Menstrual solutions in adolescent schoolgirls in western Kenya: an acceptability, feasibility and safety study
Lead Research Organisation:
Liverpool School of Tropical Medicine
Department Name: Child and Reproductive Health
Abstract
Adolescent schoolgirls consider menstrual management as one of their main stressors. Menstrual difficulties result in missed schooling and drop-out, but studies on the true impact are limited, and baseline tools and data are lacking. One solution is Mooncups, silicone bell receptacles that store menstrual flow, available since the 1930s and marketed in Kenya and internationally. We will conduct a randomized proof of concept feasibility study on menstrual solutions to quantify cultural acceptance, use, satisfaction, costs and safety of Mooncups, sanitary pads and 'usual practice' in 750 schoolgirls in 15 schools in the demographic health and surveillance site in western Kenya. School nurse screening, self-completed menstrual calendars, behaviour surveys, water / sanitation / hygiene (WASH) evaluation in schools and homes, measures of school attrition, and laboratory checks on Staph aureus contamination, HIV, STI and reproductive tract infections will enable us to determine prevalence rates for outcome indicators, and exclude toxic shock syndrome and other safety concerns. Qualitative studies will provide contextual information to understand reasons for outcomes and behaviours. Data will inform policy and provide baseline information and statistics for the preparation of a randomized controlled trial to examine the cost-effectiveness of menstrual solutions to reduce school attrition and improve wellbeing
Technical Summary
Disproportionate mortality and morbidity in adolescent girls in sub-Saharan Africa reflects high HIV and STI prevalence, and poor teen maternal outcomes. Over a quarter of girls report first sexual encounter was forced, and early sexual debut is a risk factor for STIs. These neglected harms prevent attainment of millennium development goals. Sanitation studies identify poor menstrual management and fear of pregnancy as top stressors. Girls use unsanitary products which leak and irritate, impact on school engagement, and exacerbate sexual exposure as males consider them sexually mature, and girls seek money for pads from sex.
An FDA approved silicon-bell vaginal receptacle (menstrual cup; Mcup), which collects menstrual blood without leakage, is a potential cost-effective solution to enhance school engagement, reduce sexual exposure and harms, and improve girls? quality of life. This 3-year, open 2-armed cluster-randomised controlled prevention trial will be conducted in western Kenya, an area with high rates of HIV, STI, forced sex, and school drop-out among girls, with a well-established health and demographic surveillance system. It is designed to detect a 33% reduction in absenteeism in girls from 21% to 14%; unit of randomisation: schools. Sample size: 76 paired clusters of 40 girls per cluster; power 90%, alpha 0.05, ICC 0.1; enrolling 7600 girls allowing 20% loss-to-follow-up.
Secondary outcomes include Mcup tolerability, HIV incidence, sexual and reproductive tract infections, frequency of partners, forced sex, and age at debut. Data will be generated from unannounced school attendance surveys, pre- and post-HIV testing, 6-weekly nurse screening on Mcup use and infections (with laboratory confirmation), sexual behaviour and quality of life surveys, daily menstrual diaries and social studies over 24 months intervention. Economic sub-studies will examine return on investment for free, subsidised or full cost Mcups. Analysis will be by intention to treat and per-protocol using Poisson regression or negative binomial regression, taking the cluster design into account. The study will have one interim analysis at 12 months.
The trial strengthens existing collaborations between Liverpool and Bangor Universities, the KEMRI/CDC Research and Public Health Collaboration, the African Population Health and Research Centre, the Ministries of Public Health and Sanitation, Medical Services, and Education. Advisory support from DFID-sponsored SWASH (school water and sanitation), PATH, the German development agency (GIZ), and WHO Collaborating Centre on Violence, provides further partnership development. Findings will inform policy on prevention and care of adolescent girls, through menstrual solutions, at local, national, and international level, and the cost implications.
An FDA approved silicon-bell vaginal receptacle (menstrual cup; Mcup), which collects menstrual blood without leakage, is a potential cost-effective solution to enhance school engagement, reduce sexual exposure and harms, and improve girls? quality of life. This 3-year, open 2-armed cluster-randomised controlled prevention trial will be conducted in western Kenya, an area with high rates of HIV, STI, forced sex, and school drop-out among girls, with a well-established health and demographic surveillance system. It is designed to detect a 33% reduction in absenteeism in girls from 21% to 14%; unit of randomisation: schools. Sample size: 76 paired clusters of 40 girls per cluster; power 90%, alpha 0.05, ICC 0.1; enrolling 7600 girls allowing 20% loss-to-follow-up.
Secondary outcomes include Mcup tolerability, HIV incidence, sexual and reproductive tract infections, frequency of partners, forced sex, and age at debut. Data will be generated from unannounced school attendance surveys, pre- and post-HIV testing, 6-weekly nurse screening on Mcup use and infections (with laboratory confirmation), sexual behaviour and quality of life surveys, daily menstrual diaries and social studies over 24 months intervention. Economic sub-studies will examine return on investment for free, subsidised or full cost Mcups. Analysis will be by intention to treat and per-protocol using Poisson regression or negative binomial regression, taking the cluster design into account. The study will have one interim analysis at 12 months.
The trial strengthens existing collaborations between Liverpool and Bangor Universities, the KEMRI/CDC Research and Public Health Collaboration, the African Population Health and Research Centre, the Ministries of Public Health and Sanitation, Medical Services, and Education. Advisory support from DFID-sponsored SWASH (school water and sanitation), PATH, the German development agency (GIZ), and WHO Collaborating Centre on Violence, provides further partnership development. Findings will inform policy on prevention and care of adolescent girls, through menstrual solutions, at local, national, and international level, and the cost implications.
