Table 4.
Cox Proportional Hazard Regression for the Impact of Point-of-Care Versus Central Laboratory–Based Testing on Time to Sexually Transmitted Infection Adverse Event Reporting Among Women
| Variable | Category | Model A: NG/CT Outcome | Model B: TVa Outcome | ||||
|---|---|---|---|---|---|---|---|
| AEs Reported/PD | aHR (95% CI) | P Value | AEs Reported/PD | aHR (95% CI) | P Value | ||
| Age group in y | 18–24 | 302/19 938.0 | 1 | 34/3567.4 | 1 | ||
| 25–34 | 94/7049.9 | 0.96 (.77–1.2) | .705 | 26/1453.8 | 1.53 (.96–2.43) | .074 | |
| ≥35 | 8/1499.9 | 0.46 (.22–.95) | .035 | 8/820.9 | 0.95 (.52–1.73) | .871 | |
| School level completed | High school | 249/17 610.0 | 1 | 37/3705.0 | 1 | ||
| Primary school | 154/10 730.4 | 1.84 (.43–7.93) | .413 | 30/2096.3 | 1.79 (1.12–2.86) | .014 | |
| No school | 1/147.4 | 1.91 (.44–8.22) | .386 | 1/113.3 | 2.00 (1.36–2.93) | <.001 | |
| CRSb | Verulam/Isipingoc | 272/22 453.1 | 1 | 49/4384.0 | 1 | ||
| eThekwinid | 132/6034.5 | 3.38 (2.23–5.13) | <.001 | 19/1461.8 | 1.38 (.86–2.21) | .183 | |
| Study visit type at which STI-AEs were reported | Scheduled | 394/28 346.2 | 1 | 67/5914.4 | 1 | ||
| Unscheduled | 10/141.6 | 1.76 (1.22–2.54) | .002 | 1/0.3 | 0.99 (.67–1.46) | .960 | |
Denominators that do not equal the sample sizes are due to missing data.
Abbreviations: AE, adverse event; aHR, adjusted hazard ratio; CI, confidence interval; CRS, clinical research site; CT, Chlamydia trachomatis; NG, Neisseria gonorrhoeae; PD, person-days; STI, sexually transmitted infection; TV, Trichomonas vaginalis.
All CRSs used point-of-care (POC) assays for TV testing.
Variable specified as a time-varying covariate in Model A to satisfy proportional hazard assumption. Model B satisfied the proportional hazard assumption (Schoenfeld test P = .4881).
Central laboratory–based testing for NG/CT was conducted at the Isipingo and Verulam CRSs.
POC testing for NG/CT was conducted at the eThekwini CRS.