NCT06986590

Brief Summary

The ADHINCRA Program is a bundle of multilevel evidence-based interventions that address multiple predictors of controlled hypertension, including patient-, provider-, and health system-level factors. The successful implementation of the ADHINCRA program will provide a rigorous and scalable model for improving hypertension control in Africa, which would ultimately reduce the risk of cardiovascular disease, stroke and kidney disease.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
28mo left

Started Jan 2026

Typical duration for not_applicable hypertension

Geographic Reach
3 countries

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Sep 2028

First Submitted

Initial submission to the registry

May 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

January 9, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

May 15, 2025

Last Update Submit

January 13, 2026

Conditions

High Blood PressureHypertension

Outcome Measures

Primary Outcomes (1)

  • Number of participants with systolic blood pressure <140 mmHg

    Blood pressure control among participants defined as systolic blood pressure \<140 mmHg

    Baseline and 12 months post-randomization

Secondary Outcomes (4)

  • Number of participants with diastolic blood pressure <90 mmHg

    Baseline, 12 months, 24 months post-randomization

  • Medication adherence as assessed by Hill-Bone Medication Adherence Scale

    Baseline, 12 months, 24 months post-randomization

  • Percentage of sites that adopt and maintain the intervention as assessed by the Pragmatic Robust Implementation and Sustainability Model

    Baseline, 12 months, 24 months post-randomization

  • Difference in cost of intervention compared to usual care as assessed by the Pragmatic Robust Implementation and Sustainability Model

    Baseline, 12 months, 24 months post-randomization

Study Arms (4)

Cohort 1

EXPERIMENTAL

This cohort will be the first to participate in the ADHINCRA Program, which includes home blood pressure monitoring, an mHealth app, nurse-led lifestyle counselling and treatment with a simplified hypertension control protocol.

Behavioral: ADHINCRA Program

Cohort 2

EXPERIMENTAL

This cohort will begin the ADHINCRA Program 3 months after Cohort 1.

Behavioral: ADHINCRA Program

Cohort 3

EXPERIMENTAL

This cohort will begin the ADHINCRA Program 6 months after Cohort 1.

Behavioral: ADHINCRA Program

Cohort 4

EXPERIMENTAL

This cohort will begin the ADHINCRA Program 9 months after Cohort 1.

Behavioral: ADHINCRA Program

Interventions

ADHINCRA ProgramBEHAVIORAL

The ADHINCRA Program is a nurse-led intervention that includes the use of home blood pressure monitoring, a mobile health app, lifestyle counselling, and a simplified hypertension treatment protocol to achieve blood pressure control among people diagnosed with hypertension.

Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 -70 years.
  • Diagnosis of hypertension and elevated systolic blood pressure measure (≥140 mmHg) on the most recent clinic visit without a diabetes diagnosis.
  • Hypertension treatment naive or on monotherapy.
  • Receives primary care at one of the participating sites.
  • Willing and able to provide informed consent in English, Twi, Dagbani, Ewe, Hausa, or Yoruba.
  • Owns a smartphone (Android or iOS).

You may not qualify if:

  • Age \<18 years or \>70 years.
  • Severely elevated BP (≥180/110mmHg).
  • Diagnosis of stroke, coronary artery disease, or kidney disease.
  • Diagnosis of end-stage renal disease (ESRD) treated with dialysis.
  • Serious medical condition which either limits life expectancy or requires active management (e.g., cancer).
  • Cognitive impairment or other conditions preventing study participation
  • Pregnant or currently nursing a child
  • Unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

ACTIVE NOT RECRUITING

Dominase SDA Hospital

Bekwai, Ashanti Region, Ghana

NOT YET RECRUITING

Kumasi South Hospital

Kumasi, Ashanti Region, Ghana

NOT YET RECRUITING

Manhyia Government Hospital

Kumasi, Ashanti Region, Ghana

RECRUITING

Tafo Government Hospital

Tafo, Ashanti Region, Ghana

NOT YET RECRUITING

Berekum Holy Family Hospital

Berekum, Bono, Ghana

NOT YET RECRUITING

St. John of God Catholic Hospital

Duayaw Nkwanta, Bono, Ghana

RECRUITING

Northern Regional Hospital

Tamale, Northern Region, Ghana

RECRUITING

Tamale Teaching Hospital

Tamale, Northern Region, Ghana

NOT YET RECRUITING

Ho Municipal Hospital

Ho, Volta Region, Ghana

NOT YET RECRUITING

South Tongu District Hospital

Sogakope, Volta Region, Ghana

NOT YET RECRUITING

Akure South Hospital

Akure, Ondo State, Nigeria

RECRUITING

Akoko North East

Ondo, Ondo State, Nigeria

NOT YET RECRUITING

Akoko North West

Ondo, Ondo State, Nigeria

NOT YET RECRUITING

Akoko South East

Ondo, Ondo State, Nigeria

NOT YET RECRUITING

Akoko South West

Ondo, Ondo State, Nigeria

NOT YET RECRUITING

Owo General Hospital

Owo, Ondo State, Nigeria

NOT YET RECRUITING

Related Publications (1)

  • Commodore-Mensah Y, Sarfo FS, Turkson-Ocran RA, Foti K, Mobula LM, Himmelfarb CD, Carson KA, Appiah LT, Degani M, Lang'at C, Nyamekye G, Molello NE, Ahima R, Cooper LA. Addressing Hypertension Care in Africa (ADHINCRA): Study protocol for a cluster-randomized controlled pilot trial. Contemp Clin Trials. 2023 Feb;125:107077. doi: 10.1016/j.cct.2022.107077. Epub 2022 Dec 30.

    PMID: 36592818BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Yvonne Commodore-Mensah, PhD, MHS, RN

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Fred S Sarfo, MBBS, PhD, FWACP

    Kwame Nkrumah University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Dike B Ojji, MBBS, PhD, FWACP

    University of Abuja

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne Commodore-Mensah, PhD, MHS, RN

CONTACT

410-614-1519ycommod1@jhmi.edu

Research Program Manager

CONTACT

adhincra@jh.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Stepped wedge cluster randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2025

First Posted

May 23, 2025

Study Start

January 9, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

NG(6)US(1)GH(10)