Study design considerations for evaluating efficacy of systemic preexposure prophylaxis interventions.

Publication Type:

Journal Article


Journal of acquired immune deficiency syndromes (1999), Volume 63 Suppl 2, p.S130-4 (2013)


2013, Center-Authored Paper, July 2013, Public Health Sciences Division, Research Trials Office Core Facility - Biostatistics Service, Vaccine and Infectious Disease Division


The development of interventions for systemic pre-exposure prophylaxis (PrEP) faces several significant challenges following the US Food and Drug Administration's approval of emtricitabine/tenofovir (FTC/TDF) for HIV prevention. This development is particularly complex because of inconsistency of efficacy results of FTC/TDF PrEP trials for HIV prevention.