Table 2. TB prevalence by trial arm, overall and stratified by sex, age group, and HIV status.
| Arm A | Arm B | Arm A+B | Arm C | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Overall | Triplet | n/N1 | %2 | n/N1 | %2 | n/N1 | %2 | n/N1 | %2 |
| 1 | 11.4/1,971 | 0.58 | 12.9/1,905 | 0.67 | 24.3/3,876 | 0.62 | 10.4/3,494 | 0.30 | |
| 2 | 17.5/2,088 | 0.84 | 4.9/2,122 | 0.23 | 22.4/4,210 | 0.52 | 22.6/4,064 | 0.56 | |
| 3 | 20.7/2,887 | 0.72 | 18.7/2,235 | 0.84 | 39.4/5,122 | 0.78 | 22.1/3,813 | 0.58 | |
| 4 | 10.9/1,609 | 0.68 | 2.1/1,548 | 0.13 | 13.0/3,157 | 0.41 | 4.2/3,172 | 0.13 | |
| 5 | 22.7/2,049 | 1.11 | 24.5/1,804 | 1.36 | 47.2/3,853 | 1.25 | 51.9/4,022 | 1.29 | |
| 6 | 20.7/1,772 | 1.17 | 15.5/693 | 2.24 | 36.2/2,465 | 1.46 | 61.6/3,042 | 2.03 | |
| 7 | 25.5/1,530 | 1.66 | 23.9/1,480 | 1.62 | 49.4/3,010 | 1.63 | 52.7/2,256 | 2.33 | |
| Overall (triplets 1–7 combined) | 129.4/13,906 | 0.93 | 102.4/11,787 | 0.87 | 231.8/25,693 | 0.90 | 225.5/23,863 | 0.94 | |
| TB prevalence, geometric mean3 | 0.91 | 0.70 | 0.80 | 0.69 | |||||
| Unadjusted PR, 95% CI, p-value | 1.31 | [0.70, 2.45] p = 0.36 | 1.01 | [0.54, 1.90] p = 0.97 | 1.15 | [0.67, 1.98] p = 0.58 | referent | ||
| aPR4, 95% CI, p-value | 1.29 | [0.69, 2.39] p = 0.38 | 1.01 | [0.54, 1.88] p = 0.97 | 1.14 | [0.67, 1.95] p = 0.60 | referent | ||
| Males | Overall (triplets 1–7 combined) | 93.7/5,354 | 1.75 | 71.5/4,505 | 1.59 | 165.2/9,859 | 1.68 | 139.0/9,611 | 1.45 |
| TB prevalence, geometric mean | 1.70 | 1.25 | 1.46 | 1.07 | |||||
| aPR, 95% CI, p-value | 1.53 | [0.79, 2.95] p = 0.18 | 1.12 | [0.58, 2.18] p = 0.70 | 1.31 | [0.74, 2.32] p = 0.32 | referent | ||
| Females | Overall (triplets 1–7 combined) | 35.7/8,552 | 0.42 | 30.9/7,282 | 0.42 | 66.6/15,834 | 0.42 | 86.5/14,252 | 0.61 |
| TB prevalence, geometric mean | 0.39 | 0.33 | 0.36 | 0.42 | |||||
| aPR, 95% CI, p-value | 0.90 | [0.40, 2.04] p = 0.78 | 0.80 | [0.35, 1.80] p = 0.55 | 0.85 | [0.42, 1.71] p = 0.61 | referent | ||
| Age <30 years | Overall (triplets 1–7 combined) | 45.0/7,094 | 0.63 | 28.4/6,095 | 0.47 | 73.4/13,189 | 0.56 | 70.2/12,517 | 0.56 |
| TB prevalence, geometric mean | 0.60 | 0.18 | 0.33 | 0.36 | |||||
| aPR, 95% CI, p-value | 1.73 | [0.66, 4.54] p = 0.23 | 0.86 | [0.32, 2.32] p = 0.74 | 1.22 | [0.53, 2.84] p = 0.60 | referent | ||
| Age ≥30 years | Overall (triplets 1–7 combined) | 84.4/6,812 | 1.24 | 74.0/5,692 | 1.30 | 158.4/12,504 | 1.27 | 155.3/11,346 | 1.37 |
| TB prevalence, geometric mean | 1.21 | 1.09 | 1.15 | 1.04 | |||||
| aPR, 95% CI, p-value | 1.16 | [0.68, 1.98] p = 0.56 | 1.05 | [0.62, 1.79] p = 0.84 | 1.10 | [0.69, 1.75] p = 0.65 | referent | ||
| HIV–negative | Overall (triplets 1–7 combined) | 81.7/10,688 | 0.76 | 64.9/8,916 | 0.73 | 146.6/19,604 | 0.75 | 148.0/17,391 | 0.85 |
| TB prevalence, geometric mean | 0.73 | 0.57 | 0.64 | 0.59 | |||||
| aPR, 95% CI, p-value | 1.25 | [0.65, 2.42] p = 0.47 | 0.98 | [0.51, 1.91] p = 0.96 | 1.11 | [0.62, 1.97] p = 0.70 | referent | ||
| HIV–positive | Overall (triplets 1–7 combined) | 33.2/2,322 | 1.43 | 22.7/1,847 | 1.23 | 55.9/4,169 | 1.34 | 53.7/3,808 | 1.41 |
| TB prevalence, geometric mean | 1.28 | 1.00 | 1.13 | 1.13 | |||||
| aPR, 95% CI, p-value | 1.16 | [0.46, 2.89] p = 0.72 | 0.97 | [0.38, 2.46] p = 0.94 | 1.06 | [0.48, 2.35] p = 0.87 | referent | ||
1 Number of individuals with prevalent TB/total participants. Number of individuals with prevalent TB is calculated after multiple imputation of missing data on prevalent TB status and is an average across 300 imputed datasets—hence not a whole number.
2 Percentage with prevalent TB.
3 Geometric mean of TB prevalence across 7 communities.
4 Adjusted triplet, sex, age group, HIV status.
aPR, adjusted PR; CI, confidence interval; HIV, human immunodeficiency virus; PR, prevalence ratio; TB, tuberculosis.