Evidence and Research

Today's PrEP research agenda seeks to clarify how to deliver what's available—and identify new strategies.

PrEP research today spans implementation research on delivering daily oral tenofovir-based PrEP and clinical trials of new agents, including vaginal ARV-containing rings and long-acting injectables. Policy and program decisions are guided by data from the original randomized clinical trials as well as newer studies. There are many moving pieces and many product types.

No single PrEP option—and no single prevention option—is right for all people, or for any one person all the time. Demonstration projects are providing information about what's available, even as research continues for additional options.

Read below to find out more about evidence from:

Clinical Trials Evidence

The 2012 US FDA decision and WHO guidance on PrEP demonstration projects were based on data from randomized controlled trials of tenofovir-based PrEP. Additional randomized trials since then have added to this evidence base.

  • Table of Findings by Trial – where they took place, who enrolled, what they found
  • Adherence Matters – summary of randomized controlled trial data on the relationship between adherence and efficacy
  • PrEP Fact Sheet – includes a narrative description of randomized controlled trials to date

Open Label and Demonstration Project Evidence

Concluded and ongoing pilot projects, demonstration projects and open label studies offer insight into how PrEP works in the “real world”—outside of the controlled environment of a clinical trial.

  • “Real-World” Effectiveness to Date: Summary table of PrEP demonstration and implementation studies
  • Implementation Research Maps: Africa, Global

Ongoing Research

There are a range of ARV-based prevention options being evaluated today. These include long-acting injectable ARVs for HIV-negative people, a vaginal ring containing the ARV dapivirine, non-TDF PrEP drugs (e.g., Maraviroc), and exploration of “multipurpose prevention technologies” that could provide contraception and protection against HIV prevention.

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