Ethical considerations in determining standard of prevention packages for HIV prevention trials: examining PrEP

Dev World Bioeth. 2013 Aug;13(2):87-94. doi: 10.1111/dewb.12032. Epub 2013 May 31.

Abstract

The successful demonstration that antiretroviral (ARV) drugs can be used in diverse ways to reduce HIV acquisition or transmission risks--either taken as pre-exposure prophylaxis (PrEP) by those who are uninfected or as early treatment for prevention (T4P) by those living with HIV--expands the armamentarium of existing HIV prevention tools. These findings have implications for the design of future HIV prevention research trials. With the advent of multiple effective HIV prevention tools, discussions about the ethics and the feasibility of future HIV prevention trial designs have intensified. This article outlines arguments concerning the inclusion of newly established ARV-based HIV prevention interventions as standard of prevention in HIV prevention trials from multiple perspectives. Ultimately, there is a clear need to incorporate stakeholders in a robust discussion to determine the appropriate trial design for each study population.

Keywords: HIV/AIDS; antiretroviral therapy; developing world bioethics; guidelines; international justice; research ethics.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adenine / administration & dosage
  • Adenine / analogs & derivatives
  • Anti-HIV Agents / administration & dosage*
  • Clinical Trials as Topic / ethics*
  • Clinical Trials as Topic / standards*
  • Community-Based Participatory Research / ethics*
  • Community-Based Participatory Research / standards
  • Community-Based Participatory Research / trends
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Drug Therapy, Combination
  • Emtricitabine
  • Ethics, Research
  • HIV Infections / prevention & control*
  • Health Services Needs and Demand
  • Humans
  • Organophosphonates / administration & dosage
  • Practice Guidelines as Topic
  • Primary Prevention / ethics*
  • Primary Prevention / methods
  • Research Design
  • Tenofovir
  • Treatment Failure
  • United States
  • United States Food and Drug Administration

Substances

  • Anti-HIV Agents
  • Organophosphonates
  • Deoxycytidine
  • Tenofovir
  • Emtricitabine
  • Adenine