title: Menstrual cups and sanitary pads to reduce school attrition, and sexually transmitted and reproductive tract infections: a cluster randomised controlled feasibility study in rural Western Kenya.
abstract: Conduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes.
  
  
  
  3-arm single-site open cluster randomised controlled pilot study.
  
  
  
  30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System.
  
  
  
  Primary schoolgirls 14-16 years, experienced 3 menses, no precluding disability, and resident in the study area.
  
  
  
  1 insertable menstrual cup, or monthly sanitary pads, against 'usual practice' control. All participants received puberty education preintervention, and hand wash soap during intervention. Schools received hand wash soap.
  
  
  
  Primary: school attrition (drop-out, absence); secondary: sexually transmitted infection (STI) (Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoea), reproductive tract infection (RTI) (bacterial vaginosis, Candida albicans); safety: toxic shock syndrome, vaginal Staphylococcus aureus.
  
  
  
  Of 751 girls enrolled 644 were followed-up for a median of 10.9 months. Cups or pads did not reduce school dropout risk (control=8.0%, cups=11.2%, pads=10.2%). Self-reported absence was rarely reported and not assessable. Prevalence of STIs in the end-of-study survey among controls was 7.7% versus 4.2% in the cups arm (adjusted prevalence ratio (aPR) 0.48, 0.24 to 0.96, p=0.039), 4.5% with pads (aPR=0.62; 0.37 to 1.03, p=0.063), and 4.3% with cups and pads pooled (aPR=0.54, 0.34 to 0.87, p=0.012). RTI prevalence was 21.5%, 28.5% and 26.9% among cup, pad and control arms, 71% of which were bacterial vaginosis, with a prevalence of 14.6%, 19.8% and 20.5%, per arm, respectively. Bacterial vaginosis was less prevalent in the cups (12.9%) compared with pads (20.3%, aPR=0.65, 0.44 to 0.97, p=0.034) and control (19.2%, aPR=0.67, 0.43 to 1.04, p=0.075) arm girls enrolled for 9 months or longer. No adverse events were identified.
  
  
  
  Provision of menstrual cups and sanitary pads for ∼1 school-year was associated with a lower STI risk, and cups with a lower bacterial vaginosis risk, but there was no association with school dropout. A large-scale trial on menstrual cups is warranted.
  
  
  
  ISRCTN17486946; Results.
authors.affiliation: Department of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.|Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
authors.forename: Penelope A
authors.initials: PA
authors.lastname: Phillips-Howard
authors.affiliation: Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Nyothach
authors.affiliation: Department of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.|Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
authors.forename: Feiko O
authors.initials: FO
authors.lastname: Ter Kuile
authors.affiliation: Siaya District Hospital, Ministry of Health, Siaya, Kenya.
authors.forename: Jackton
authors.initials: J
authors.lastname: Omoto
authors.affiliation: Department of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.
authors.forename: Duolao
authors.initials: D
authors.lastname: Wang
authors.affiliation: Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.|Centers for Disease Control and Prevention (CDC)-Kenya, Kisumu, Kenya.
authors.forename: Clement
authors.initials: C
authors.lastname: Zeh
authors.affiliation: Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.|Centers for Disease Control and Prevention (CDC)-Kenya, Kisumu, Kenya.
authors.forename: Clayton
authors.initials: C
authors.lastname: Onyango
authors.affiliation: Department of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.
authors.forename: Linda
authors.initials: L
authors.lastname: Mason
authors.affiliation: Department of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.
authors.forename: Kelly T
authors.initials: KT
authors.lastname: Alexander
authors.affiliation: Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
authors.forename: Frank O
authors.initials: FO
authors.lastname: Odhiambo
authors.affiliation: Safe Water and AIDS Project (SWAP), Kisumu, Kenya.
authors.forename: Alie
authors.initials: A
authors.lastname: Eleveld
authors.affiliation: Division of Reproductive Health, Ministry of Public Health and Sanitation, Nairobi, Kenya.
authors.forename: Aisha
authors.initials: A
authors.lastname: Mohammed
authors.affiliation: Department of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.
authors.forename: Anna M
authors.initials: AM
authors.lastname: van Eijk
authors.affiliation: Centre for Economics and Policy in Health, Bangor University, UK.
authors.forename: Rhiannon Tudor
authors.initials: RT
authors.lastname: Edwards
authors.affiliation: Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
authors.forename: John
authors.initials: J
authors.lastname: Vulule
authors.affiliation: Department of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), UK.
authors.forename: Brian
authors.initials: B
authors.lastname: Faragher
authors.affiliation: Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.|Division of Global Health Protection, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors.forename: Kayla F
authors.initials: KF
authors.lastname: Laserson
mesh_terms: D000041:Absenteeism; D000293:Adolescent; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007630:Kenya / Q000453:epidemiology; D016014:Linear Models; D052576:Menstrual Hygiene Products / Q000706:statistics & numerical data*; D015999:Multivariate Analysis; D010865:Pilot Projects; D060737:Reproductive Tract Infections / Q000453:epidemiology*; D012424:Rural Population; D012574:Schools; D012749:Sexually Transmitted Diseases / Q000453:epidemiology*; D013332:Student Dropouts; D013334:Students; D016585:Vaginosis, Bacterial / Q000453:epidemiology*
keywords: adolescent; menstrual cups; menstrual hygiene management; reproductive tract infections; sexual and reproductive health; sexually transmitted infections