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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Inflammation; Stress; Malnutrition; Urinary Tract Infections; Menstrual Hygiene
• Intervention / Treatment: Other: School infrastructure; Behavioral: Peer leadership/sensitization + sanitary pads

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 3080
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: School infrastructure only; Construction of latrines and handwashing basins	Other: 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	Behavioral: 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	Other: School infrastructure; Construction of latrines and handwashing basins; Behavioral: Peer leadership/sensitization + sanitary pads; Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Learning - Academic Test Scores	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	Official school grades (140-school full evaluation sample and and 80-school biomarker subsample)	Up to 19 months
Psychosocial Wellbeing - Heart Rate	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	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	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	Self-reported menstrual stigma (140-school full evaluation sample)	Up to 17 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California Santa Cruz
• Collaborators: Care International; Paris School of Economics; Laboratoire d'Analyses Médicales Malagasy (LA2M); Consultant Associates
• Investigators: Principal Investigator: Audrie Lin, PhD, MPH, University of California Santa Cruz; Principal Investigator: Karen Macours, PhD, Paris School of Economics; Principal Investigator: Duncan Webb, PhD, Nova School of Business and Economics; Principal Investigator: Mariachiara Iannuzzi, MS, Paris School of Economics; Principal Investigator: Oscar M Díaz, MS, Paris School of Economics; Principal Investigator: William Amedanou, MS, Paris School of Economics; Principal Investigator: Juliet Ellenbach, BS, University of California Santa Cruz; Principal Investigator: Eliane Z Ralison, Consultant Associates; Principal Investigator: Andry M Andrianarivelo, MD, Laboratoire d'Analyses Médicales Malagasy; Principal Investigator: Ianja I Razanadrakoto, MD, Laboratoire d'Analyses Médicales Malagasy; Principal Investigator: Tantely J Ramontalambo, MD, Laboratoire d'Analyses Médicales Malagasy

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers; anemia; adolescents; inflammation; gut microbiome; cortisol; cluster-randomized trial; Madagascar; urinary tract infection; school-based intervention; psychosocial stress; environmental enteric dysfunction; menstrual hygiene management; menstrual hygiene intervention; menstrual stigma reduction intervention; WASH (water, sanitation, and hygiene); menstrual stigma
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Hematologic Diseases; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Malnutrition; Inflammation; Urinary Tract Infections; Anemia; Equipment and Supplies; Feminine Hygiene Products; Menstrual Hygiene Products
• Other Study ID Numbers: HS-FY2025-210; AEARCTR-0014423 (Registry Identifier: The American Economic Association's RCT Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No