Table 2.
ITT and PP analysis: Primary and secondary study outcomes
| Intention to treat | Per protocol | |||||||
|---|---|---|---|---|---|---|---|---|
|
Intervention (n = 68) |
Comparison (n = 63) |
t-test | p |
Intervention (n = 24) |
Comparison (n = 29) |
t-test | p | |
| ≥ 95% Adherence, % (95% CI) | ||||||||
| Final 30 days of intervention | 16.4 (6.3, 26.5) | 9.1 (1.3, 16.9) | -1.14 | 0.26 | 16.7 (0.6, 32.7) | 10.3 (-1.4, 22.1) | -0.67 | 0.51 |
| Full Interventiona | 11.8 (3.9, 19.6) | 9.5 (2.1, 17.0) | -0.41 | 0.68 | 20.8 (3.3, 38.4) | 3.5 (-3.6, 10.5) | -2.03 | 0.05 |
| Pre-deliveryb | 20.9 (10.9, 30.9) | 21.0 (10.5, 31.4) | 0.01 | 0.99 | 34.8 (13.7, 55.8) | 28.6 (10.7, 46.4) | -0.46 | 0.64 |
| Post-deliveryc | 13.1 (4.4, 21.8) | 8.5 (1.2, 15.8) | -0.82 | 0.42 | 20.8 (3.3, 38.4) | 6.9 (-2.9, 16.7) | -1.43 | 0.16 |
| Change from pre- to post-delivery | -8.3 (-20.3, 3.6) | -10.3 (-23.1, 2.4) | -0.23 | 0.82 | -13.0 (-36.7, 10.7) | -21.7 (-43.7, 0.60) | -0.53 | 0.60 |
| ≥ 80% Adherence, % (95% CI) | ||||||||
| Final 30 days of intervention | 30.9 (18.3, 43.5) | 29.1 (16.7, 41.5) | -0.21 | 0.84 | 50.0 (28.4, 71.6) | 34.5 (16.1, 52.9) | -1.13 | 0.26 |
| Full Interventiona | 36.8 (25.0, 48.5) | 34.9 (22.8, 47.0) | -0.22 | 0.83 | 66.7 (46.3, 87.0) | 41.4 (22.3, 60.5) | -1.87 | 0.07 |
| Pre-deliveryb | 55.2 (43.0, 67.4) | 50.0 (37.2, 62.8) | -0.59 | 0.56 | 78.3 (60.0, 96.5) | 60.7 (41.4, 80.0) | -1.36 | 0.19 |
| Post-deliveryc | 36.1 (23.7, 48.5) | 33.9 (21.5, 46.3) | -0.25 | 0.81 | 58.3 (37.1, 79.6) | 37.9 (19.2, 56.7) | -1.48 | 0.14 |
| Change from pre- to post-delivery | -23.3 (-35.3, -11.3) | -17.2 (-30.4, -4.1) | 0.68 | 0.49 | -21.7 (-40.0, -3.5) | -25.0 (-42.1, -7.9) | -0.27 | 0.79 |
| Mean adherence, % (95% CI) | ||||||||
| Final 30 days of intervention | 49.6 (39.4, 59.8) | 52.9 (43.3, 62.6) | 0.48 | 0.63 | 63.4 (48.3, 78.6) | 63.1 (50.8, 75.5) | -0.03 | 0.97 |
| Full Interventiona | 63.4 (56.2, 70.5) | 62.1 (54.5, 69.7) | -0.23 | 0.82 | 75.0 (62.7, 87.3) | 66.3 (56.2, 76.3) | -1.14 | 0.26 |
| Pre-deliveryb | 70.2 (62.7, 77.7) | 68.5 (60.8, 76.1) | -0.33 | 0.75 | 83.2 (72.0, 94.5) | 73.8 (63.0, 84.7) | -1.24 | 0.23 |
| Post-deliveryc | 56.7 (48.2, 65.3) | 54.4 (45.7, 63.2) | -0.38 | 0.71 | 67.8 (53.7, 81.8) | 59.3 (47.7, 70.9) | -0.96 | 0.34 |
| Change from pre- to post-delivery | -15.9 (-22.7, -9.2) | -14.3 (-21.6, 7.0) | 0.33 | 0.74 | -16.2 (-25.7, 6.8) | -15.5 (-27.5, -3.6) | 0.10 | 0.93 |
| HIV disease progression | ||||||||
| Mean CD4-cell count at PPM3, cells/µL (SD) | 747.0 (443.7) | 877.8 (606.0) | 1.40 | 0.16 | 672.5 (370.5) | 911.8 (592.1) | 1.79 | 0.08 |
| Change in CD4-cell count, baseline to PPM3 | ||||||||
| Mean change, cells/µL (SD) | -215.7 (424.1) | -291.5 (483.4) | -0.95 | 0.35 | -104.8 (306.7) | -362.6 (509.9) | -2.27 | 0.03 |
| Proportion whose CD4-cell count rose, n (%) | 15 (22.1) | 8 (12.7) | -1.46 | 0.15 | 9 (37.5) | 5 (17.2) | -1.64 | 0.11 |
| Undetectable viral load at PPM3, n (%) | 39 (57.4) | 27 (42.9) | -1.66 | 0.10 | 14 (58.3) | 17 (58.6) | 0.02 | 0.98 |
a Numbers for full intervention were: ITT = 68 (intervention), 63 (comparison); PP = 24 (intervention), 29 (comparison)
b Two women delivered prior to the start of the intervention and were excluded from the pre-delivery period outcomes. ITT numbers for pre-delivery period were 67 (intervention), 62 (comparison)
c Eleven women had no adherence data for the post-delivery period. ITT numbers for post-delivery period were 61 (intervention), 59 (comparison)