Menstrual cups and unconditional cash transfer to reduce sexual and reproductive harm and school drop-out in adolescent schoolgirls in western Kenya

Girls in low-income countries leave school early due to pregnancy, illness, early marriage, and lack of money for schooling and personal needs, including for menstrual hygiene management (MHM). School drop-out places girls at greater risk of sexual and reproductive health harms such as pregnancy, increased fertility, sexually transmitted infections (STIs) including HIV, and higher mortality of their children. School drop-out also reduces economic opportunity, keeping girls' in poverty and thereby at risk of increased morbidity and reduced quality of life. For economic, health, and social reasons, these are government ministry priorities, and interventions are needed to keep girls in school and improve their sexual and reproductive health. The Liverpool School of Tropical Medicine, with Kenyan partners including the Ministries of Education and Health (MOE/MOH), have completed a Joint Global Health Trials-funded pilot study, examining girls' use of menstrual cups and sanitary pads in rural primary schools in western Kenya. Pre-intervention, girls reported using rags, bedding or paper for MHM, causing discomfort, humiliating leaks and odour, reducing ability to concentrate in school, and causing them to skip school. Girls followed up revealed pads and cups were comfortable, increased their ability to engage in class, prevented leakage, and reduced the need to have sex with boyfriends in return for money to buy pads. No health or safety issues were found. At study completion girls were checked for STIs, and school drop-out (for pregnancy, marriage or other reasons). These negative outcomes combined were halved in girls using pads or cups compared with girls in control schools. Girls using cups preferred these to pads, because pads are ten-fold more costly, cause chafing if not changed frequently, and packs have to be shared with others. Girls did not share cups for fear of infection. We now propose to conduct a large-scale trial in the same area, in secondary schoolgirls, who are older but have increased drop-out rates (over a third higher), and a higher risk of HIV, STI, and pregnancy. We will examine if cups enable girls to stay in school and reduce their sexual and reproductive harms; while cups will improve dignity, health and wellbeing, and confidence at school, they may not be sufficient to resolve all girls' unmet needs, which cause them to drop-out of school. Cash transfer (CT) is an alternate but more expensive intervention, with studies showing it reduces absenteeism, drop-out, and sexual risks. In Malawi, CT reduced schoolgirls risk of HIV and human simplex virus (HSV-2; an indicator of girls' sexual risk behaviour), and reduced pregnancy. Cash amounts vary by study but the researchers recommend $5(£3.5) a month as sufficient. Our 4.5 year trial will examine if cash, cups, or cash and cups both provided, will prevent school drop-out and improve girls' sexual and reproductive health. For statistical rigor we will recruit 4032 secondary schoolgirls in 56 schools, provide interventions and follow-up them for 2 school years (6 terms). We will evaluate the cost per outcome (school drop-out including for pregnancy, HIV and HSV-2) prevented for single and combined interventions. The study will provide vital information on the comparative value of each intervention, how the interventions are used, any problems encountered, and their effect on girls' sexual behaviour, their wellbeing and school completion. We will seek advice from girls, schools, communities and stakeholders, working with all beneficiaries including MOE/MOH, using workshops to evaluate progress and develop materials for implementation packages. Girls clubs will be funded to encourage peer-support and advocacy. Packages will support scale-up should the trial demonstrate cost-effective outcomes. Findings will be widely disseminated to strengthen the evidence base supporting advocacy to improve the quality and equity of girls' lives.

Cluster randomised controlled 4-arm superiority trial examining the impact and cost-effectiveness of menstrual cups, compared or combined with unconditional cash transfer, to improve rural girls' retention in secondary school and protect their sexual and reproductive health (SRH) in western Kenya. The objective is to reduce girls' exposure to drivers which increase SRH harms and compromise girls' successful school completion. A sample of 4032 girls, in 56 school clusters block randomised into 4 arms, will be followed for 2 years (6 terms). Allowing 8%/year migration loss this gives a power of 90% to detect 30% reduction in a composite primary endpoint (HIV, HSV-2, and school drop-out incidence); and 89% to detect a 52% reduction in HSV-2, 80% to detect a 36.3% reduction in drop-out, and 20% to detect a 50% reduction in HIV alone. Demographic surveillance facilitates home consent and follow-up to differentiate migration loss from school drop-out. Secondary outcomes measured through costings, surveys and qualitative studies are the cost-effectiveness of harms averted, intervention use and safety, girls' sexual behaviour, and quality of life measures. The trial follows completion of a pilot study showing safe cup use by rural Kenyan primary schoolgirls, and potential impact on STI's and school drop-out. Cash transfer reduced HIV, HSV-2 and sexual risks in Malawian schoolgirls but requires replication and comparison with alternative interventions. Hazards were not detected in prior studies but adverse events will be monitored. Girls clubs, beneficiary trial advocacy groups and government ministry partners will guide development, assess process evaluation, and develop materials for implementation packages that have direct application for programme scale-up. Trial outcomes will be disseminated widely to inform policy, guide research, and advocate for the health and equity of adolescent schoolgirls in impoverished communities.

Interventions that improve the retention of adolescent girls in school will have multiple benefits for schoolgirls, parents and their communities, schools and teachers; health and education services; research staff, and at national and global level. Impacts will multiply over time as girls become financially independent adults. Girls will be financially independent and/or to be in control of their own menstrual hygiene; this will prevent or reduce the negative psycho-social pressures from dealing with the humiliation of poor menstrual care, pregnancy fear, and vulnerability to sexual exploitation, violence, illness and premature marriage. Staying in school will enable girls to retain their social networks, increase their knowledge and skills, complete their education, leading to employment. Girls will be free to enjoy and participate fully in school activities, including sport and play. Health benefits include a lower risk of STI, HIV, and teen pregnancy, and an increase in their health and wellbeing. Parents and communities will benefit from healthier girls who can achieve financial independence. While girls' are at school, parents will benefit from reduced cost-outlays for girls' menstrual and other personal needs. Freed income can be used for other family essentials, raising the quality of their lives. Communities will benefit from an increase in social capital, and a reduction in resources required to support unemployed, sick, and pregnant girls. Schools will be beneficiaries, as our trial will translate into improving water hygiene and sanitation in schools, in parallel with enhanced menstrual care. Teachers will benefit from girls' improved attention in class and equitable teaching. As more girls' complete education, there will be greater opportunity for training female teachers, redressing the gender imbalance. More engaged pupils will increase teachers' job satisfaction and better grades will raise school profiles. Partnerships between education and the health sector will be strengthened. Economic benefits would translate nationally; for example, researchers estimate that in Kenya, if all 1.6m adolescent girls were able to complete secondary school, and the ~220,000 girls who were pregnant and delivered could be educated, there would be a cumulative effect adding up to £2.1 billion towards Kenya's gross income per year. The trial will build skills in research and programme operations in schools. We intend to attach PhD students to this study, enabling Kenyan researchers to extend their skills and advance their academic careers. Researchers will benefit by improving the quality of research and outputs, with publication of findings and presentation at national and international research meetings. Ministry staff will be trained on research and programme activities enhancing their technical knowledge and fostering long-term links between research and programme staff. Intervention strategies will inform national school health, poverty reduction, and sexual and reproductive health policies and programmes. The global research and programme community will benefit from trial findings; findings will contribute to developing school health interventions. Implementation of successful intervention globally will increase the number of girls' completing school, reducing the current global estimate of 44m adolescent girls out of school. Implementing interventions that retain girls through secondary school will have global economic benefits, as it is estimated that countries growth rates would increase on average by ~1% annually if girls' education was raised one level higher (i.e. secondary status). Interventions will reduce the prevalence of teen births and poor maternal outcomes, and the rate of new HIV infections in adolescence which currently account for ~40% of new infections. This will decrease the burden of HIV programme costs for antiretroviral drugs and antenatal care to prevent mother to child transmission.