title: Adherence in a pragmatic randomized controlled trial on prophylactic iron supplementation during pregnancy in Maputo, Mozambique.
abstract: OBJECTIVE
  Assessing the level of adherence and its determinants is important in appraising the overall effectiveness of trials. The present study aimed to evaluate the extent of adherence and its determinants in a pragmatic randomized controlled trial of Fe prophylaxis during pregnancy in Maputo, Mozambique.
  
  
  METHODS
  A pragmatic randomized controlled trial.
  
  
  METHODS
  Two health centres (1° de Maio and Machava) in Maputo, Mozambique.
  
  
  METHODS
  Pregnant women (≥12 weeks' gestation, ≥18 years old, non-high-risk pregnancy; n 4326) attending prenatal care consultations at two health centres were randomized to receive routine Fe (n 2184; 60 mg ferrous sulfate plus 400 μg folic acid daily throughout pregnancy) or selective Fe (n 2142; screening and treatment for anaemia and daily intake of 1 mg folic acid).
  
  
  RESULTS
  The level of adherence was 79% for having two or more visits, 53% for adequate prenatal care and 67% for complete intake of Fe/folic acid tablets during the trial. The correlation between the adherence measures ranged between 0·151 and 0·739. Adherence did not differ by trial arm, but there were centre differences in adequate prenatal visits and intake of tablets. Older women (>20 years) and those with a history of abortion were more likely to achieve greater adherence, whereas an increased number of previous births decreased the likelihood of adherence. HIV positivity decreased the likelihood of adherence in one trial centre and increased it in the other.
  
  
  CONCLUSIONS
  The variation in adherence by trial centre, women's characteristics and outcome measures suggests that adherence in trials fully depends on participants' behaviour and can be increased by paying attention to contextual factors.
authors.affiliation: 1Centre for Population Health Sciences,The University of Edinburgh,Medical School, Doorway 3,Teviot Place,Edinburgh EH8 9AG,UK.
authors.forename: Bright I
authors.initials: BI
authors.lastname: Nwaru
authors.affiliation: 3Department of Physiological Sciences,Eduardo Mondlane University,Maputo,Mozambique.
authors.forename: Graça
authors.initials: G
authors.lastname: Salomé
authors.affiliation: 4Department of Community Health,Eduardo Mondlane University,Maputo,Mozambique.
authors.forename: Fatima
authors.initials: F
authors.lastname: Abacassamo
authors.affiliation: 4Department of Community Health,Eduardo Mondlane University,Maputo,Mozambique.
authors.forename: Orvalho
authors.initials: O
authors.lastname: Augusto
authors.affiliation: 4Department of Community Health,Eduardo Mondlane University,Maputo,Mozambique.
authors.forename: Julie
authors.initials: J
authors.lastname: Cliff
authors.affiliation: 4Department of Community Health,Eduardo Mondlane University,Maputo,Mozambique.
authors.forename: Cesar
authors.initials: C
authors.lastname: Sousa
authors.affiliation: 5National Institute for Health and Welfare,Health Services and Policy Research,Helsinki,Finland.
authors.forename: Elena
authors.initials: E
authors.lastname: Regushevskaya
authors.affiliation: 5National Institute for Health and Welfare,Health Services and Policy Research,Helsinki,Finland.
authors.forename: Saara
authors.initials: S
authors.lastname: Parkkali
authors.affiliation: 5National Institute for Health and Welfare,Health Services and Policy Research,Helsinki,Finland.
authors.forename: Elina
authors.initials: E
authors.lastname: Hemminki
mesh_terms: D000293:Adolescent; D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000150:complications / Q000517:prevention & control* / Q000821:virology; D003151:Community Health Centers; D003906:Developing Countries; D019587:Dietary Supplements; D005260:Female; D005296:Ferrous Compounds / Q000008:administration & dosage; D005492:Folic Acid / Q000627:therapeutic use; D006679:HIV Seropositivity / Q000150:complications / Q000821:virology; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D019266:Iron, Dietary / Q000627:therapeutic use*; D009073:Mozambique; D010349:Patient Compliance; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000097:blood / Q000517:prevention & control* / Q000821:virology; D011251:Pregnancy Complications, Infectious / Q000097:blood / Q000821:virology; D039401:Prenatal Nutritional Physiological Phenomena; D017584:Reproductive History; D055815:Young Adult
chemical_list: D005296:Ferrous Compounds; D006397:Hematinics; D019266:Iron, Dietary; C020748:ferrous sulfate; D005492:Folic Acid
keywords: Mozambique