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

• ClinicalTrials.gov Identifier: NCT05068505
• Recruitment Status: Completed
• First Posted: October 6, 2021
• Last Update Posted: February 29, 2024
• Sponsor: Charite University, Berlin, Germany
• Collaborators: University of Miami; Makerere University; Yale University; London School of Hygiene and Tropical Medicine; Johns Hopkins University; Ministry of Health, Uganda; African Community Center for Social Sustainability
• Information provided by (Responsible Party): Prof. Dr. med. Felix Knauf, Charite University, Berlin, Germany

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Community Health Workers	Behavioral: Community health worker delivered multicomponent intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 869 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Participant Recruiters
• Primary Purpose: Health Services Research
• Official Title: Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda: a Stepped Wedge, Cluster Randomized Control Trial
• Actual Study Start Date: January 5, 2023
• Actual Primary Completion Date: February 1, 2024
• Actual Study Completion Date: February 28, 2024

Arms and Interventions

Arm	Intervention/treatment
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
No Intervention: Control; All clusters will be observed under both the intervention and control arm through sequential crossover.

Outcome Measures

Primary Outcome Measures :

1. Blood pressure control [ Time Frame: 3 months ]
   Decrease in the average systolic and/or diastolic blood pressure between the intervention and control arms.

Secondary Outcome Measures :

1. Glycemic control [ Time Frame: 3 months ]
   Defined as a reduction >1% in heamoglobin A1C
2. Proportion of participants with blood pressure control [ Time Frame: 3 months ]
   Defined as blood pressure <140/90 mmHg

Other Outcome Measures:

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Uganda

Makerere University College of Health Sciences

Kampala, Uganda

Sponsors and Collaborators

Charite University, Berlin, Germany

University of Miami

Makerere University

Yale University

London School of Hygiene and Tropical Medicine

Johns Hopkins University

Ministry of Health, Uganda

African Community Center for Social Sustainability

Investigators

• Principal Investigator: Felix Knauf, Prof.Dr.med.; Charité University, Berlin, Germany

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Prof. Dr. med. Felix Knauf, Director of the Charité Mitte Campus - Senior Physician, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT05068505
• Other Study ID Numbers: Balamu2021
• First Posted: October 6, 2021
• Last Update Posted: February 29, 2024
• Last Verified: February 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. med. Felix Knauf, Charite University, Berlin, Germany:

Hypertension; Community health workers; Uncontrolled blood pressure; Uganda

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases