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Area of Science:

  • Infectious Diseases
  • Epidemiology
  • Clinical Trials

Background:

  • Standard-of-care HIV pre-exposure prophylaxis (PrEP) has high efficacy, but low uptake and adherence to daily oral pills limit its effectiveness.
  • Evaluating new PrEP products requires innovative trial designs to overcome challenges posed by large sample size requirements in traditional noninferiority trials.

Purpose of the Study:

  • To propose and assess a novel counterfactual approach for estimating HIV incidence in clinical trials for new pre-exposure prophylaxis (PrEP) products.
  • To determine the feasibility and statistical power of using external HIV incidence data, derived from recent infection testing algorithms (RITAs), to evaluate the efficacy of alternative PrEP interventions.

Main Methods:

  • Proposed an external counterfactual method comparing HIV incidence in participants on new PrEP products with estimated incidence in an untreated population.
  • Utilized HIV recent infection testing algorithms (RITAs), specifically limiting antigen avidity assay combined with viral load, on screening specimens from untreated HIV-positive individuals to estimate incidence.
  • Analyzed sample size requirements based on RITA performance, expected intervention efficacy, and population incidence rates.

Main Results:

  • Screening sample sizes for detecting an 80% HIV incidence reduction in key populations were found to be modest and comparable to recent phase III PrEP trials.
  • The proposed counterfactual approach demonstrated feasibility and high statistical power, providing a nearly contemporaneous comparison group.
  • Larger sample sizes would be necessary in populations with lower incidence, higher false recency rates, or lower expected PrEP efficacy.

Conclusions:

  • The proposed counterfactual approach using RITA-based HIV incidence estimation is a feasible and statistically powerful method for evaluating new PrEP products.
  • This innovative trial design can help overcome the limitations of traditional noninferiority trials with large sample sizes.
  • The approach holds potential as a model for future HIV vaccine trials and the development of other infectious disease prevention strategies.