title: Testing the waters: Ethical considerations for including PrEP in a phase IIb HIV vaccine efficacy trial.
abstract: BACKGROUND
  The field of HIV prevention research has recently experienced some mixed results in efficacy trials of pre-exposure prophylaxis, vaginal microbicides, and HIV vaccines. While there have been positive trial results in some studies, in the near term, no single method will be sufficient to quell the epidemic. Improved HIV prevention methods, choices among methods, and coverage for all at-risk populations will be needed. The emergence of partially effective prevention methods that are not uniformly available raises complex ethical and scientific questions regarding the design of ongoing prevention trials.
  
  
  METHODS
  We present here an ethical analysis regarding inclusion of pre-exposure prophylaxis in an ongoing phase IIb vaccine efficacy trial, HVTN 505. This is the first large vaccine efficacy trial to address the issue of pre-exposure prophylaxis, and the decisions made by the protocol team were informed by extensive stakeholder consultations. The key ethical concerns are analyzed here, and the process of stakeholder engagement and decision-making described.
  
  
  CONCLUSIONS
  This discussion and analysis will be useful as current and future research teams grapple with ethical and scientific study design questions emerging with the rapidly expanding evidence base for HIV prevention.
authors: Division of AIDS, NIH/NIAID, Bethesda, MD, USA dawsonl@niaid.nih.gov.
authors: Liza
authors: L
authors: Dawson
authors: Henry M. Jackson Foundation, Bethesda, MD, USA.
authors: Sam
authors: S
authors: Garner
authors: AstraZeneca, Gaithersburg, MD, USA.
authors: Chuka
authors: C
authors: Anude
authors: Medical Research Council of Zimbabwe, Harare, Zimbabwe.
authors: Paul
authors: P
authors: Ndebele
authors: Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors: Shelly
authors: S
authors: Karuna
authors: Program for Appropriate Technology in Health (PATH), Seattle, WA, USA.
authors: Renee
authors: R
authors: Holt
authors: Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors: Gail
authors: G
authors: Broder
authors: AVAC: Global Advocacy for HIV Prevention, New York, NY, USA.
authors: Jessica
authors: J
authors: Handibode
authors: Department of Medicine, Columbia University, New York, NY, USA.
authors: Scott M
authors: SM
authors: Hammer
authors: Department of Medicine, Columbia University, New York, NY, USA.
authors: Magdalena E
authors: ME
authors: Sobieszczyk
mesh_terms: D016915:AIDS Vaccines; D000293:Adolescent; D000328:Adult; D017322:Clinical Trials, Phase II as Topic / Q000941:ethics*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D065129:Pre-Exposure Prophylaxis; D012107:Research Design; D036302:Therapeutic Human Experimentation / Q000941:ethics*; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines
keywords: HIV prevention; HIV vaccine trials; clinical trial design; ethics; standard of prevention