Table 2. Primary and secondary study outcomes by group.
| Outcome | Standard group (n = 250) | Same-day treatment group (n = 250) | RD (95% CI) | p-Value |
|---|---|---|---|---|
| Primary outcome | ||||
| 48-week HIV-1 RNA <200 copies/mL* | 168 (67·2) | 152 (60·8) | −0·06 (−0·15, 0·02) | 0·14 |
| Secondary outcomes | ||||
| 48-week HIV-1 RNA <50 copies/mL* | 159 (63·6) | 137 (54·8) | −0·09 (−0·17, −0·002) | 0·045 |
| 48-week HIV-1 RNA <1,000 copies/mL* | 176 (70·4) | 159 (63·6) | −0·07 (−0·15, 0·01) | 0·11 |
| Forty-eight-week outcomes** | ||||
| Attended 48-week study visit* | 229 (91·6) | 218 (87·2) | −0·04 (−0·10, 0·01) | 0·11 |
| Died | 6 (2·4) | 9 (3·6) | 0·01 (−0·02, 0·05) | 0·43 |
| Lost to follow-up | 10 (4·0) | 14 (5·6) | 0·02 (−0·02, 0·06) | 0·40 |
| Missed 48-week visit due to gap in care, with subsequent return to care | 4 (1·6) | 6 (2·4) | 0·01 (−0·02, 0·04) | 0·52 |
| Transferred | 1 (0·4) | 3 (1·2) | 0·01 (-0·01, 0·03) | 0·62 |
*Nine participants in the standard treatment and 7 in the same-day group attended 48-week visit without HIV-1 RNA testing.
**These are mutually exclusive outcomes which include all 500 randomized participants.
CI, confidence interval; RD, risk difference.