Table 2. Effect of the intervention on primary and secondary outcomes.
| Intervention | Control | |||||||
|---|---|---|---|---|---|---|---|---|
| Primary outcome | Rate/100 py (deaths/py) | Rate/100 py (deaths/py) | Unadjusted HR | 95% CI | P-value | Adjusted HR * | 95% CI | P-value |
|
| ||||||||
| Mortality rate over 6 months | 19·0 (134/704) |
21.6 (151/699) |
0.92 | (0.67, 1.26) | 0.58 | 0.87† | (0.61, 1.24) | 0.41 |
| Rate/100 py (deaths/py) | Rate/100 py (deaths/py) | Unadjusted RD | 95% CI | P-value | Adjusted RD * | 95% CI | P-value | |
|
|
||||||||
| 19·0 (134/704) |
21.6 (151/699) |
-2.14 | (-7.76, 3.49) | 0.44 | -2.19† | (-5.43, 1.05) | 0.17 | |
| Secondary outcomes | % (n/N) | % (n/N) | Unadjusted RR | 95% CI | P-value | Adjusted RR * | 95% CI | P-value |
|
| ||||||||
| Hospital admission over 6 months | 13·3% (201/1507) |
10·4% (158/1515) |
1·19 | (0·94–1·50) | 0·14 | 1·11 | (0·89–1·38) | 0·34 |
| Retention in care by 6 months | 62·0% (934/1507) |
62·4% (945/1515) |
1·01 | (0·82–1·23) | 0·94 | 1·02‡ | (0·83–1·24) | 0·87 |
| Started ART within 30 days of enrolment | 66·4% (1001/1507) |
72·9% (1104/1515) |
0·89 | (0·76–1·04) | 0·13 | 0·91§ | (0·79–1·05) | 0·17 |
| Rate/100 py (deaths/py) | Rate/100 py (deaths/py) | Unadjusted HR | 95% CI | P-value | Adjusted HR * | 95% CI | P-value | |
|
|
||||||||
| Rate of starting ART by 6 months | 834·5 (1338/160·3) |
1034 (1347/130·3) |
0·68 | (0·41–1·15) | 0·14 | 0·69¶ | (0·46–1·04) | 0·07 |
| Post hoc analysis | % (n/N) | % (n/N) | Unadjusted RR | 95% CI | P-value | Adjusted RR * | 95% CI | P-value |
|
| ||||||||
| Risk of starting ART by 6 months | 88·8% (1338/1507) |
88·9% (1347/1515) |
0·99 | (0·94–1·04) | 0·75 | 1·0¶ | (0·95–1·04) | 0·84 |
HR=hazard ratio. RD=rate difference. RR=risk ratio. CI=confidence interval. ART=antiretroviral therapy. py=person-years.
*
Analyses adjusted for sex, age, BMI, CD4, taking IPT at baseline, TB symptoms, TB tests on last 6 months, previously treated for TB and randomisation strata. Analysis of time to starting ART also adjusted for follow-up time. All adjusted analyses included 3009 participants (1504 intervention and 1505 control).
†
Includes 284 deaths (134 in intervention and 150 in control).
‡
Includes 1872 outcomes (932 in intervention and 940 in control).
§
Includes 2098 outcomes (999 in intervention and 1099 in control).
¶
Includes 2677 outcomes (1336 in intervention and 1341 in control).