Evaluation of a Comprehensive School Health Programme in Zambia: a Cluster-randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28,700
- 试验地点
- 6
- 主要终点
- Synthetic morbidity index
研究概览
简要总结
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.
- What is the impact of the program on health-seeking, health, and education outcomes?
- What are the indirect effects of the program on teachers and clinics?
- 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)?
- How costly is the comprehensive SHP, and what factors affect its implementation?
- What are the potential benefits of the program for long-term human capital accumulation (learning, well-being etc)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
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.
干预措施: Deworming and vitamin A supplementation delivery (Other)
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.
干预措施: Deworming and vitamin A supplementation delivery (Other)
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.
干预措施: Comprehensive School Health Programme (Other)
结局指标
主要结局
Synthetic morbidity index
时间窗: 18 months after intervention start
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.
Average attendance rate over 24 months
时间窗: 24 months after intervention start
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.
Any healthcare utilisation
时间窗: 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 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 healthcare
时间窗: 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 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 rate
时间窗: 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)
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) attendance
时间窗: 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)
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.
次要结局
- 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.)
- Menstrual health practices(Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.)
- 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.)
- Duration of illness episodes - all episodes(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.)
- Duration of illness episodes - serious episodes(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.)
- Menstrual health stigma index(Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.)
- Learning - Literacy(Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.)
- Learning - Numeracy(Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.)
- Learning - Science and Health(Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.)
- Learning - overall(Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.)
- Students' working memory and attention(Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.)
- Combined measure of attendance and retention(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))
- Attendance rate including learners transfered to other study schools(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))
- Illness- or menstruation-related absence(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.)
- Menstrual health knowledge(Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.)