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. Author manuscript; available in PMC: 2018 Apr 1.
Published in final edited form as: Clin Trials. 2017 Jan 26;14(2):201–210. doi: 10.1177/1740774516679666

Table 1.

Some possible effects of interest: When the control arm differs, we show the description of Design1/Design2.

Description of Study Arms & Treatment Regimes Trial Units (Int. x Con.)
Effects Intervention Control Yrs Design1 Design2
UTT before PrEP UTT hia A1 = 1 UTT lowb A1 = 0 0–3 16x16 16x16
PrEP in UTT intervention arm UTT hia+PrEP hic A = (1, 1) UTT hia A = (1, 0) 3–7 8x8 8x8
PrEP in UTT control arm UTT low-to-hid+PrEP hic A = (0, 1) UTT low-to-hid A = (0, 0) 3–7 NA 8x8
UTT without PrEP UTT hia A = (1, 0) UTT lowb/low-to-hid A = (0, 0) 0–7 8x16 8x8
UTT with PrEP UTT hia+PrEP hic A = (1, 1) UTT low-to-hid+PrEP hic A = (0, 1) 0–7 NA 8x8
Main PrEP effecte PrEP hic A2 = 1 Std. of care PrEP A2 = 0 3–7 NA 16x16
Main UTT effectf UTT hia A1 = 1 UTT low-to-hid A1 = 0 0–7 NA 16x16
Joint UTT & PrEP effect UTT hia+PrEP hic A = (1, 1) UTT lowb/low-to-hid A = (0, 0) 0–7 8x16 8x8

Int.: Intervention arm; Con.: Control arm; Yrs.: Years; UTT: universal test-and-treat; hi: high; Std.: Standard

A1: first randomization assignment; A2: second randomization assignment; A = (A1, A2): joint treatment assignment

a

UTT with high coverage: 85% of HIV+ on antiretroviral therapy & suppressed

b

UTT with low coverage: 55% of HIV+ on antiretroviral therapy & suppressed

c

PrEP with high coverage: 85% of eligible HIV- on PrEP & adherent

d

UTT with low coverage (55%) until year 3, then UTT with high coverage (85%) - Design 2 only

e

This comparison averages or collapses over the UTT arms: A = (1, 1) & A = (0, 1) versus A = (1, 0) & A = (0, 0)

f

This comparison averages or collapses over the PrEP arms: A = (1,1) & A = (1,0) versus A = (0,1) & A = (0,0)