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Field
Last Published
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Before
June 26, 2026 12:57 PM
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After
July 11, 2026 08:05 AM
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Field
Primary Outcomes (End Points)
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Before
• Learning. Standardized test scores in mathematics and literacy (direct assessment of 17 girls per school), and official school grades (79 girls per school).
• Psychosocial wellbeing – objective measures of stress (e.g. heart rate, blood pressure, cortisol).
• Menstrual stigma (self-reported)
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After
• Learning. Standardized test scores in mathematics and literacy (direct assessment of 17 girls per school), and official school grades (79 girls per school).
• Psychosocial wellbeing and physiological stress: objective measures of stress, including heart rate, blood pressure, and salivary cortisol reactivity. The prespecified primary cortisol endpoint is the area under the salivary cortisol concentration curve with respect to increase (AUCi), constructed from three saliva samples collected during the endline biomarker visit.
• Menstrual stigma (self-reported)
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Primary Outcomes (Explanation)
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Before
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After
Salivary cortisol will be measured at endline, up to approximately 19 months after baseline, in a nested biomarker subsample covering approximately 80 of the trial's 140 schools. The sample will include up to approximately 17 girls per school, with a planned maximum of approximately 1,360 girls.
Three saliva samples will be collected: (1) when the girl arrives at the clinic, before clinical procedures; (2) approximately 5-8 minutes before venipuncture; and (3) approximately 20 minutes after venipuncture. Venipuncture provides the acute stressor. Let C₁, C₂, and C₃ denote cortisol concentrations measured at elapsed times t₁, t₂, and t₃. We will calculate the area under the curve with respect to ground using the trapezoidal rule: AUCg = [(C₁ + C₂)/2] × (t₂ − t₁) + [(C₂ + C₃)/2] × (t₃ − t₂). The primary cortisol endpoint will be AUCi = AUCg − C₁ × (t₃ − t₁) and will be reported in μg/dL × min.
Cortisol AUCi is the single primary cortisol outcome. Individual cortisol concentrations, AUCg, changes between individual samples, percentage changes, and classifications based on cortisol response or recovery will be treated as secondary or exploratory outcomes.
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Experimental Design (Public)
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Before
The study will be an RCT in 140 secondary schools in rural areas of the Amoron’I Mania region in Madagascar. The schools will be randomly assigned to one of 4 treatment arms:
1. Control (35 schools)
2. Infrastructure only (35 schools) – only construction of latrines and handwashing basins
3. Sensitization interventions + free sanitary pads (35 schools) – only Young Girl Leaders, teacher sensitization, school-based hygiene competition, and free distribution of menstrual pads. 2-6 girls are nominated in each school to be Young Girl Leaders.
4. The full package (35 schools) – combine all interventions from (2) and (3).
Hypotheses being tested:
• Effect of infrastructure. Understanding the impacts of the infrastructure by comparing arms with and without infrastructure is crucial for evaluating the overall cost-effectiveness of the program, since it is expected to contribute to about 60% of the overall cost. Measuring the psychosocial wellbeing effects of physical infrastructure is also crucial. Our qualitative work has indicated that in this setting, with very high rates of poverty and little state presence, having salient interventions in schools (visits from officials or construction of visible infrastructure) could have important effects on motivation and other psychosocial factors driving education, even if they do not target these outcomes directly.
• Effect of sensitization + sanitary pad interventions. Conversely, since the rest of the bundle of interventions is substantially cheaper to implement, finding that it is sufficient to generate learning effects could imply that it is very cost effective, competitive with the most cost-effective interventions described by a Global Advisory panel on education interventions (GEEAP 2023).
• Complementarity between infrastructure and other interventions. There may be important complementarities between the two types of interventions: for example, girls may only be able to change their hygiene behaviour and begin handwashing if they have access to handwashing basins at school. The 4th arm thus enables us to test this complementarity.
Data collection:
• Baseline (pre-intervention, October 2024), midline (after 1 year of intervention), and endline (after 2 years of intervention)
• Girls’ survey (17 girls per school) using surveys at the household of the 2,380 teenage girls and their mothers; teacher and director survey (maximum 3 per school); school-level survey.
In midline and endline, we also add approximately 4-5 girls per school to the sample who were potential nominees to be Young Girl Leaders (both in treatment and control schools, regardless of whether they were eventually trained), in order to measure causal effects on YGLs themselves.
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After
The study will be an RCT in 140 secondary schools in rural areas of the Amoron’I Mania region in Madagascar. The schools will be randomly assigned to one of 4 treatment arms:
1. Control (35 schools)
2. Infrastructure only (35 schools) – only construction of latrines and handwashing basins
3. Sensitization interventions + free sanitary pads (35 schools) – only Young Girl Leaders, teacher sensitization, school-based hygiene competition, and free distribution of menstrual pads. 2-6 girls are nominated in each school to be Young Girl Leaders.
4. The full package (35 schools) – combine all interventions from (2) and (3).
Hypotheses being tested:
• Effect of infrastructure. Understanding the impacts of the infrastructure by comparing arms with and without infrastructure is crucial for evaluating the overall cost-effectiveness of the program, since it is expected to contribute to about 60% of the overall cost. Measuring the psychosocial wellbeing effects of physical infrastructure is also crucial. Our qualitative work has indicated that in this setting, with very high rates of poverty and little state presence, having salient interventions in schools (visits from officials or construction of visible infrastructure) could have important effects on motivation and other psychosocial factors driving education, even if they do not target these outcomes directly.
• Effect of sensitization + sanitary pad interventions. Conversely, since the rest of the bundle of interventions is substantially cheaper to implement, finding that it is sufficient to generate learning effects could imply that it is very cost effective, competitive with the most cost-effective interventions described by a Global Advisory panel on education interventions (GEEAP 2023).
• Complementarity between infrastructure and other interventions. There may be important complementarities between the two types of interventions: for example, girls may only be able to change their hygiene behaviour and begin handwashing if they have access to handwashing basins at school. The 4th arm thus enables us to test this complementarity.
Data collection:
• Baseline (pre-intervention, October 2024), midline (after 1 year of intervention), and endline (after 2 years of intervention)
• Girls’ survey (17 girls per school) using surveys at the household of the 2,380 teenage girls and their mothers; teacher and director survey (maximum 3 per school); school-level survey.
In midline and endline, we also add approximately 4-5 girls per school to the sample who were potential nominees to be Young Girl Leaders (both in treatment and control schools, regardless of whether they were eventually trained), in order to measure causal effects on YGLs themselves.
BIOMARKER OUTCOMES:
Biomarker outcomes will be collected at endline in a nested subsample of approximately 80 schools spanning all four randomized treatment arms. The sample will include up to approximately 17 girls per school, with a planned maximum of approximately 1,360 girls. The biomarker sample will be selected before biomarker assay results and treatment-effect analysis. School selection reflects the operational accessibility and cold-chain requirements of biomarker collection while preserving coverage and balance across treatment arms. Within selected schools, the target is up to 17 girls from the original study sample. Up to three Young Girl Leaders will be prioritized where available.
We will estimate intent-to-treat effects according to each school's original randomized assignment. The main specification will regress each biomarker outcome on indicators for the infrastructure-only, sensitization-plus-free-pads, and combined-treatment arms, with control schools as the omitted category. We will also report the p-values pooled factorial comparisons of infrastructure versus no infrastructure and sensitization versus no sensitization, together with tests comparing the treatment arms.
Regressions will include randomization-stratum fixed effects and baseline-grade fixed effects. We will use post-double-selection LASSO to select additional controls from prespecified pre-treatment covariates (Belloni, Chernozhukov, and Hansen, 2014). The selection procedure will take the union of variables that predict the outcome and randomized treatment assignment, while always including randomization strata and baseline grade into the model. An exact baseline measure of the outcome will also be included when one exists (although no baseline salivary cortisol or CRP measure was collected). Standard errors will be clustered at the school level.
The set of prespecified pre-treatment covariates for the post-double-selection LASSO was fixed prior to endline data collection and outcome unblinding. As a robustness check, we will additionally report an unadjusted specification, without LASSO-selected controls, to demonstrate that results are not sensitive to the covariate-selection procedure.
Reference
Belloni, A., Chernozhukov, V., & Hansen, C. (2014). Inference on treatment effects after selection among high-dimensional controls. The Review of Economic Studies, 81(2), 608–650. https://doi.org/10.1093/restud/rdt044
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Planned Number of Observations
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Before
The main sample includes 17 girls per school in each school, giving a total sample of 2,380.
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After
The main evaluation sample remains approximately 17 girls in each of 140 schools, for a planned total of 2,380 girls. Salivary cortisol and CRP will be collected at endline in a nested biomarker subsample covering approximately 80 schools, with up to approximately 17 girls per school and a planned maximum of approximately 1,360 girls.
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Secondary Outcomes (End Points)
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Before
• Hygiene and menstrual hygiene knowledge and behaviour (self-reported measures, distinguishing between menstrual health practices and other health & hygiene practices).
• Student and teacher motivation (self-reported measures)
• Network integration and bullying (self-reported)
• Self-reported psychosocial wellbeing
• Information diffusion measures (self-reported exposure to discussions on hygiene/menstruation)
• School attendance (official school attendance and self-reported measures)
• School educational outcomes (grades progression, repetition, and previous school history).
• Results on standardized cognitive tests (direct assesment)
• Measures regarding early sexual activity and pregnancy (self-reported)
• Health – health measures including self-reported infectious diseases, middle upper-arm circumference measures, urinary tract infections, and inflammation (CRP)
• Additional outcomes for YGLs: self-confidence/self-perception, openness to discussion
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After
• Hygiene and menstrual hygiene knowledge and behaviour (self-reported measures, distinguishing between menstrual health practices and other health & hygiene practices).
• Student and teacher motivation (self-reported measures)
• Network integration and bullying (self-reported)
• Self-reported psychosocial wellbeing
• Information diffusion measures (self-reported exposure to discussions on hygiene/menstruation)
• School attendance (official school attendance and self-reported measures)
• School educational outcomes (grades progression, repetition, and previous school history).
• Results on standardized cognitive tests (direct assesment)
• Measures regarding early sexual activity and pregnancy (self-reported)
• Health – health measures including self-reported infectious diseases, middle upper-arm circumference measures, urinary tract infections, and inflammation (blood-based C-reactive protein (CRP), measured during the endline biomarker visit in the same nested biomarker subsample)
• Additional outcomes for YGLs: self-confidence/self-perception, openness to discussion
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Secondary Outcomes (Explanation)
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Before
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After
CRP will be measured once from blood collected during the endline biomarker visit and reported in milligrams per liter (mg/L). CRP is a secondary outcome and is separate from the primary cortisol endpoint.
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