NCT07823231

Brief Summary

Karamoja, in north-eastern Uganda, is among the most water-insecure regions in sub-Saharan Africa. Only 24 per cent of households can access the WHO-recommended 20 litres of water per person per day. Only 11.7 per cent have access to improved sanitation. A rapid vulnerability assessment covered all 182 operational primary schools in the sub-region between October and November 2025. It identified 53 schools as severely water insecure and a further 37 as moderately water insecure. Together, these schools serve an estimated 196,000 learners. The assessment also found that 89 schools lacked enough latrines to meet the national pupil-to-latrine ratio. Seventy-eight schools had no functional menstrual health management facilities. This study is a three-arm, phase-in cluster-randomised controlled trial. It evaluates the causal effects of a climate-resilient school WASH package on children's health and school attendance. It also examines adolescent girls' menstrual health self-efficacy. The study covers 60 primary schools that were found to be water-insecure across Karamoja's nine districts. The schools were stratified into three geographic zones. The researchers then used covariate-constrained randomisation to assign schools to three study arms. Phase 1 includes 30 schools receiving the intervention early. Phase 2 includes 20 schools receiving it later. The remaining 10 schools form the pure control group. The intervention combines climate-resilient WASH infrastructure with capacity-building and social and behaviour change activities. The infrastructure includes motorised boreholes, sex-disaggregated latrines and handwashing stations built to national standards. A subset of the boreholes will have data loggers for remote monitoring. The package also provides dedicated menstrual health facilities. These include enclosed changing areas and hygienic waste-disposal systems. Community water access points will be installed next to each school. Capacity-building activities will involve School Management Committees, Parent-Teacher Associations, teachers, District Water Officers and School Health Clubs. Data will be collected through three repeated cross-sectional rounds. The baseline will take place in the fourth quarter of 2026. The midline will take place in the first quarter of 2028, and the endline in the first quarter of 2030. Seven instruments will be used. These include pupil and matched caregiver surveys, school WASH facility and classroom roll-call observations, and head teacher and teacher surveys. The study will also digitise school enrolment, attendance and examination records. Community leaders will be interviewed separately. In each round, the sample will include 20 post-menarche girls and 20 general pupils per school. The study will interview one caregiver for each sampled pupil. The study will also interview six teachers, the head teacher and four community leaders in each school catchment. The study has three co-primary outcomes. The first is the pupil absence rate, measured using digitised attendance registers. The second is the seven-day prevalence of diarrhoea among pupils. The third is menstrual health self-efficacy among post-menarche girls. We will measure this using the 26-item Self-Efficacy in Addressing Menstrual Needs Scale (SAMNS-26). The primary analysis will estimate the intent-to-treat effect of assignment to Phase 1. At midline, Phase 1 schools will be compared with Phase 2 and pure control schools. We will conduct two comparisons at endline. First, we will compare all treated schools with the pure control group. Second, Phase 1 schools will be compared with Phase 2 schools to test whether effects differ by exposure duration.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,380

participants targeted

Target at P75+ for not_applicable

Timeline
51mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 19, 2026

Expected
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2030

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

3.4 years

First QC Date

September 10, 2026

Last Update Submit

September 10, 2026

Conditions

Keywords

water sanitation and hygienecluster randomised controlled trialmenstrual healthabsenteeismUganda

Outcome Measures

Primary Outcomes (3)

  • School absence rate among enrolled pupils

    Proportion of scheduled school days on which a pupil is recorded absent in the school's termly attendance registers for the full academic year preceding each survey round. Registers are digitised at each round by photographic capture with pupil name columns covered (whole-school, de-identified) and by transcription for the approximately 40 consented sampled pupils per school. Computed at pupil level and aggregated to school level, disaggregated by sex. Source: Module 6, School Records. Analysed as an intent-to-treat contrast of Phase 1 assignment against Phase 2 and pure control at midline, with school-clustered standard errors.

    Baseline (month 0), midline (month 15), endline (month 40)

  • Seven-day period prevalence of diarrhoea among pupils

    Proportion of sampled pupils reporting three or more loose or watery stools on any one day during the seven days preceding the interview, following the WHO IMCI case definition and the recall structure used in Freeman et al. 2012/2014 and Bick et al. 2024. Self-reported by the pupil in a private interview. Source: Module 1, Pupil Survey, item B2. A two-day recall measure (item B1) is retained as a lower-bias secondary measure of the same construct.

    Baseline (month 0), midline (month 15), endline (month 40)

  • Self-efficacy in addressing menstrual needs (SAMNS-26) among post-menarche girls

    Score on the Self-Efficacy in Addressing Menstrual Needs Scale (SAMNS-26; Hunter et al. 2022), administered to the sub-sample of 20 post-menarche girls aged approximately 11-17 per school by trained female enumerators. Twenty-six items, each prefixed "How sure are you that..." and scored on a 0-3 scale (0 = not at all sure, 3 = very sure). Subscale and total scores are computed as the item mean rescaled to 0-100. Three subscales are reported: menstrual hygiene preparation and maintenance, menstrual pain management, and engagement in stigmatised tasks. Higher scores indicate greater self-efficacy. Source: Module 1, Section O.

    Baseline (month 0), midline (month 15), endline (month 40)

Study Arms (3)

Phase 1: Early implementation

EXPERIMENTAL

Thirty schools were randomised to receive the full climate-resilient WASH, menstrual health and social and behaviour change package from mid-2026, ahead of baseline data collection in Q4 2026. By midline (Q1 2028), these schools will have had approximately 18 months of intervention exposure.

Other: Climate-resilient school WASH infrastructure packageBehavioral: WASH and menstrual health capacity building and social and behaviour change package

Phase 2: Delayed implementation

EXPERIMENTAL

Twenty schools were randomised to receive the identical intervention package after midline data collection concludes in Q1 2028. These schools serve as untreated comparison clusters at baseline and midline, and as a differential-exposure comparison against Phase 1 at endline, by which point they will have had at least 18 months of exposure.

Other: Climate-resilient school WASH infrastructure packageBehavioral: WASH and menstrual health capacity building and social and behaviour change package

Pure control

NO INTERVENTION

Ten schools were randomised to receive no element of the intervention package during the evaluation period. These schools continue to receive whatever routine district WASH and education services are ordinarily available. Ten clusters is the maximum untreated group compatible with the programme's commitment to reach 50 water-scarce schools.

Interventions

Construction of climate-resilient water systems on school grounds, comprising motorised boreholes (15 fitted with data loggers for remote monitoring of functionality and water levels); construction or rehabilitation of sex-disaggregated latrines and handwashing stations to meet national pupil-to-latrine ratio standards; construction of dedicated menstrual health sanitary facilities with enclosed changing areas, water supply and hygienic waste disposal; construction of community water access points adjacent to each school extending water access to surrounding households; and groundwater monitoring, water quality testing and surveillance. The UNICEF Uganda Country Office contracts the works, and UNICEF engineers and district local governments jointly supervise them.

Phase 1: Early implementationPhase 2: Delayed implementation

Training of District Water Officers on WASH-in-schools monitoring protocols and water quality testing; training of School Management Committees and Parent-Teacher Associations on operation and maintenance of WASH facilities including basic repair, record-keeping and maintenance budgeting; training of teachers and school prefects on menstrual hygiene management; formation or strengthening of School Health Clubs as a peer-to-peer platform for hygiene and menstrual health promotion; community engagement and social and behaviour change campaigns; provision of information, education and communication materials; and training on local manufacture of menstrual health products. Delivered through UNICEF implementing partners and embedded within district health and education systems.

Phase 1: Early implementationPhase 2: Delayed implementation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • CLUSTER LEVEL (school)
  • Government primary school, operational at the time of the October-November 2025 rapid vulnerability assessment, located in one of the nine districts of the Karamoja sub-region (Abim, Amudat, Kaabong, Karenga, Kotido, Moroto, Nabilatuk, Nakapiripirit, Napak)
  • Classified in the severe or acutely affected moderate water insecurity tier on the adapted HWISE assessment, and among the 60 highest composite priority scores across all 182 assessed schools
  • Hydrological viability confirmed: sub-surface geology and groundwater survey establish the feasibility of a viable water source at or adjacent to the school site
  • Head teacher and school administration grant permission for facility observation and school records capture
  • INDIVIDUAL LEVEL
  • Pupils:
  • Enrolled in grades P2 to P7 at a trial school and appearing on the current enrolment register at the time of sampling
  • Selected by systematic random sampling from the enrolment register with proportional representation across grades
  • Parent or legal guardian has provided written informed consent, and the pupil has provided assent
  • For the menstrual health sub-sample: post-menarche, approximately aged 11 to 17
  • Caregivers:
  • Parent or legal guardian of a sampled pupil, matched one-to-one
  • Provides own informed consent
  • Teachers and head teachers:
  • +6 more criteria

You may not qualify if:

  • Schools not confirmed hydrologically viable for a school-site water source
  • Schools outside the top 60 composite priority scores
  • Pupils not appearing on the current enrolment register at the time of sampling
  • Any individual for whom consent (and, for pupils, both guardian consent and pupil assent) is not obtained
  • Any individual who declines or withdraws at any point, without requirement to give a reason and without consequence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trial schools

Moroto, Uganda

RECRUITING

Related Publications (5)

  • Nelson KA, Lagony S, Kansiime C, Torondel B, Tanton C, Ndekezi D, Mugenyi L, Batuusa R, Baleke C, Thomas KA, Ssesanga T, Bakanoma R, Namirembe P, Tumuhimbise A, Nanyonga B, Nambi R, Obicho E, Ssenyondwa D, Bucci D, Belfield S, Akech Ocen A, Nakalema S, Alezuyo C, Matovu F, Neema S, Kyegombe N, Greco G, Jerrim J, Bonell C, Seeley JA, Weiss HA. Effects and costs of a multi-component menstrual health intervention (MENISCUS) on mental health problems, educational performance, and menstrual health in Ugandan secondary schools: an open-label, school-based, cluster-randomised controlled trial. Lancet Glob Health. 2025 May;13(5):e888-e899. doi: 10.1016/S2214-109X(25)00007-5.

    PMID: 40288398BACKGROUND
  • Hunter EC, Murray SM, Sultana F, Alam MU, Sarker S, Rahman M, Akter N, Mobashara M, Momata M, Winch PJ. Development and validation of the Self-Efficacy in Addressing Menstrual Needs Scale (SAMNS-26) in Bangladeshi schools: A measure of girls' menstrual care confidence. PLoS One. 2022 Oct 6;17(10):e0275736. doi: 10.1371/journal.pone.0275736. eCollection 2022.

    PMID: 36201478BACKGROUND
  • Bick S, Ezezew A, Opondo C, Leurent B, Argaw W, Hunter EC, Cumming O, Allen E, Dreibelbis R. Impact of a school-based water and hygiene intervention on child health and school attendance in Addis Ababa, Ethiopia: a cluster-randomised controlled trial. BMC Med. 2024 Sep 2;22(1):348. doi: 10.1186/s12916-024-03558-x.

    PMID: 39218883BACKGROUND
  • Freeman MC, Greene LE, Dreibelbis R, Saboori S, Muga R, Brumback B, Rheingans R. Assessing the impact of a school-based water treatment, hygiene and sanitation programme on pupil absence in Nyanza Province, Kenya: a cluster-randomized trial. Trop Med Int Health. 2012 Mar;17(3):380-91. doi: 10.1111/j.1365-3156.2011.02927.x. Epub 2011 Dec 18.

    PMID: 22175695BACKGROUND
  • UNICEF (2026). Impact Evaluation of Climate-Resilient WASH Services in Schools in Karamoja, Uganda: Inception Report. UNICEF Evaluation Office, New York.

    BACKGROUND

MeSH Terms

Conditions

DiarrheaRespiratory Tract Infections

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Study Officials

  • Innocent Mwaka, PhD

    Center for Evaluation and Development (C4ED)

    PRINCIPAL INVESTIGATOR
  • Matthew C. Freeman, PhD

    Emory University

    PRINCIPAL INVESTIGATOR
  • Andrew Kaiser-Tedesco, MSc

    UNICEF

    STUDY DIRECTOR
  • Elijah Kipchumba, PhD

    UNICEF

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Kaiser-Tedesco, MSc

CONTACT

Elijah Kipchumba, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study is a three-arm cluster-randomised trial with a phased roll-out. Schools are the unit of randomisation. Sixty government primary schools were randomised. Individual pupils, caregivers, teachers and head teachers are the units of observation and analysis. Standard errors will be clustered at the school level. Phase 1 comprises 30 schools and receives the intervention from mid-2026. Phase 2 comprises 20 schools and receives the same intervention after the midline survey in the first quarter of 2028. The remaining 10 schools form the pure control group. They receive no intervention during the evaluation period. We stratified randomisation by three geographic zones. We allocated arm quotas proportionally within each zone. We then used covariate-constrained randomisation based on three school-level covariates. We will collect data through three repeated cross-sectional rounds. We will draw a new independent sample from current enrolment registers in each round. The study will th
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Impact Evaluation Consultant

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 16, 2026

Study Start (Estimated)

October 19, 2026

Primary Completion (Estimated)

March 30, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

September 16, 2026

Record last verified: 2026-09

Locations