Design and Analysis Considerations for a Sequentially Randomized HIV Prevention Trial

• Activity Number: 540 - Statistical Methods for Adolescent HIV Trials
• Type: Topic Contributed
• Date/Time: Thursday, August 6, 2020 : 1:00 PM to 2:50 PM
• Sponsor: Biometrics Section
• Author(s): David Benkeser* and Keith Horvath and Cathy J Reback and Joshua Rusow and Michael Hudgens
• Companies: Emory University and University of California, San Diego and Friends Research Institute and Friends Research Institute and UNC
• Keywords: HIV prevention; SMART trial; targeted learning; causal inference; mobile health

Abstract

TechStep is a randomized trial of a mobile health intervention targeted towards transgender adolescents. The interventions include an automated short messaging system, a mobile-optimized web application with social networking components, and personalized electronic counseling. The outcomes are PrEP uptake/adherence and self-reported sexual risk behaviors. The trial will be sequentially randomized in order to evaluate the efficacy of several different combinations of mHealth interventions. In this talk, I will discuss the motivation for this design, the complications in planning and analysis induced by the design, and some methods for providing robust analysis of the trial data.