title: Interventions to increase immunisation coverage among children 12-23 months of age in India through participatory learning and community engagement: pilot study for a cluster randomised trial.
abstract: 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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  ISRCTN16703097.
authors.affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, Québec, Canada Département d'administration de la santé, École de santé publique, Université de Montréal, Montréal, Québec, Canada.
authors.forename: Mira
authors.identifier: http://orcid.org/0000-0001-5642-787X
authors.initials: M
authors.lastname: Johri
authors.affiliation: Pratham Education Foundation (ASER Centre), New Delhi, India.
authors.forename: Dinesh
authors.initials: D
authors.lastname: Chandra
authors.affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, Québec, Canada.
authors.forename: Georges K
authors.initials: GK
authors.lastname: Koné
authors.affiliation: Pratham Education Foundation (ASER Centre), New Delhi, India.
authors.forename: Sakshi
authors.initials: S
authors.lastname: Dudeja
authors.affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, Québec, Canada Département de medicine sociale et preventive, École de santé publique, Université de Montréal, Montréal, Québec, Canada.
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Sylvestre
authors.affiliation: National Health Systems Resource Centre (NHSRC), Ministry of Health and Family Welfare, Government of India, New Delhi, India.
authors.forename: Jitendar K
authors.initials: JK
authors.lastname: Sharma
authors.affiliation: Pratham Education Foundation (ASER Centre), New Delhi, India.
authors.forename: Smriti
authors.initials: S
authors.lastname: Pahwa
mesh_terms: D016000:Cluster Analysis; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007114:Immunization / Q000639:trends*; D007194:India / Q000453:epidemiology; D007223:Infant; D007231:Infant, Newborn; D017053:Infection Control / Q000379:methods*; D007239:Infections / Q000453:epidemiology*; D009017:Morbidity / Q000639:trends; D010865:Pilot Projects; D012189:Retrospective Studies; D012424:Rural Population
keywords: INFECTIOUS DISEASES; PUBLIC HEALTH