Effect of Hygiene and Menstrual Hygiene Interventions on Learning and Psychosocial Wellbeing in Madagascar
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Peer leadership/sensitization + sanitary pads, School infrastructure.
- Кому может быть актуально
- Состояния в реестре: Urinary Tract Infections, Malnutrition, Inflammation, Stress. Базовые параметры: 11 лет — 21 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Madagascar
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Disentangling the Effects of Infrastructure, Sensitization, and Sanitary Pad Distribution on Health, Learning, and Psychosocial Wellbeing Among Adolescent Girls in Rural Madagascar: A Cluster-Randomized Trial
Обзор
A previous study in schools in rural Madagascar found that a bundle of hygiene-focused interventions substantially improved girls' learning outcomes. This study disentangles the effects of physical infrastructure (latrines, handwashing basins) from other intervention components (peer sensitization and free sanitary pad distribution) in a cluster-randomized trial across 140 secondary schools in the Amoron'i Mania region. The trial originally measured learning and psychosocial wellbeing outcomes and was prospectively registered with the AEA RCT Registry (AEARCTR-0014423). The study team is now also collecting secondary health biomarker outcomes (e.g., salivary cortisol and blood-based C-reactive protein) and is registering those health biomarker endpoints with ClinicalTrials.gov.
Подробное описание
140 secondary schools were randomly assigned to one of four arms: (1) control, (2) infrastructure only, (3) sensitization + free sanitary pads, or (4) the full combined package. Outcomes are assessed via girls' surveys, teacher/director surveys, and school-level surveys at baseline (Oct 2024), midline, and endline.
This registration draws on two overlapping analytic samples. The first is the full 140-school evaluation sample (35 schools/arm; approximately 3,080 girls, \~22/school), used for the cognitive/academic composite, self-reported psychosocial well-being (GAD-7, PHQ-9), and health outcomes that do not require biospecimen collection or laboratory processing - self-reported infectious disease symptoms, mid-upper-arm circumference (MUAC), and self-reported urinary tract infection. These are collected during the social-science endline survey (May-June 2026), concurrent with the parent trial's learning and psychosocial data collection. The second is a 80-school biomarker subsample (approximately 20 schools/arm; \~1,360 girls, \~17/school), used specifically for salivary cortisol and blood-based C-reactive protein (CRP) drawn from a venipuncture. These outcomes require biospecimen collection, cold-chain transport, and laboratory assay, and are therefore restricted to the subset of schools logistically accessible for that purpose. They are collected at a separate endline health/biomarker visit at a Basic Health Center (July-August 2026, \~19 months post-baseline).
This registration covers the biomarker outcomes component of the trial, with data collection and analysis completing by approximately December 2026; the broader parent Kilonga 2 trial (registered with the AEA RCT Registry, AEARCTR-0014423) has a longer overall completion date of December 2027, covering the full set of learning and psychosocial endpoints. The biospecimen collection protocol includes additional biomarkers, cortisol and C-reactive protein, as registered secondary outcomes.
This trial was registered with ClinicalTrials.gov retrospectively, after participant enrollment had already begun. At inception (October 2024), the study was designed and IRB-approved (Paris School of Economics IRB #2024-046, approved September 17, 2024) as a social science evaluation focused on learning outcomes, and was prospectively registered with the AEA RCT Registry (AEARCTR-0014423) on September 23, 2024. Registration with ClinicalTrials.gov was initiated upon expanding the study to include health-related biomarker secondary endpoints, in order to comply with ICMJE requirements for biomedical journal publication. The Pre-Analysis Plan covering these health endpoints will be timestamped on the Open Science Framework prior to the start of health data collection in July 2026.
Вмешательства
- Поведенческое Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers - Другое School infrastructure
Construction of latrines and handwashing basins
Первичные конечные точки
- Learning - Academic Test Scores [Срок оценки: Up to 19 months]
- Learning - School Grades [Срок оценки: Up to 19 months]
- Psychosocial Wellbeing - Heart Rate [Срок оценки: Up to 19 months]
- Psychosocial Wellbeing - Blood Pressure [Срок оценки: Up to 19 months]
- Psychosocial Wellbeing - Salivary Cortisol Reactivity [Срок оценки: Up to 19 months]
- Menstrual stigma [Срок оценки: Up to 17 months]
Вторичные конечные точки (12)
- Hygiene Knowledge [Срок оценки: Up to 17 months]
- Hygiene Behavior [Срок оценки: Up to 17 months]
- Menstrual Knowledge [Срок оценки: Up to 17 months]
- Menstrual Behavior [Срок оценки: Up to 17 months]
- Student/Teacher Motivation [Срок оценки: Up to 17 months]
- Network Integration [Срок оценки: Up to 17 months]
- Bullying [Срок оценки: Up to 17 months]
- Self-reported Psychosocial Wellbeing [Срок оценки: Up to 19 months]
- Information Diffusion [Срок оценки: Up to 17 months]
- School Attendance [Срок оценки: Up to 17 months]
- School History [Срок оценки: Up to 17 months]
- Sexual Activity [Срок оценки: Up to 17 months]
Критерии участия
Критерии включения
- Girl identified in the Kilonga 2 evaluation sample (randomly selected during the December 2024-January 2025 baseline from class registers across the 140 participating schools); participants were 11-20 years old at baseline enrollment and are approximately 12-21 years old at the time of endline/health-outcomes data collection (May-August 2026)
- Full evaluation sample (n\~3,080; \~22 girls/school): all girls in the Kilonga 2 sample across the 140 schools are eligible for the cognitive, self-reported psychosocial, and non-biospecimen health outcomes, collected at the social-science endline.
- Biomarker subsample (n\~1,360; \~17 girls/school): girls attending one of the 80 schools selected for the health biomarker subsample (logistically accessible for biospecimen collection and cold-chain maintenance) are additionally eligible for salivary cortisol and blood-based C-reactive protein outcomes.
- Informed consent obtained from parent/legal guardian, and assent obtained from the participant herself
Критерии исключения
- Adolescents not meeting the inclusion criteria above
- Adolescents (or their parent/legal guardian) who refuse to participate or who withdraw consent/assent at any time
- Adolescents for whom sample collection is judged impossible or contraindicated at the time of collection (e.g., health status precluding collection)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Факторный дизайн
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
Madagascar · 1 центр
- Laboratoire d'Analyses Médicales Malagasy — Antananarivo
Идентификаторы
NCT: NCT07702916 · HS-FY2025-210 · AEARCTR-0014423