Menstrual health interventions, schooling and mental health symptoms among Ugandan students (MENISCUS): a school-based cluster-randomised trial

许多女孩缺乏安全和有尊严地管理月经的基本知识、设施和/或材料。改善月经健康可以为教育、健康和发展带来持续、长期的好处。许多政府和非政府组织对引入干预措施以改善月经健康感兴趣(包括英国政府时期贫困问题特别工作组)。然而，缺乏指导政策和确保干预措施有效的证据。我们已经完成的形成性研究表明，i)月经健康不良是导致乌干达瓦基索地区女孩焦虑和缺课的关键因素，ii)需要有效的干预措施来解决缺乏青春期和月经知识以及社会环境(以减少耻辱)的问题，以及使女孩能够更好地管理其经期的实用方法，即提供避孕垫、关于有效疼痛管理的教育和改善学校厕所设施。我们的研究表明，针对这些因素的干预可能会改善教育和心理健康结果，但需要一项随机对照试验来确定结果，以推动政策变化。试验的目的是评估干预(“半月板”)是否改善了乌干达中学女孩的教育程度、心理健康症状、月经管理和生活质量。这项干预是与教师和学校共同制定的，并于2017-2018年在两所学校成功试点。该试验将对干预措施的影响进行评估，随机选择两个地区的48所中学，24所学校接受半月板干预，24所学校接受优化的日常护理(提供政府月经健康指南和其他相关印刷材料)。一年后将比较中学生(平均年龄15岁)和ARM之间的结果，并对基线测量进行调整。主要结果是：i)基于干预年教授的课程的考试表现；以及ii)心理健康症状，包括情绪症状、注意力和同伴关系问题。我们还将评估干预对其他结果的影响，包括(女孩和男孩)月经知识和态度；(仅限女孩)月经习惯(正确使用月经垫和/或月经杯)、自我效能(月经前后的耻辱和尴尬)、学校和课堂出勤率以及泌尿生殖系统感染的流行率。主要结果将在所有在中二阶段接受干预的学生身上进行评估。后两种结果将在1920名女生中进行评估。干预措施的设计符合文化上的适当、与政府的指导方针一致、成本效益高、环境友好，并且在学校内实际上是可持续的。我们将通过过程评估、卫生经济学分析和政策分析来评估这些因素。这种干预在几个方面都是新颖的。它将是第一个)真正多组成部分(即，不主要关注教育、提供卫生间或改善厕所设施)，ii)解决疼痛管理(女孩缺课的一个主要原因)，iii)关注男孩和女孩(使我们能够解决耻辱和改善学校环境)，以及iv)包括农村和城市周边地区的中学(以前的大多数研究都在农村地区的小学进行)。在试验结束时，控制组中的学校将获得干预方案。我们将通过研讨会和会议与当地、国家和国际利益攸关方分享调查结果，以便酌情扩大干预措施，并提供必要的证据，以指导迅速增长的致力于改善全球月经健康的执行伙伴社区。

Many girls lack basic knowledge, facilities and/or materials for managing menstruation safely and with dignity. Improving menstrual health can lead to sustained, long-term benefits to education, health and development. Many governmental and non-governmental organisations are interested in introducing interventions to improve menstrual health, (including the UK Government Period Poverty Taskforce). However, there is a lack of evidence to guide policies and ensure interventions are effective.We have completed formative studies showing that i) poor menstrual health is a key factor associated with anxiety among girls, and with missing secondary school or class in Wakiso District, Uganda, and ii) an effective intervention needs to address lack of knowledge of puberty and menstruation, and the social environment (to reduce stigma), as well as practical methods to enable girls to better manage their periods i.e. pad provision, education about effective pain management, and improvements to school toilet facilities. Our studies suggest that an intervention addressing these elements can potentially improve education and mental health outcomes, but a randomised controlled trial is needed for definitive results to drive forward policy changes.The aim of the trial is to assess whether the intervention ("MENISCUS") improves educational attainment, mental health symptoms, menstrual management and quality of life outcomes among girls in secondary school in Uganda. The intervention has been developed with teachers and schools, and was successfully piloted in two schools in 2017-2018. The trial will evaluate the impact of the intervention by randomising 48 secondary schools in two districts, so that 24 schools receive the MENISCUS intervention, and 24 receive optimised usual care (provision of Government Menstrual Health guidelines and other relevant printed materials). The outcomes will be compared in secondary students (mean age 15 years) between arms after one year, adjusting for baseline measures.The primary outcomes are i) examination performance based on the curriculum taught during the intervention year; and ii) mental health symptoms including emotional symptoms, attention and peer relationship problems. We will also assess the impact of the intervention on other outcomes including (in both girls and boys) menstrual knowledge and attitudes; and (in girls only) menstrual practices (correct use of pads and/or menstrual cups), self-efficacy (stigma and embarrassment around menstruation), school and class attendance, and prevalence of urogenital infections. The main outcomes will be assessed in all students who were exposed to the intervention in Secondary 2. The latter two outcomes will be assessed in a sub-group of 1920 girls.The intervention has been designed to be culturally appropriate, aligned with Government guidelines, cost-effective, environmentally-friendly and practically sustainable within the schools. We will assess these elements through a process evaluation, health economics analysis and policy analysis.The intervention is novel in several ways. It will be the first to i) be truly multi-component (i.e. not focusing primarily on either education, provision of pads, or improvement of toilet facilities), ii) address pain management (a major reason for school absence in girls), iii) focus on boys as well as girls (enabling us to address stigma and improve the school environment), and iv) include secondary schools in rural and peri-urban areas (most previous studies have been in primary schools in rural areas). At the end of the trial, the schools in the control arm will be offered the intervention package. We will share findings with local, national and international stakeholders through a workshop and meetings so that the intervention can be scaled-up as appropriate, and provide needed evidence to guide the rapidly growing community of implementing partners working to improve menstrual health globally.