Effect of WASH and IYCF Inventories on early child development at 24 months among HIV-exposed children
| Primary continuous outcomes | Effects by each randomised arm compared with the SOC ARM | ||||||
| Treatment group | N | Mean (SD) | Unadjusted difference (95% CI) | P value | Adjusted difference* (95% CI) | P value | |
| MDAT total score | SOC | 66 | 90.9 (8.2) | 0.0 (ref) | 0.0 (ref) | ||
| IYCF | 66 | 91.7 (8.8) | 0.81 (−1.99 to 3.61) | 0.572 | −0.91 (−3.40 to 1.58) | 0.476 | |
| WASH | 83 | 89.6 (9.2) | −1.26 (−3.80 to 1.28) | 0.330 | −1.63 (−4.26 to 0.99) | 0.222 | |
| IYCF+WASH | 103 | 95.3 (9.0) | 4.57 (1.91 to 7.23) | 0.001 | 3.05 (0.86 to 5.25) | 0.006 | |
| MDAT gross motor | SOC | 66 | 23.1 (2.8) | 0.0 (ref) | 0.0 (ref) | ||
| IYCF | 66 | 23.4 (2.7) | 0.38 (−0.50 to 1.27) | 0.398 | 0.01 (−0.88 to 0.91) | 0.977 | |
| WASH | 83 | 22.7 (3.2) | −0.25 (−1.00 to 0.49) | 0.504 | −0.57 (−1.39 to 0.25) | 0.174 | |
| IYCF+WASH | 103 | 24.3 (3.3) | 1.50 (0.53 to 2.47) | 0.002 | 0.84 (0.08 to 1.61) | 0.031 | |
| MDAT fine motor | SOC | 66 | 23.0 (2.4) | 0.0 (ref) | 0.0 (ref) | ||
| IYCF | 66 | 22.7 (3.5) | −0.31 (−1.37 to 0.74) | 0.558 | −0.50 (−1.52 to 0.51) | 0.329 | |
| WASH | 83 | 22.9 (2.6) | −0.10 (−0.86 to 0.66) | 0.804 | −0.21 (−1.11 to 0.68) | 0.637 | |
| IYCF+WASH | 103 | 23.8 (2.6) | 0.74 (−0.02 to 1.50) | 0.055 | 0.59 (−0.21 to 1.38) | 0.148 | |
| MDAT language | SOC | 66 | 20.7 (3.7) | 0.0 (ref) | 0.0 (ref) | ||
| IYCF | 66 | 20.9 (4.2) | 0.21 (−1.13 to 1.55) | 0.756 | −0.65 (−1.76 to 0.46) | 0.250 | |
| WASH | 83 | 20.0 (3.9) | −0.73 (−1.87 to 0.41) | 0.209 | −1.09 (−2.24 to 0.06) | 0.062 | |
| IYCF+WASH | 103 | 22.2 (4.1) | 1.48 (0.20 to 2.77) | 0.024 | 0.65 (−0.33 to 1.63) | 0.196 | |
| MDAT social | SOC | 66 | 24.1 (2.1) | 0.0 (ref) | 0.0 (ref) | ||
| IYCF | 66 | 24.7 (2.2) | 0.53 (−0.00 to 1.06) | 0.052 | 0.19 (−0.37 to 0.75) | 0.510 | |
| WASH | 83 | 24.0 (2.4) | −0.08 (−0.70 to 0.55) | 0.811 | −0.23 (−0.80 to 0.34) | 0.431 | |
| IYCF+WASH | 103 | 25.0 (2.2) | 0.99 (0.49 to 1.48) | <0.001 | 0.61 (0.13 to 1.09) | 0.013 | |
| MacArthur Bates (CDI) | SOC | 66 | 56.6 (18.5) | 0.0 (ref) | 0.0 (ref) | ||
| IYCF | 65 | 57.6 (21.3) | 1.00 (−5.74 to 7.55) | 0.771 | −2.47 (−8.60 to 3.67) | 0.431 | |
| WASH | 79 | 58.2 (20.1) | 1.58 (−4.12 to 7.29) | 0.586 | −2.27 (−8.14 to 3.60) | 0.448 | |
| IYCF+WASH | 99 | 65.1 (17.0) | 8.50 (3.66 to 13.33) | 0.001 | 6.01 (1.14 to 10.88) | 0.015 | |
| Effects comparing WASH vs non-WASH and IYCF vs non-IYCF | ||||||||||
| Treatment group | N | Mean (SD) | Treatment group | N | Mean (SD) | Unadjusted difference (95% CI) | P value | Adjusted* difference (95% CI) | P value | |
| A not B | SOC | 55 | 7.9 (1.3) | IYCF: no | 131 | 7.8 (1.4) | 0.0 (ref) | 0.0 (ref) | ||
| IYCF | 62 | 7.7 (1.3) | IYCF: yes | 156 | 7.7 (1.3) | −0.11 (−0.42 to 0.20) | 0.487 | 0.05 (−0.24 to 0.34) | 0.745 | |
| WASH | 76 | 7.8 (1.5) | WASH: no | 117 | 7.8 (1.3) | 0.0 (ref) | 0.0 (ref) | |||
| IYCF+WASH | 94 | 7.7 (1.3) | WASH: yes | 170 | 7.8 (1.4) | 0.0 (−0.30 to 0.31) | 0.994 | −0.10 (−0.38 to 0.18) | 0.472 | |
| Primary dichotomous outcomes | Treatment group | N | n (%) | Treatment group | N | n (%) | Unadjusted relative risk (95% CI) | P value | Adjusted relative risk (95% CI) | P value |
| Self-control task (hidden) | SOC | 62 | 17 (27.4%) | IYCF: no | 144 | 49 (34.0%) | 1.00 (ref) | 1.00 (ref) | ||
| IYCF | 66 | 25 (37.9%) | IYCF: yes | 168 | 58 (34.5%) | 1.00 (0.74 to 1.34) | 0.975 | 1.05 (0.77 to 1.45) | 0.743 | |
| WASH | 82 | 32 (39.0%) | WASH: no | 128 | 42 (32.8%) | 1.00 (ref) | 1.00 (ref) | |||
| IYCF+WASH | 102 | 33 (32.4%) | WASH: yes | 184 | 65 (35.3%) | 1.08 (0.78 to 1.49) | 0.631 | 0.97 (0.69 to 1.37) | 0.878 | |
| Self-control task (unhidden) | SOC | 61 | 30 (49.2%) | IYCF: no | 142 | 79 (55.6%) | 1.00 (ref) | 1.00 (ref) | ||
| IYCF | 66 | 35 (53.0%) | IYCF: yes | 166 | 88 (53.0%) | 0.94 (0.77 to 1.41) | 0.522 | 0.92 (0.73 to 1.15) | 0.458 | |
| WASH | 81 | 49 (60.5%) | WASH: no | 127 | 65 (51.2%) | 1.00 (ref) | 1.00 (ref) | |||
| IYCF+WASH | 100 | 53 (53.0%) | WASH: yes | 181 | 102 (56.4%) | 1.11 (0.90 to 1.36) | 0.350 | 1.09 (0.86 to 1.38) | 0.467 |
| Secondary dichotomous language outcomes | Effects by each randomised arm compared with the SOC ARM | ||||||
| Treatment group | N | N (%) | Unadjusted relative risk (95% CI) | P | Adjusted relative risk (95% CI) | P | |
| Uses plurals | SOC | 66 | 8 (12.1%) | 1.00 (ref) | 1.00 (ref) | ||
| IYCF | 66 | 17 (25.8%) | 1.97 (0.91 to 4.27) | 0.087 | 1.05 (0.49 to 2.22) | 0.906 | |
| WASH | 83 | 14 (16.7%) | 1.21 (0.51 to 2.88) | 0.667 | 1.15 (0.58 to 2.26) | 0.695 | |
| IYCF+WASH | 103 | 27 (26.2%) | 2.08 (0.98 to 4.41) | 0.055 | 1.57 (0.79 to 3.11) | 0.195 | |
| Combines two words | SOC | 66 | 64 (97.0%) | 1.00 (ref) | 1.00 (ref) | ||
| IYCF | 66 | 63 (95.5%) | 0.99 (0.92 to 1.06) | 0.737 | 0.99 (0.92 to 1.05) | 0.646 | |
| WASH | 83 | 82 (98.8%) | 1.02 (0.97 to 1.07) | 0.407 | 1.01 (0.96 to 1.07) | 0.722 | |
| IYCF+WASH | 103 | 103 (100.0%) | 1.03 (0.99 to 1.08) | 0.158 | 1.01 (0.97 to 1.06) | 0.566 | |
| Uses imperatives | SOC | 66 | 49 (74.2%) | 1.00 (ref) | 1.00 (ref) | ||
| IYCF | 66 | 46 (69.7%) | 0.94 (0.78 to 1.13) | 0.479 | 0.92 (0.75 to 1.11) | 0.380 | |
| WASH | 83 | 57 (68.7%) | 0.91 (0.81 to 1.02) | 0.123 | 0.86 (0.71 to 1.05) | 0.139 | |
| IYCF+WASH | 102 | 77 (75.5%) | 1.00 (0.87 to 1.15) | 0.973 | 1.01 (0.84 to 1.21) | 0.940 | |
*Scores were adjusted for the following variables: maternal baseline mid-upper arm circumference, education, employment status, CD4 count, cotrimoxazole prophylaxis and antiretroviral treatment during pregnancy, capabilities (perceived physical health and decision-making autonomy), access to improved latrine; infant low birth weight, prematurity, gender and age at assessment; season of recruitment and research nurse who carried out the assessment.
CDI, Communication Development Inventories; IYCF, infant and young child feeding; MDAT, Malawi Developmental Assessment Tool; SOC, standard-of-care; WASH, water, sanitation and hygiene.