Primary and secondary outcomes: complete case, best/worst case analyses.
| Participants | Adjusted analysis* | |||
| Intervention | Control | OR (95% CI) | P value | |
| Primary outcome | ||||
| Fully protected intercourses, n/N (%) | ||||
| Complete case† | 25/145 (17.2) | 23/160 (14.4) | 1.4 (0.7 to 2.8) | 0.30 |
| Best case‡ | 94/214 (43.9) | 82/219 (37.4) | 1.4 (0.9 to 2.1) | 0.10 |
| Worst case§ | 19/214 (8.9) | 19/219 (9.7) | 1.2 (0.6 to 2.4) | 0.66 |
| Secondary outcomes | ||||
| Mean number of partners | ||||
| Complete case† | 4.1 | 4.3 | 0.8 (0.5 to 1.2) | 0.32 |
| Best case‡ | 2.8 | 3.1 | 0.8 (0.5 to 1.1) | 0.11 |
| Worst case§ | 6.0 | 5.8 | 1.1 (0.8 to 1.5) | 0.73 |
| Occurrence of STI, n/N (%) | ||||
| Complete case† | 30/145 (20.7) | 28/160 (17.5) | 1.2 (0.7 to 2.5) | 0.48 |
| Best case‡ | 35/214 (16.4) | 36/219 (16.4) | 1.0 (0.6 to 1.6) | 0.91 |
| Worst case§ | 69/214 (32.2) | 69/219 (31.5) | 1.1 (0.7 to 1.6) | 0.83 |
| STI testing, n/N (%) | ||||
| Complete case† | 111/145 (76.6) | 109/160 (68.1) | 1.4 (0.9 to 2.4) | 0.17 |
| Best case‡ | 111/214 (51.9) | 109/219 (49.8) | 1.1 (0.7 to 1.6) | 0.78 |
| Worst case§ | 180/214 (84.1) | 168/219 (76.7) | 1.5 (0.9 to 2.5) | 0.08 |
| Occurrence of pregnancy, n/N (%) | ||||
| Complete case† | 1/145 (0.7) | 5/160 (3.1) | 0.2 (0.0 to 1.9) | 0.17 |
| Best case‡ | 1/214 (0.5) | 6/219 (2.7) | 0.2 (0.0 to 1.4) | 0.09 |
| Worst case§ | 35/214 (16.4) | 39/219 (17.8) | 0.9 (0.6 to 1.6) | 0.80 |
*Adjusted for sex, condom proportion at baseline, relationship status at baseline and previous experience of STI.
†Complete case, that is, participants that answered all follow-up questionnaires.
‡Best case scenario imputed for missing values, that is, 0 partners, no tested positive for STI, no did not experience pregnancy and no did not test for STI.
§Worst case scenario imputed for missing values, that is, 10 or more partners, yes tested positive for STI, yes experienced pregnancy and yes tested for STI during study period.