一项关于 BabyWASH 家庭游戏空间的随机对照可行性试验：CAMPI 研究。
A randomised controlled feasibility trial of a BabyWASH household playspace: The CAMPI study.
机构信息
Cranfield Water Science Institute, Cranfield University, Cranfield, United Kingdom.
Faculty of Engineering and Physical Sciences, University of Leeds, Leeds, United Kingdom.
出版信息
PLoS Negl Trop Dis. 2021 Jul 14;15(7):e0009514. doi: 10.1371/journal.pntd.0009514. eCollection 2021 Jul.
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.
背景
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。
方法
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。
发现
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。
结论
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。
资金来源
人们的需求；捷克发展署。
试验注册
RIDIE-ID-5de0b6938afb8。
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