP, PrEP Vaginal Ring, and Injectable CAB for PrEP 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.

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.

In July 2022, the WHO released guidelines recommending injectable cabotegravir (CAB) as an additional HIV prevention option, following US FDA approval in December 2021.

This template can be adapted for the development of national guidelines for daily oral PrEP, event-driven PrEP, PrEP vaginal ring, and injectable CAB for PrEP.

Costing Guidelines and Rollout Analysis

PrEP Costing Guidelines

Cost-Effectiveness Studies

Engage the Private Sector

Greater Than the Sum of its Parts: Blended finance roadmap for global health (USAID 2019)

WHO PrEP Implementation Tool App

This app, available for iPhone and Android, provides on-the-go access to the WHO PrEP Implementation Tool—a digital pocket reference for clinicians, pharmacists, providers of HIV tests and PrEP users.

Implementation Plan and Timeline

Develop a road map for when and where PrEP will first be introduced, and how access will scale up over time. This timeline shows oral PrEP moving from a proof-of-concept to rollout.

Post-Exposure Prophylaxis (PEP) Policy: Brief

This brief summarizes the PEP policy landscape, policy and implementation barriers, and recommends ways to increase 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 inform and expand access to PEP.