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

PLoS Negl Trop Dis. 2021 Jul 14;15(7):e0009514. doi: 10.1371/journal.pntd.0009514. eCollection 2021 Jul.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Animals
  • Campylobacter / physiology
  • Campylobacter Infections / microbiology
  • Campylobacter Infections / prevention & control*
  • Campylobacter Infections / psychology
  • Child
  • Child Nutrition Disorders / microbiology
  • Child Nutrition Disorders / prevention & control*
  • Child Nutrition Disorders / psychology
  • Child, Preschool
  • Family Characteristics
  • Feasibility Studies
  • Female
  • Housing
  • Humans
  • Hygiene*
  • Infant
  • Infant Health*
  • Livestock
  • Male
  • Mothers / psychology
  • Rural Population / statistics & numerical data
  • Young Adult

Grants and funding

SB is jointly funded as a research student by both Cranfield University and People In Need, who received funding from the Czech Development Agency for the project. No other external funds supported this work. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.