Table 3.
Secondary outcomes in cohort 1
| Intervention group | Control group |
Effect estimate* |
p value | Intra-cluster correlation coefficient | Regression model* | ||
|---|---|---|---|---|---|---|---|
| Type | Estimate (95% CI) | ||||||
| Started on ART | 3712/5390 (69%) | 2418/3862 (63%) | Risk ratio | 1·24 (0·88 to 1·73) | 0·218 | 0·065 | Binomial |
| Time to ART†‡ | .. | .. | Subdistribution hazard ratio | 1·14 (0·92 to 1·43) | 0·232 | 0·065 | Competing risk |
| New tuberculosis diagnosis | 1057/5390 (20%) | 510/3862 (13%) | Risk ratio | 1·46 (1·18 to 1·81) | 0·001 | 0·051 | Binomial |
| Received co-trimoxazole prophylaxis | 3899/5390 (72%) | 2767/3862 (72%) | Risk ratio | 1·03 (0·93 to 1·13) | 0·608 | 0·149 | Binomial |
| Programme retention§ | 3373/5390 (63%) | 2254/3862 (58%) | Risk ratio | 1·10 (1·04 to 1·16) | <0·001 | 0·019 | Binomial |
| Baseline CD4 cell count of patients starting ART | 132 (82); n=3470 | 131 (82); n=2083 | Difference in means | 0·102 (−13·1 to 13·4) | 0·988 | 0·030 | Linear |
| Suppressed viral load in patients who started ART¶ | 1706/2375 (72%) | 1062/1449 (73%) | Risk ratio | 0·97 (0·90 to 1·03) | 0·324 | 0·040 | Binomial |
| Proportion with a missing viral load in patients who started ART | 1274/3712 (34%) | 945/2219 (43%) | Risk ratio | 0·86 (0·71 to 1·04) | 0·120 | 0·014 | Binomial |
| Weight at follow-up (kg) | 62·6 (14·0); n=2712 | 62·4 (13·7); n=1503 | Difference in means | 0·10 (−1·35 to 1·56) | 0·884 | 0·019 | Linear |
| CD4 count at follow-up (cells per μL) | 161·3 (175·2); n=2345 | 141·7 (161·6); n=1544 | Difference in means | 22·3 (3·6 to 40·9) | 0·021 | 0·026 | Linear |
Data are n/N (%) or mean (SD), unless otherwise stated. ART=antiretroviral therapy.
Regression models adjusted for randomisation strata and intra-cluster correlation of outcomes.
Follow-up censored, so no mean time to ART listed.
Adjusted for the competing risk of death.
Patients were judged to be retained by the programme when after 12 months they were alive, were not known to have withdrawn or relocated, and had documentation of a clinic visit or laboratory test in the previous 6 months (if started ART or last known CD4 count was less than 200 cells per μL) or in the past 9 months (if they had not started ART and last known CD4 count was more than 200 cells per μL).
Patients with at least 6 months of ART and viral load results available.