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Hypertension Treatment in Nigeria: Hypertension Diabetes Integration Study- Formative Aim 3 (HTN2)

11. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

2800

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Implementation of program based on WHO HEARTS-D guidelines
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.
Medicin: Metformin
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.
Medicin: Glimepiride
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.
Enhed: Point-of-care blood glucose monitor (glucometer) and compatible test strips
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.
Andre navne:
  • Capillary blood glucose meter
  • finger-stick glucose meter
Adfærdsmæssigt: HEARTS-D training and quarterly supportive supervision for community health extension workers (CHEWs)
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.
Andre navne:
  • Provider training
  • Supportive supervision

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in 6-month rolling average diabetes treatment (proportion of eligible patients prescribed any glucose-lowering medication) between pre-implementation and implementation periods
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in the proportion of patients with serious adverse events (SAEs) between pre-implementation and implementation periods
Tidsramme: 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
Tidsramme: 36 months
Safety Outcome: e.g., hypoglycemia, hyperglycemia, medication allergies, common medication side effects in pre-implementation and implementation periods.
36 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Washington University School of Medicine

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)
University of Abuja Teaching Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

30. april 2029

Studieafslutning (Anslået)

31. januar 2030

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

11. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UATH/HREC/PR/557/A3
  • R01HL144708 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individual patient data will be shared through NHLBI BioData Catalyst

IPD-delingstidsramme

Data will be available within 1 year of study conclusion

IPD-delingsadgangskriterier

Access to study data will be managed through NHLBI BioData Catalyst.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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