Inflammation, Malnutrition, Menstrual Hygiene, Stress, Urinary Tract Infections
Conditions
Keywords
menstrual hygiene management, menstrual hygiene intervention, menstrual stigma reduction intervention, adolescents, school-based intervention, WASH (water, sanitation, and hygiene), Madagascar, cluster-randomized trial, biomarkers, psychosocial stress, cortisol, inflammation, anemia, urinary tract infection, environmental enteric dysfunction, gut microbiome, menstrual stigma
Brief summary
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.
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.
Interventions
BEHAVIORALPeer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
OTHERSchool infrastructure
Construction of latrines and handwashing basins
Sponsors
University of California Santa Cruz
Paris School of Economics
Laboratoire d'Analyses Médicales Malagasy (LA2M)
Consultant Associates
Care International
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 21 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Learning - Academic Test Scores | Up to 19 months | Standardized math/literacy test scores and official school grades (140-school full evaluation sample and 80-school biomarker subsample) |
| Learning - School Grades | Up to 19 months | Official school grades (140-school full evaluation sample and and 80-school biomarker subsample) |
| Psychosocial Wellbeing - Heart Rate | Up to 19 months | Objective stress measure: heart rate, beats per minute (140-school full evaluation sample and 80-school biomarker subsample) |
| Psychosocial Wellbeing - Blood Pressure | Up to 19 months | Objective stress measure: systolic/diastolic blood pressure, mmHg (140-school full evaluation sample and 80-school biomarker subsample) |
| Psychosocial Wellbeing - Salivary Cortisol Reactivity | 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. |
| Menstrual stigma | Up to 17 months | Self-reported menstrual stigma (140-school full evaluation sample) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hygiene Knowledge | Up to 17 months | Self-reported hygiene knowledge (140-school full evaluation sample) |
| Hygiene Behavior | Up to 17 months | Self-reported hygiene behavior (140-school full evaluation sample) |
| Menstrual Knowledge | Up to 17 months | Self-reported menstrual hygiene knowledge (140-school full evaluation sample) |
| Menstrual Behavior | Up to 17 months | Self-reported menstrual hygiene behavior (140-school full evaluation sample) |
| Student/Teacher Motivation | Up to 17 months | Self-reported student/teacher motivation (140-school full evaluation sample) |
| Network Integration | Up to 17 months | Self-reported social network integration (140-school full evaluation sample) |
| Bullying | Up to 17 months | Self-reported bullying (140-school full evaluation sample) |
| Self-reported Psychosocial Wellbeing | Up to 19 months | Self-reported psychosocial wellbeing (140-school full evaluation sample and 80-school biomarker subsample) |
| Information Diffusion | Up to 17 months | Self-reported exposure to hygiene/menstruation discussions (140-school full evaluation sample) |
| School Attendance | Up to 17 months | Official school attendance records (140-school full evaluation sample) |
| School History | Up to 17 months | Official school records of dropout/withdrawal status and grade repetition (140-school full evaluation sample) |
| Sexual Activity | Up to 17 months | Self-reported early sexual activity (140-school full evaluation sample) |
| Pregnancy | Up to 19 months | Self-reported pregnancy (140-school full evaluation sample and 80-school biomarker subsample) |
| Health - Infectious Disease Symptoms | Up to 19 months | Self-reported infectious disease symptoms (140-school full evaluation sample and 80-school biomarker subsample) |
| Health - Mid-Upper-Arm Circumference (MUAC) | Up to 19 months | MUAC, cm (140-school full evaluation sample and 80-school biomarker subsample) |
| Health - Urinary Tract Infection | Up to 19 months | Self-reported urinary tract infection (140-school full evaluation sample and 80-school biomarker subsample) |
| Health - C-Reactive Protein | Up to 19 months | Blood-based C-reactive protein, mg/L (80-school biomarker subsample) |
Countries
Madagascar
Contacts
PRINCIPAL_INVESTIGATORAudrie Lin, PhD, MPH
University of California Santa Cruz
PRINCIPAL_INVESTIGATORKaren Macours, PhD
Paris School of Economics
PRINCIPAL_INVESTIGATORDuncan Webb, PhD
Nova School of Business and Economics
PRINCIPAL_INVESTIGATORMariachiara Iannuzzi, MS
Paris School of Economics
PRINCIPAL_INVESTIGATOROscar M Díaz, MS
Paris School of Economics
PRINCIPAL_INVESTIGATORWilliam Amedanou, MS
Paris School of Economics
PRINCIPAL_INVESTIGATORJuliet Ellenbach, BS
University of California Santa Cruz
PRINCIPAL_INVESTIGATOREliane Z Ralison
Consultant Associates
PRINCIPAL_INVESTIGATORAndry M Andrianarivelo, MD
Laboratoire d'Analyses Médicales Malagasy
PRINCIPAL_INVESTIGATORIanja I Razanadrakoto, MD
Laboratoire d'Analyses Médicales Malagasy
PRINCIPAL_INVESTIGATORTantely J Ramontalambo, MD
Laboratoire d'Analyses Médicales Malagasy
Outcome results
None listed