Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda (CHW-HTC)

Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda: a Stepped Wedge, Cluster Randomized Control Trial

Over 80% of the morbidity and mortality related to non-communicable diseases (NCDs) occurs in low-income and middle-income countries (LMICs). Community health workers (CHWs) may improve disease control and medication adherence among patients with NCDs in LMICs, but data are scarce, particularly in sub-Saharan African settings. In Uganda, and the majority of LMICs, management of uncontrolled blood pressure remains limited in constrained health systems. Intervening at the primary care level, using CHWs to improve medical treatment outcomes has not been well studied. The investigators aim to determine the effectiveness of a CHW-led intervention in blood pressure control among confirmed hypertensive patients and patient-related factors associated with uncontrolled hypertension. Methods: Conduction of a stepped-wedge cluster randomized controlled trial study of 869 adult patients with hypertension attending two NCD clinics to test the effectiveness, acceptability and fidelity of a CHW-led intervention. The multi-component intervention will be centered on monthly household visits by trained CHWs for a period of seven months, consisting of the following; (1) blood pressure and sugar monitoring; (2) BMI monitoring; (3) cardiovascular disease risk assessment; (4) Using checklists to guide monitoring and referral to clinics; (5) healthy lifestyle counselling and education. During home visits, CHWs will remind patients of follow-up visits. The investigators will measure blood pressure at baseline and 3-monthly for the entire cohort. The investigators will additionally test acceptability of the intervention and fidelity over the course of the intervention. The investigators will conduct individual-level mixed effects analyses of study data, adjusting for time and clustering by patient and community. Conclusion: The results of this study will inform community delivered hypertension management across a range of LMIC settings.

Study Overview

• Status: Completed
• Conditions: Hypertension; Community Health Workers
• Intervention / Treatment: Behavioral: Community health worker delivered multicomponent intervention

• Study Type: Interventional
• Enrollment (Actual): 869
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Felix Knauf, Prof.Dr.med.; Phone Number: +49 30 450 514466; Email: felix.knauf@charite.de
• Study Contact Backup: Name: Rebecca Ingenhoff, MSc; Phone Number: +49 30 450 530068; Email: rebecca.ingenhoff@charite.de

Study Locations

• Uganda
  • Kampala, Uganda
    • Makerere University College of Health Sciences
    • Contact: Robert Kalyesubula, Dr.; Phone Number: +256702442700; Email: rkalyesubula@gmail.com
    • Principal Investigator: Robert Kalyesubula, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with hypertension (Systolic >140 and/or Diastolic >90)
• Participants attending the two NCD clinics
• Adults 18 years and above
• Participants residing in the three sub counties (Nakaseke Town Council, Nakaseke Sub County and Kasangombe of Nakaseke district)
• Participants able to give informed consent.

Exclusion Criteria:

• Patients diagnosed with hypertension but already controlled
• Pregnant women
• Patients with an expected life expectancy of less than one year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; All clusters will be observed under both the intervention and control arm through sequential crossover.
Experimental: Community health worker delivered multicomponent intervention; The study will employ a closed cohort stepped wedge cluster randomized design. There will be a sequential crossover of clusters from the control to the intervention arms and the order of the cross over will be randomly determined. This study will be conducted in 21 clusters within Nakaseke district. Each cluster will consist of 4-5 villages. We plan to rollout the intervention in three clusters per month.	Behavioral: Community health worker delivered multicomponent intervention; The multi-component intervention will be centered on monthly household visits by trained CHWs for a period of seven months in a rural setting in Nakaseke, Uganda, consisting of the following; (1) blood pressure and sugar monitoring; (2) BMI monitoring; (3) cardiovascular disease risk assessment; (4) Using checklists to guide monitoring and referral to clinics; (5) healthy lifestyle counselling and education. During home visits, CHWs will remind patients of follow-up visits. We will measure blood pressure at baseline and 3-monthly for the entire cohort. We will conduct individual-level mixed effects analyses of study data, adjusting for time and clustering by patient and community. We will conduct an interim analysis at 3 months to assess differences between groups. If a statistically significant difference is detected the intervention will be applied across the remaining clusters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure control	Decrease in the average systolic and/or diastolic blood pressure between the intervention and control arms.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control	Defined as a reduction >1% in heamoglobin A1C	3 months
Proportion of participants with blood pressure control	Defined as blood pressure <140/90 mmHg	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite negative clinical cardiovascular disease (CVD) outcomes	Including CVD related admissions, stroke, and myocardial infarction, incident heart failure will be assessed.	3 months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: London School of Hygiene and Tropical Medicine; Johns Hopkins University; University of Miami; Yale University; Makerere University; Ministry of Health, Uganda; African Community Center for Social Sustainability
• Investigators: Principal Investigator: Felix Knauf, Prof.Dr.med., Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Ingenhoff R, Nandawula J, Siddharthan T, Ssekitoleko I, Munana R, Bodnar BE, Weswa I, Kirenga BJ, Mutungi G, van der Giet M, Kalyesubula R, Knauf F. Effectiveness of a community health worker-delivered care intervention for hypertension control in Uganda: study protocol for a stepped wedge, cluster randomized control trial. Trials. 2022 May 24;23(1):440. doi: 10.1186/s13063-022-06403-9.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; Community health workers; Uganda; Uncontrolled blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Balamu2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No