title: Community mobilisation with women's groups facilitated by Accredited Social Health Activists (ASHAs) to improve maternal and newborn health in underserved areas of Jharkhand and Orissa: study protocol for a cluster-randomised controlled trial.
abstract: BACKGROUND
  Around a quarter of the world's neonatal and maternal deaths occur in India. Morbidity and mortality are highest in rural areas and among the poorest wealth quintiles. Few interventions to improve maternal and newborn health outcomes with government-mandated community health workers have been rigorously evaluated at scale in this setting.The study aims to assess the impact of a community mobilisation intervention with women's groups facilitated by ASHAs to improve maternal and newborn health outcomes among rural tribal communities of Jharkhand and Orissa.
  
  
  METHODS
  The study is a cluster-randomised controlled trial and will be implemented in five districts, three in Jharkhand and two in Orissa. The unit of randomisation is a rural cluster of approximately 5000 population. We identified villages within rural, tribal areas of five districts, approached them for participation in the study and enrolled them into 30 clusters, with approximately 10 ASHAs per cluster. Within each district, 6 clusters were randomly allocated to receive the community intervention or to the control group, resulting in 15 intervention and 15 control clusters. Randomisation was carried out in the presence of local stakeholders who selected the cluster numbers and allocated them to intervention or control using a pre-generated random number sequence. The intervention is a participatory learning and action cycle where ASHAs support community women's groups through a four-phase process in which they identify and prioritise local maternal and newborn health problems, implement strategies to address these and evaluate the result. The cycle is designed to fit with the ASHAs' mandate to mobilise communities for health and to complement their other tasks, including increasing institutional delivery rates and providing home visits to mothers and newborns. The trial's primary endpoint is neonatal mortality during 24 months of intervention. Additional endpoints include home care practices and health care-seeking in the antenatal, delivery and postnatal period. The impact of the intervention will be measured through a prospective surveillance system implemented by the project team, through which mothers will be interviewed around six weeks after delivery. Cost data and qualitative data are collected for cost-effectiveness and process evaluations.
  
  
  BACKGROUND
  ISRCTN: ISRCTN31567106.
authors.affiliation: Ekjut, Potka, Po-Chakradharpur, District West Singhbhum, Jharkhand, India. prasanta.ekjut@gmail.com
authors.forename: Prasanta
authors.initials: P
authors.lastname: Tripathy
authors.forename: Nirmala
authors.initials: N
authors.lastname: Nair
authors.forename: Rajendra
authors.initials: R
authors.lastname: Mahapatra
authors.forename: Shibanand
authors.initials: S
authors.lastname: Rath
authors.forename: Raj Kumar
authors.initials: RK
authors.lastname: Gope
authors.forename: Suchitra
authors.initials: S
authors.lastname: Rath
authors.forename: Aparna
authors.initials: A
authors.lastname: Bajpai
authors.forename: Vijay
authors.initials: V
authors.lastname: Singh
authors.forename: Vikash
authors.initials: V
authors.lastname: Nath
authors.forename: Sarfraz
authors.initials: S
authors.lastname: Ali
authors.forename: Alok Kumar
authors.initials: AK
authors.lastname: Kundu
authors.forename: Dibarkar
authors.initials: D
authors.lastname: Choudhury
authors.forename: Sanjib
authors.initials: S
authors.lastname: Ghosh
authors.forename: Swati
authors.initials: S
authors.lastname: Sarbani
authors.forename: Rajesh
authors.initials: R
authors.lastname: Sinha
authors.forename: Christina
authors.initials: C
authors.lastname: Pagel
authors.forename: Anthony
authors.initials: A
authors.lastname: Costello
authors.forename: Tanja Aj
authors.initials: TA
authors.lastname: Houweling
authors.forename: Audrey
authors.initials: A
authors.lastname: Prost
mesh_terms: D002662:Child Health Services / Q000191:economics / Q000458:organization & administration*; D016000:Cluster Analysis; D003153:Community Health Services / Q000191:economics / Q000458:organization & administration*; D019058:Community Networks / Q000191:economics / Q000458:organization & administration*; D003362:Cost-Benefit Analysis; D003906:Developing Countries; D005260:Female; D015438:Health Behavior; D017048:Health Care Costs; D007722:Health Knowledge, Attitudes, Practice; D006292:Health Priorities; D006801:Humans; D007194:India; D007226:Infant Mortality; D007231:Infant, Newborn; D008427:Maternal Health Services / Q000191:economics / Q000458:organization & administration*; D008428:Maternal Mortality; D008507:Medically Underserved Area; D009937:Organizational Objectives; D010342:Patient Acceptance of Health Care; D010353:Patient Education as Topic; D011247:Pregnancy; D011446:Prospective Studies; D012107:Research Design; D019035:Rural Health Services / Q000191:economics / Q000458:organization & administration*; D013997:Time Factors