Effect of Hygiene and Menstrual Hygiene Interventions on Learning and Psychosocial Wellbeing in Madagascar (KILONGA2)
8 juillet 2026 mis à jour par: University of California Santa Cruz
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
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.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
3080
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Antananarivo, Madagascar
- Laboratoire d'Analyses Médicales Malagasy
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Contrôler
Aucune intervention
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|
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Expérimental: School infrastructure only
Construction of latrines and handwashing basins
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Construction of latrines and handwashing basins
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Expérimental: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
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Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
|
|
Expérimental: Full package
Combination of all interventions: Construction of latrines and handwashing basins and Peer leadership/sensitization + sanitary pads
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Construction of latrines and handwashing basins
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Learning - Academic Test Scores
Délai: Up to 19 months
|
Standardized math/literacy test scores and official school grades (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
|
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Learning - School Grades
Délai: Up to 19 months
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Official school grades (140-school full evaluation sample and and 80-school biomarker subsample)
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Up to 19 months
|
|
Psychosocial Wellbeing - Heart Rate
Délai: Up to 19 months
|
Objective stress measure: heart rate, beats per minute (140-school full evaluation sample and 80-school biomarker subsample)
|
Up to 19 months
|
|
Psychosocial Wellbeing - Blood Pressure
Délai: Up to 19 months
|
Objective stress measure: systolic/diastolic blood pressure, mmHg (140-school full evaluation sample and 80-school biomarker subsample)
|
Up to 19 months
|
|
Psychosocial Wellbeing - Salivary Cortisol Reactivity
Délai: Up to 19 months
|
Salivary cortisol reactivity (80-school biomarker subsample).
Cortisol reactivity, calculated as the area under the curve with respect to increase (AUCi), based on samples collected at clinic arrival (baseline), 5-8 minutes pre-venipuncture, and 20 minutes post-venipuncture.
AUCi is calculated using the trapezoidal method: the area under the curve with respect to ground (AUCg) is first calculated by summing the areas of the trapezoids formed between each pair of consecutive cortisol values and their corresponding time interval, then subtracting the area under the baseline value across the total sampling duration.
This is expressed as AUCg = Σ[(Ci + Ci+1)/2 × Ti], where Ci is the cortisol concentration at a given timepoint, Ci+1 is the concentration at the subsequent timepoint, and Ti is the time interval between them.
AUCi = AUCg - (baseline cortisol × total sampling duration).
Reported in µg/dL×min.
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Up to 19 months
|
|
Menstrual stigma
Délai: Up to 17 months
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Self-reported menstrual stigma (140-school full evaluation sample)
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Up to 17 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hygiene Knowledge
Délai: Up to 17 months
|
Self-reported hygiene knowledge (140-school full evaluation sample)
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Up to 17 months
|
|
Hygiene Behavior
Délai: Up to 17 months
|
Self-reported hygiene behavior (140-school full evaluation sample)
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Up to 17 months
|
|
Menstrual Knowledge
Délai: Up to 17 months
|
Self-reported menstrual hygiene knowledge (140-school full evaluation sample)
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Up to 17 months
|
|
Menstrual Behavior
Délai: Up to 17 months
|
Self-reported menstrual hygiene behavior (140-school full evaluation sample)
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Up to 17 months
|
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Student/Teacher Motivation
Délai: Up to 17 months
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Self-reported student/teacher motivation (140-school full evaluation sample)
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Up to 17 months
|
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Network Integration
Délai: Up to 17 months
|
Self-reported social network integration (140-school full evaluation sample)
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Up to 17 months
|
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Bullying
Délai: Up to 17 months
|
Self-reported bullying (140-school full evaluation sample)
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Up to 17 months
|
|
Self-reported Psychosocial Wellbeing
Délai: Up to 19 months
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Self-reported psychosocial wellbeing (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
|
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Information Diffusion
Délai: Up to 17 months
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Self-reported exposure to hygiene/menstruation discussions (140-school full evaluation sample)
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Up to 17 months
|
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School Attendance
Délai: Up to 17 months
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Official school attendance records (140-school full evaluation sample)
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Up to 17 months
|
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School History
Délai: Up to 17 months
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Official school records of dropout/withdrawal status and grade repetition (140-school full evaluation sample)
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Up to 17 months
|
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Sexual Activity
Délai: Up to 17 months
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Self-reported early sexual activity (140-school full evaluation sample)
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Up to 17 months
|
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Pregnancy
Délai: Up to 19 months
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Self-reported pregnancy (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
|
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Health - Infectious Disease Symptoms
Délai: Up to 19 months
|
Self-reported infectious disease symptoms (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
|
|
Health - Mid-Upper-Arm Circumference (MUAC)
Délai: Up to 19 months
|
MUAC, cm (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
|
|
Health - Urinary Tract Infection
Délai: Up to 19 months
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Self-reported urinary tract infection (140-school full evaluation sample and 80-school biomarker subsample)
|
Up to 19 months
|
|
Health - C-Reactive Protein
Délai: Up to 19 months
|
Blood-based C-reactive protein, mg/L (80-school biomarker subsample)
|
Up to 19 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Audrie Lin, PhD, MPH, University of California Santa Cruz
- Chercheur principal: Karen Macours, PhD, Paris School of Economics
- Chercheur principal: Duncan Webb, PhD, Nova School of Business and Economics
- Chercheur principal: Mariachiara Iannuzzi, MS, Paris School of Economics
- Chercheur principal: Oscar M Díaz, MS, Paris School of Economics
- Chercheur principal: William Amedanou, MS, Paris School of Economics
- Chercheur principal: Juliet Ellenbach, BS, University of California Santa Cruz
- Chercheur principal: Eliane Z Ralison, Consultant Associates
- Chercheur principal: Andry M Andrianarivelo, MD, Laboratoire d'Analyses Médicales Malagasy
- Chercheur principal: Ianja I Razanadrakoto, MD, Laboratoire d'Analyses Médicales Malagasy
- Chercheur principal: Tantely J Ramontalambo, MD, Laboratoire d'Analyses Médicales Malagasy
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 octobre 2024
Achèvement primaire (Estimé)
1 août 2026
Achèvement de l'étude (Estimé)
1 décembre 2026
Dates d'inscription aux études
Première soumission
1 juillet 2026
Première soumission répondant aux critères de contrôle qualité
8 juillet 2026
Première publication (Réel)
14 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 juillet 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
- biomarqueurs
- anémie
- ados
- inflammation
- microbiote intestinal
- cortisol
- essai randomisé en grappes
- Madagascar
- infection urinaire
- intervention en milieu scolaire
- stress psychosocial
- dysfonctionnement entérique environnemental
- menstrual hygiene management
- menstrual hygiene intervention
- menstrual stigma reduction intervention
- WASH (water, sanitation, and hygiene)
- menstrual stigma
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Processus pathologiques
- Troubles nutritionnels
- Maladies urogénitales masculines
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Infections
- Maladies hématologiques
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Maladies hémiques et lymphatiques
- Malnutrition
- Inflammation
- Infections des voies urinaires
- Anémie
- Équipement et fournitures
- Produits d'hygiène féminine
- Produits d'Hygiène Menstruelle
Autres numéros d'identification d'étude
- HS-FY2025-210
- AEARCTR-0014423 (Identificateur de registre: The American Economic Association's RCT Registry)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be made publicly available.
Per the approved protocol (UCSC IRB: HS-FY2025-210), all survey and biospecimen data are de-identified at the point of collection; identifiers are stored separately from research data and accessible only to authorized project personnel.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .