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

8 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

3080

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Controle
Geen tussenkomst
Experimenteel: School infrastructure only
Construction of latrines and handwashing basins
Ander: School infrastructure
Construction of latrines and handwashing basins
Experimenteel: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
Gedragsmatig: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
Experimenteel: Full package
Combination of all interventions: Construction of latrines and handwashing basins and Peer leadership/sensitization + sanitary pads
Ander: School infrastructure
Construction of latrines and handwashing basins
Gedragsmatig: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Learning - Academic Test Scores
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to 17 months
Self-reported menstrual stigma (140-school full evaluation sample)
Up to 17 months

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California Santa Cruz

Medewerkers

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

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 oktober 2024

Primaire voltooiing (Geschat)

1 augustus 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

1 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2026

Eerst geplaatst (Werkelijk)

14 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

8 juli 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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