Table 2:
Primary and secondary outcomes
| Intervention group (n=195) | Standard-of-care group (n=195) | Absolute risk difference, % (95% CI) | p value | |
|---|---|---|---|---|
| Composite primary outcome | 175 (90%) | 148 (76%) | 13·9% (6·4 to 21·2) | 0·00040 |
| Components of primary outcome | ||||
| Viral suppression (<200 copies per mL) | 182 (93%) | 162 (83%) | 10·3% (3·9 to 16·8) | 0·0025 |
| Retention in care at study clinic | 180 (92%) | 165 (85%) | 7·7% (1·3 to 14·2) | 0·026 |
| Other secondary outcomes | ||||
| Viral suppression (<200 copies per mL) and retention at any clinic | 177 (91%) | 153 (79%) | 12·3% (5·2 to 19·4) | 0·0011 |
| Viral load <1000 copies per mL and retention at study clinic | 176 (90%) | 152 (78%) | 12·3% (5·1 to 19·5) | 0·0013 |
| Viral load <50 copies per mL and retention at study clinic | 167 (86%) | 139 (71%) | 14·4% (6·2 to 22·3) | 0·0080 |
| Viral load <1000 copies per mL | 184 (94%) | 166 (85%) | 9·2% (3·2 to 15·4) | 0·0041 |
| Viral load <50 copies per mL | 172 (88%) | 152 (78%) | 10·3% (2·8 to 17·6) | 0·0099 |
| Retention in care at any clinic at 12 months | 182 (93%) | 170 (87%) | 6·2% (0·2 to 12·2) | 0·059 |
| Viral suppression among those with a result at study exit | ||||
| Viral load <1000 copies per ml | 184/189 (97%) | 166/178 (93%) | 4·1% (–0·3 to 9·0) | 0·082 |
| Viral load <200 copies per ml | 182/189 (96%) | 162/178 (91%) | 5·3% (0·2 to 10·7) | 0·051 |
| Viral load <50 copies per ml | 172/189 (91%) | 152/178 (85%) | 5·6% (–1·0 to 12·4) | 0·11 |
| Communication of viral load result to participant | ||||
| Enrolment viral load communicated to participant | 195/195 (100%) | 171/192 (89%) | 10·9% (6·8 to 16·1) | <0·0001 |
| Mid-study viral load communicated to participant | 191/192 (>99%) | 127/170 (75%) | 24·8% (18·4 to 31·8) | <0·0001 |
| All viral load results communicated to participant | 397/398 (>99%) | 304/373 (82%) | 18·3% (14·5 to 22·5) | <0·0001 |
| Referral into community-based ART delivery programme | 116 (60%) | 52 (27%) | 32·8% (23·2 to 41·6) | <0·0001 |
Data are n (%) or n/N (%), unless otherwise stated. ART=antiretroviral therapy.