Table 2.
TOC positive rates by arm in intent to treat, sensitivity and stratified analyses (n=623)
| 7 daydose | Single-dose | 7 day-dose vs. single-dose rate difference (95% C.I.) | Relative Risk (95% C.I.) Multi- vs. Single | p-value* | |
|---|---|---|---|---|---|
| Primary outcome T. vaginalis per NAAT or Culture | |||||
| Overall per ITT | 34/312 (10·9%) |
58/311 (18·6%) |
−7·8 (−2·2 to −13·3) | 0·55 (0·34 −0·70) | 0.001 |
| Among those with BV at baseline | 16/125 (12·8%) |
26/125 (20·8%) |
−8·0 (−12·8 to −20·8) | 0·59 (0·43–0·80) | 0·001 |
| Among those without BV at baseline | 13/139 (9·4%) |
24/140 (17·1%) |
−7·8 (−0·2 to −15·8) | 0·57 (0·45–0·71) | 0·001 |
| Sensitivity Analyses | |||||
| All missing reclassified as negative | 29/312 (9·3%) |
51/311 (16·4%) |
−7·1 (−1·9 to −12·4) | 0·57 (0·45–0·71) | 0·001 |
| All missing reclassified as positive | 71/312 (22·8%) |
92/311 (29·6%) |
−6·8 (−0·1 to −13·7) | 0·77 (0·70–0·85) | 0·001 |
| Culture as outcome m- ITT*** |
22/269 (8·2%) |
41/270 (15·2%) |
−7·0 (−1·3 to −12·7) | 0·54 (0·39–0·75) | 0·001 |
| Overall NAAT or culture as outcome m-ITT*** | 29/270 (10·7%) |
51/270 (18·9%) |
−8·2 (−2·2 to −14·1) | 0·57 (0·45–0·71) | 0·001 |
*
Relative Risks and p-values from GEE analysis clustering by site.
**
missing data imputed using multiple imputations using fully conditional specification
***
m-ITT (modified ITT using complete case as denominator)