Background and study aims

Adolescent girls are acutely susceptible to sexual and reproductive health (SRH) harms through incomplete biological development, inadequate knowledge of menstruation and puberty, lack of autonomy, social pressures around sex, and harmful gender norms. In many low- and middle-income countries (LMICs), including Kenya, where poverty and gender-based violence are pervasive, girls face sexual abuse, have limited agency to navigate sexual encounters safely, and may resort to transactional sex to obtain daily essentials including menstrual hygiene products. This leaves girls vulnerable to adolescent pregnancy, child marriage, sexually transmitted infections (STIs) and school dropout, with lasting effects across the life course. Trials are needed to test interventions that combine effects that improve girls’ menstrual needs, reduce risky sexual behaviours, and modify social norms. We have conducted prior trials evaluating the impact of menstrual (cups, sanitary pads) and structural (cash transfer) interventions on SRH and school outcomes in about 4750 schoolgirls in rural Kenya. We found menstrual cups were acceptable to parents and to younger and older adolescents, and girls reported improved menstrual hygiene and school engagement and reduced stigma. Cups reduced the incidence of STIs and bacterial vaginosis, suggesting they are a multipurpose tool, improving menstrual care and reducing sexual risks. Our data suggested earlier-aged cup use, e.g., soon after the first menstrual period, may offer the highest protection to maintain a healthy vaginal microbiome. However, our prior trials missed robust measurement and evaluation of the effect of menstrual cups on adolescent pregnancy and on education outcomes such as school dropout, absence, and exam scores. Funding has been provided allowing us to improve our study methods to fully evaluate menstrual cups as a multipurpose tool. Our study aims to evaluate if the provision of menstrual cups will impact educational, sexual and reproductive health and social equity outcomes compared with girls maintaining usual practice in junior schools in western Kenya.

Who can participate?

The main trial participants are girls attending as day students in junior schools in Siaya County, western Kenya. Girls can participate if they live in the study area, attend the selected junior schools, have parent consent and themselves assent, and have no disability that would preclude them from being able to join the study activities. Our target population are girls in the first year of junior school (grade 7), who would be followed up until they complete junior school (grade 9), e.g., over approximately 2.5 years.

What does the study involve?

This study includes a menstrual cup group and a control group (where participants are provided the menstrual cup at the end of the study). At the randomisation ceremony head teachers allocate schools to the cup or control group. Informed parent consent through school meetings will first take place before eligible schoolgirls are invited to join and assent. Following participant enrolment, a baseline self-completed survey will be conducted among participants in school, with follow-up surveys conducted every 6 months. A variety of qualitative studies will be conducted among participants agreeing to join activities across the course of the study. Absence will be recorded through software, enabling more accurate recording by teachers. Participants reported to drop out will be visited in their homes to verify this, record pregnancies, and continue biannual surveys to maximise completeness of survey coverage. In a sample of about 10 schools, a sub-study will take place in about 600 girls (300 in the cup group and 300 in the control group). Following parent consent and their assent, participants will be invited to do vaginal swabs, in a private setting, to investigate the vaginal microbiome and to diagnose if they have bacterial vaginosis and/or an STI. Private individual treatment will take place after test rests are obtained. Costings will be conducted throughout to enable the trial data to be used for cost-benefit and cost-effectiveness analysis. In addition to activities among the participants, additional studies will be conducted among a variety of stakeholders to provide contextual information to help understand trial outcomes and to inform policy implications.

What are the possible benefits and risks of participating?

Girls will receive a menstrual cup, puberty and hygiene education, and training on safe and effective use. The control group will receive a small stationary item at enrolment and a menstrual cup (with training) at the end of the study. Participants are thought likely to benefit from improving their self-esteem and autonomy by contributing to the study. Participants in our previous studies reported enhanced esteem through study participation.

The risks for schoolgirls participating in this study include initial embarrassment discussing menstruation with possible shame associated with poor management. This will be mitigated by discussion with the female staff who have worked with adolescent girls for many years. Girls may also feel discomfort when first using the menstrual cup until they are familiar. This will be addressed through training of female experts who will be available to support safe and effective use, with repeat training monthly for 3 months, then quarterly, plus SMS messaging if further support in between training is required. Girls may be triggered by some questions on sexual and reproductive health or behaviours; our female counselling staff will be available, and we have a safeguarding pathway prepared should girls need additional counselling support. Girls in the sub-study investigating STIs and the vaginal microbiome may find the process of swabbing overwhelming; we have trained nurses and female counsellors to assist with every step, and all activities will be conducted in privacy. Treatment of infections is conducted confidentially by our study nurses. Finally, participants are informed from study start and during procedures that they have the right to withdraw at any time with no negative consequences should they so wish.

Where is the study run from?

Kenyan Medical Research Institute (Kenya)

When is the study starting and how long is it expected to run for?

May 2026 to February 2029

Who is funding the study?

Bill and Melinda Gates Foundation (USA)

Who is the main contact?

Prof. Penelope Phillips-Howard, send email