Primary outcomes
| Outcome | Intervention arm | Standard of care arm | Adjusted mean difference* (95% CI) | Measure of effect (95% CI) | Coefficient of variation (k) |
| Mullen scales (T-scores), mean (95% CI), adjusted mean difference | n=257 | n=249 | |||
| Early learning composite score | 88.1 (84.0, 92.2) | 87.6 (83.1, 92.1) | 0.06 (−2.68 to 2.80) p=0.97 | – | 0.09 |
| Expressive language Mullen scale | 44.9 (43.1, 46.7) | 45.3 (43.3, 47.3) | −0.44 (−2.03 to 1.14) p=0.58 | −0.44 (−2.03 to 1.14) p=0.58 | |
| Receptive language Mullen scale | 45.3 (43.1, 47.5) | 45.8 (43.1, 48.4) | −0.11 (−1.82 to 1.60) p=0.90 | −0.11 (−1.82 to 1.60) p=0.90 | |
| Fine motor Mullen scale | 41.7 (39.3, 44.2) | 41.0 (38.5, 43.6) | −0.23 (−2.38 to 1.92) p=0.83 | −0.23 (−2.38 to 1.92) p=0.83 | |
| Gross motor Mullen scale | 50.2 (47.7, 52.6) n=196 | 48.2 (45.4, 51.0) n=201 | 1.99 (−0.54 to 4.51) p=0.12 | 1.99 (−0.54 to 4.51) p=0.12 | |
| Visual reception Mullen scale | 42.8 (40.1, 45.5) | 41.5 (38.6, 44.4) | 0.84 (−1.44 to 3.12) p=0.47 | 0.84 (−1.44 to 3.12) p=0.47 | |
| Child retention in HIV care | 201/257 (78.2%) | 207/249 (83.1%) | – | OR=0.73 (0.47 to 1.14 p=0.16 | |
| Virological failure children as proportion of those HIV positive | 4/8 (50%) | 4/6 (67%) | – | – | |
| Virological failure mothers | 33/246 (13.4%) | 25/239 (10.5%) | – | OR=1.33 (0.72 to 2.46) p=0.36 |
*Positive mean difference indicates that those in the intervention arm have higher Mullen scores.