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MalariaNCT06560853

Evaluation of a Comprehensive School Health Programme in Zambia

A study testing Comprehensive School Health Programme and Deworming and vitamin A supplementation delivery in people with Malaria and Anemia, run by London School of Economics and Political Science at 6 sites in Zambia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 5 years and olderHealthy volunteers can take part
Conditions the study is for
Malaria, Anemia, Diarrhea
What is being tested?
Comprehensive School Health Programme and Deworming and vitamin A supplementation delivery
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28,700 participants
Where
6 sitesZambia
Study dates
27 Feb 2024to 31 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 5 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Zambia6 sites
  • Chingola District Education Board

    Chingola, Copperbelt

  • Kawambwa District Education Board

    Kawambwa, Luapula Province

  • Luanshya District Education Board

    Luanshya, Copperbelt

  • Masaiti District Education Board

    Masaiti, Copperbelt

  • Mwense District Education Board

    Mwense, Luapula Province

  • Samfya District Education Board

    Samfya, Luapula Province

Other trials in Zambia

About this study

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

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)?
Conditions
Malaria, Anemia, Diarrhea
Being tested
Comprehensive School Health Programme, Deworming and vitamin A supplementation delivery
Keywords
School Health Services
Medical subject headings
Malaria, Anemia, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive School Health ProgrammeOther

    Also called SHP

    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.
  • Deworming and vitamin A supplementation deliveryOther

    Also called Deworming

    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.

Study groups in NCT06560853
Study groupRoleWhat they receive
School health programme (SHP)ExperimentalSHP developed by Healthy Learners (HL) in collaboration with the Ministry of Education (MOE), which follows the WHO guidelines on school health activities. HL supports the upgrading of basic sanitation facilities and construction of a dedicated 'health room' in the school; trains selected teachers to become school health workers (SHWs) who deliver health and sanitation education, coordinate deworming and vitamin A supplementation in the school, and assess sick learners in the school health room using a clinical decision support system (CDSS), either treating in school or referring to the local health centre. At the health centre, children referred by SHWs are given priority by health care workers who see them within 30 minutes of arriving at the facility. Schools also create student networks (a "buddy" system) whereby learners monitor each other's absence and coordinate with SHWs, who can then follow up with the household.
Receives: Other: Comprehensive School Health Programme; Other: Deworming and vitamin A supplementation delivery
Deworming and vitamin A supplementationActive comparatorHealthy Learners will enusre reliable delivery of the national deworming programme twice a year, during the same period as in the SHP arm, for comparability of the effect of prevention alone to the full SHP.
Receives: Other: Deworming and vitamin A supplementation delivery
Status quoNo interventionSchools to operate as usual with no intervention other than the usual activities planned and organized by the government, as set out the 2006 School Health and Nutrition Policy, until the end of the trial.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Any healthcare utilisation

    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.

    Measured: Eight-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.

  2. Proportion of serious illness episodes where child sought healthcare

    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).

    Measured: Eight-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.

  3. Panel-based attendance rate

    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.

    Measured: Repeated 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)

  4. Register-based (cross-sectional) attendance

    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.

    Measured: Repeated 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)

Secondary outcomes (18)
  1. Malaria prevalence (proportion of children testing positive for malaria)

    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).

    Measured: 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.

  2. Proportion of children with moderate or severe anaemia

    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.

    Measured: 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.

  3. Proportion of children with diarrhoea

    Incidence of diarrhoea - carer report of the child experiencing three or more loose or watery stools.

    Measured: Eight-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.

  4. Haematuria prevalence

    An indicator for incidence of haematuria (blood in urine) reported by the caregiver.

    Measured: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Recall over last 7 days.

  5. Share of diary days with any reported symptom

    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.

    Measured: Eight-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.

  6. Duration of illness episodes - all episodes

    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.

    Measured: Eight-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.

  7. Duration of illness episodes - serious episodes

    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.

    Measured: Eight-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.

  8. Menstrual health knowledge

    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.

    Measured: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.

  9. Menstrual health practices

    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.

    Measured: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.

  10. Menstrual health stigma index

    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.

    Measured: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.

  11. Learning - Literacy

    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.

    Measured: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.

  12. Learning - Numeracy

    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.

    Measured: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.

  13. Learning - Science and Health

    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.

    Measured: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.

  14. Learning - overall

    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.

    Measured: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.

  15. Students' working memory and attention

    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.

    Measured: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.

  16. Combined measure of attendance and retention

    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.

    Measured: Repeated 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)

  17. Attendance rate including learners transfered to other study schools

    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.

    Measured: Repeated 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)

  18. Illness- or menstruation-related absence

    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.

    Measured: Eight-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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start27 Feb 2024
  3. Primary completion15 Jul 2026
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
28,700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06560853
Sponsor's protocol ID
264865
Status last verified
Jul 2026
First submitted
12 Aug 2024
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators will share a complete dataset at the individual-level containing all primary and secondary study outcomes, any other variables used in the analysis, and treatment assignments. Data will be anonymised to ensure no participants can be personally identified (directly or indirectly)

Questions about this trial

What is this clinical trial studying?

A study testing Comprehensive School Health Programme and Deworming and vitamin A supplementation delivery in people with Malaria and Anemia, run by London School of Economics and Political Science at 6 sites in Zambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Zambia. 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?

Any healthcare utilisation (time frame: Eight-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 study lists 4 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 27 Aug 2026.

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