Reproductive health and education Other
Conditions
Interventions
Schools are the unit of randomisation (clusters), and girls the unit of measurement. A census of junior schools in the area will be completed. A computer-generated randomisation list will be produced
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
Female
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: Schools: 1. Junior day schools in select sub-counties in Siaya County 2. Schools that educate girls or are co-educational 3. Schools receiving approval to participate from the Head Teacher Main trial participants: 1. Girls attending junior schools (JS) 2. Girls who are day students 3. Girls who live in the study area 4. Girls who have parental consent and assented 5. Girls who have no severe disability precluding them from participating 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: 1. Boys-only schools 2. Girls’ schools that require boarding 3. Special needs schools Main trial participants: 1. Girls who live outside the study area 2. Girls who attend boarding schools 3. Girls whose parental consent or girl’s assent is refused 4. Girls with a severe disability precluding participation 5. Girls cannot take part if they have an allergy to silicone or if they plan to move from the study area within the next 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 |
|---|---|
| The combined incidence of adolescent pregnancy and/or school dropout measured using follow-up surveys at 6 monthly intervals and verification house visits over approximately 2.5 years;Safety: Incident cases of toxic shock syndrome measured using community surveillance at endline, approximately 2.5 years;AKIBA Sub-Study: Prevalence of optimal community state type (CST-I, Lactobacillus crispatus dominated) measured using follow-up surveys at termly intervals over approximately 2.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adolescent pregnancy measured using follow-up surveys at 6 monthly intervals and verification house visits over approximately 2.5 years;Incidence of school dropout measured using follow-up surveys at 6 monthly intervals and verification house visits over approximately 2.5 years;Incident mental health disorders measured using follow-up surveys using Patient Health Questionnaire-9 (PHQ-9) and EuroQoL at 6 monthly intervals over approximately 2.5 years;AKIBA Sub-Study: Incidence of bacterial vaginosis (BV) and sexually transmitted infections (STIs) (composite of gonorrhea, chlamydia, trichomoniasis) measured using follow-up surveys at annual intervals over approximately 2.5 years | — |
Countries
Kenya
Contacts
Public ContactPenelope Phillips-Howard
Outcome results
None listed