Table 3:
Time to event results for secondary outcomes
| Intervention group |
Standard-of-care group |
Hazard ratio (95% CI) | p value | |||
|---|---|---|---|---|---|---|
| n/N (%) | Median, days (IQR) | n/N (%) | Median, days (IQR) | |||
| Time to entry of viral load result into health-information system* | ||||||
| Enrolment blood draw | 195/195 (100%) | 0 (0–0) | 192/192 (100%) | 3 (2–4) | 96·0 (23·8–386·4) | <0·0001 |
| Mid-study blood draw | 192/192 (100%) | 0 (0–0) | 170/170 (100%) | 2 (1–3) | 11·6 (7·8–17·3) | <0·0001 |
| Any blood draw | 398/398 (100%) | 0 (0–0) | 373/373 (100%) | 2 (1–4) | 11·7 (8·9–15·3) | <0·0001 |
| Time to communication of viral load result to participant | ||||||
| Enrolment blood draw | 195/195 (100%) | 0 (0–0) | 171/192 (89%) | 28 (28–30) | ··† | <0·0001† |
| Mid-study blood draw | 191/192 (>99%) | 0 (0–0) | 127/170 (75%) | 41 (28–69) | 12·7 (8·5–19·1) | <0·0001 |
| Any blood draw | 397/398 (>99%) | 0 (0–0) | 304/373 (34%) | 28 (28–54) | 17·7 (13·0–24·2) | <0·0001 |
| Follow-up HIV treatment and care | ||||||
| Enrolment to detection of viral failure | 7/195 (4%) | 55 (55–57) | 9/195 (5%) | 123 (98–162) | 0·8 (0·3–2·2) | 0·69 |
| Appropriate switch to second-line ART after viral failure‡ | 6/6 (100%) | 0 (0–7) | 4/9 (44%) | 76 (20–134) | 10·9 (2·1–57·5) | 0·0050 |
| Enrolment to referral into community-based ART delivery program | 116/195 (59%) | 168 (168–175) | 52/195 (27%) | 261 (231–281) | 3·5 (2·5–4·8) | <0·0001 |
ART=antiretroviral therapy.
*
During the study, 2·9% of point-of-care viral load tests had invalid results, and all were repeated on the same day, whereas 1·1% of laboratory-based viral load tests had invalid results and were repeated.
†
Data excludes people evaluated for viral load after the 12-month study exit visit.
‡
Hazard ratio could not be calculated for time to communication of viral load results to participant for the enrolment blood draw because the events are separated by group: in the intervention group, all events were on day 0 or within 1 day of the blood draw, whereas for control participant events the earliest event was on day 12. The p value from a log rank test is provided instead.