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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Antananarivo、マダガスカル
- Laboratoire d'Analyses Médicales Malagasy
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：コントロール
介入なし
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実験的：School infrastructure only
Construction of latrines and handwashing basins
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Construction of latrines and handwashing basins
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実験的：Peer leadership/sensitization + sanitary pads
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
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Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
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実験的：Full package
Combination of all interventions: Construction of latrines and handwashing basins and Peer leadership/sensitization + sanitary pads
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Construction of latrines and handwashing basins
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Learning - Academic Test Scores
時間枠：Up to 19 months
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Standardized math/literacy test scores and official school grades (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
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Learning - School Grades
時間枠：Up to 19 months
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Official school grades (140-school full evaluation sample and and 80-school biomarker subsample)
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Up to 19 months
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Psychosocial Wellbeing - Heart Rate
時間枠：Up to 19 months
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Objective stress measure: heart rate, beats per minute (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
|
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Psychosocial Wellbeing - Blood Pressure
時間枠：Up to 19 months
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Objective stress measure: systolic/diastolic blood pressure, mmHg (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
|
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Psychosocial Wellbeing - Salivary Cortisol Reactivity
時間枠：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.
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Up to 19 months
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Menstrual stigma
時間枠：Up to 17 months
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Self-reported menstrual stigma (140-school full evaluation sample)
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Up to 17 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hygiene Knowledge
時間枠：Up to 17 months
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Self-reported hygiene knowledge (140-school full evaluation sample)
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Up to 17 months
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Hygiene Behavior
時間枠：Up to 17 months
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Self-reported hygiene behavior (140-school full evaluation sample)
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Up to 17 months
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Menstrual Knowledge
時間枠：Up to 17 months
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Self-reported menstrual hygiene knowledge (140-school full evaluation sample)
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Up to 17 months
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Menstrual Behavior
時間枠：Up to 17 months
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Self-reported menstrual hygiene behavior (140-school full evaluation sample)
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Up to 17 months
|
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Student/Teacher Motivation
時間枠：Up to 17 months
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Self-reported student/teacher motivation (140-school full evaluation sample)
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Up to 17 months
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Network Integration
時間枠：Up to 17 months
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Self-reported social network integration (140-school full evaluation sample)
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Up to 17 months
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Bullying
時間枠：Up to 17 months
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Self-reported bullying (140-school full evaluation sample)
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Up to 17 months
|
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Self-reported Psychosocial Wellbeing
時間枠：Up to 19 months
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Self-reported psychosocial wellbeing (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
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Information Diffusion
時間枠：Up to 17 months
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Self-reported exposure to hygiene/menstruation discussions (140-school full evaluation sample)
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Up to 17 months
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School Attendance
時間枠：Up to 17 months
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Official school attendance records (140-school full evaluation sample)
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Up to 17 months
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School History
時間枠：Up to 17 months
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Official school records of dropout/withdrawal status and grade repetition (140-school full evaluation sample)
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Up to 17 months
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Sexual Activity
時間枠：Up to 17 months
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Self-reported early sexual activity (140-school full evaluation sample)
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Up to 17 months
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Pregnancy
時間枠：Up to 19 months
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Self-reported pregnancy (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
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Health - Infectious Disease Symptoms
時間枠：Up to 19 months
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Self-reported infectious disease symptoms (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
|
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Health - Mid-Upper-Arm Circumference (MUAC)
時間枠：Up to 19 months
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MUAC, cm (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
|
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Health - Urinary Tract Infection
時間枠：Up to 19 months
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Self-reported urinary tract infection (140-school full evaluation sample and 80-school biomarker subsample)
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Up to 19 months
|
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Health - C-Reactive Protein
時間枠：Up to 19 months
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Blood-based C-reactive protein, mg/L (80-school biomarker subsample)
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Up to 19 months
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協力者と研究者
協力者
捜査官
- 主任研究者：Audrie Lin, PhD, MPH、University of California Santa Cruz
- 主任研究者：Karen Macours, PhD、Paris School of Economics
- 主任研究者：Duncan Webb, PhD、Nova School of Business and Economics
- 主任研究者：Mariachiara Iannuzzi, MS、Paris School of Economics
- 主任研究者：Oscar M Díaz, MS、Paris School of Economics
- 主任研究者：William Amedanou, MS、Paris School of Economics
- 主任研究者：Juliet Ellenbach, BS、University of California Santa Cruz
- 主任研究者：Eliane Z Ralison、Consultant Associates
- 主任研究者：Andry M Andrianarivelo, MD、Laboratoire d'Analyses Médicales Malagasy
- 主任研究者：Ianja I Razanadrakoto, MD、Laboratoire d'Analyses Médicales Malagasy
- 主任研究者：Tantely J Ramontalambo, MD、Laboratoire d'Analyses Médicales Malagasy
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- HS-FY2025-210
- AEARCTR-0014423 (レジストリ識別子：The American Economic Association's RCT Registry)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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