Clinical trial NCT06986590: Addressing Hypertension Care in Africa Program
Official title: Addressing Hypertension Care in Africa (ADHINCRA) Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
High Blood Pressure
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-05-23
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped wedge cluster randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* Aged 18 -70 years.
* Diagnosis of hypertension and elevated systolic blood pressure measure (≥140 mmHg) on the most recent clinic visit (within the previous 6 months) without a diabetes diagnosis.
* Receives primary care at one of the participating sites.
* Willing and able to provide informed consent in English, Twi, Dagbani, Ewe or Yoruba.
* Owns a smartphone (Android or iOS).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants with systolic blood pressure <140 mmHg
timeFrame: Baseline and 12 months post-randomization
Secondary outcomes:
measure: Number of participants with diastolic blood pressure <90 mmHg
timeFrame: Baseline, 12 months, 24 months post-randomization
measure: Medication adherence as assessed by Hill-Bone Medication Adherence Scale
timeFrame: Baseline, 12 months, 24 months post-randomization
measure: Percentage of sites that adopt and maintain the intervention as assessed by the Pragmatic Robust Implementation and Sustainability Model
timeFrame: Baseline, 12 months, 24 months post-randomization
measure: Difference in cost of intervention compared to usual care as assessed by the Pragmatic Robust Implementation and Sustainability Model
timeFrame: Baseline, 12 months, 24 months post-randomization
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Bekwai
country: Ghana
facility: Dominase SDA Hospital
state: Ashanti Region
city: Kumasi
country: Ghana
facility: Kumasi South Hospital
state: Ashanti Region
city: Kumasi
country: Ghana
facility: Manhyia Government Hospital
state: Ashanti Region
city: Tafo
country: Ghana
facility: Tafo Government Hospital
state: Ashanti Region
city: Berekum
country: Ghana
facility: Berekum Holy Family Hospital
state: Bono Region
city: Duayaw Nkwanta
country: Ghana
facility: St. Johns Hospital
state: Bono Region
city: Tamale
country: Ghana
facility: Northern Regional Hospital
state: Northern Region
city: Tamale
country: Ghana
facility: Tamale Teaching Hospital
state: Northern Region
city: Ho
country: Ghana
facility: Ho Municipal Hospital
state: Volta Region
city: Sogakofe
country: Ghana
facility: South Tongu District Hospital
state: Volta Region
city: Akure
country: Nigeria
facility: Akure South Hospital
state: Ondo State
city: Ondo
country: Nigeria
facility: Akoko North East
state: Ondo State
city: Ondo
country: Nigeria
facility: Akoko North West
state: Ondo State
city: Ondo
country: Nigeria
facility: Akoko South East
state: Ondo State
city: Ondo
country: Nigeria
facility: Akoko South West
state: Ondo State
city: Owo
country: Nigeria
facility: Owo General Hospital
state: Ondo State
Study officials:
affiliation: Johns Hopkins University
name: Yvonne Commodore-Mensah, PhD, MHS, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Kwame Nkrumah University of Science and Technology
name: Fred S Sarfo, MBBS, PhD, FWACP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Abuja
name: Dike B Ojji, MBBS, PhD, FWACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.