Risk of acquisition of STIs by treatment arm
| BufferGel n=775 | PRO 2000 n=769 | Placebo Gel n=771 | No Gel n=772 | |
|---|---|---|---|---|
| Gonorrhoea | ||||
| Number of cases | 17 | 28 | 17 | 20 |
| PYAR | 1271 | 1297 | 1272 | 1275 |
| IR* (95% CI) | 1.34 (0.6 to 2.0) | 2.16 (1.3 to 3.0) | 1.34 (0.7 to 2.0) | 1.57 (0.7 to 2.5) |
| HR† (95% CI) vs Placebo | 0.99 (0.49 to 2.00) | 1.66 (0.90 to 3.06) | Ref | NA |
| HR† (95% CI) vs No Gel | 0.88 (0.43 to 1.80) | 1.45 (0.78 to 2.70) | 0.83 (0.43 to 1.61) | Ref |
| Chlamydia | ||||
| Number of cases | 45 | 54 | 46 | 53 |
| PYAR | 1271 | 1297 | 1272 | 1275 |
| IR* (95% CI) | 3.54 (2.4 to 4.7) | 4.16 (3.0 to 5.4) | 3.62 (2.5 to 4.7) | 4.16 (3.0 to 5.3) |
| HR† (95% CI) vs Placebo | 1.00 (0.64 to 1.57) | 1.16 (0.76 to 1.79) | Ref | NA |
| HR† (95% CI) vs No Gel | 0.88 (0.57 to 1.35) | 0.97 (0.65 to 1.46) | 0.85 (0.56 to 1.30) | Ref |
| Trichomoniasis | ||||
| Number of cases | 180 | 220 | 186 | 206 |
| PYAR | 1285 | 1308 | 1286 | 1298 |
| IR* (95% CI) | 14.01 (11.4 to 16.6) | 16.82 (14.0 to 19.6) | 14.46 (11.6 to 17.3) | 15.87 (13.0 to 18.8) |
| HR† (95% CI) vs Placebo | 0.95 (0.71 to 1.25) | 1.18 (0.90 to 1.53) | Ref | NA |
| HR† (95% CI) vs No Gel | 0.87 (0.66 to 1.14) | 1.06 (0.82 to 1.38) | 0.91 (0.68 to 1.20) | Ref |
*Incidence rate (per 100 person-years follow-up).
†HR from discrete time Andersen-Gill proportional hazards model.
PYAR, person-years at risk; STI, sexually transmitted infection.