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Study design approaches for future active-controlled HIV prevention trials.

Deborah Donnell1,2, Sheila Kansiime3,4, David V Glidden5

  • 1Fred Hutchinson Cancer Center, Seattle, WA, USA.

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|January 22, 2024
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Summary
This summary is machine-generated.

Future human immunodeficiency virus (HIV) prevention trials need novel designs. Six approaches for active-controlled trials, assessing efficacy without placebo arms, offer reliable evidence for new biomedical interventions.

Keywords:
HIV preventionrandomized controlled trialsstatistical design

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Area of Science:

  • Clinical Trials
  • HIV Prevention Research
  • Biomedical Interventions

Background:

  • Evolving landscape of HIV prevention necessitates advanced trial designs.
  • Highly effective prevention products mean future trials will likely be active-controlled, omitting placebo arms.
  • Novel approaches are crucial for accurately assessing new interventions against active controls.

Purpose of the Study:

  • To address challenges in active control trial designs for HIV prevention.
  • To identify and discuss potential solutions for evaluating new interventions.
  • To explore methods for assessing efficacy in trials without placebo arms.

Main Methods:

  • A virtual workshop series (Oct 2020-Mar 2021) convened experts to discuss challenges.
  • Principles of non-inferiority trial designs were adopted for proposed approaches.
  • Six potential study design approaches were discussed for evaluating absolute prevention efficacy.

Main Results:

  • Six novel design approaches were proposed for active-controlled HIV prevention trials.
  • These approaches utilize data from registrational cohorts, recency assays, external placebo arms, and biomarkers (incidence, drug concentration, immune response).
  • Each method aims to provide reliable evidence of efficacy for new biomedical interventions.

Conclusions:

  • Proposed novel approaches offer potential for reliable efficacy evidence in active-controlled trials.
  • Further statistical research is needed to refine these designs.
  • These innovative designs are essential for advancing future HIV prevention research.