School, social, and health outcomes associated with menstrual hygiene management in schoolgirls Not Applicable
Conditions
Interventions
1. Arm 1 - menstrual cups, one cup size B for girls. Mooncup (R) brand used, as FDA approval, and tested among girls and women in low income countries
2. Arm 2 - sanitary pads, 2 packs
Sponsors
Kenya Medical Research Institute
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Primary school girls, in classes 5 upwards 2. Attend a study school 3. Reached menarche, experienced a minimum of three menses 4. Are aged 14-16 years at enrolment 5. Resident in the health and demographic surveillance system study area 6. Parents/guardian provided written informed consent 7. Participating girl provided written informed assent
Exclusion criteria
Exclusion criteria: 1. Not attending primary school, or below class 5 2. Not reached menarche or experienced minimum of 3 menses 3. Are outside the study age (14-16 years at enrolment) 4. Not resident in health and demographic surveillance system study area 5. Do not attends one of the study schools 6. Parent/guardian refused informed consent 7. Participant refused informed assent 8. Participant declares presence of an intrauterine device; 9. Participants has a severe physical / learning disability preventing informed consent or ability to participate 10. Participant has suffered from toxic shock syndrome; 11. Participant is pregnant pre-intervention (determined through observed/declared pregnancy, and birth; not through pregnancy testing)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of cumulative school attrition over one school year per arm: Nurse screening of all participants twice termly identified girls missing from school. Using geo-location data from health and demographic surveillance system, field staff (village reporters) visited homes to confirm if participants had dropped-out of school, and reasons for this, or if drop-out was due to migration out of the study area, or transfer to another school. Data capture has been throughout study, with endpoint confirmation through household visits to all homes of participants in 2014. Absence from school (note absenteeism is difficult to measure, so different methods adopted to determine which generates precision data): collected from monthly menstrual calendars provided to participants, from school registries compared against twice termly unannounced school visit headcounts, and girls separate private screening surveys. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feasibility of conducting a menstrual solutions study among primary schoolgirls: proportion of schools agreeing to participate, proportion of parents and target aged girls agreeing to participate, proportion of girls withdrawing from participation - generated from baseline records and ongoing screening, and study supervisors survey lists. 2. Effect of knowledge, attitudes, and practices to menstruation and menstrual hygiene management: conducted among participant girls, parents, and school teachers, through focus group discussions generating qualitative data, at baseline, mid-study, and end-study, on cultural social and schooling factors influencing study and study outcomes. 3. Prevalence of reproductive tract infections per study arm: generated as an endpoint using self-completed (nurse assisted) vaginal swabs conducted through cross-sectional survey of participants at closure of the study . This includes non-sexual (candida albucans, bacterial vaginosis), and sexual (trichomoniasis vaginalis, chlamydia trachomatis, and neisseriae gonorrhoea) 4. Prevalence of staph aureus in participants, and prevalence of toxic shock syndrome toxin-1 in positive staph aureus participants, per study arm: measured through self-conducted vaginal swabs during repeat cross sectional survey at beginning and mid-point in study. 5. Proportion of participants using allocated intervention: generated from twice termly nurse screening checks consisting of face to face interview with participants, plus parallel separate girls' survey where girls reported confidentially using netbook computer. In addition, girls in the cup arm were requested to bring cup each screening, for nurse assessment of cup viability (defined use was change in colour associated with menstrual blood). Girls in pad group also answered question on how many pads they used per menses. Girls in usual practice (control) reported what items they had used. | — |
Countries
Kenya
Outcome results
None listed