Objectives Conduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes.
Design 3-arm single-site open cluster randomised controlled pilot study.
Setting 30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System.
Participants Primary schoolgirls 14–16 years, experienced 3 menses, no precluding disability, and resident in the study area.
Interventions 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 and secondary outcome measures 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.
Results 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.
Conclusions 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.
Trial registration ISRCTN17486946; Results
- menstrual hygiene management
- sexual and reproductive health
- sexually transmitted infections
- reproductive tract infections
- menstrual cups
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Contributors PAP-H and KFL designed the study, coordinated the field work and analysis, led data interpretation, drafted the manuscript, and obtained funding. EN, FOO, and AE managed the data collection and participated in writing of the manuscript. FOtK and BF participated in the study design, data interpretation, writing of the manuscript, and obtaining funding. JO participated in study design, provided clinical training and data interpretation, and writing of the manuscript. DW analysed the data and participated in writing of the manuscript. LM, KTA and AMvE participated in the study design, interpretation of the data, and writing of the manuscript. CZ and CO participated in study design, managed laboratory data collection, data interpretation, and participated in writing of the manuscript. AM, RTE, and JV participated in designing of the study, writing of the manuscript and obtaining of the funding.
Funding This work was supported by the UK-Medical Research Institute/Department for International Development/Wellcome Trust Global Health Trials award; grant number G1100677/1.
Disclaimer The findings and conclusions in this paper are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention. Funders had no role in study design, data collection and analysis, decision to publish, or manuscript preparation.
Competing interests None declared.
Ethics approval Kenya Medical Research Institute; Liverpool School of Tropical Medicine.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
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