Clinical trial NCT06560853: Evaluation of a Comprehensive School Health Programme in Zambia
Official title: Evaluation of a Comprehensive School Health Programme in Zambia: a Cluster-randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Helminth Infection
Malaria
Schistosomiasis
Anemia
UTI
Diarrhea
Skin Rash
Cough
Keywords: School Health Services
Lead sponsor: London School of Economics and Political Science
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: Healthy Learners
name: United States Agency for International Development (USAID)
name: Medical Research Council
First posted: 2024-08-19
Enrollment: 28700
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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. We expect low rates of transfers and will track any transfers which do occur.
Primary purpose: HEALTH_SERVICES_RESEARCH

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)?


Eligibility 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

Primary outcomes:
measure: Synthetic morbidity index
timeFrame: 18 months after intervention start
measure: Average attendance rate over 24 months
timeFrame: 24 months after intervention start
Secondary outcomes:
Other outcomes:
Locations:
city: Chingola
country: Zambia
facility: Chingola District Education Board
state: Copperbelt
city: Luanshya
country: Zambia
facility: Luanshya District Education Board
state: Copperbelt
city: Masaiti
country: Zambia
facility: Masaiti District Education Board
state: Copperbelt
city: Kawambwa
country: Zambia
facility: Kawambwa District Education Board
state: Luapula
city: Mwense
country: Zambia
facility: Mwense District Education Board
state: Luapula
city: Samfya
country: Zambia
facility: Samfya District Education Board
state: Luapula
Study officials:
affiliation: London School of Economics and Political Science
name: Mylene Lagarde, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Stellenbosch
name: David Ross, PhD
role: STUDY_CHAIR
References: