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Due to the heterogeneity of the randomized controlled trial (RCT) andexternal target populations, the estimated treatment effect from the RCT is notdirectly applicable to the target population. For example, the patientcharacteristics of the ACTG 175 HIV trial are significantly different from thatof the three external target populations of interest: US early-stage HIVpatients, Thailand HIV patients, and southern Ethiopia HIV patients. This paperconsiders several methods to transport the treatment effect from the ACTG 175HIV trial to the target populations beyond the trial population. Most transportmethods focus on continuous and binary outcomes; on the contrary, we derive anddiscuss several transport methods for survival outcomes: an outcome regressionmethod based on a Cox proportional hazard (PH) model, an inverse probabilityweighting method based on the models for treatment assignment, sampling score,and censoring, and a doubly robust method that combines both methods, calledthe augmented calibration weighting (ACW) method. However, as the PH assumptionwas found to be incorrect for the ACTG 175 trial, the methods that depend onthe PH assumption may lead to the biased quantification of the treatmenteffect. To account for the violation of the PH assumption, we extend the ACWmethod with the linear spline-based hazard regression model that does notrequire the PH assumption. Applying the aforementioned methods fortransportability, we explore the effect of PH assumption, or the violationthereof, on transporting the survival results from the ACTG 175 trial tovarious external populations.

Transporting survival of an HIV clinical trial to the external target populations