title: Ethical considerations in determining standard of prevention packages for HIV prevention trials: examining PrEP.
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.
authors.affiliation: Centre for Values, Ethics and the Law in Medicine, University of Sydney, Medical Foundation Building, Parramatta Road, Camperdown, Sydney, New South Wales 2050 Australia. bridget.haire@sydney.edu.au
authors.forename: Bridget
authors.initials: B
authors.lastname: Haire
authors.forename: Morenike Oluwatoyin
authors.initials: MO
authors.lastname: Folayan
authors.forename: Catherine
authors.initials: C
authors.lastname: Hankins
authors.forename: Jeremy
authors.initials: J
authors.lastname: Sugarman
authors.forename: Sheena
authors.initials: S
authors.lastname: McCormack
authors.forename: Gita
authors.initials: G
authors.lastname: Ramjee
authors.forename: Mitchell
authors.initials: M
authors.lastname: Warren
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards*; D055812:Community-Based Participatory Research / Q000941:ethics* / Q000592:standards / Q000639:trends; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D032984:Ethics, Research; D015658:HIV Infections / Q000517:prevention & control*; D006301:Health Services Needs and Demand; D006801:Humans; D063065:Organophosphonates / Q000008:administration & dosage; D017410:Practice Guidelines as Topic; D011322:Primary Prevention / Q000941:ethics* / Q000379:methods; D012107:Research Design; D000068698:Tenofovir; D017211:Treatment Failure; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine
keywords: HIV/AIDS; antiretroviral therapy; developing world bioethics; guidelines; international justice; research ethics