Hypertension Treatment in Nigeria: Hypertension Diabetes Integration Study- Formative Aim 3 (HTN2)
11 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
- Autre: Implementation of program based on WHO HEARTS-D guidelines
- Médicament: Metformin
- Médicament: Glimepiride
- Dispositif: Point-of-care blood glucose monitor (glucometer) and compatible test strips
- Comportemental: HEARTS-D training and quarterly supportive supervision for community health extension workers (CHEWs)
Type d'étude
Interventionnel
Inscription (Estimé)
2800
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Dike Ojji, MD
- Numéro de téléphone: +234-806-009-4456
- E-mail: dike.ojji@uniabuja.edu.ng
Sauvegarde des contacts de l'étude
- Nom: Mark Huffman, MD
- E-mail: m.huffman@wustl.edu
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
Autres noms:
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.
Délai: 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
|
|
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
Délai: 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.
|
36 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in 6-month rolling average diabetes treatment (proportion of eligible patients prescribed any glucose-lowering medication) between pre-implementation and implementation periods
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in the proportion of patients with serious adverse events (SAEs) between pre-implementation and implementation periods
Délai: 36 months
|
Safety Outcome: between-period (pre-implementation versus implementation) differences in proportions of serious adverse events
|
36 months
|
|
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
Délai: 36 months
|
Safety Outcome: e.g., hypoglycemia, hyperglycemia, medication allergies, common medication side effects in pre-implementation and implementation periods.
|
36 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 mai 2026
Achèvement primaire (Estimé)
30 avril 2029
Achèvement de l'étude (Estimé)
31 janvier 2030
Dates d'inscription aux études
Première soumission
29 avril 2026
Première soumission répondant aux critères de contrôle qualité
11 mai 2026
Première publication (Réel)
15 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UATH/HREC/PR/557/A3
- R01HL144708 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Individual patient data will be shared through NHLBI BioData Catalyst
Délai de partage IPD
Data will be available within 1 year of study conclusion
Critères d'accès au partage IPD
Access to study data will be managed through NHLBI BioData Catalyst.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .