Urinary Tract InfectionsKILONGA2NCT07702916
Effect of Hygiene and Menstrual Hygiene Interventions on Learning and Psychosocial Wellbeing in Madagascar
A study testing Peer leadership/sensitization + sanitary pads and School infrastructure in people with Urinary Tract Infections and Malnutrition, run by University of California Santa Cruz at 1 site in Madagascar.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections, Malnutrition, Inflammation
- What is being tested?
- Peer leadership/sensitization + sanitary pads and School infrastructure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,080 participants
- Where
- 1 siteMadagascar
- Study dates
- 1 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Urinary Tract Infections, Malnutrition, Inflammation, Stress, Menstrual Hygiene
- Being tested
- Peer leadership/sensitization + sanitary pads, School infrastructure
- 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
- Medical subject headings
- Urinary Tract Infections, Malnutrition, Inflammation, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer leadership/sensitization + sanitary padsBehavioural
Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers
School infrastructureOther
Construction of latrines and handwashing basins
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| School infrastructure only | Experimental | Construction of latrines and handwashing basins Receives: Other: School infrastructure |
| Peer leadership/sensitization + sanitary pads | Experimental | Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers Receives: Behavioral: Peer leadership/sensitization + sanitary pads |
| Full package | Experimental | Combination of all interventions: Construction of latrines and handwashing basins and Peer leadership/sensitization + sanitary pads Receives: Behavioral: Peer leadership/sensitization + sanitary pads; Other: School infrastructure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning - Academic Test Scores
Standardized math/literacy test scores and official school grades (140-school full evaluation sample and 80-school biomarker subsample)
Measured: Up to 19 months
Learning - School Grades
Official school grades (140-school full evaluation sample and and 80-school biomarker subsample)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: Up to 19 months
Menstrual stigma
Self-reported menstrual stigma (140-school full evaluation sample)
Measured: Up to 17 months
Secondary outcomes (17)
Hygiene Knowledge
Self-reported hygiene knowledge (140-school full evaluation sample)
Measured: Up to 17 months
Hygiene Behavior
Self-reported hygiene behavior (140-school full evaluation sample)
Measured: Up to 17 months
Menstrual Knowledge
Self-reported menstrual hygiene knowledge (140-school full evaluation sample)
Measured: Up to 17 months
Menstrual Behavior
Self-reported menstrual hygiene behavior (140-school full evaluation sample)
Measured: Up to 17 months
Student/Teacher Motivation
Self-reported student/teacher motivation (140-school full evaluation sample)
Measured: Up to 17 months
Network Integration
Self-reported social network integration (140-school full evaluation sample)
Measured: Up to 17 months
Bullying
Self-reported bullying (140-school full evaluation sample)
Measured: Up to 17 months
Self-reported Psychosocial Wellbeing
Self-reported psychosocial wellbeing (140-school full evaluation sample and 80-school biomarker subsample)
Measured: Up to 19 months
Information Diffusion
Self-reported exposure to hygiene/menstruation discussions (140-school full evaluation sample)
Measured: Up to 17 months
School Attendance
Official school attendance records (140-school full evaluation sample)
Measured: Up to 17 months
School History
Official school records of dropout/withdrawal status and grade repetition (140-school full evaluation sample)
Measured: Up to 17 months
Sexual Activity
Self-reported early sexual activity (140-school full evaluation sample)
Measured: Up to 17 months
Pregnancy
Self-reported pregnancy (140-school full evaluation sample and 80-school biomarker subsample)
Measured: Up to 19 months
Health - Infectious Disease Symptoms
Self-reported infectious disease symptoms (140-school full evaluation sample and 80-school biomarker subsample)
Measured: Up to 19 months
Health - Mid-Upper-Arm Circumference (MUAC)
MUAC, cm (140-school full evaluation sample and 80-school biomarker subsample)
Measured: Up to 19 months
Health - Urinary Tract Infection
Self-reported urinary tract infection (140-school full evaluation sample and 80-school biomarker subsample)
Measured: Up to 19 months
Health - C-Reactive Protein
Blood-based C-reactive protein, mg/L (80-school biomarker subsample)
Measured: Up to 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Oct 2024
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California Santa Cruz
- Sponsor type
- University, hospital or other
- Collaborators
- Paris School of Economics, Laboratoire d'Analyses Médicales Malagasy (LA2M), Consultant Associates, Care International
- Responsible party
- Sponsor
- Investigators
- Audrie Lin, PhD, MPH, Principal investigator, University of California Santa CruzKaren Macours, PhD, Principal investigator, Paris School of EconomicsDuncan Webb, PhD, Principal investigator, Nova School of Business and EconomicsMariachiara Iannuzzi, MS, Principal investigator, Paris School of EconomicsOscar M Díaz, MS, Principal investigator, Paris School of EconomicsWilliam Amedanou, MS, Principal investigator, Paris School of EconomicsJuliet Ellenbach, BS, Principal investigator, University of California Santa CruzEliane Z Ralison, Principal investigator, Consultant Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702916
- Sponsor's protocol ID
- HS-FY2025-210
- Other IDs
- AEARCTR-0014423
- Acronym
- KILONGA2
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07702916
- Acronym / sponsor ID
- KILONGA2 / HS-FY2025-210
- Conditions
- Urinary Tract Infections, Malnutrition, Inflammation, Stress, Menstrual Hygiene
- Keywords
- menstrual hygiene management, menstrual hygiene intervention, menstrual stigma reduction intervention, adolescents, school-based intervention, WASH (water, sanitation, and hygiene), Madagascar, cluster-randomized trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,080 participants (estimated)
- Lead sponsor
- University of California Santa CruzUniversity, hospital or other
- Collaborators
- Paris School of Economics, Laboratoire d'Analyses Médicales Malagasy (LA2M), Consultant Associates, Care International
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| School infrastructure only | Experimental | Other: School infrastructureConstruction of latrines and handwashing basins |
| Peer leadership/sensitization + sanitary pads | Experimental | Behavioral: Peer leadership/sensitization + sanitary padsYoung Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers |
| Full package | Experimental | Behavioral: Peer leadership/sensitization + sanitary pads, Other: School infrastructureCombination of all interventions: Construction of latrines and handwashing basins and Peer leadership/sensitization + sanitary pads |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer leadership/sensitization + sanitary padsYoung Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers | Behavioural | Full package, Peer leadership/sensitization + sanitary pads |
| School infrastructureConstruction of latrines and handwashing basins | Other | Full package, School infrastructure only |
Primary outcome
Learning - Academic Test Scores
Time frame: 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
Time frame: Up to 19 months
Official school grades (140-school full evaluation sample and and 80-school biomarker subsample)
Psychosocial Wellbeing - Heart Rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 17 months
Self-reported menstrual stigma (140-school full evaluation sample)
17 secondary outcomes
Hygiene Knowledge
Time frame: Up to 17 months
Hygiene Behavior
Time frame: Up to 17 months
Menstrual Knowledge
Time frame: Up to 17 months
Menstrual Behavior
Time frame: Up to 17 months
Student/Teacher Motivation
Time frame: Up to 17 months
Network Integration
Time frame: Up to 17 months
Bullying
Time frame: Up to 17 months
Self-reported Psychosocial Wellbeing
Time frame: Up to 19 months
Information Diffusion
Time frame: Up to 17 months
School Attendance
Time frame: Up to 17 months
School History
Time frame: Up to 17 months
Sexual Activity
Time frame: Up to 17 months
Pregnancy
Time frame: Up to 19 months
Health - Infectious Disease Symptoms
Time frame: Up to 19 months
Health - Mid-Upper-Arm Circumference (MUAC)
Time frame: Up to 19 months
Health - Urinary Tract Infection
Time frame: Up to 19 months
Health - C-Reactive Protein
Time frame: Up to 19 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Audrie Lin, PhD, MPH principal investigator
University of California Santa Cruz
Karen Macours, PhD principal investigator
Paris School of Economics
Duncan Webb, PhD principal investigator
Nova School of Business and Economics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer leadership/sensitization + sanitary pads and School infrastructure in people with Urinary Tract Infections and Malnutrition, run by University of California Santa Cruz at 1 site in Madagascar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Madagascar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning - Academic Test Scores (time frame: Up to 19 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.