Standard of Prevention in the Real World: A Qualitative Study of Principal Investigators in HIV Biomedical Prevention Trials

Abstract

Background: UNAIDS guidelines require that participants in HIV prevention trials are provided with “state-of-the-art” risk reduction measures. Published data showing that new HIV prevention strategies are highly, but not completely, effective problematize “standard of prevention” packages that provide access to condoms and counseling only. This qualitative study asks how principal investigators on HIV prevention studies determine appropriate standards of prevention. It builds on previous work mapping standards of care in HIV prevention trials by investigating how decisions were arrived at, in addition to reporting what was decided. Methods: Semistructured interviews were conducted with 14 principal investigators of biomedical HIV prevention trials. Interviews were transcribed, coded, and analyzed thematically using predetermined categories derived from the ethics literature and spontaneous coding. Results: A spectrum of views was given by informants as to how standard of prevention should be determined, ranging from an ethical requirement to include newly validated technologies as soon as feasible, to a perceived need to reduce the prevention package to make it more like real life, thus enabling subsequent trials to test interventions against basic prevention packages. Each informant argued her position with reference to keeping the size and cost of studies reasonable, the need for conclusive data on the effectiveness of preventive interventions, perceived duties to trial participants, and regulatory requirements. Some saw reconsent as the critical issue in ongoing trials when relevant data from other studies were released. Conclusions: There was no ethical consensus about the standard of prevention among principal investigators. Rational arguments were made to support disparate positions. These results suggest a need to examine and articulate the ways that the narrow aims and obligations of a research study sit within the broader context of disease burden and inequitable access to health care in the resource-poor world in order to address how future research should proceed.