title: The REFANI-N study protocol: a cluster-randomised controlled trial of the effectiveness and cost-effectiveness of early initiation and longer duration of emergency/seasonal unconditional cash transfers for the prevention of acute malnutrition among children, 6-59 months, in Tahoua, Niger.
abstract: BACKGROUND
  The global burden of acute malnutrition among children remains high, and prevalence rates are highest in humanitarian contexts such as Niger. Unconditional cash transfers are increasingly used to prevent acute malnutrition in emergencies but lack a strong evidence base. In Niger, non-governmental organisations give unconditional cash transfers to the poorest households from June to September; the 'hunger gap'. However, rising admissions to feeding programmes from March/April suggest the intervention may be late.
  
  
  METHODS
  This cluster-randomised controlled trial will compare two types of unconditional cash transfer for 'very poor' households in 'vulnerable' villages defined and identified by the implementing organisation. 3,500 children (6-59 months) and 2,500 women (15-49 years) will be recruited exhaustively from households targeted for cash and from a random sample of non-recipient households in 40 villages in Tahoua district. Clusters of villages with a common cash distribution point will be assigned to either a control group which will receive the standard intervention (n = 10), or a modified intervention group (n = 10). The standard intervention is 32,500 FCFA/month for 4 months, June to September, given cash-in-hand to female representatives of 'very poor' households. The modified intervention is 21,500 FCFA/month for 5 months, April, May, July, August, September, and 22,500 FCFA in June, providing the same total amount. In both arms the recipient women attend an education session, women and children are screened and referred for acute malnutrition treatment, and the households receive nutrition supplements for children 6-23 months and pregnant and lactating women. The trial will evaluate whether the modified unconditional cash transfer leads to a reduction in acute malnutrition among children 6-59 months old compared to the standard intervention. The sample size provides power to detect a 5 percentage point difference in prevalence of acute malnutrition between trial arms. Quantitative and qualitative process evaluation data will be prospectively collected and programme costs will be collected and cost-effectiveness ratios calculated.
  
  
  CONCLUSIONS
  This randomised study design with a concurrent process evaluation will provide evidence on the effectiveness and cost-effectiveness of earlier initiation of seasonal unconditional cash transfer for the prevention of acute malnutrition, which will be generalisable to similar humanitarian situations.
  
  
  BACKGROUND
  ISRCTN25360839, registered March 19, 2015.
authors.affiliation: UCL Institute for Global Health, London, WC1N 1EH, UK. victoria.sibson@ucl.ac.uk.
authors.forename: Victoria L
authors.initials: VL
authors.lastname: Sibson
authors.affiliation: UCL Institute for Global Health, London, WC1N 1EH, UK. c.eternod@ucl.ac.uk.
authors.forename: Carlos S
authors.initials: CS
authors.lastname: Grijalva-Eternod
authors.affiliation: Concern Worldwide, Niamey, Niger. leila.bourahla@concern.net.
authors.forename: Leila
authors.initials: L
authors.lastname: Bourahla
authors.affiliation: UCL Institute for Global Health, London, WC1N 1EH, UK. h.haghparast-bidgoli@ucl.ac.uk.
authors.forename: Hassan
authors.initials: H
authors.lastname: Haghparast-Bidgoli
authors.affiliation: UCL Institute for Global Health, London, WC1N 1EH, UK. joanna.morrison@ucl.ac.uk.
authors.forename: Joanna
authors.initials: J
authors.lastname: Morrison
authors.affiliation: Action Against Hunger, New York, USA. cpuett@actionagainsthunger.org.
authors.forename: Chloe
authors.initials: C
authors.lastname: Puett
authors.affiliation: Action Against Hunger, New York, USA. ltrenouth@actionagainsthunger.org.
authors.forename: Lani
authors.initials: L
authors.lastname: Trenouth
authors.affiliation: UCL Institute for Global Health, London, WC1N 1EH, UK. a.seal@ucl.ac.uk.
authors.forename: Andrew
authors.initials: A
authors.lastname: Seal
mesh_terms: D000328:Adult; D002648:Child; D002664:Child Nutritional Physiological Phenomena; D002669:Child Welfare / Q000191:economics* / Q000706:statistics & numerical data; D002675:Child, Preschool; D019587:Dietary Supplements / Q000191:economics; D004630:Emergencies; D005191:Family Characteristics; D005260:Female; D006078:Government Programs / Q000191:economics*; D006801:Humans; D007223:Infant; D044342:Malnutrition / Q000191:economics* / Q000517:prevention & control*; D008875:Middle Aged; D009548:Niger / Q000453:epidemiology; D011203:Poverty / Q000706:statistics & numerical data; D011247:Pregnancy; D015995:Prevalence; D055815:Young Adult