Clinical trial NCT05846503: iHEART-SA Intervention Study
Official title: The Integrating HIV and hEART Health in South Africa Intervention Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
HIV
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
Collaborators: name: Emory University
name: Massachusetts General Hospital
name: UMC Utrecht
First posted: 2023-05-06
Enrollment: 4378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cluster stepped-wedge study design where clinics will be assigned to a time at which they initiate the intervention. There are nine clinics which have been classification (low, medium and high) according to their volume. One clinic from each classification has been randomized to a cluster such that there are three clusters each with a low, medium and high volume clinic.
Primary purpose: OTHER

Brief summary: Using qualitative data during the formative phase the IHEART-SA research study filled deficiencies in knowledge regarding: 1) what barriers exist to integrating hypertension care within the HIV care setting in South Africa and, 2) how a hypertension care intervention can be adapted to effectively and sustainably function in this care setting. These data have been used to design a context-relevant intervention package for implementation in the next phase of effectiveness-implementation testing, answering the research question: How does an intervention aimed at enhancing hypertension diagnosis and management in people living with HIV improve the delivery of guideline-recommended care in primary healthcare clinics in Gauteng, South Africa, and hypertension control among patients?

The study will use an effectiveness-implementation study design. This design allows for the testing of strategies to promote integration of proven interventions in real-world practice (i.e., implementation strategies), while simultaneously assessing clinical effectiveness (i.e., patient level outcomes). For this the study will use a randomized cluster stepped-wedge study design where nine clinics (grouped in clusters of three) will be assigned to a time at which they initiate the intervention.

Detailed description: Investigational interventions:

Implementation facilitation of improved hypertension screening and management in the HIV care setting through the iHEART-SA intervention model comprising:

1. Information management system
2. Task shifting
3. Audit and feedback
4. Healthcare worker education and training
5. Patient education and support

Study design:

Cluster randomized stepped wedge effectiveness-implementation type 2 hybrid

Study objectives:

1. Assess the short- and long-term effects of an implementation strategy (i.e., healthcare worker intervention) on the adoption and implementation of hypertension screening and treatment among healthcare workers
2. Assess the short- and long-term effects of a clinical intervention (i.e., patient-level intervention) on patient blood pressure control among patients living with HIV and hypertension

Duration of participation: 27 months Study duration: 37 months

Intervention audience:

1. Healthcare workers (nurses and doctors)
2. Adult patients living with HIV from the 9 primary healthcare clinics

Eligibility criteria: Inclusion Criteria:

Healthcare workers:

1. Adult \>18 years men and women working in clinical roles at the selected clinics
2. Provide informed consent (only those participating in the qualitative components)

Patients:

1. Adults \>18 years living with HIV and hypertension
2. Enrolled in the study clinic
3. Willing and able to provide informed consent

Exclusion Criteria:

Patients:

1. Unable or unwilling to provide informed consent
2. Planning to relocate or change service providers/clinics

Primary outcomes:
measure: Healthcare worker
timeFrame: 24 months
measure: Patient
timeFrame: 12 months
Secondary outcomes:
measure: Healthcare worker implementation
timeFrame: 24 months
measure: Healthcare worker adoption
timeFrame: 24 months
measure: Healthcare worker maintenance - BP measurement
timeFrame: 12 months
measure: Healthcare worker satisfaction
timeFrame: 24 months
measure: Healthcare worker costing
timeFrame: 27 months
measure: Patient adoption
timeFrame: 24 months
measure: Patient satisfaction
timeFrame: 24 months
measure: Healthcare worker maintenance - BP management
timeFrame: 12 months
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Sunnyside Office Park
state: Gauteng
Study officials:
affiliation: Ezintsha, University of the Witwatersrand
name: Willem DF Venter, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: