Evidence and Research

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

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

As more countries approve daily oral PrEP for prevention (visit AVAC’s Global PrEP Tracker for the latest) and begin to scale up national PrEP programs, there are opportunities to understand how services may be optimized and adapted. Already, many of these programs have provided valuable lessons.

• Early Lesson from South Africa’s Roll-out of Oral PrEP to Sex Workers
• OPTIONS Country Situation Analysis Interim Findings: South Africa