Good, better or best: A study of standards of prevention and care in HIV prevention trials

Introduction This study examines the negotiation of benefits to participants in efficacy trials of biomedical HIV prevention technologies (HPT). It was conducted from 2009-2012, during which time there were positive efficacy results from six large, randomised controlled trials of HPT. Debates about obligations to trial participants are reconsidered in the light of abovementioned results. Methods Empirical • Survey of principal investigators of HPT • 14 in-depth interviews with principal investigators • Additional data from document analysis and personal communications. Normative Key normative issues examined are: • Ethical justification for antiretroviral (ARV)-based prevention • Impact of partial efficacy results on HIV prevention research • Implications of incorporating newly validated technologies into standard of prevention (SOP). Results • There is no consensus on whether or when new interventions should be added to SOP. • Access to ARV for seroconverters has become a norm. • Ancillary care provision is also a norm. • Post-trial access differs in both the duration and the timeliness of provision. Conclusion Partially effective interventions raise questions about standards in both research and implementation contexts. While ongoing research into HPT is crucial, reducing HIV incidence in trial populations remains a legitimate goal. Adding an active comparator in HIV prevention trials could balance protection of participants with research imperatives