Willingness to risk death endpoint in HIV cure-related research with otherwise healthy volunteers is misleading

Abstract

This viewpoint article critiques two recent articles examining 'willingness to risk death' to advance HIV cure-related research. The 'willingness to risk death' endpoint sends the wrong signal to the HIV cure-related research community about ongoing research in otherwise healthy volunteers living with HIV. Socio-behavioural scientists have examined the acceptability of a 99% risk of death scenario, which is unrealistic and would not be acceptable by current regulatory and ethical standards. We believe that the field needs robust and relevant socio-behavioural research reflecting ongoing biomedical HIV cure-related trials. These studies will need to withstand regulatory and ethical scrutiny if cure or remission regimens are to proceed to the licensing stage. The HIV cure-related research community must continue to protect the public trust in the HIV cure-related research field and sustain societal value generated by such research. We call for the utmost prudence in designing biomedical HIV cure trials as well as in setting up socio-behavioural research experiments related to these complex trials.

Keywords: HIV cure-related research; otherwise healthy volunteers; risk of death; socio-behavioural research; willingness to participate (WTP).