title: Study designs for identifying risk compensation behavior among users of biomedical HIV prevention technologies: balancing methodological rigor and research ethics.
abstract: The growing evidence base for biomedical HIV prevention interventions - such as oral pre-exposure prophylaxis, microbicides, male circumcision, treatment as prevention, and eventually prevention vaccines - has given rise to concerns about the ways in which users of these biomedical products may adjust their HIV risk behaviors based on the perception that they are prevented from infection. Known as risk compensation, this behavioral adjustment draws on the theory of "risk homeostasis," which has previously been applied to phenomena as diverse as Lyme disease vaccination, insurance mandates, and automobile safety. Little rigorous evidence exists to answer risk compensation concerns in the biomedical HIV prevention literature, in part because the field has not systematically evaluated the study designs available for testing these behaviors. The goals of this Commentary are to explain the origins of risk compensation behavior in risk homeostasis theory, to reframe risk compensation as a testable response to the perception of reduced risk, and to assess the methodological rigor and ethical justification of study designs aiming to isolate risk compensation responses. Although the most rigorous methodological designs for assessing risk compensation behavior may be unavailable due to ethical flaws, several strategies can help investigators identify potential risk compensation behavior during Phase II, Phase III, and Phase IV testing of new technologies. Where concerns arise regarding risk compensation behavior, empirical evidence about the incidence, types, and extent of these behavioral changes can illuminate opportunities to better support the users of new HIV prevention strategies. This Commentary concludes by suggesting a new way to conceptualize risk compensation behavior in the HIV prevention context.
authors.affiliation: Yale Center for Interdisciplinary Research on AIDS and Yale Law School, Yale University, New Haven, CT 06520, USA. kristen.underhill@yale.edu
authors.forename: Kristen
authors.initials: K
authors.lastname: Underhill
mesh_terms: D020811:Biomedical Technology; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D032984:Ethics, Research; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018570:Risk Assessment / Q000379:methods; D012309:Risk-Taking
keywords: Behavioral disinhibition; Condom migration; HIV prevention; Placebo-controlled trial; Research ethics; Risk compensation; Risk homeostasis; Study design