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| ID | Type | Description | Link |
|---|---|---|---|
| AEARCTR-0014423 | Registry Identifier | The American Economic Association's RCT Registry |
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| Name | Class |
|---|---|
| Paris School of Economics | OTHER |
| Laboratoire d'Analyses Médicales Malagasy (LA2M) | UNKNOWN |
| Consultant Associates | UNKNOWN |
| Care International |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No intervention | |
| School infrastructure only | Experimental | Construction of latrines and handwashing basins |
|
| Peer leadership/sensitization + sanitary pads | Experimental | Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers |
|
| Full package | Experimental | Combination of all interventions: Construction of latrines and handwashing basins and Peer leadership/sensitization + sanitary pads |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer leadership/sensitization + sanitary pads | Behavioral | Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratoire d'Analyses Médicales Malagasy | Antananarivo | Madagascar |
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.
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| UNKNOWN |
This is a 2×2 factorial design crossing two intervention components, each present or absent: (1) physical infrastructure (construction of latrines and handwashing basins) and (2) a sensitization and sanitary pad distribution bundle (Young Girl Leaders peer program, teacher sensitization, WASH committee/competition, and free sanitary pad vouchers). The four resulting arms are: Control (neither component), Infrastructure only, Sensitization+pads only, and the Full package (both components combined). The factorial structure allows estimation of each component's independent effect as well as any complementarity (interaction) between the two - for example, whether girls can only act on improved hygiene knowledge if handwashing infrastructure is also available at school.
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The outcome assessment team is separate from the implementation team, however due to the nature of the interventions there may be intervention contents visible during the assessment. Data analysis will be masked to randomization status of clusters.
| School infrastructure | Other | Construction of latrines and handwashing basins |
|
| Menstrual stigma | Self-reported menstrual stigma (140-school full evaluation sample) | Up to 17 months |
| 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 |
| Ianja I Razanadrakoto, MD |
| Laboratoire d'Analyses Médicales Malagasy |
| Principal Investigator |
| Tantely J Ramontalambo, MD | Laboratoire d'Analyses Médicales Malagasy | Principal Investigator |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D044342 | Malnutrition |
| D007249 | Inflammation |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D052576 | Menstrual Hygiene Products |
| ID | Term |
|---|---|
| D053566 | Feminine Hygiene Products |
| D004864 | Equipment and Supplies |
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