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Not yet recruiting NCT07351162

Hypertension Treatment in Nigeria 2.0

No phase Interventional Hypertension (HTN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implementation of a modified WHO HEARTS Hypertension Treatment Bundle.
Who it may be relevant to
Registry conditions: Hypertension (HTN). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Hypertension Treatment in Nigeria Program 2.0

Overview

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, Nigeria. This program demonstrated significant improvements in hypertension treatment and control. HTN 2.0 will expand implementation of the HEARTS bundle to 5 new states in 5 geopolitical zones in Nigeria (Abia, Delta, Gombe, Jigawa, and Oyo) while also evaluating sustainment of hypertension control in the Federal Capital Territory.

Interventions

  • Other Implementation of a modified WHO HEARTS Hypertension Treatment Bundle
    The intervention seeks to the scale-up of the World Health Organization HEARTS package in 50 primary healthcare centers across five Nigerian states using a type II hybrid effectiveness implementation design. Following a 12-month pre-implementation period, centers will transition into a 24-month implementation period that includes state-level training of health workers, non-physician hypertension screening, diagnosis, and treatment, simplified hypertension treatment guidelines, monthly audit and

Primary outcome measures

  • Primary Effectiveness Outcome [Time frame: 36 months]
  • Primary Implementation Outcome [Time frame: 36 months]
Secondary outcome measures (12)
  • Secondary Effectiveness outcome (hypertension treatment) [Time frame: 36 months]
  • Secondary Effectiveness Outcomes (mean systolic blood presure) [Time frame: 36 months]
  • Secondary Effectiveness Outcome (mean diastolic blood pressure) [Time frame: 36 months]
  • Secondary Implementation Outcomes: Proportion of selected PHCs who participated in baseline hypertension training [Time frame: 36 months]
  • Secondary Implementation Outcome: Proportion of selected PHCs who participated in site initiation training [Time frame: 36 months]
  • Secondary Implementation Outcome: Proportion of selected PHCs who received at least one supportive supervision visit in the past 12 months [Time frame: 36 months]
  • Secondary Implementation Outcome: Proportion of selected PHCs who received an audit and feedback report within the past 3-months [Time frame: 36 months]
  • Secondary Implementation Outcome: Percentage of PHCs with a working blood pressure monitor at the site on the day of assessment [Time frame: 36 months]
  • Secondary Implementation Outcome: Percentage of PHCs with blood pressure medicines available on the day of assessment [Time frame: 36 months]
  • Secondary Implementation Outcome: Percentage of patients with step up indicated who received step up treatment in the last 6-months [Time frame: 36 months]
  • Secondary Implementation Outcome: Number and proportion of adult patients with hypertension who are registered/total number of adult patients with elevated blood pressure within participating PHCs within the past 3 working days [Time frame: 36 months]
  • Secondary implementation Outcome: Monthly proportion of registered patients with appropriate stepped care/total number of registered patients [Time frame: 36 months]

Eligibility criteria

Inclusion criteria

  • Adults (≥18 years old),
  • Elevated blood pressure (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg) documented or measured by a health care professional (e.g., physician, community health extension worker, or community health officer) on two separate occasions or taking a BP-lowering medication, or a history of hypertension.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07351162 · UATH/HREC/PR/557/A2 · R01HL144708

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗