Evaluation of a Comprehensive School Health Programme in Zambia

NCT06560853 | Active Not Recruiting DMC

• 1 other identifier: 264865
• Study Type: interventional
• Target: 28,700
• Locations: 1 country
• Sites: 6

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. 1.What is the impact of the program on health-seeking, health, and education outcomes?
2. 2.What are the indirect effects of the program on teachers and clinics?
3. 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. 4.How costly is the comprehensive SHP, and what factors affect its implementation?
5. 5.What are the potential benefits of the program for long-term human capital accumulation (learning, well-being etc)?

Conditions

Malaria; Anemia; Diarrhea

Keywords

School Health Services

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

• 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).

  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.

• 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.

  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)

• 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.

  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)

• 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.

• Proportion of children with moderate or severe anaemia

  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.

• Proportion of children with diarrhoea

  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.

• Haematuria prevalence

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

• Share of diary days with any reported symptom

  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.

Other Outcomes (24)

• Boys' menstrual health knowledge

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

• Boys' menstrual health stigma

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

• School environment and belonging

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

Study Arms (3)

School health programme (SHP)

EXPERIMENTAL

SHP 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.

Other: Comprehensive School Health Programme; Other: Deworming and vitamin A supplementation delivery

Deworming and vitamin A supplementation

ACTIVE COMPARATOR

Healthy 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.

Other: Deworming and vitamin A supplementation delivery

Status quo

NO INTERVENTION

Schools 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.

Interventions

Comprehensive School Health Programme OTHER

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.

Also known as: SHP

School health programme (SHP)

Deworming and vitamin A supplementation delivery OTHER

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.

Also known as: Deworming

Deworming and vitamin A supplementation; School health programme (SHP)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Virginia: collaborator
• Healthy Learners: collaborator
• United States Agency for International Development (USAID): collaborator
• Medical Research Council: collaborator
• London School of Economics and Political Science: lead
• University of Notre Dame: collaborator
• University of Zambia: collaborator

Study Sites (6)

Chingola District Education Board

Chingola, Copperbelt, Zambia

Location

Luanshya District Education Board

Luanshya, Copperbelt, Zambia

Location

Masaiti District Education Board

Masaiti, Copperbelt, Zambia

Location

Kawambwa District Education Board

Kawambwa, Luapula Province, Zambia

Location

Mwense District Education Board

Mwense, Luapula Province, Zambia

Location

Samfya District Education Board

Samfya, Luapula Province, Zambia

Location

MeSH Terms

Conditions

Malaria; Anemia; Diarrhea

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mylene Lagarde, PhD

  London School of Economics and Political Science

  PRINCIPAL INVESTIGATOR

• David Ross, PhD

  University of Stellenbosch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 19, 2024
• Study Start: February 27, 2024
• Primary Completion: July 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available permanently. They will become available along with the publication of the study in a journal, and investigators will provide a replication package as part of the publication.

Locations

ZA (6)