Design and Analysis Considerations for a Sequentially Randomized HIV Prevention Trial

• DOI: 10.1007/s12561-020-09274-3
• Publication Date: 2020-03-25T19:02:46Z
• Authors: David Benkeser; Keith Horvath; Cathy J. Reback; Joshua Rusow; Michael Hudgens
• Keywords: mHealth; Biostatistics

The TechStep study is an ongoing randomized controlled trial in HIV-negative transgender youths and young adults, which will evaluate the efficacy of mobile health interventions for reducing risk behaviors. Several mobile interventions are available, which complicates the design. To evaluate different combinations of mHealth interventions, TechStep is utilizing a sequentially randomized design. In this work, we discuss the motivation for this design, propose robust methodology for the analysis of the trial, and evaluate the methodology via simulation.