title: A cluster randomised controlled trial of the community effectiveness of two interventions in rural Malawi to improve health care and to reduce maternal, newborn and infant mortality.
abstract: BACKGROUND
  The UN Millennium Development Goals call for substantial reductions in maternal and child mortality, to be achieved through reductions in morbidity and mortality during pregnancy, delivery, postpartum and early childhood. The MaiMwana Project aims to test community-based interventions that tackle maternal and child health problems through increasing awareness and local action.
  
  
  METHODS
  This study uses a two-by-two factorial cluster-randomised controlled trial design to test the impact of two interventions. The impact of a community mobilisation intervention run through women's groups, on home care, health care-seeking behaviours and maternal and infant mortality, will be tested. The impact of a volunteer-led infant feeding and care support intervention, on rates of exclusive breastfeeding, uptake of HIV-prevention services and infant mortality, will also be tested. The women's group intervention will employ local female facilitators to guide women's groups through a four-phase cycle of problem identification and prioritisation, strategy identification, implementation and evaluation. Meetings will be held monthly at village level. The infant feeding intervention will select local volunteers to provide advice and support for breastfeeding, birth preparedness, newborn care and immunisation. They will visit pregnant and new mothers in their homes five times during and after pregnancy.The unit of intervention allocation will be clusters of rural villages of 2500-4000 population. 48 clusters have been defined and randomly allocated to either women's groups only, infant feeding support only, both interventions, or no intervention. Study villages are surrounded by 'buffer areas' of non-study villages to reduce contamination between intervention and control areas. Outcome indicators will be measured through a demographic surveillance system. Primary outcomes will be maternal, infant, neonatal and perinatal mortality for the women's group intervention, and exclusive breastfeeding rates and infant mortality for the infant feeding intervention.Structured interviews will be conducted with mothers one-month and six-months after birth to collect detailed quantitative data on care practices and health-care-seeking. Further qualitative, quantitative and economic data will be collected for process and economic evaluations.
  
  
  BACKGROUND
  ISRCTN06477126.
authors.affiliation: Centre for International Health and Development, UCL Institute of Child Health, London, UK. s.lewycka@ich.ucl.ac.uk
authors.forename: Sonia
authors.initials: S
authors.lastname: Lewycka
authors.forename: Charles
authors.initials: C
authors.lastname: Mwansambo
authors.forename: Peter
authors.initials: P
authors.lastname: Kazembe
authors.forename: Tambosi
authors.initials: T
authors.lastname: Phiri
authors.forename: Andrew
authors.initials: A
authors.lastname: Mganga
authors.forename: Mikey
authors.initials: M
authors.lastname: Rosato
authors.forename: Hilda
authors.initials: H
authors.lastname: Chapota
authors.forename: Florida
authors.initials: F
authors.lastname: Malamba
authors.forename: Stefania
authors.initials: S
authors.lastname: Vergnano
authors.forename: Marie-Louise
authors.initials: ML
authors.lastname: Newell
authors.forename: David
authors.initials: D
authors.lastname: Osrin
authors.forename: Anthony
authors.initials: A
authors.lastname: Costello
mesh_terms: D000293:Adolescent; D000328:Adult; D001942:Breast Feeding; D002648:Child; D016000:Cluster Analysis; D019058:Community Networks; D005260:Female; D015658:HIV Infections / Q000401:mortality / Q000517:prevention & control / Q000635:transmission; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D017589:Immunization Programs; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D057226:Information Seeking Behavior; D008295:Malawi; D008425:Maternal Behavior; D008427:Maternal Health Services; D008428:Maternal Mortality; D008875:Middle Aged; D011247:Pregnancy; D011314:Preventive Health Services; D012107:Research Design; D019035:Rural Health Services; D014838:Volunteers; D055815:Young Adult