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

8. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

3080

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Styre
Ingen inngrep
Eksperimentell: School infrastructure only
Construction of latrines and handwashing basins
Annen: School infrastructure
Construction of latrines and handwashing basins
Eksperimentell: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
Atferdsmessig: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
Eksperimentell: Full package
Combination of all interventions: Construction of latrines and handwashing basins and Peer leadership/sensitization + sanitary pads
Annen: School infrastructure
Construction of latrines and handwashing basins
Atferdsmessig: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Learning - Academic Test Scores
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 17 months
Self-reported menstrual stigma (140-school full evaluation sample)
Up to 17 months

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California Santa Cruz

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. oktober 2024

Primær fullføring (Antatt)

1. august 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

1. juli 2026

Først innsendt som oppfylte QC-kriteriene

8. juli 2026

Først lagt ut (Faktiske)

14. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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