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

8. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

3080

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Kontrolle
Kein Eingriff
Experimental: School infrastructure only
Construction of latrines and handwashing basins
Sonstiges: School infrastructure
Construction of latrines and handwashing basins
Experimental: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
Verhalten: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
Experimental: Full package
Combination of all interventions: Construction of latrines and handwashing basins and Peer leadership/sensitization + sanitary pads
Sonstiges: School infrastructure
Construction of latrines and handwashing basins
Verhalten: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Learning - Academic Test Scores
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 17 months
Self-reported menstrual stigma (140-school full evaluation sample)
Up to 17 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hygiene Knowledge
Zeitfenster: Up to 17 months
Self-reported hygiene knowledge (140-school full evaluation sample)
Up to 17 months
Hygiene Behavior
Zeitfenster: Up to 17 months
Self-reported hygiene behavior (140-school full evaluation sample)
Up to 17 months
Menstrual Knowledge
Zeitfenster: Up to 17 months
Self-reported menstrual hygiene knowledge (140-school full evaluation sample)
Up to 17 months
Menstrual Behavior
Zeitfenster: Up to 17 months
Self-reported menstrual hygiene behavior (140-school full evaluation sample)
Up to 17 months
Student/Teacher Motivation
Zeitfenster: Up to 17 months
Self-reported student/teacher motivation (140-school full evaluation sample)
Up to 17 months
Network Integration
Zeitfenster: Up to 17 months
Self-reported social network integration (140-school full evaluation sample)
Up to 17 months
Bullying
Zeitfenster: Up to 17 months
Self-reported bullying (140-school full evaluation sample)
Up to 17 months
Self-reported Psychosocial Wellbeing
Zeitfenster: Up to 19 months
Self-reported psychosocial wellbeing (140-school full evaluation sample and 80-school biomarker subsample)
Up to 19 months
Information Diffusion
Zeitfenster: Up to 17 months
Self-reported exposure to hygiene/menstruation discussions (140-school full evaluation sample)
Up to 17 months
School Attendance
Zeitfenster: Up to 17 months
Official school attendance records (140-school full evaluation sample)
Up to 17 months
School History
Zeitfenster: 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
Zeitfenster: Up to 17 months
Self-reported early sexual activity (140-school full evaluation sample)
Up to 17 months
Pregnancy
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: Up to 19 months
MUAC, cm (140-school full evaluation sample and 80-school biomarker subsample)
Up to 19 months
Health - Urinary Tract Infection
Zeitfenster: 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
Zeitfenster: Up to 19 months
Blood-based C-reactive protein, mg/L (80-school biomarker subsample)
Up to 19 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California Santa Cruz

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Oktober 2024

Primärer Abschluss (Geschätzt)

1. August 2026

Studienabschluss (Geschätzt)

1. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

1. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juli 2026

Zuerst gepostet (Tatsächlich)

14. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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