title: The feasibility of community level interventions for pre-eclampsia in South Asia and Sub-Saharan Africa: a mixed-methods design.
abstract: BACKGROUND
  Globally, pre-eclampsia and eclampsia are major contributors to maternal and perinatal mortality; of which the vast majority of deaths occur in less developed countries. In addition, a disproportionate number of morbidities and mortalities occur due to delayed access to health services. The Community Level Interventions for Pre-eclampsia (CLIP) Trial aims to task-shift to community health workers the identification and emergency management of pre-eclampsia and eclampsia to improve access and timely care. Literature revealed paucity of published feasibility assessments prior to initiating large-scale community-based interventions. Arguably, well-conducted feasibility studies can provide valuable information about the potential success of clinical trials prior to implementation. Failure to fully understand the study context risks the effective implementation of the intervention and limits the likelihood of post-trial scale-up. Therefore, it was imperative to conduct community-level feasibility assessments for a trial of this magnitude.
  
  
  METHODS
  A mixed methods design guided by normalization process theory was used for this study in Nigeria, Mozambique, Pakistan, and India to explore enabling and impeding factors for the CLIP Trial implementation. Qualitative data were collected through participant observation, document review, focus group discussion and in-depth interviews with diverse groups of community members, key informants at community level, healthcare providers, and policy makers. Quantitative data were collected through health facility assessments, self-administered community health worker surveys, and household demographic and health surveillance.
  
  
  RESULTS
  Refer to CLIP Trial feasibility publications in the current and/or forthcoming supplement.
  
  
  CONCLUSIONS
  Feasibility assessments for community level interventions, particularly those involving task-shifting across diverse regions, require an appropriate theoretical framework and careful selection of research methods. The use of qualitative and quantitative methods increased the data richness to better understand the community contexts.
  
  
  BACKGROUND
  NCT01911494.
authors.affiliation: Division of Women & Child Health, Aga Khan University, Karachi, Pakistan.|Department of Obstetrics and Gynaecology, and the Child and Family Research Institute, University of British Columbia, Vancouver, Canada.
authors.forename: Asif Raza
authors.initials: AR
authors.lastname: Khowaja
authors.affiliation: Division of Women & Child Health, Aga Khan University, Karachi, Pakistan. rahat.qureshi@aku.edu.
authors.forename: Rahat Najam
authors.initials: RN
authors.lastname: Qureshi
authors.affiliation: Department of Obstetrics and Gynaecology, and the Child and Family Research Institute, University of British Columbia, Vancouver, Canada.
authors.forename: Diane
authors.initials: D
authors.lastname: Sawchuck
authors.affiliation: Centre for Research in Reproductive Health (CRRH), Olabisi Onabanjo University Teaching Hospital, Sagamu, Ogun State, Nigeria.
authors.forename: Olufemi T
authors.initials: OT
authors.lastname: Oladapo
authors.affiliation: Centre for Research in Reproductive Health (CRRH), Olabisi Onabanjo University Teaching Hospital, Sagamu, Ogun State, Nigeria.
authors.forename: Olalekan O
authors.initials: OO
authors.lastname: Adetoro
authors.affiliation: Centre for Research in Reproductive Health (CRRH), Olabisi Onabanjo University Teaching Hospital, Sagamu, Ogun State, Nigeria.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Orenuga
authors.affiliation: KLE University's JN Medical College, Belgaum & SN Medical College, Bagalkot, India.
authors.forename: Mrutyunjaya
authors.initials: M
authors.lastname: Bellad
authors.affiliation: KLE University's JN Medical College, Belgaum & SN Medical College, Bagalkot, India.
authors.forename: Ashalata
authors.initials: A
authors.lastname: Mallapur
authors.affiliation: KLE University's JN Medical College, Belgaum & SN Medical College, Bagalkot, India.
authors.forename: Umesh
authors.initials: U
authors.lastname: Charantimath
authors.affiliation: Manhiça Health Research Centre (CISM), Mozambique and Faculty of Medicine, Universidade Eduardo Mondlane (UEM), Maputo, Mozambique.
authors.forename: Esperança
authors.initials: E
authors.lastname: Sevene
authors.affiliation: Manhiça Health Research Centre (CISM), Mozambique and Faculty of Medicine, Universidade Eduardo Mondlane (UEM), Maputo, Mozambique.
authors.forename: Khátia
authors.initials: K
authors.lastname: Munguambe
authors.affiliation: Manhiça Health Research Centre (CISM), Mozambique and Faculty of Medicine, Universidade Eduardo Mondlane (UEM), Maputo, Mozambique.
authors.forename: Helena Edith
authors.initials: HE
authors.lastname: Boene
authors.affiliation: Department of Obstetrics and Gynaecology, and the Child and Family Research Institute, University of British Columbia, Vancouver, Canada.
authors.forename: Marianne
authors.initials: M
authors.lastname: Vidler
authors.affiliation: Division of Women & Child Health, Aga Khan University, Karachi, Pakistan.
authors.forename: Zulfiqar A
authors.initials: ZA
authors.lastname: Bhutta
authors.affiliation: Department of Obstetrics and Gynaecology, and the Child and Family Research Institute, University of British Columbia, Vancouver, Canada.
authors.forename: Peter
authors.initials: P
authors.lastname: von Dadelszen
mesh_terms: D000293:Adolescent; D000328:Adult; D017954:Africa South of the Sahara; D001208:Asia; D002648:Child; D003153:Community Health Services / Q000706:statistics & numerical data*; D003256:Community Participation; D004461:Eclampsia; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008428:Maternal Mortality; D008875:Middle Aged; D008880:Midwifery; D010342:Patient Acceptance of Health Care; D010465:Perception; D011225:Pre-Eclampsia; D011247:Pregnancy; D011295:Prenatal Care; D036301:Qualitative Research; D012111:Residence Characteristics; D055815:Young Adult
keywords: Community-based interventions; Eclampsia; Feasibility study; Methodology; Pre-eclampsia