Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls: study protocol of a cluster-randomised controlled trial in western Kenya

Young persons aged 10–24 years (yr.) make up a quarter of the world’s population, contributing 1.8 billion persons of whom approximately 90% live in low or middle-income countries (LMIC). Adolescence is a critical time of psychological and biological change, and advocacy has increased to identify interventions that protect young peoples’ lives [1]. These interventions include ways to protect against sexual and reproductive health (SRH) harms, which are disproportionately high among adolescent girls in sub-Saharan Africa (SSA) [2, 3]. Each year an estimated 14 million girls aged 15-19 yr. give birth [2]. Maternal causes kill more girls in this age group than any other cause [2]. Thus, delaying pregnancy to adulthood is important for women’s reproductive health and infant survival, as well as girls economic and social empowerment [4]. In much of east and southern Africa including western Kenya, where unprotected transactional sex is common, young females are highly vulnerable to sexually transmitted infections (STIs), including HIV which may result in mother-to-child transmission [2, 3]. The burden of young female SRH harms is high for individuals, and on their communities and health services, yet sustainable preventive interventions are lacking. Evidence of a positive association between girls’ education, and their health and economic potential, has strengthened international resolve to improve educational opportunities for adolescent girls. While SRH education has not been demonstrated to have a large impact on SRH harms [5], staying in school has shown to protect girls against early marriage, teen pregnancy, and HIV infection, with schoolgirls reporting less frequent sex, and fewer partners with less age disparity [6‐8]. Building on the Millennium Development Goals (MDG), which focused on primary school attendance, the post-2015 Sustainable Development Goals encourage investment in secondary, tertiary and vocational education to build human capital, encourage innovation and spur economic growth [9].

Intervention studies using cash transfer (CT) have demonstrated a protective effect on girls SRH (including HIV, HSV-2) and school indicators [8, 10, 11], although results in other studies have been inconclusive [12, 13]. Dropout before secondary school completion is partly explained by girls’ vulnerability once they engage in premarital sex, which is often a precursor to unintended pregnancy or early marriage [7, 14, 15]. Studies have illustrated adolescent girls’ vulnerability to transactional or coercive sex, to obtain necessities such as soap, sanitary products, and underwear [16‐19]. Products for menstrual hygiene management (MHM) are one such necessity, and their accessibility remains a pervasive problem in LMIC. A lack of MHM materials, awareness, and facilities, as well as stigma, negatively impact girls’ school-life [20, 21], and can be a driver of girls’ vulnerability to coercive sex. In western Kenya, 10% of 15 yr. old girls self-reported they obtained money through sex to purchase sanitary products [22]. To better understand girls MHM needs in western Kenya, a pilot study in rural primary schools was conducted measuring girls’ menstrual practices, uptake, and safety of a reusable menstrual cup (MS Pilot Study) [23, 24]. The pilot results demonstrated acceptability of the menstrual cup [25], with a lower prevalence of STI and bacterial vaginosis found at 9 and 12 month follow-up among girls using the cup when compared to controls [26], and good clinical safety [16]. Prevalence of school dropout after 12 months was lower but inconclusive due to the small sample [26].

To verify the results of the MS Pilot Study and examine the efficacy, safety, and cost-effectiveness of different school-based interventions in improving girls’ SRH, schooling, and life-chances in rural western Kenya, a randomized controlled trial was designed with a larger population and follow-up duration. The study is designed to inform evidence-based policy to improve girls’ health, school equity and their life-chances which is summarised in this article.

In this study we are hypothesizing that, as a result of receiving the trial interventions, participating adolescent girls’ health and schooling will improve. Prior studies have illustrated that the provision of a menstrual cup can lower rates of reproductive tract and sexually transmitted infections [26]; and that the provision of cash transfer impacts positively on girls’ schooling outcomes [8, 13]. Moreover, evidence is building that enrolment and consistent attendance in school acts as a social vaccine with multiple benefits for girls [6, 15]. This trial will determine if provision of a menstrual solution alone, or in combination with cash transfer directly to schoolgirls can improve their life chances, in terms of reducing their risk of HIV, STI (HSV-2), and school dropout. In our trial, we postulate the interventions tested (cups alone, CT alone, or cups and CT) will lead to a reduction in schoolgirls’ exposure to sexual and reproductive harms, while increasing their opportunity to complete their schooling, compared with controls. Enrolment, intervention and follow-up of participants across a wide geographical area in rural Africa requires a strong collaboration with schools, communities and organisations. The collaboration in western Kenya between KEMRI, LSTM, SWAP, CDC and government of Kenya (GoK) provides this. Parallel small group sessions evaluating programme fidelity and uptake will inform and strengthen the development of programmatic materials for implementation, should the trial show positive outcomes.

Our research will be communicated to the UK and Kenyan public, Kenyan local, county and national ministries, NGO and aid agencies, national and international universities, research groups, international development and aid agencies, donor organizations, and international agencies setting global policy. We will use multiple communication strategies to target information to the correct audience, as appropriate. Much will be through face-to-face interactions at workshops, meetings, local forum presentations, and international conferences. Communication through technology transfer will be used to disseminate more widely to a broader audience, through online networks, webinars, online news, blogs, and publication portals.

We hope that if the interventions prove to be successful and our communication strategy sound, this trial could contribute to improved retention of adolescent girls in school, and could have multiple benefits for health and education services, and national and global level development. This growing evidence base must be used to help girls complete their educations and become financially independent adults, better manage their own menstrual hygiene, and reduce the negative psycho-social pressures and stigma leading to sexual exploitation, violence, illness, premature marriage, and death during childbirth. Cascading benefits may include that communities will benefit from an increase in social capital, and a reduction in resources required to support unemployed, sick, and pregnant girls. Evidence-based-policy will lead to schools being beneficiaries, by improving girls’ experience of menstrual care in school; and 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 1.6 m 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 [4]. Implementation of successful interventions globally will increase the number of girls completing school, reducing the current global estimate of 44 m 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.