Menstrual Solutions Study

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.

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.
6. Wellbeing of participants: measured at baseline, then quarterly to measure indicators of wellbeing - using the PEDSQL instrument.
Cup contamination: a random sample of cups were switched for new ones among recorded users, representing varying duration of use; these were tested to detect presence of e. coli contamination (by duration of use).
7. Girls menstrual hygiene: generated from nurse screening and girls personal surveys, twice termly, on Handwashing, use of soap, cleaning of menstrual products.
8. Water, sanitation, and hygiene (WASH) conditions in study schools: repeat cross-sectional surveys conducted through unannounced spot checks by trained WASH field team through physical observation, followed by informant interview, to evaluate WASH standards at baseline, and longitudinally 1-2 times per term over study, by study arm.
9. Direct and indirect costs incurred by study arm: ongoing collection of cost data for all elements of the study, generated from financial records, invoices of intervention costs, discussion with field staff, records of study activities with estimates of time spent by participants, beneficiaries and staff.
10. Safety of menstrual solutions (physical or personal problems with using items; toxic shock syndrome, reproductive tract infections): nurse screening of participants twice termly with ongoing teacher and field staff vigilance in case of an event; ongoing review of all death reports in the area through health and demographic surveillance system, liaison with health services, and a review of health clinic registers.