Effect of WASH and IYCF inventories on early child development at 24 months among HIV-exposed uninfected children
| Primary continuous outcomes | Effects by each randomised arm compared with the SOC arm | ||||
| Treatment group | N | Mean (SD) | Unadjusted difference between means (95% CI) | P value | |
| MDAT total score | SOC | 63 | 90.7 (8.1) | 0.0 (ref) | |
| IYCF | 63 | 91.8 (8.6) | 1.26 (–1.40 to 3.91) | 0.353 | |
| WASH | 79 | 89.6 (9.2) | −0.81 (–3.30 to 1.68) | 0.525 | |
| IYCF+WASH | 95 | 95.5 (9.0) | 5.70 (3.00 to 8.39) | <0.001 | |
| MDAT gross motor | SOC | 63 | 23.0 (2.6) | 0.0 (ref) | |
| IYCF | 63 | 23.5 (2.8) | 0.51 (–0.40 to 1.41) | 0.271 | |
| WASH | 79 | 22.7 (3.3) | −0.27 (–1.06 to 0.52) | 0.500 | |
| IYCF+WASH | 95 | 24.2 (3.3) | 1.21 (0.37 to 2.06) | 0.005 | |
| MDAT fine motor | SOC | 63 | 22.9 (2.4) | 0.0 (ref) | |
| IYCF | 63 | 22.7 (3.5) | −0.24 (–1.33 to 0.85) | 0.662 | |
| WASH | 79 | 22.9 (2.7) | −0.03 (–0.80 to 0.75) | 0.946 | |
| IYCF+WASH | 95 | 23.8 (2.6) | 0.88 (0.11 to 1.65) | 0.024 | |
| MDAT language | SOC | 63 | 20.7 (3.8) | 0.0 (ref) | |
| IYCF | 63 | 21.0 (4.1) | 0.29 (–1.03 to 1.61) | 0.669 | |
| WASH | 79 | 20.1 (3.9) | −0.64 (–1.80 to 0.53) | 0.284 | |
| IYCF+WASH | 95 | 22.4 (4.0) | 1.78 (0.45 to 3.11) | 0.009 | |
| MDAT social | SOC | 63 | 24.1 (2.1) | 0.0 (ref) | |
| IYCF | 63 | 24.7 (2.2) | 0.55 (0.00 to 1.09) | 0.050 | |
| WASH | 79 | 24.0 (2.4) | −0.04 (–0.65 to 0.57) | 0.896 | |
| IYCF+WASH | 95 | 25.1 (2.2) | 1.08 (0.56 to 1.60) | <0.001 | |
| MacArthur Bates (CDI) | SOC | 63 | 56.9 (18.3) | 0.0 (ref) | |
| IYCF | 62 | 58.4 (20.7) | 1.70 (–4.84 to 8.24) | 0.610 | |
| WASH | 75 | 58.4 (18.9) | 1.65 (–3.57 to 6.87) | 0.535 | |
| IYCF+WASH | 91 | 66.0 (15.9) | 9.36 (4.62 to 14.10) | <0.001 | |
| Effects comparing WASH versus non-WASH and IYCF versus non-IYCF | |||||
| Effects comparing WASH versus non-WASH and IYCF versus non-IYCF | ||||||||
| Treatment group | N | Mean (SD) | Treatment group | N | Mean (SD) | Unadjusted difference between means (95% CI) | P value | |
| A not B | SOC | 52 | 7.8 (1.3) | IYCF: no | 124 | 7.8 (1.4) | 0.0 (ref) | |
| IYCF | 59 | 7.6 (1.3) | IYCF: yes | 145 | 7.7 (1.3) | −0.11 (–0.43 to 0.22) | 0.529 | |
| WASH | 72 | 7.8 (1.5) | WASH: no | 111 | 7.7 (1.3) | 0.0 (ref) | ||
| IYCF+WASH | 86 | 7.7 (1.3) | WASH: yes | 158 | 7.8 (1.4) | 0.03 (–0.30 to 0.35) | 0.878 | |
| Primary dichotomous outcomes | Treatment group | N | n (%) | Treatment group | N | n (%) | Unadjusted relative risk (95% CI) | P value |
| Self-control task (hidden) | SOC | 59 | 16 (27.1%) | IYCF: no | 137 | 47 (34.3%) | 1.00 (ref) | |
| IYCF | 63 | 24 (38.1%) | IYCF: yes | 157 | 53 (33.8%) | 1.07 (0.77 to 1.49) | 0.698 | |
| WASH | 78 | 31 (39.7%) | WASH: no | 122 | 40 (32.8%) | 1.00 (ref) | ||
| IYCF+WASH | 94 | 29 (30.9%) | WASH: yes | 172 | 60 (34.9%) | 0.97 (0.71 to 1.32) | 0.839 | |
| Self-control task (unhidden) | SOC | 58 | 27 (46.6%) | IYCF: no | 135 | 74 (54.8%) | 1.00 (ref) | |
| IYCF | 63 | 34 (54.0%) | IYCF: yes | 155 | 83 (53.5%) | 0.94 (0.77 to 1.15) | 0.563 | |
| WASH | 77 | 47 (61.0%) | WASH: no | 121 | 61 (50.4%) | 1.00 (ref) | ||
| IYCF+WASH | 92 | 49 (53.3%) | WASH: yes | 169 | 96 (56.8%) | 1.14 (0.92 to 1.41) | 0.219 |
| Secondary dichotomous language outcomes | Effects by each randomised arm compared with the SOC ARM | |||
| Treatment group | N | Unadjusted Relative Risk (95% CI) | P value | |
| Uses plurals | SOC | 63 | 1.00 (ref) | |
| IYCF | 63 | 1.87 (0.85 to 4.12) | 0.118 | |
| WASH | 79 | 1.14 (0.48 to 2.68) | 0.764 | |
| IYCF+WASH | 95 | 2.18 (1.03 to 4.60) | 0.041 | |
| Combines two words | SOC | 63 | 1.00 (ref) | |
| IYCF | 63 | 1.00 (0.94 to 1.06) | 0.990 | |
| WASH | 79 | 1.02 (0.97 to 1.07) | 0.446 | |
| IYCF+WASH | 95 | * | – | |
| Uses imperatives | SOC | 63 | 1.00 (ref) | |
| IYCF | 63 | 0.96 (0.80 to 1.15) | 0.645 | |
| WASH | 79 | 0.93 (0.80 to 1.09) | 0.387 | |
| IYCF+WASH | 95 | 1.01 (0.87 to 1.17) | 0.869 | |
*All the children in the IYCF+WASH arm combined two words.
CDI, Communicative Development Inventories; IYCF, infant and young child feeding; MDAT, Malawi Developmental Assessment Tool;SOC, standard-of-care; WASH, water, sanitation and hygiene.