A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study
Sophie Budge1, Paul Hutchings2, Alison Parker1
1Cranfield Water Science Institute, Cranfield University, Cranfield, United Kingdom.
Insights
A household playspace (HPS) intervention in Ethiopia showed promising acceptability for infant health and injury prevention. While adherence varied, a definitive trial is recommended with adjustments for improved efficacy in water, sanitation, and hygiene (WASH) programs.
Area of Science:
- Public Health
- Global Health
- Pediatrics
Background:
- Inconsistent results exist for water, sanitation, and hygiene (WASH) interventions supporting infant growth.
- Interventions often overlook age-specific behaviors and transmission pathways.
- Household playspaces (HPS) may mitigate fecal-oral transmission.
Purpose of the Study:
- To assess the feasibility of a randomized controlled trial for a HPS intervention in rural Ethiopia.
- To evaluate the HPS's impact on infant health, injury prevention, and women's time.
- To inform the design of a definitive trial.
Main Methods:
- A two-armed, parallel-group, randomized controlled feasibility trial was conducted in rural Ethiopia.
- 100 households were randomized to either an intervention (HPS) or control group.
- Data on recruitment, attrition, adherence, and acceptability were collected over four weeks.
Main Results:
- Recruitment and attrition met predefined criteria.
- Adherence for HPS use (48.0%) and cleaning (56.0%) partially met criteria (≥50%).
- Acceptability was high, with 41.0% of infants using the HPS during visits, but decreased use during certain activities was noted. Secondary benefits included reduced women's time burden and infant injury prevention.
Conclusions:
- The HPS feasibility trial demonstrated mixed adherence but good acceptability in intervention households.
- Despite failing some feasibility criteria, the study supports proceeding to a definitive trial.
- Recommended adjustments to the intervention protocol are necessary for future efficacy studies.
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.
