HIV oral pre-exposure prophylaxis (PrEP) trials: A systematic review and systematic ethics appraisal

Abstract

BACKGROUND. Pre-exposure prophylaxis (PrEP) is an experimental HIV prevention approach whereby antiretroviral pills are used before anticipated exposure. It is unclear how ethical considerations have been addressed by investigators. METHODS. A systematic review of PrEP controlled prospective studies was conducted. Pre-determined data items were extracted from registries, protocols, reports, and consent forms. Study characteristics, methods, and ethics considerations were synthesized. RESULTS. Among sixteen studies included, twelve involved resource-limited countries. Quality scores were generally high and overall risk of bias was low. Considerations for social value were the least reported whereas considerations for the fair selection of study population were the most reported. More ethics considerations tend to be reported with time. No meta-analysis was performed, as few data were available. CONCLUSION. As critical as clinical data generation is for scientific progress, ethics should be monitored and adequately reported, lest lack of consideration for key principles be uncovered after the facts.