Evaluation of a Comprehensive School Health Programme in Zambia

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)?

Study Overview

• Status: Active, not recruiting
• Conditions: Diarrhea; Cough; Anemia; Malaria; UTI; Skin Rash; Schistosomiasis; Helminth Infection
• Intervention / Treatment: Other: Comprehensive School Health Programme; Other: Deworming and vitamin A supplementation delivery

• Study Type: Interventional
• Enrollment (Actual): 28700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Copperbelt
    • Chingola, Copperbelt, Zambia
      • Chingola District Education Board
    • Luanshya, Copperbelt, Zambia
      • Luanshya District Education Board
    • Masaiti, Copperbelt, Zambia
      • Masaiti District Education Board
  • Luapula
    • Kawambwa, Luapula, Zambia
      • Kawambwa District Education Board
    • Mwense, Luapula, Zambia
      • Mwense District Education Board
    • Samfya, Luapula, Zambia
      • Samfya District Education Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: School health programme (SHP); 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; 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.; Other Names: SHP; Other: Deworming 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.; Other Names: Deworming
Active Comparator: Deworming and vitamin A supplementation; 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; 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.; Other Names: Deworming
No Intervention: Status quo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Synthetic morbidity index	Because the SHP delivers treatment of several diseases, we will create a composite disease burden index of the following outcomes: malaria positive (using a rapid diagnostic test); moderate to high worm load (using a stool test); anaemia (using a hemocue test); schistosomiasis (using a urine test); diarrhoea in the past week (learner self-report) We test these outcomes in a randomly selected panel of 13,300 learners recruited at baseline, which ensures variety of age groups and balance of genders.	18 months after intervention start
Average attendance rate over 24 months	We will measure attendance during unannounced attendance spot checks (one per term over a 2-year period). Multiple measurements are required to capture seasonal variation. On each spot check visit, we will check attendance of a panel of learners randomly selected at baseline, which ensures variety of age groups and balance of genders. We will calculate each child's attendance rate across all the spot checks.	24 months after intervention start

Collaborators and Investigators

• Sponsor: London School of Economics and Political Science
• Collaborators: United States Agency for International Development (USAID); Medical Research Council; University of Virginia; Healthy Learners
• Investigators: Principal Investigator: Mylene Lagarde, PhD, London School of Economics and Political Science; Study Chair: David Ross, PhD, University of Stellenbosch

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: School Health Services
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Signs and Symptoms, Digestive; Vector Borne Diseases; Parasitic Diseases; Trematode Infections; Exanthema; Diarrhea; Helminthiasis; Schistosomiasis; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: 264865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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)
• IPD Sharing Time Frame: Data will be available permanently. They will become available along with the publication of the study in a journal, as we will provide a replication package as part of the publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No