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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Antananarivo, 마다가스카르
- Laboratoire d'Analyses Médicales Malagasy
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 제어
개입 없음
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실험적: School infrastructure only
Construction of latrines and handwashing basins
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Construction of latrines and handwashing basins
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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Learning - Academic Test Scores
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to 19 months
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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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hygiene Knowledge
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Audrie Lin, PhD, MPH, University of California Santa Cruz
- 수석 연구원: Karen Macours, PhD, Paris School of Economics
- 수석 연구원: Duncan Webb, PhD, Nova School of Business and Economics
- 수석 연구원: Mariachiara Iannuzzi, MS, Paris School of Economics
- 수석 연구원: Oscar M Díaz, MS, Paris School of Economics
- 수석 연구원: William Amedanou, MS, Paris School of Economics
- 수석 연구원: Juliet Ellenbach, BS, University of California Santa Cruz
- 수석 연구원: Eliane Z Ralison, Consultant Associates
- 수석 연구원: Andry M Andrianarivelo, MD, Laboratoire d'Analyses Médicales Malagasy
- 수석 연구원: Ianja I Razanadrakoto, MD, Laboratoire d'Analyses Médicales Malagasy
- 수석 연구원: Tantely J Ramontalambo, MD, Laboratoire d'Analyses Médicales Malagasy
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- HS-FY2025-210
- AEARCTR-0014423 (레지스트리 식별자: The American Economic Association's RCT Registry)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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