A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study.
<h4>Background</h4>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...
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oai:doaj.org-article:05c004ec4ddc4047a35a494913a801b22021-11-25T06:33:31ZA randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study.1935-27271935-273510.1371/journal.pntd.0009514https://doaj.org/article/05c004ec4ddc4047a35a494913a801b22021-07-01T00:00:00Zhttps://doi.org/10.1371/journal.pntd.0009514https://doaj.org/toc/1935-2727https://doaj.org/toc/1935-2735<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Findings</h4>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.<h4>Interpretation</h4>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.<h4>Funding</h4>People In Need; Czech Development Agency.<h4>Trial registration</h4>RIDIE-ID-5de0b6938afb8.Sophie BudgePaul HutchingsAlison ParkerSean TyrrelSam NortonCamila GarbuttFitsume WoldemedhinMohammed Yasin JemalMathewos MogesSiraj HussenHunachew BeyenePublic Library of Science (PLoS)articleArctic medicine. Tropical medicineRC955-962Public aspects of medicineRA1-1270ENPLoS Neglected Tropical Diseases, Vol 15, Iss 7, p e0009514 (2021) |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Sophie Budge Paul Hutchings Alison Parker Sean Tyrrel Sam Norton Camila Garbutt Fitsume Woldemedhin Mohammed Yasin Jemal Mathewos Moges Siraj Hussen Hunachew Beyene A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study. |
description |
<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Findings</h4>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.<h4>Interpretation</h4>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.<h4>Funding</h4>People In Need; Czech Development Agency.<h4>Trial registration</h4>RIDIE-ID-5de0b6938afb8. |
format |
article |
author |
Sophie Budge Paul Hutchings Alison Parker Sean Tyrrel Sam Norton Camila Garbutt Fitsume Woldemedhin Mohammed Yasin Jemal Mathewos Moges Siraj Hussen Hunachew Beyene |
author_facet |
Sophie Budge Paul Hutchings Alison Parker Sean Tyrrel Sam Norton Camila Garbutt Fitsume Woldemedhin Mohammed Yasin Jemal Mathewos Moges Siraj Hussen Hunachew Beyene |
author_sort |
Sophie Budge |
title |
A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study. |
title_short |
A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study. |
title_full |
A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study. |
title_fullStr |
A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study. |
title_full_unstemmed |
A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study. |
title_sort |
randomised controlled feasibility trial of a babywash household playspace: the campi study. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2021 |
url |
https://doaj.org/article/05c004ec4ddc4047a35a494913a801b2 |
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