Design and analysis considerations for a sequentially randomized HIV prevention trial

Stat Biosci. 2020 Dec;12(3):446-467. doi: 10.1007/s12561-020-09274-3. Epub 2020 Mar 25.


TechStep is a randomized trial of a mobile health interventions targeted towards transgender adolescents. The interventions include a short message system, a mobile-optimized web application, and electronic counseling. The primary outcomes are self-reported sexual risk behaviors and uptake of HIV preventing medication. In order that we may evaluate the efficacy of several different combinations of interventions, the trial has a sequentially randomized design. We use a causal framework to formalize the estimands of the primary and key secondary analyses of the TechStep trial data. Targeted minimum loss-based estimators of these quantities are described and studied in simulation.