Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

8 juli 2026 uppdaterad 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.

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

3080

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Faktoriell uppgift
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Kontrollera
Inget ingripande
Experimentell: School infrastructure only
Construction of latrines and handwashing basins
Övrig: School infrastructure
Construction of latrines and handwashing basins
Experimentell: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
Beteende: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
Experimentell: Full package
Combination of all interventions: Construction of latrines and handwashing basins and Peer leadership/sensitization + sanitary pads
Övrig: School infrastructure
Construction of latrines and handwashing basins
Beteende: Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Learning - Academic Test Scores
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to 17 months
Self-reported menstrual stigma (140-school full evaluation sample)
Up to 17 months

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of California Santa Cruz

Samarbetspartners

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

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 oktober 2024

Primärt slutförande (Beräknad)

1 augusti 2026

Avslutad studie (Beräknad)

1 december 2026

Studieregistreringsdatum

Först inskickad

1 juli 2026

Först inskickad som uppfyllde QC-kriterierna

8 juli 2026

Första postat (Faktisk)

14 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 juli 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera