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Evaluation of a Comprehensive School Health Programme in Zambia

Evaluation of a Comprehensive School Health Programme in Zambia: a Cluster-randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06560853
Enrollment
28700
Registered
2024-08-19
Start date
2024-02-27
Completion date
2026-12-31
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Diarrhea, Malaria

Keywords

School Health Services

Brief summary

In Zambia, the health and well-being of children aged 5 to 14 has often been overlooked, leading to various health challenges affecting their development and education. The Healthy Learners (HL) program, in collaboration with the Zambian Government, aims to address this gap by implementing a comprehensive school health program. Trained teachers, known as school health workers (SHWs), play a key role by delivering health education, coordinating preventative care with local clinics, and overseeing a 'school health room' for sick students. This study is a large cluster-randomized control trial in 225 schools. The goal of this trial is to compare the effects of the comprehensive school health programme (SHP) developed by HL against two alternatives: the current level of school health provision and the current school health activities enhanced with deworming and vitamin A coordination by HL, with their technical and financial support ensuring the reliable delivery of all health activities currently planned by the government. 1. What is the impact of the program on health-seeking, health, and education outcomes? 2. What are the indirect effects of the program on teachers and clinics? 3. What is the added value of such a comprehensive SHP, compared to (i) optimized (ii) or imperfect (status-quo) delivery of a limited range of school health activities (e.g., deworming and vitamin A supplements)? 4. How costly is the comprehensive SHP, and what factors affect its implementation? 5. What are the potential benefits of the program for long-term human capital accumulation (learning, well-being etc)?

Interventions

OTHERComprehensive School Health Programme

Combination intervention which consists of: * Upgrading sanitation facilities and constructing a 'health room' in the school * Health teacher training: 5-10 teachers per school are recruited and trained for two weeks to become School Health Workers (SHWs) by Healthy Learners * The SHWs: (1) deliver education on health and good sanitation and hygiene (2) coordinate with local clinics to deliver preventive care (e.g. school deworming and vitamin A supplementation); (3) assess sick students in the health room with a tablet-based clinical decision support system (CDSS); (4) treat sick students in the health room for some conditions (malaria, diarrhoea, schistosomiasis, pneumonia, conjunctivitis) or (5) refer to the health facility for treatment; (6) monitor absence of learners * Referral: learners referred by SHWs are given a referral form by the SHW, which contains information about symptoms and suggested diagnosis by the CDSS. The learners are prioritised in the local clinic.

OTHERDeworming and vitamin A supplementation delivery

Schools implement the government policy of distributing deworming drugs and vitamin A supplementation to learners twice a year. Additional support from Healthy Learners ensures reliable delivery.

Sponsors

London School of Economics and Political Science
Lead SponsorOTHER
University of Virginia
CollaboratorOTHER
Healthy Learners
CollaboratorUNKNOWN
United States Agency for International Development (USAID)
CollaboratorFED
Medical Research Council
CollaboratorOTHER_GOV
University of Notre Dame
CollaboratorOTHER
University of Zambia
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

Blinding of intervention units, i.e. schools, to their own treatment (or that of others) is not feasible. After the initial scoping and baseline data collection (during which treatment was masked to all participants and assessors), due to the nature of the intervention, there will be no blinding: both the beneficiaries and assessors monitoring the outcomes will be able to infer whether the school is receiving the HL programme or not.

Intervention model description

Clusters (schools) are randomised to one of 3 treatment arms. Non-compliance with treatment or control is possible if participants move between schools. The investigators expect low rates of transfers and will track any transfers which do occur.

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Schools: eligible for SHP (not inaccessible in the rainy season, within 10km of health centre) * School administrator: has at least one year experience in school and is the primary or deputy school manager (e.g., headteacher, deputy headteacher, senior teacher acting as financial officer) * Learners: registered and in attendance in school during baseline, in grade 1, grade 3, or grade 5 * Parents, primary caregivers or guardians of selected learners. Guardians are eligible if they stay with the child and make schooling and health decisions for the child in the absence of parents/primary caregivers. * Teachers: any teacher employed by study eligible schools (not volunteers) * Health facilities: designated facilities in the catchment area of study schools * Health facility staff: any staff doing OPD consultation present during facility data collection days

Design outcomes

Primary

MeasureTime frameDescription
Any healthcare utilisationEight-week daily health-diary window, completed once per child in either term 1 (rainy season, January-March 2026; ~16-18 months after intervention start) or term 2 (cold season, May-July 2026; ~20-22 months). Data reported across both rounds.The proportion of learners who sought formal care (any government health centre or hospital, or the school health room). Equals one if reported at least once during the health diary observation period.
Proportion of serious illness episodes where child sought healthcareEight-week daily health-diary window, completed once per child in either term 1 (rainy season, January-March 2026; ~16-18 months after intervention start) or term 2 (cold season, May-July 2026; ~20-22 months). Data reported across both rounds.The investigators will calculate this as the proportion of "serious" illness episodes for which a child seeks care, at the child level. In other words, the number of serious illness episodes with care divided by the total number of serious illness episodes, for all children with at least one serious illness episode. A serious illness episode is one during which a child's ill-health symptoms are severe enough to require medical care, either immediately or the next day. This classification is based on WHO tools (c-IMCI and IMAI): Care is needed when (i) a child experiences any red-flag symptom (e.g. difficulty breathing, convulsions); (ii) has symptoms suggestive of certain conditions (e.g. measles, malaria); (iii) has experienced mild symptoms for a long time (coughing for 14 days, etc). During an illness episode, a child will be considered to seek medical care if they visit (i) the health room (treatment arm) or (ii) a government clinic or hospital (any arm).
Panel-based attendance rateRepeated measure captured at each of five unannounced attendance spot checks: term 1 2025, term 2 2025, term 3 2025, term 1 2026, and term 2 2026 (alongside endline), approximately 4-22 months after the start of the intervention (September 2024)The program's effect on school attendance is assessed using data collected through repeated, unannounced spot checks at each school. The primary attendance measure will be based on the sample of children enrolled in the study at baseline and confirmed to still be enrolled in their original school at the time of the visit. In this sample, the attendance rate, measured at each attendance spot check, will be the proportion of those children confirmed present in class on the day of the visit.
Register-based (cross-sectional) attendanceRepeated measure captured at each of four unannounced attendance spot checks: term 2 2025, term 3 2025, term 1 2026, and term 2 2026 (alongside endline), approximately 8-22 months after the start of the intervention (September 2024)Additional measure of attendance, focusing on students in grades 1, 3, 5, and 7 at the time of the spot check. This register-based measure is defined as the proportion of children on the register who are present on the day of the spot check and confirmed by school staff as enrolled in the selected class on the visit day.

Secondary

MeasureTime frameDescription
Malaria prevalence (proportion of children testing positive for malaria)Single biomarker measurement at the end of the child's diary round - term 1 (~March 2026; ~18 months after intervention start) or term 2 (~July 2026; ~22 months). Data reported across both rounds.Testing for the presence of P. falciparum, non-falciparum species, or a mixed infection. The tests are performed using a rapid diagnostic test (RDT) on the sample of children taking part in the health diaries (testing will occur at the end of the period).
Proportion of children with moderate or severe anaemiaSingle biomarker measurement at the end of the child's diary round - term 1 (~March 2026; ~18 months after intervention start) or term 2 (~July 2026; ~22 months). Data reported across both rounds.Haemoglobin concentration measured using a HemoCue photometer in the sample of children taking part in the health diaries (testing will occur at the end of the period). Anemia severity categories will be based on the WHO classification which depends on the age and sex of the child. Haemoglobin is first adjusted for elevation using the WHO (2024) continuous adjustment, defined in g/L as 0.0056384 times elevation in metres plus 0.0000003 times elevation squared, evaluated at each school's recorded GPS elevation and subtracted from the measured value. Moderate-to-severe anaemia is considered when adjusted haemoglobin is below 11.0 g/dL, a threshold common to all age bands represented in the sample.
Proportion of children with diarrhoeaEight-week daily health-diary window, completed once per child in either term 1 (rainy season, January-March 2026; ~16-18 months after intervention start) or term 2 (cold season, May-July 2026; ~20-22 months). Data reported across both rounds.Incidence of diarrhoea - carer report of the child experiencing three or more loose or watery stools.
Haematuria prevalenceEndline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Recall over last 7 days.An indicator for incidence of haematuria (blood in urine) reported by the caregiver.
Share of diary days with any reported symptomEight-week daily health-diary window, completed once per child in either term 1 (rainy season, January-March 2026; ~16-18 months after intervention start) or term 2 (cold season, May-July 2026; ~20-22 months). Data reported across both rounds.The share of days on which the child was reported to have any symptom, over the eight week symptom diary recording period (0 days if no symptoms recorded). Proportion of completed health-diary days on which the child reported one or more symptoms. Computed per child as (diary days with ≥1 reported symptom) ÷ (completed diary days). Defined for all children in the diary sub-sample; no conditioning on illness status.
Duration of illness episodes - all episodesEight-week daily health-diary window, completed once per child in either term 1 (rainy season, January-March 2026; ~16-18 months after intervention start) or term 2 (cold season, May-July 2026; ~20-22 months). Data reported across both rounds.Mean number of consecutive symptom-days per illness episode, among episodes in children who reported illness during the diary window. Estimated from a discrete-time hazard model for symptom resolution: episodes still ongoing at the end of the observation window contribute their observed (censored) days rather than being dropped; episodes already symptomatic on the first diary day are excluded (start date unobservable / left-truncated). Reported as a restricted mean over the eight-week observation window.
Duration of illness episodes - serious episodesEight-week daily health-diary window, completed once per child in either term 1 (rainy season, January-March 2026; ~16-18 months after intervention start) or term 2 (cold season, May-July 2026; ~20-22 months). Data reported across both rounds.As for the all-episodes duration outcome, restricted to episodes classified as serious. A serious illness episode is one during which a child's ill-health symptoms are severe enough to require medical care, either immediately or the next day. This classification is based on WHO tools (c-IMCI and IMAI): Care is needed when (i) a child experiences any red-flag symptom (e.g. difficulty breathing, convulsions); (ii) has symptoms suggestive of certain conditions (e.g. measles, malaria); (iii) has experienced mild symptoms for a long time (coughing for 14 days, etc). Mean consecutive symptom-days per serious episode, estimated from the same discrete-time hazard model, with ongoing episodes contributing observed (censored) days and day-1 episodes excluded as left-truncated. Reported as a restricted mean over the eight-week window.
Menstrual health knowledgeEndline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.Share of correct responses across three menstrual health knowledge items. The item set is the final items retained after in-country piloting for comprehension and relevance, from a pre-specified pool adapted from validated instruments. Computed per respondent as (correct responses) / (items answered), averaged within the relevant sub-sample: girls grade 5 or above who have heard of menstruation. Higher values indicate greater knowledge.
Menstrual health practicesEndline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.Share of responses indicating good menstrual management across the practices items. Item set is the final 5 items pilot-retained from a pre-specified pool adapted from the same validated instruments. Computed per respondent as (good-management responses) / (items answered), averaged across girls who have reached menarche in the sub-sample. Higher values indicate better practices.
Menstrual health stigma indexEndline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.First principal component of a PCA over the menstrual health stigma items (final 4 items pilot-retained from a pre-specified pool adapted from the same validated instruments; construction rule fixed prior to piloting). Loadings estimated on the pooled sample; scores standardised to the control-group mean and standard deviation. Oriented so that higher values indicate lesser stigma; a beneficial programme effect corresponds to a reduction. Constructed for girls grade 5 or above who have heard of menstruation.
Learning - LiteracyEndline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.Item-response-theory (IRT) ability score in literacy, estimated over per-item responses from the grade-banded exam blocks (lower-, middle-, and upper-grade versions) placed on a common within-domain scale via shared anchor items. Standardised to the control-group mean and standard deviation. Higher values indicate greater literacy ability.
Learning - NumeracyEndline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.IRT ability score in numeracy, estimated over per-item responses from the grade-banded exam blocks (lower-, middle-, upper-grade versions) linked to a common within-domain scale via shared anchor items. Standardised to the control-group mean and SD. Higher values indicate greater numeracy ability.
Learning - Science and HealthEndline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.IRT ability score in science and health knowledge, estimated over per-item responses from the grade-banded exam blocks (lower-, middle-, upper-grade versions) linked to a common within-domain scale via shared anchor items. Standardised to the control-group mean and SD. Higher values indicate greater ability.
Learning - overallEndline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.Composite learning score, defined as the mean of the three control-standardised domain scores (literacy, numeracy, science), each an IRT ability score placed on a common within-domain scale across grade bands via anchor items and standardised to the control-group mean and SD. Domains enter with equal weight. Higher values indicate greater overall learning ability.
Students' working memory and attentionEndline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.Students' working memory and attention is measured using the Digit Span task, a widely used short-term memory and working memory assessment. Enumerators orally present a sequence of digits at a rate of one per second, and students are asked to repeat the digits in the same order (Digit Span Forward) and then in reverse order (Digit Span Backward). The task measures students' auditory attention, concentration, and working memory capacity, which are foundational components of general cognitive functioning and predictive of academic achievement. Scores are recorded as the total number of correct sequences reproduced, following standard administration and scoring procedures.
Combined measure of attendance and retentionRepeated measure captured at each of five unannounced attendance spot checks: term 1 2025, term 2 2025, term 3 2025, term 1 2026, and term 2 2026 (alongside endline), approximately 4-22 months after the start of the intervention (September 2024)Proportion of children confirmed present in class on the day of the visit, out of the total number of children enrolled at the school at baseline and still alive. This measure effectively treats children who may have transferred to another study school as 'absent', dropped out, or temporarily relocated.
Attendance rate including learners transfered to other study schoolsRepeated measure captured at each of five unannounced attendance spot checks: term 1 2025, term 2 2025, term 3 2025, term 1 2026, and term 2 2026 (alongside endline), approximately 4-22 months after the start of the intervention (September 2024)Proportion of children confirmed present in class on the day of the visit either in their original school or in another school to which they have transferred if that school is one of the study schools, out of the total number of children enrolled at baseline and still alive. Analysis will follow Intention-to-Treat principle, treating participants as assigned to their original treatment arm, even if they moved to a different study arm school.
Illness- or menstruation-related absenceEight-week daily health-diary window, completed once per child in either term 1 (rainy season, January-March 2026; ~16-18 months after intervention start) or term 2 (cold season, May-July 2026; ~20-22 months). Data reported across both rounds.From the diary's daily records, caregivers flag whether the child attended school each day and records the reason for each absent day. The reasons are: illness (1), was menstruating (2), farming (3), school closure or school event (4), bad weather (5), religious reasons (6), market day (7), public holiday (8), fishing (9), mining (10), working with parents (11), no uniform/shoes/books (12), and other (-97). A day missed is considered caused by an illness or menstruation-related absence when the reason is (1) or (2). The sample is restricted to school days by dropping weekends and public holidays. This measure is the share of the child's school days in the diary window lost to health-related absence: health-related absence days divided by total school days observed.

Countries

Zambia

Contacts

PRINCIPAL_INVESTIGATORMylene Lagarde, PhD

London School of Economics and Political Science

STUDY_CHAIRDavid Ross, PhD

University of Stellenbosch

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026