Hypertension Treatment in Nigeria: Hypertension Diabetes Integration Study- Formative Aim 3 (HTN2)
11 maggio 2026 aggiornato da: Mark Huffman, Washington University School of Medicine
Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design - Aim 3
The purpose of the second phase of the Hypertension Treatment in Nigeria (HTN 2.0) Program is to build upon the success of the first phase of the HTN Program (2020-2023), which implemented the WHO HEARTS package across 60 primary healthcare centers (PHCs) in the Federal Capital Territory (FCT).
This program demonstrated significant improvements in hypertension treatment and control.
The focus of aim 3 will be evaluating diabetes management through the implementation of the HEARTS-D bundle in 10 PHCs across the FCT that previously participated in the initial HTN Program.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
- Altro: Implementation of program based on WHO HEARTS-D guidelines
- Droga: Metformin
- Droga: Glimepiride
- Dispositivo: Point-of-care blood glucose monitor (glucometer) and compatible test strips
- Comportamentale: HEARTS-D training and quarterly supportive supervision for community health extension workers (CHEWs)
Tipo di studio
Interventistico
Iscrizione (Stimato)
2800
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Dike Ojji, MD
- Numero di telefono: +234-806-009-4456
- Email: dike.ojji@uniabuja.edu.ng
Backup dei contatti dello studio
- Nome: Mark Huffman, MD
- Email: m.huffman@wustl.edu
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Aim 3 Inclusion Criteria:
Patients will be screened for diabetes with symptoms of hyperglycemia or BMI >25 kg/m2 and over the age of 18 years old. Upon first or previous diagnosis, diabetes patients will be registered.
- Adults (≥18 years),
- Patients with previous diabetes diagnosis
- Patients with persistently elevated random glucose >200 mg/dl, fasting glucose >126 mg/dl, or hemoglobin A1c >6.5% on two or more occasions (when available)
- Patients taking glucose lowering medications
- Pregnant women are eligible for this program, or
- Cognitively impaired adults are eligible for this program.
Exclusion Criteria:
- This program will not include any of the following special populations:
- Individuals who are not yet adults (minors): i.e. infants, children, or teenagers <18 years old, or
- Prisoners or other detained individuals.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Primary Health Care Centers in the Federal Capital Territory
10 primary healthcare centers in Nigeria's Federal Capital Territory who previously demonstrated capacity to deliver hypertension care in HTN 1.0.
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This study uses an interrupted time series design to compare diabetes screening, diagnosis, treatment, and control across a 12-month pre-implementation period and a 24-month implementation period in 10 primary healthcare centers in Nigeria's Federal Capital Territory.
Sites previously demonstrated capacity to deliver hypertension care and will continue hypertension services while expanding to diabetes care through the HEARTS diabetes module (HEARTS-D).
Pre-implementation includes registry setup and provision of glucometers without diabetes treatment training.
Implementation includes HEARTS-D training, supply provision, expansion of the drug revolving fund to diabetes medicines, and quarterly supportive supervision.
Description: Oral biguanide used as first-line glucose-lowering therapy within the HEARTS-D stepped-care protocol.
Dosing per protocol: 500 mg once daily (Step 1), 1000 mg once daily (Step 2), 1000 mg twice daily (Step 3 and Step 4).
Supplied through the expanded drug revolving fund during the implementation period.
Oral sulfonylurea used as add-on therapy at Step 4 of the HEARTS-D stepped-care protocol when blood glucose remains uncontrolled on metformin.
Starting dose 1 mg once daily, titrated by 1-2 mg to a maximum of 8 mg daily.
Supplied through the expanded drug revolving fund during the implementation period.
Point-of-care capillary blood glucose monitor with compatible single-use test strips and lancets, used at participating primary health centers for diabetes screening, diagnosis, and monitoring per WHO HEARTS-D.
Glucometers and test strips are provided to all sites during pre-implementation (registry setup) and replenished during implementation through the supply chain and drug revolving fund.
Altri nomi:
Structured training of CHEWs on the HEARTS-D protocol covering diabetes screening, diagnosis, stepped-care treatment, follow-up, and referral, delivered at the start of the implementation period and reinforced by quarterly supportive supervision visits with audit-and-feedback throughout the 24-month implementation period.
Altri nomi:
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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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Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.
Lasso di tempo: 36 months
|
Primary Implementation Outcome: Description: Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.
|
36 months
|
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Difference in 6-month rolling average diabetes screening in eligible adults (random plasma glucose with hyperglycemia symptoms; fasting plasma glucose if ≥18 y and BMI >25 kg/m²; or HbA1c) per WHO HEARTS-D, pre- vs. implementation
Lasso di tempo: 36 months
|
Primary effectiveness outcome: The primary outcome will be the difference in the 6-month rolling average of the diabetes screening among eligible patients, screening defined as a random plasma glucose screening among adults with symptoms of hyperglycemia or a fasting plasma glucose among adults > 18 years old and body mass index > 25 kg/m2 in accordance with HEARTS-D, between the pre-implementation and implementation periods.
Hemoglobin A1c may also be used if available.
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36 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Difference in 6-month rolling average diabetes treatment (proportion of eligible patients prescribed any glucose-lowering medication) between pre-implementation and implementation periods
Lasso di tempo: 36 months
|
Secondary Effectiveness Outcome (diabetes treatment): 6-month rolling average of diabetes treatment levels in the pre-implementation and implementation periods.
|
36 months
|
|
Difference in 6-month rolling average blood sugar control (per WHO HEARTS-D: fasting plasma glucose <126 mg/dL, postprandial <160 mg/dL, or HbA1c <7%) between pre-implementation and implementation periods
Lasso di tempo: 36 months
|
Secondary Effectiveness Outcome (blood sugar control): 6-month rolling average of blood sugar control in the pre-implementation and implementation periods.
Control will be defined according to the WHO HEARTS-D module2, specifically: fasting glucose <126 mg/dl, postprandial glucose <160 mg/dl, or HbA1c <7%.
|
36 months
|
|
Difference in 6-month rolling average mean fasting plasma glucose (mg/dL) between pre-implementation and implementation periods
Lasso di tempo: 36 months
|
Secondary Effectiveness Outcomes (mean fasting glucose levels): 6-month rolling average of mean fasting glucose levels in the pre-implementation and implementation periods.
|
36 months
|
|
Proportion of selected primary health centers (PHCs) that participated in baseline diabetes training (A ÷ B; A = PHCs that participated, B = total selected PHCs)
Lasso di tempo: 36 months
|
Secondary Implementation Outcome: A = Number of PHCs who participated in baseline diabetes training B = Total number of selected PHCs Calculation: A ÷ B |
36 months
|
|
Proportion of selected PHCs that received at least one supportive supervision visit in the past 12 months (A ÷ B; B = total selected PHCs)
Lasso di tempo: 36 months
|
Secondary Implementation Outcome: A = Number of PHCs who received at least one supportive supervision visit in the past 12 months B = Total number of selected PHCs Calculation: A ÷ B |
36 months
|
|
Proportion of eligible PHCs that received at least one audit-and-feedback report within the past 3 months (A ÷ B)
Lasso di tempo: 36 months
|
Secondary Implementation Outcome: A = Number of PHCs who received at least an audit and feedback report within the past 3-months B = Total number of selected PHCs Calculation: A ÷ B |
36 months
|
|
Percentage of PHCs with a working blood glucose monitor on-site on the day of assessment (last supervision visit) (A ÷ B)
Lasso di tempo: 36 months
|
Secondary Implementation Outcome: A = Number of PHCs with a working blood glucose monitor at the site on the day of assessment (time point: last supervision visit) B = Total number of selected PHCs Calculation: A ÷ B |
36 months
|
|
Percentage of PHCs with diabetes medicines available on-site on the day of assessment (last supervision visit) (A ÷ B)
Lasso di tempo: 36 months
|
Secondary Implementation Outcome: A = Number of PHCs with diabetes medicines available on the day of assessment (time point: last supervision visit) B = Total number of selected PHCs Calculation: A ÷ B |
36 months
|
|
6-monthly rolling average percentage of registered diabetes patients with clinically indicated step-up who received step-up treatment within 6 months (A = patients needing and receiving step-up; B = patients registered per month)
Lasso di tempo: 36 months
|
Secondary Implementation Outcome: A = Number of patients who need step up treatment and received it B = Total number of patients who are registered per month Calculation: A ÷ B, 6-monthly rolling average rate |
36 months
|
|
6-monthly rolling average monthly proportion of registered diabetes patients receiving appropriate stepped care, out of total registered patients (A ÷ B)
Lasso di tempo: 36 months
|
Secondary Implementation Outcome: A = Number of patients who need step up treatment and received it B = Total number of patients who are registered per month Calculation: A ÷ B, 6-monthly rolling average rate |
36 months
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Difference in the proportion of patients with serious adverse events (SAEs) between pre-implementation and implementation periods
Lasso di tempo: 36 months
|
Safety Outcome: between-period (pre-implementation versus implementation) differences in proportions of serious adverse events
|
36 months
|
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Difference in the proportion of patients with adverse events of special interest (hypoglycemia, hyperglycemia, medication allergies, common medication side effects) between pre-implementation and implementation periods
Lasso di tempo: 36 months
|
Safety Outcome: e.g., hypoglycemia, hyperglycemia, medication allergies, common medication side effects in pre-implementation and implementation periods.
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36 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 maggio 2026
Completamento primario (Stimato)
30 aprile 2029
Completamento dello studio (Stimato)
31 gennaio 2030
Date di iscrizione allo studio
Primo inviato
29 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
11 maggio 2026
Primo Inserito (Effettivo)
15 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UATH/HREC/PR/557/A3
- R01HL144708 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Individual patient data will be shared through NHLBI BioData Catalyst
Periodo di condivisione IPD
Data will be available within 1 year of study conclusion
Criteri di accesso alla condivisione IPD
Access to study data will be managed through NHLBI BioData Catalyst.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .