Testing the waters: Ethical considerations for including PrEP in a phase IIb HIV vaccine efficacy trial
Year: 2015
Type: article
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. DISCUSSION: 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.
Source: Clinical Trials
Authors: Liza Dawson, Sam Garner, Chuka Anude, Paul Ndebele, Shelly Karuna, Renee Holt, Gail Broder, Jessica Handibode, Scott M Hammer, Magdalena E Sobieszczyk, for the NIAID HIV Vaccine Trials Network
Institutions: National Institutes of Health, National Institute of Allergy and Infectious Diseases, Henry M. Jackson Foundation, AstraZeneca (United States), Medical Research Council of Zimbabwe, Fred Hutch Cancer Center, Program for Appropriate Technology in Health, Program for Appropriate Technology in Health, Columbia University
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G1050281965, G1173804917, G119332616, G1386795942, G1424059659, UT Southwestern Center for Translational Medicine (UL1/KL2/TL1), G1663837155, G1772303406, G183157880, Targeting High-Risk Women for HVTN and Microbicide Trials, Colorado Clinical and Translational Science Institute (UL1), G2270113717, G2548217053, G3172506895, G3395997892, G360827231, G3873853564, G390975780, G4099673573, Case Clinical Trials Unit, G5469398932, G547379174, UT-Southwestern Clinical and Translational Alliance for Research (UT-STAR) (TL1), G6465116000, G681742546, G7183217200, G7940782042, Clinical and Translational Science Award, G8080150456, G819814859, G8838525055, HIV Vaccine Trials Network Laboratory Center, HIV Vaccines Clinical Trials Network Leadership and Operations Center, Rustbelt Center for AIDS Research (Case/UHC-Pitt CFAR), Center for AIDS Research at Emory University, Columbia Collaborative HIV/AIDS Clinical Trials Unit, G99424851
OpenAlex ID: W2003995414