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| Name | Class |
|---|---|
| University of Virginia | OTHER |
| Healthy Learners | UNKNOWN |
| United States Agency for International Development (USAID) | FED |
| Medical Research Council |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive School Health Programme | Other | Combination intervention which consists of:
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| 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:
| 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 |
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| Name | Affiliation | Role |
|---|---|---|
| Mylene Lagarde, PhD | London School of Economics and Political Science | Principal Investigator |
| David Ross, PhD | University of Stellenbosch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chingola District Education Board | Chingola | Copperbelt | Zambia | |||
| Luanshya District Education Board |
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)
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2024 | Aug 7, 2024 |
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| OTHER_GOV |
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.
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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.
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| 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. |
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| Luanshya |
| Copperbelt |
| Zambia |
| Masaiti District Education Board | Masaiti | Copperbelt | Zambia |
| Kawambwa District Education Board | Kawambwa | Luapula Province | Zambia |
| Mwense District Education Board | Mwense | Luapula Province | Zambia |
| Samfya District Education Board | Samfya | Luapula Province | Zambia |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 7, 2023 | Aug 15, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| D008288 | Malaria |
| D012552 | Schistosomiasis |
| D000740 | Anemia |
| D003967 | Diarrhea |
| D005076 | Exanthema |
| D003371 | Cough |
| ID | Term |
|---|---|
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D011528 | Protozoan Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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