期刊
BMJ OPEN
卷 5, 期 9, 页码 -出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/bmjopen-2015-007972
关键词
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资金
- Bill & Melinda Gates Foundation [OPP1067851]
- Canadian Institutes for Health Research [299960]
- Shastri Indo-Canadian Institute [SRG201314]
- Bill and Melinda Gates Foundation [OPP1067851] Funding Source: Bill and Melinda Gates Foundation
Objective: With the aim of conducting a future cluster randomised trial to assess intervention impact on child vaccination coverage, we designed a pilot study to assess feasibility and aid in refining methods for the larger study. Trial design: Cluster-randomised design with a 1:1 allocation ratio. Methods: Clusters were 12 villages in rural Uttar Pradesh. All women residing in a selected village who were mothers of a child 0-23 months of age were eligible; participants were chosen at random. Over 4 months, intervention group (IG) villages received: (1) home visits by volunteers; (2) community mobilisation events to promote immunisation. Control group (CG) villages received community mobilisation to promote nutrition. A toll-free number for immunisation was offered to all IG and CG village residents. Primary outcomes were ex-ante criteria for feasibility of the main study related to processes for recruitment and randomisation (50% of villages would agree to participate and accept randomisation; 30 women could be recruited in 70% of villages), and retention of participants (50% of women retained from baseline to endline). Clusters were assigned to IG or CG using a computer-generated randomisation schedule. Neither participants nor those delivering interventions were blinded, but those assessing outcomes were blinded to group assignment. Results: All villages contacted agreed to participate and accepted randomisation. 36 women were recruited per village; 432 participants were randomised (IG n=216; CG n=216). No clusters were lost to follow-up. The main analysis included 86% (373/432) of participants, 90% (195/216) from the IG and 82% (178/216) from the CG. Conclusions: Criteria related to feasibility were satisfied, giving us confidence that we can successfully conduct a larger cluster randomised trial. Methodological lessons will inform design of the main study.
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