Cranfield Water Science Institute, Cranfield University, Cranfield, United Kingdom.
Faculty of Engineering and Physical Sciences, University of Leeds, Leeds, United Kingdom.
PLoS Negl Trop Dis. 2021 Jul 14;15(7):e0009514. doi: 10.1371/journal.pntd.0009514. eCollection 2021 Jul.
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.
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.
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.
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.
People In Need; Czech Development Agency.
RIDIE-ID-5de0b6938afb8.
水、环境卫生和个人卫生（WASH）干预措施应当有助于婴儿的成长，但试验结果并不一致。通常，这些干预措施没有考虑到特定年龄段的行为或传播途径。家庭游戏空间（HPS）是一种可能阻断粪-口传播的干预措施组成部分。本研究是在埃塞俄比亚农村地区进行的一项 HPS 的两臂、平行组、随机、对照可行性试验。其目的是为后续的确定性试验提供建议。次要结果包括对婴儿健康、伤害预防和妇女时间的影响。
2019 年 11 月至 2020 年 1 月，确定了 106 户家庭并对其进行了资格评估。招募的家庭（N=100）被随机（在试验开始前进行盲法）分为干预组或对照组（各 50 户）。结果包括招募、失访、依从性和可接受性。数据在基线、两周和四周时收集。
招募满足了事先设定的标准（≥80%）。没有失访，也没有不使用的情况，满足了依从性标准（均≤10%）。此外，48.0%（95%CI 33.7-62.6；n=24）的家庭在四周内正确使用并清洁了 HPS，部分满足了依从性标准（≥50%）。对于可接受性，在随机访问期间，有 41.0%（31.3-51.3；n=41）的婴儿在 HPS 中，未达到标准（≥50%）。此外，在某些活动期间，HPS 的使用比例下降，未达到标准（使用比例没有下降）。一项改进的障碍分析表明，干预家庭的可接受性良好，且具有多种次要益处，包括减轻妇女的时间负担和预防婴儿受伤。
尽管一些事先设定的标准未达标，但该试验表明干预家庭的依从性存在差异，但可接受性良好。如果进行建议的调整，就有必要进行一项确定疗效的确定性试验。
人们的需求；捷克发展署。
RIDIE-ID-5de0b6938afb8。
