Table 2.
Intention-to-treat and per-protocol effects in the higher HIV incidence African setting and generalized to the lower incidence US setting, estimated using g-computation
| Parameter | African Trials (trial n=4000) |
US/African Composite Trials (trial n=500/4000) |
US Trial (n=10,000) |
||||||
|---|---|---|---|---|---|---|---|---|---|
| RR | 2.5th | 97.5th | RR | 2.5th | 97.5th | RR | 2.5th | 97.5th | |
| Intention to treat | 0.65 | 0.47 | 0.88 | 0.42 | 0.20 | 0.62 | 0.41 | 0.19 | 0.68 |
| Per protocol | 0.20 | 0.08 | 0.34 | 0.17 | 0.03 | 0.38 | 0.13 | 0.00 | 0.31 |
Abbreviations: HIV, human immunodeficiency virus; US, United States; n: sample size; RR, average risk ratio; 2.5th: 2.5th percentile of the 2000 simulation RRs or, for the US trial, of 500 bootstrap resamples; 97.5th: 97.5th percentile of the 2000 simulation RRs or, for the US trial, of 500 bootstrap resamples