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Randomized Controlled Trial
. 2021 Jul 14;15(7):e0009514.
doi: 10.1371/journal.pntd.0009514. eCollection 2021 Jul.

A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study

Affiliations
Randomized Controlled Trial

A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study

Sophie Budge et al. PLoS Negl Trop Dis. .

Erratum in

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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Modified version of CONSORT 2010 flow diagram of participants in the CAMPI feasibility trial.

References

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