Table 1.

Factors Associated With False-Negative Tests (Primary Analyses) and With Oral Fluid OraQuick Conversion Delay Times >180 Days (Secondary Analyses), in the Botswana TDF/FTC Oral HIV Prophylaxis Trial, the Bangkok Tenofovir Study, and the Bangkok MSM Cohort Study, According To Univariable Modeling Results Based on a Log-Binomial Regression Model

	Primary Analysis Factors
Factor	TDF2	BTS	BMCS
Participant age <25 y	1.45 (.4–5.26), P = .56	0.79 (.27–2.3), P = .67	1.1 (.58–2.1), P = .77
Participant sex	0.72 (.19–2.66), P = .62	0.42 (.13–1.31), P = .13	NA
High operator workload	1.9 (.86–4.17), P = .11	0.96 (.5–1.81), P = .88	0.83 (.41–1.7), P = .61
Operator age <35 y	3.64 (1.33–9.94), P < .01	0.89 (.44–1.78), P = .74	0.37 (.18-.75), P < .01
Operator proficiency	3.94 (1.61–9.63), P < .01	0.8 (.42–1.52), P = .48	NA
Time to kit expiration	3.46 (1.66–723), P < .01	2.41 (1.27–4.56), P < .01	4.3 (2.09–8.85), P < .01
Randomization to PrEP	1.56 (.38–6.41), P = .53	2.73 (1.22–6.09), P = .01	NA
HIV pVL (participants w/ vs w/o FN)	0.53	0.23	0.86
HIV subtype	NA	1.15 (.32–4.11), P = .83	0.95 (.42–2.14), P = .89
Operator	Yes	Yes	Yes
Location	Yes	Yes	NA
Secondary analysis (factors associated with delay >180 d)
Randomization to PrEP	P = 1.0	P = .26	NA
Low HIV pVL	P = .96	P < .016	P = .93
HIV subtype	NA	P = .55	P = 1.0

Quantitative measures are indicated with prevalence ratios (95% confidence interval) and/or P values. Dichotomous qualitative measures associated and not associated with FN tests are shown as “yes” and “no,” respectively. Significant P-values are shown in bold.

Abbreviations: BMCS, Bangkok MSM Cohort Study; BTS, Bangkok Tenofovir Study; FN, false-negative; FTC, emtricitabine; HIV, human immunodeficiency virus; MSM, men who have sex with men; NA, not applicable; OFOQ, oral fluid OraQuick test; PrEP preexposure prophylaxis; pVL, plasma viral load; TDF, tenofovir disoproxil fumarate; TDF2, Botswana TDF/FTC Oral HIV Prophylaxis Trial.