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Effect of Hygiene and Menstrual Hygiene Interventions on Learning and Psychosocial Wellbeing in Madagascar (KILONGA2)

8. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zápis na pozvánku

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

3080

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Madagaskar
      • Antananarivo, Madagaskar
        • Laboratoire d'Analyses Médicales Malagasy

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Řízení
Žádný zásah
Experimentální: School infrastructure only
Construction of latrines and handwashing basins
Jiný: School infrastructure
Construction of latrines and handwashing basins
Experimentální: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
Behaviorální: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
Experimentální: Full package
Combination of all interventions: Construction of latrines and handwashing basins and Peer leadership/sensitization + sanitary pads
Jiný: School infrastructure
Construction of latrines and handwashing basins
Behaviorální: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Learning - Academic Test Scores
Časové okno: Up to 19 months
Standardized math/literacy test scores and official school grades (140-school full evaluation sample and 80-school biomarker subsample)
Up to 19 months
Learning - School Grades
Časové okno: Up to 19 months
Official school grades (140-school full evaluation sample and and 80-school biomarker subsample)
Up to 19 months
Psychosocial Wellbeing - Heart Rate
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Up to 19 months
Menstrual stigma
Časové okno: Up to 17 months
Self-reported menstrual stigma (140-school full evaluation sample)
Up to 17 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Hygiene Knowledge
Časové okno: Up to 17 months
Self-reported hygiene knowledge (140-school full evaluation sample)
Up to 17 months
Hygiene Behavior
Časové okno: Up to 17 months
Self-reported hygiene behavior (140-school full evaluation sample)
Up to 17 months
Menstrual Knowledge
Časové okno: Up to 17 months
Self-reported menstrual hygiene knowledge (140-school full evaluation sample)
Up to 17 months
Menstrual Behavior
Časové okno: Up to 17 months
Self-reported menstrual hygiene behavior (140-school full evaluation sample)
Up to 17 months
Student/Teacher Motivation
Časové okno: Up to 17 months
Self-reported student/teacher motivation (140-school full evaluation sample)
Up to 17 months
Network Integration
Časové okno: Up to 17 months
Self-reported social network integration (140-school full evaluation sample)
Up to 17 months
Bullying
Časové okno: Up to 17 months
Self-reported bullying (140-school full evaluation sample)
Up to 17 months
Self-reported Psychosocial Wellbeing
Časové okno: Up to 19 months
Self-reported psychosocial wellbeing (140-school full evaluation sample and 80-school biomarker subsample)
Up to 19 months
Information Diffusion
Časové okno: Up to 17 months
Self-reported exposure to hygiene/menstruation discussions (140-school full evaluation sample)
Up to 17 months
School Attendance
Časové okno: Up to 17 months
Official school attendance records (140-school full evaluation sample)
Up to 17 months
School History
Časové okno: Up to 17 months
Official school records of dropout/withdrawal status and grade repetition (140-school full evaluation sample)
Up to 17 months
Sexual Activity
Časové okno: Up to 17 months
Self-reported early sexual activity (140-school full evaluation sample)
Up to 17 months
Pregnancy
Časové okno: Up to 19 months
Self-reported pregnancy (140-school full evaluation sample and 80-school biomarker subsample)
Up to 19 months
Health - Infectious Disease Symptoms
Časové okno: Up to 19 months
Self-reported infectious disease symptoms (140-school full evaluation sample and 80-school biomarker subsample)
Up to 19 months
Health - Mid-Upper-Arm Circumference (MUAC)
Časové okno: Up to 19 months
MUAC, cm (140-school full evaluation sample and 80-school biomarker subsample)
Up to 19 months
Health - Urinary Tract Infection
Časové okno: Up to 19 months
Self-reported urinary tract infection (140-school full evaluation sample and 80-school biomarker subsample)
Up to 19 months
Health - C-Reactive Protein
Časové okno: Up to 19 months
Blood-based C-reactive protein, mg/L (80-school biomarker subsample)
Up to 19 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of California Santa Cruz

Spolupracovníci

Care International
Paris School of Economics
Laboratoire d'Analyses Médicales Malagasy (LA2M)
Consultant Associates

Vyšetřovatelé

  • Vrchní vyšetřovatel: Audrie Lin, PhD, MPH, University of California Santa Cruz
  • Vrchní vyšetřovatel: Karen Macours, PhD, Paris School of Economics
  • Vrchní vyšetřovatel: Duncan Webb, PhD, Nova School of Business and Economics
  • Vrchní vyšetřovatel: Mariachiara Iannuzzi, MS, Paris School of Economics
  • Vrchní vyšetřovatel: Oscar M Díaz, MS, Paris School of Economics
  • Vrchní vyšetřovatel: William Amedanou, MS, Paris School of Economics
  • Vrchní vyšetřovatel: Juliet Ellenbach, BS, University of California Santa Cruz
  • Vrchní vyšetřovatel: Eliane Z Ralison, Consultant Associates
  • Vrchní vyšetřovatel: Andry M Andrianarivelo, MD, Laboratoire d'Analyses Médicales Malagasy
  • Vrchní vyšetřovatel: Ianja I Razanadrakoto, MD, Laboratoire d'Analyses Médicales Malagasy
  • Vrchní vyšetřovatel: Tantely J Ramontalambo, MD, Laboratoire d'Analyses Médicales Malagasy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. října 2024

Primární dokončení (Odhadovaný)

1. srpna 2026

Dokončení studie (Odhadovaný)

1. prosince 2026

Termíny zápisu do studia

První předloženo

1. července 2026

První předloženo, které splnilo kritéria kontroly kvality

8. července 2026

První zveřejněno (Aktuální)

14. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. července 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • HS-FY2025-210
  • AEARCTR-0014423 (Identifikátor registru: The American Economic Association's RCT Registry)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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