Budge, Sophie; Hutchings, Paul; Parker, Alison; Tyrrel, Sean; Norton, Sam; Garbutt, Camila; Woldemedhin, Fitsume; Jemal, Mohammed Yasin; Moges, Mathewos; Hussen, Siraj; +1 more... Beyene, Hunachew; (2021) A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study. PLoS neglected tropical diseases, 15 (7). e0009514-. ISSN 1935-2727 DOI: https://doi.org/10.1371/journal.pntd.0009514
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Abstract
BACKGROUND: Water, sanitation and hygiene (WASH) interventions should support infant growth but trial results are inconsistent. Frequently, interventions do not consider behaviours or transmission pathways specific to age. A household playspace (HPS) is one intervention component which may block faecal-oral transmission. This study was a two-armed, parallel-group, randomised, controlled feasibility trial of a HPS in rural Ethiopia. It aimed to recommend proceeding to a definitive trial. Secondary outcomes included effects on infant health, injury prevention and women's time. METHODS: November 2019-January 2020 106 households were identified and assessed for eligibility. Recruited households (N = 100) were randomised (blinded prior to the trial start) to intervention or control (both n = 50). Outcomes included recruitment, attrition, adherence, and acceptability. Data were collected at baseline, two and four weeks. FINDINGS: Recruitment met a priori criteria (≥80%). There was no loss to follow-up, and no non-use, meeting adherence criteria (both ≤10%). Further, 48.0% (95% CI 33.7-62.6; n = 24) of households appropriately used and 56.0% (41.3-70.0; n = 28) cleaned the HPS over four weeks, partly meeting adherence criteria (≥50%). For acceptability, 41.0% (31.3-51.3; n = 41) of infants were in the HPS during random visits, failing criteria (≥50%). Further, the proportion of HPS use decreased during some activities, failing criteria (no decrease in use). A modified Barrier Analysis described good acceptability and multiple secondary benefits, including on women's time burden and infant injury prevention. INTERPRETATION: Despite failing some a priori criteria, the trial demonstrated mixed adherence and good acceptability among intervention households. A definitive trial to determine efficacy is warranted if recommended adjustments are made. FUNDING: People In Need; Czech Development Agency. TRIAL REGISTRATION: RIDIE-ID-5de0b6938afb8.
Item Type | Article |
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Faculty and Department | Faculty of Epidemiology and Population Health > Dept of Population Health (2012- ) |
PubMed ID | 34260591 |
Elements ID | 197798 |
Official URL | http://dx.doi.org/10.1371/journal.pntd.0009514 |
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