- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06560853
Valutazione di un programma sanitario scolastico completo in Zambia
Valutazione di un programma sanitario scolastico completo in Zambia: uno studio controllato randomizzato su cluster
In Zambia, la salute e il benessere dei bambini dai 5 ai 14 anni sono stati spesso trascurati, il che ha portato a diverse sfide sanitarie che influiscono sul loro sviluppo e sulla loro istruzione. Il programma Healthy Learners (HL), in collaborazione con il governo dello Zambia, mira a colmare questa lacuna implementando un programma sanitario scolastico completo. Gli insegnanti formati, noti come operatori sanitari scolastici (SSS), svolgono un ruolo chiave fornendo educazione sanitaria, coordinando le cure preventive con le cliniche locali e supervisionando una “sala sanitaria scolastica” per gli studenti malati.
Questo studio è un ampio studio di controllo randomizzato in cluster in 225 scuole. L'obiettivo di questo studio è confrontare gli effetti del programma sanitario scolastico globale (SHP) sviluppato da HL rispetto a due alternative: l'attuale livello di fornitura sanitaria scolastica e le attuali attività sanitarie scolastiche migliorate con la sverminazione e il coordinamento della vitamina A da parte di HL, con il loro supporto tecnico e finanziario garantendo la fornitura affidabile di tutte le attività sanitarie attualmente pianificate dal governo.
- Qual è l’impatto del programma sui risultati in termini di ricerca di salute, salute e istruzione?
- Quali sono gli effetti indiretti del programma su insegnanti e cliniche?
- Qual è il valore aggiunto di un Piccolo Idroelettrico così completo, rispetto alla fornitura (i) ottimizzata (ii) o imperfetta (status quo) di una gamma limitata di attività sanitarie scolastiche (ad esempio, sverminazione e integratori di vitamina A)?
- Quanto costa il Piccolo Idroelettrico completo e quali fattori influenzano la sua implementazione?
- Quali sono i potenziali benefici del programma per l’accumulazione di capitale umano a lungo termine (apprendimento, benessere, ecc.)?
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Copperbelt
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Chingola, Copperbelt, Zambia
- Chingola District Education Board
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Luanshya, Copperbelt, Zambia
- Luanshya District Education Board
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Masaiti, Copperbelt, Zambia
- Masaiti District Education Board
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Luapula Province
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Kawambwa, Luapula Province, Zambia
- Kawambwa District Education Board
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Mwense, Luapula Province, Zambia
- Mwense District Education Board
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Samfya, Luapula Province, Zambia
- Samfya District Education Board
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
- Scuole: idonee al Piccolo Idroelettrico (non inaccessibile nella stagione delle piogge, entro 10 km dal centro sanitario)
- Amministratore scolastico: ha almeno un anno di esperienza nella scuola ed è il direttore della scuola primaria o supplente (ad esempio, preside, vice preside, insegnante senior che funge da responsabile finanziario)
- Studenti: registrati e presenti a scuola durante il periodo di riferimento, nel grado 1, grado 3 o grado 5
- Genitori, tutori primari o tutori di studenti selezionati. I tutori sono ammissibili se rimangono con il bambino e prendono decisioni relative alla scuola e alla salute del bambino in assenza dei genitori/tutori primari.
- Insegnanti: qualsiasi insegnante impiegato da scuole ammissibili allo studio (non volontari)
- Strutture sanitarie: strutture designate nel bacino di utenza delle scuole studio
- Personale della struttura sanitaria: qualsiasi personale che effettua consultazioni OPD presente durante i giorni di raccolta dei dati della struttura
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Programma sanitario scolastico (SHP)
SHP sviluppato da Healthy Learners (HL) in collaborazione con il Ministero dell'Istruzione (MOE), che segue le linee guida dell'OMS sulle attività sanitarie scolastiche.
HL sostiene il potenziamento dei servizi igienici di base e la costruzione di una "sala sanitaria" dedicata nella scuola; forma insegnanti selezionati affinché diventino operatori sanitari scolastici (SSB) che forniscono educazione sanitaria e igienico-sanitaria, coordinano la sverminazione e l'integrazione di vitamina A nella scuola e valutano gli studenti malati nell'ambulatorio scolastico utilizzando un sistema di supporto alle decisioni cliniche (CDSS), trattando in scuola o rivolgendosi al centro sanitario locale.
Al centro sanitario, i bambini indirizzati da SSB ricevono la priorità dagli operatori sanitari che li visitano entro 30 minuti dall’arrivo alla struttura.
Le scuole creano anche reti di studenti (un sistema "buddy") in base al quale gli studenti monitorano le reciproche assenze e si coordinano con SSB, che possono poi seguire la famiglia.
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Intervento combinato che consiste in:
Altri nomi:
Le scuole attuano la politica del governo di distribuire agli studenti farmaci contro i vermi e integratori di vitamina A due volte l’anno.
Il supporto aggiuntivo da parte di Healthy Learners garantisce una consegna affidabile.
Altri nomi:
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Comparatore attivo: Sverminazione e integrazione di vitamina A
Gli studenti in buona salute garantiranno la fornitura affidabile del programma nazionale di sverminazione due volte l'anno, durante lo stesso periodo del braccio SHP, per la comparabilità dell'effetto della sola prevenzione con l'intero SHP.
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Le scuole attuano la politica del governo di distribuire agli studenti farmaci contro i vermi e integratori di vitamina A due volte l’anno.
Il supporto aggiuntivo da parte di Healthy Learners garantisce una consegna affidabile.
Altri nomi:
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Nessun intervento: Status quo
Le scuole funzioneranno come al solito, senza alcun intervento diverso dalle consuete attività pianificate e organizzate dal governo, come stabilito nella Politica scolastica sulla salute e la nutrizione del 2006, fino alla fine della sperimentazione.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Any healthcare utilisation
Lasso di tempo: 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.
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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.
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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.
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Proportion of serious illness episodes where child sought healthcare
Lasso di tempo: 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.
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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.
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Panel-based attendance rate
Lasso di tempo: 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)
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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.
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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)
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Register-based (cross-sectional) attendance
Lasso di tempo: 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)
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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.
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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)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Malaria prevalence (proportion of children testing positive for malaria)
Lasso di tempo: 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.
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Testing for the presence of P. falciparum, non-falciparum species, or a mixed infection.
The tests are performed using a rapid diagnostic test (RDT) on the sample of children taking part in the health diaries (testing will occur at the end of the period).
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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.
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Proportion of children with moderate or severe anaemia
Lasso di tempo: 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.
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Haemoglobin concentration measured using a HemoCue photometer in the sample of children taking part in the health diaries (testing will occur at the end of the period).
Anemia severity categories will be based on the WHO classification which depends on the age and sex of the child.
Haemoglobin is first adjusted for elevation using the WHO (2024) continuous adjustment, defined in g/L as 0.0056384 times elevation in metres plus 0.0000003 times elevation squared, evaluated at each school's recorded GPS elevation and subtracted from the measured value.
Moderate-to-severe anaemia is considered when adjusted haemoglobin is below 11.0 g/dL, a threshold common to all age bands represented in the sample.
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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.
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Proportion of children with diarrhoea
Lasso di tempo: 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.
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Incidence of diarrhoea - carer report of the child experiencing three or more loose or watery stools.
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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.
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Haematuria prevalence
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Recall over last 7 days.
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An indicator for incidence of haematuria (blood in urine) reported by the caregiver.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Recall over last 7 days.
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Share of diary days with any reported symptom
Lasso di tempo: 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.
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The share of days on which the child was reported to have any symptom, over the eight week symptom diary recording period (0 days if no symptoms recorded). Proportion of completed health-diary days on which the child reported one or more symptoms. Computed per child as (diary days with ≥1 reported symptom) ÷ (completed diary days). Defined for all children in the diary sub-sample; no conditioning on illness status. |
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.
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Duration of illness episodes - all episodes
Lasso di tempo: 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.
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Mean number of consecutive symptom-days per illness episode, among episodes in children who reported illness during the diary window.
Estimated from a discrete-time hazard model for symptom resolution: episodes still ongoing at the end of the observation window contribute their observed (censored) days rather than being dropped; episodes already symptomatic on the first diary day are excluded (start date unobservable / left-truncated).
Reported as a restricted mean over the eight-week observation window.
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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.
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Duration of illness episodes - serious episodes
Lasso di tempo: 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.
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As for the all-episodes duration outcome, restricted to episodes classified as serious. 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). Mean consecutive symptom-days per serious episode, estimated from the same discrete-time hazard model, with ongoing episodes contributing observed (censored) days and day-1 episodes excluded as left-truncated. Reported as a restricted mean over the eight-week window. |
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.
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Menstrual health practices
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Share of responses indicating good menstrual management across the practices items.
Item set is the final 5 items pilot-retained from a pre-specified pool adapted from the same validated instruments.
Computed per respondent as (good-management responses) / (items answered), averaged across girls who have reached menarche in the sub-sample.
Higher values indicate better practices.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Menstrual health stigma index
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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First principal component of a PCA over the menstrual health stigma items (final 4 items pilot-retained from a pre-specified pool adapted from the same validated instruments; construction rule fixed prior to piloting).
Loadings estimated on the pooled sample; scores standardised to the control-group mean and standard deviation.
Oriented so that higher values indicate lesser stigma; a beneficial programme effect corresponds to a reduction.
Constructed for girls grade 5 or above who have heard of menstruation.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Learning - Literacy
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Item-response-theory (IRT) ability score in literacy, estimated over per-item responses from the grade-banded exam blocks (lower-, middle-, and upper-grade versions) placed on a common within-domain scale via shared anchor items.
Standardised to the control-group mean and standard deviation.
Higher values indicate greater literacy ability.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Learning - Numeracy
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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IRT ability score in numeracy, estimated over per-item responses from the grade-banded exam blocks (lower-, middle-, upper-grade versions) linked to a common within-domain scale via shared anchor items.
Standardised to the control-group mean and SD.
Higher values indicate greater numeracy ability.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Learning - Science and Health
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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IRT ability score in science and health knowledge, estimated over per-item responses from the grade-banded exam blocks (lower-, middle-, upper-grade versions) linked to a common within-domain scale via shared anchor items.
Standardised to the control-group mean and SD.
Higher values indicate greater ability.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Learning - overall
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Composite learning score, defined as the mean of the three control-standardised domain scores (literacy, numeracy, science), each an IRT ability score placed on a common within-domain scale across grade bands via anchor items and standardised to the control-group mean and SD.
Domains enter with equal weight.
Higher values indicate greater overall learning ability.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Students' working memory and attention
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Students' working memory and attention is measured using the Digit Span task, a widely used short-term memory and working memory assessment.
Enumerators orally present a sequence of digits at a rate of one per second, and students are asked to repeat the digits in the same order (Digit Span Forward) and then in reverse order (Digit Span Backward).
The task measures students' auditory attention, concentration, and working memory capacity, which are foundational components of general cognitive functioning and predictive of academic achievement.
Scores are recorded as the total number of correct sequences reproduced, following standard administration and scoring procedures.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Combined measure of attendance and retention
Lasso di tempo: 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)
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Proportion of children confirmed present in class on the day of the visit, out of the total number of children enrolled at the school at baseline and still alive.
This measure effectively treats children who may have transferred to another study school as 'absent', dropped out, or temporarily relocated.
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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)
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Attendance rate including learners transfered to other study schools
Lasso di tempo: 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)
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Proportion of children confirmed present in class on the day of the visit either in their original school or in another school to which they have transferred if that school is one of the study schools, out of the total number of children enrolled at baseline and still alive.
Analysis will follow Intention-to-Treat principle, treating participants as assigned to their original treatment arm, even if they moved to a different study arm school.
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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)
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Illness- or menstruation-related absence
Lasso di tempo: 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.
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From the diary's daily records, caregivers flag whether the child attended school each day and records the reason for each absent day.
The reasons are: illness (1), was menstruating (2), farming (3), school closure or school event (4), bad weather (5), religious reasons (6), market day (7), public holiday (8), fishing (9), mining (10), working with parents (11), no uniform/shoes/books (12), and other (-97).
A day missed is considered caused by an illness or menstruation-related absence when the reason is (1) or (2).
The sample is restricted to school days by dropping weekends and public holidays.
This measure is the share of the child's school days in the diary window lost to health-related absence: health-related absence days divided by total school days observed.
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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.
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Menstrual health knowledge
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Share of correct responses across three menstrual health knowledge items.
The item set is the final items retained after in-country piloting for comprehension and relevance, from a pre-specified pool adapted from validated instruments.
Computed per respondent as (correct responses) / (items answered), averaged within the relevant sub-sample: girls grade 5 or above who have heard of menstruation.
Higher values indicate greater knowledge.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Boys' menstrual health knowledge
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Menstrual health knowledge index (share of correct responses), constructed identically to the girls' secondary-outcome knowledge - same item set and same (correct responses) / (items answered) construction - on the sample of boys who have heard of menstruation.
Higher values indicate greater knowledge.
Parallels the girls' secondary outcome to assess whether the programme shifts boys' menstrual knowledge.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Boys' menstrual health stigma
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Menstrual health stigma index, constructed identically to the girls' secondary-outcome stigma index - first principal component of a PCA over the same stigma items - on the sample of boys who have heard of menstruation. Standardised to the boys' control-group mean and standard deviation; oriented so that higher values indicate lesser stigma, consistent with the girls' index. Parallels the girls' secondary outcome to assess whether the programme shifts boys' menstrual stigma. |
Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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School environment and belonging
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Measured using a short school belonging and climate scale drawn from the Young Lives study, designed to capture children's subjective experiences of school in a simple, age-appropriate way.
The tool focuses on core dimensions of belonging-enjoyment, perceived care from teachers and peers, safety, respect, and mutual support-using a consistent three-point response scale ("No, almost never", "Sometimes", "Yes, almost always").
Its brevity makes it suitable for large surveys with primary-school children while still capturing meaningful variation in how supported and included students feel in their school environment.
To analyse responses, investigators will construct a simple index using principal component analysis, normalising on the control group for ease of interpretation.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Children's emotional well-being at school
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Using the child well-being at school scale developed by the Young Lives study to capture children's emotional experiences while at school in a simple and age-appropriate way.
The tool focuses on both positive and negative affective states-see appendix-and uses a consistent three-point response scale ("No, almost never", "Sometimes", "Yes, almost always").
Its simplicity makes it suitable for administration to primary school children.
To analyse responses, investigators will construct a simple index using principal component analysis, normalising on the control group for ease of interpretation.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Learner-reported teacher engagement and conduct
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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A PCA index z-scored on the control group from the learner survey, combining a conduct checklist (teacher late, absent, or on their phone) with a 5-point Likert engagement battery (teacher cares, makes lessons interesting, offers extra help, motivates), oriented so a higher score is better conduct and engagement
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Any Bullying
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Indicator equal to 1 if child responds yes to any bullying item, from a five item yes/no checklist of acts experienced in the last week attended (mean names, threats, physical harm, exclusion, lies).
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Bullying count
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Count of acts of bullying, when child responds yes to any bullying item, from a five item yes/no checklist of acts experienced in the last week attended (mean names, threats, physical harm, exclusion, lies).
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Corporal punishment
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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From a parallel yes/no checklist of acts a teacher used on the child in the past month, spanning verbal (shouting) and escalating physical acts.
The primary measure is an indicator for any act and the secondary measures are the count of distinct acts and a physical-punishment indicator restricted to the acts involving physical contact.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Corporal punishment acceptance norms
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Acceptance of corporal punishment, elicited via a teacher discipline vignette (respondents hear a scenario and rate the depicted teacher's reaction).
Standardised-mean acceptance-norms index over four items: (i) own acceptability of the reaction; (ii) injunctive social norm - number of five colleagues expected to find it acceptable (0-5); (iii) descriptive social norm - number of five colleagues expected to react likewise (0-5); (iv) own behavioural attitude - self-rated likelihood of acting the same way.
Each item is oriented so that higher indicates greater acceptance and standardised to the control-group mean and SD before averaging (standardisation places the differing item scales on a common metric).
Higher index values indicate greater acceptance of corporal punishment.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Teacher job satisfaction
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Teacher-reported job satisfaction, summarised across the eight satisfaction items (teacher satisfaction 1-8) as standardised-mean index.
Higher values indicate greater satisfaction.
Teacher-level.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Teacher burnout
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Emotional-exhaustion subscale of the Maslach Burnout Inventory, the primary burnout indicator, summarised as subscale mean.
Higher values indicate greater exhaustion.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Teacher turnover intention
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Indicator = 1 if the teacher reports intending to leave teaching at the point of the survey.
All endline-surveyed teachers.
Higher = greater intent to leave.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Realised teacher turnover
Lasso di tempo: Baseline to endline: teacher's school-presence status at endline (May-July 2026) relative to their originally sampled school at baseline ([baseline month/year]); interval of approximately 24-26 months.
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Indicator = 1 if a teacher randomly sampled at baseline is no longer at their original school at endline (whether they left teaching or moved schools), from tracking of the baseline-sampled cohort rather than the endline survey.
Population differs from the survey-based teacher outcomes; measures change over the baseline-to-endline interval.
Time Frame: Unit: proportion.
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Baseline to endline: teacher's school-presence status at endline (May-July 2026) relative to their originally sampled school at baseline ([baseline month/year]); interval of approximately 24-26 months.
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Teacher locus of control
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Locus-of-control index over four items:
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Teacher time use - health-related duties
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Self-reported hours in a typical day spent on health-related programmes in the school, from the teacher time-use module (recall over four mutually exclusive categories: teaching/instructing; planning and grading; health-related programmes; other school responsibilities).
Primary time-use quantity; the mechanism-relevant category for a school-health intervention.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Teacher time use - teaching/instruction
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Self-reported hours in a typical day spent teaching/instructing, from the teacher time-use module (recall over four mutually exclusive categories: teaching/instructing; planning and grading; health-related programmes; other school responsibilities).
Reported alongside health-duty time to capture reallocation away from core instruction.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Anthropometry - stunting prevalence
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Prevalence of stunting (chronic undernutrition) among children measured at endline.
A child is classified stunted if their height-for-age z-score (HAZ) is more than 2 SD below the reference median, using the WHO Growth Reference for school-aged children and adolescents (de Onis et al. 2007; ages 5-19, sex-specific), with z-scores computed from completed age in months at the date of measurement.
HAZ values outside -6 to +6 are treated as biologically implausible and excluded per WHO flagging conventions; the number of excluded observations is reported.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Any anaemia
Lasso di tempo: 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.
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Using the same haemoglobin measurements collected during the biomarker survey (hbg result, in g/dL), investigators will construct the proportion of children suffering from any anaemia (mild, moderate or severe), using WHO thresholds: A child is classified as anaemic if adjusted haemoglobin falls below 11.5 g/dL at ages 5 to 11, below 12.0 g/dL at ages 12 to 14, below 12.0 g/dL for non-pregnant females aged 15 and above, and below 13.0 g/dL for males aged 15 and above, with age taken at the date of the biomarker round.
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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.
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Malaria - untreated infection prevalence
Lasso di tempo: 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.
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Indicator = 1 if a child in the biomarker sample tests positive for malaria and has no treatment recorded in their diary in the past 4 weeks; 0 otherwise, including test-negative children.
Defined over all children tested, so the estimate does not condition on infection status.
Because this joint indicator reflects both infection prevalence and treatment coverage, it is interpreted as descriptive/mechanistic and read alongside overall infection prevalence, not as a standalone treatment-gap contrast.
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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.
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Malaria - asymptomatic infection prevalence
Lasso di tempo: 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.
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Indicator = 1 if a child tests positive and reports no malaria-suggestive symptom (fever, headache, vomiting, lethargy) at the time of the test or in the four preceding days; 0 otherwise, including negatives.
Over all children tested; no conditioning on infection status.
Descriptive/mechanistic; read alongside overall prevalence.
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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.
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Parental health knowledge
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Share of correct answers on a health-knowledge battery (HN01, HN04, HHK1, HHK2, DS10, HN05) covering nutrition, hygiene, and specific child illnesses.
Responses will be scored as correct or incorrect, with "don't know" treated as incorrect, and summed into an additive index.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Parental relative trust in the school health room (vs government clinic)
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Relative expected provider quality for the school health room versus the government clinic, from a paired quality-expectation vignette: respondents estimate, for the same 10 hypothetical febrile children, how many would receive a correct diagnosis and how many a full supply of correct treatment at each provider (0-10 each).
Relative-trust index = the school-health-room minus government-clinic expectation, averaged across the diagnosis and treatment items (equivalently, the mean of the two paired differences).
Positive values indicate greater expected quality at the school health room.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Willingness to pay for school health programme
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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From a takeit-or-leave-it elicitation in which each guardian is offered a randomly assigned annual fee for the school health room [10, 20, 30, 40 or 50 Kwacha - 30 is the real marginal cost of the programme] and states whether they would pay it.
For the control group, the same elicitation takes place but the programme description is hypothetical.
The willingness to pay measure is the indicator for accepting the offered price.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Anthropometry - thinness prevalence
Lasso di tempo: Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Prevalence of thinness (acute undernutrition; the WHO term for this age group) among children measured at endline.
A child is classified thin if their BMI-for-age z-score (BAZ) is more than 2 SD below the reference median, using the same WHO reference.
BMI-for-age is used rather than weight-for-age, which is confounded by stunting; BMI-for-age standardises weight against the child's own height.
BAZ values outside -5 to +5 are excluded as biologically implausible per WHO flagging; the number excluded is reported.
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Endline, May-July 2026 (approximately 20-22 months after the start of the intervention, September 2024). Single assessment.
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Mylene Lagarde, PhD, London School of Economics and Political Science
- Cattedra di studio: David Ross, PhD, University of Stellenbosch
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie trasmesse da vettori
- Malattie trasmesse dalle zanzare
- Segni e sintomi, Digestivo
- Infezioni
- Malattie ematologiche
- Infezioni da protozoi
- Malattie parassitarie
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Malattie emiche e linfatiche
- Malaria
- Anemia
- Diarrea
- Effetti fisiologici delle droghe
- Micronutrienti
- Vitamine
- Vitamina A
Altri numeri di identificazione dello studio
- 264865
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Periodo di condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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