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集群随机对照评估 Nia 项目:研究方案。

Cluster randomized evaluation of the Nia Project: study protocol.

机构信息

Population Council, P.O. Box 17643-00500, Nairobi, Kenya.

出版信息

Reprod Health. 2018 Dec 29;15(1):218. doi: 10.1186/s12978-018-0586-4.

Abstract

BACKGROUND

The onset of puberty and menarche is a specifically vulnerable time for girls, during which they begin to show interest in the opposite sex, while becoming exposed to a myriad of external pressures, including sexual coercion or harassment from boys and men, expectations to marry from their families, and the need to perform well in primary school in order to qualify for secondary school. According to several qualitative studies in Africa, such pressures are exacerbated by girls' lack of knowledge of their bodies, their rights, and the implications of their decisions, and by their inability to manage puberty and adolescence safely and comfortably with appropriate menstrual health and hygiene management (MHM) products. The evaluation of the Nia Project is one of the first to analyze the individual and combined contributions of sanitary pads and provision of comprehensive reproductive health education on girls' education and reproductive health outcomes.

METHODS

The design for the evaluation of the Nia Project is a longitudinal, cluster-randomized controlled trial consisting of a baseline survey with a cohort of Class 7 girls, a school quality survey, qualitative data collection, school attendance tracking, and an endline survey at the completion of the 18-month intervention period with the same cohort. The study involves 140 public primary schools in three rural sub-counties (Magarini, Kaloleni and Ganze) of Kilifi County in the Coastal area of Kenya. The research sample includes 3489 girls, with about 25 girls per school on average. Before program implementation, the schools were stratified by sub-county and randomized to one of four study arms (35 schools per arm): 1) control, 2) disposable sanitary pads distribution, 2) reproductive health education, and 4) sanitary pad distribution and reproductive health education.

DISCUSSION

The evidence provided will inform program investment and design, and contribute to the literature on the effect of menstrual health-based interventions on girls' agency, safety and life outcomes.

TRIAL REGISTRATION

ISRCTN10894523 . Trial Registration Date: August 22, 2017.

摘要

背景

青春期和初潮是女孩特别脆弱的时期,在此期间,她们开始对异性产生兴趣,同时也面临着无数的外部压力,包括来自男孩和男人的性胁迫或骚扰、来自家庭的结婚期望,以及为了进入中学而在小学取得好成绩的需要。根据非洲的几项定性研究,由于女孩对自己的身体、权利和决定的影响缺乏了解,以及她们无法安全、舒适地管理青春期和青少年时期,同时缺乏适当的经期健康和卫生管理 (MHM) 产品,这些压力会加剧。Nia 项目的评估是最早分析卫生垫的单独和综合贡献以及提供全面生殖健康教育对女孩教育和生殖健康结果的评估之一。

方法

Nia 项目评估的设计是一项纵向、整群随机对照试验,包括对 7 年级女生队列进行基线调查、学校质量调查、定性数据收集、出勤率跟踪以及在为期 18 个月的干预期结束时对同一队列进行的终线调查。该研究涉及肯尼亚沿海基利菲县的三个农村县(马加里尼、卡洛莱尼和甘泽)的 140 所公立小学。研究样本包括 3489 名女孩,平均每所学校约有 25 名女孩。在项目实施之前,学校按县进行分层,随机分配到四个研究组之一(每组 35 所学校):1)对照组,2)一次性卫生垫分配,2)生殖健康教育,和 4)卫生垫分配和生殖健康教育。

讨论

提供的证据将为项目投资和设计提供信息,并为基于经期健康的干预措施对女孩代理、安全和生活结果的影响的文献做出贡献。

试验注册

ISRCTN8564612。试验注册日期:2017 年 8 月 22 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e7f/6310925/502e2d0adae9/12978_2018_586_Fig1_HTML.jpg

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