Pregnancy and Childbirth Urological and Genital Diseases
Conditions
Interventions
Menstrual Cup and puberty and hygiene education for safe effective cup
Usual Practice
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Schools: Junior day schools in select sub-counties in Siaya County, Schools that educate girls or are co-educational, Schools receiving approval to participate from the Head Teacher Main trial participants: Girls attending junior schools (JS), Girls that are day students, Girls that live in the study area, Girls that have parental consent and assented, Girls that have no severe disability precluding them to participate. Others: Parents: Parents or guardians of girls participating in the trial who consent to participate. Boys: Boys in same schools as participating girls, who receive parental consent and assent. Teachers: Teachers in study schools who consent to participate. Other stakeholders/community members: Persons in the community of the study schools who work with or who have responsibility for or relationships with adolescent girls, e.g. local ministry officials, chiefs, religious leaders, community males who consent to participate
Exclusion criteria
Exclusion criteria: Schools: Boys only schools, Girls’ schools that require boarding, special needs schools. Main trial participants: Girls who live outside the study area, Girls who attend boarding schools, Girls whose parental consent or girl’s assent is refused, Girls with a severe disability precluding participation. Girls cannot take part if they have an allergy to silicone or if they plan to move from the study area within the next one year. Others: Parents: Parents in non-study schools or in study schools but whose daughters are not enrolled in the study. Boys: Boys in non-study schools or whose parents do not provide consent. Teachers: Teachers outside the study schools or who do not consent. Other stakeholders/community members: Persons with no knowledge, experience or responsibility for adolescent girls or no knowledge of the local community.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined incidence of adolescent pregnancy and / or school dropout, ;Primary Safety Outcome - Menstrual Toxic Shock Syndrome (mTSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary - Incidence of adolescent pregnancy ;Key Secondary - Incidence of school dropout;Key Secondary - Occurrence of mental health disorder symptoms (i.e. stress, depression, anxiety) ;Key Secondary Safety - Visits to health facility due to menstrual cup retention or other issues ;Key Secondary Safety - Reported health events or hospitalizations due to an episode of violence;Other Secondary - Age at child marriage, fertility rate by end of study, pregnancy outcomes;Other Secondary - Age at school dropout, pregnancy status before dropout;Other Secondary - General self-efficacy and quality of life;Other Secondary - Education outcomes – end of JS Kenya Junior School Education Assessment (KJSEA) score, annual grade progression, classroom engagement measured through bi-annual surveys, learning assessments measured at baseline and annually;Other Secondary - School absence;Other Secondary - Incidence of gender-based violence;Other Secondary - Self-reported sexual (risk taking) behaviours;Other Secondary - Menstrual cup use;Other Secondary - menstrual health outcomes;Other Secondary - Incremental cost effectiveness ratio ;Other Secondary - Cost-benefit ratio of menstrual cups | — |
Countries
Kenya
Contacts
Public ContactSandra Oketch
Senior Research Administrator Kenya Medical Research Institute
Outcome results
None listed