An interventional study of Peer leadership/sensitization + sanitary pads and School infrastructure in Urinary Tract Infections, Malnutrition and Inflammation, sponsored by University of California Santa Cruz. Enrolling by invitation at 1 site in Madagascar. Open to female participants aged 11 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by University of California Santa Cruz · Not applicable, Interventional, and Prevention
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.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's planned enrollment of 3,080 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →University of California Santa Cruz is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention
Construction of latrines and handwashing basins
Other: School infrastructure
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
Behavioral: Peer leadership/sensitization + sanitary pads
Combination of all interventions: Construction of latrines and handwashing basins and Peer leadership/sensitization + sanitary pads
Behavioral: Peer leadership/sensitization + sanitary pads · Other: School infrastructure
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
Construction of latrines and handwashing basins
Learning - Academic Test Scores
Standardized math/literacy test scores and official school grades (140-school full evaluation sample and 80-school biomarker subsample)
Time frame: Up to 19 months
Learning - School Grades
Official school grades (140-school full evaluation sample and and 80-school biomarker subsample)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: Up to 19 months
Menstrual stigma
Self-reported menstrual stigma (140-school full evaluation sample)
Time frame: Up to 17 months
Hygiene Knowledge
Self-reported hygiene knowledge (140-school full evaluation sample)
Time frame: Up to 17 months
Hygiene Behavior
Self-reported hygiene behavior (140-school full evaluation sample)
Time frame: Up to 17 months
Menstrual Knowledge
Self-reported menstrual hygiene knowledge (140-school full evaluation sample)
Time frame: Up to 17 months
Menstrual Behavior
Self-reported menstrual hygiene behavior (140-school full evaluation sample)
Time frame: Up to 17 months
Student/Teacher Motivation
Self-reported student/teacher motivation (140-school full evaluation sample)
Time frame: Up to 17 months
Network Integration
Self-reported social network integration (140-school full evaluation sample)
Time frame: Up to 17 months
Bullying
Self-reported bullying (140-school full evaluation sample)
Time frame: Up to 17 months
Self-reported Psychosocial Wellbeing
Self-reported psychosocial wellbeing (140-school full evaluation sample and 80-school biomarker subsample)
Time frame: Up to 19 months
Information Diffusion
Self-reported exposure to hygiene/menstruation discussions (140-school full evaluation sample)
Time frame: Up to 17 months
School Attendance
Official school attendance records (140-school full evaluation sample)
Time frame: Up to 17 months
School History
Official school records of dropout/withdrawal status and grade repetition (140-school full evaluation sample)
Time frame: Up to 17 months
Sexual Activity
Self-reported early sexual activity (140-school full evaluation sample)
Time frame: Up to 17 months
Pregnancy
Self-reported pregnancy (140-school full evaluation sample and 80-school biomarker subsample)
Time frame: Up to 19 months
Health - Infectious Disease Symptoms
Self-reported infectious disease symptoms (140-school full evaluation sample and 80-school biomarker subsample)
Time frame: Up to 19 months
Health - Mid-Upper-Arm Circumference (MUAC)
MUAC, cm (140-school full evaluation sample and 80-school biomarker subsample)
Time frame: Up to 19 months
Health - Urinary Tract Infection
Self-reported urinary tract infection (140-school full evaluation sample and 80-school biomarker subsample)
Time frame: Up to 19 months
Health - C-Reactive Protein
Blood-based C-reactive protein, mg/L (80-school biomarker subsample)
Time frame: Up to 19 months
Plan to share: No — 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.
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Aug 2026, 22 months after the start.
Of 136 non-industry interventional studies with no phase under Urinary Tract Infections, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 39. This study's planned 22 months is close to that.
Counting every sponsor, half of 153 studies reached it within 22 months; a quarter within 8 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California Santa Cruz