Integration of Hypertension Management Into HIV Care in Nigeria (TASSH NIMR)

NYU Langone Health

Status: Active, not recruiting

Conditions: Hypertension; Human Immunodeficiency Virus

Treatments: Behavioral: Task-shifting strategy for HTN control (TASSH) protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04704336

20-00009

R01HL147811-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study evaluates a tailored-practice facilitation (PF) strategy for integrating a task strengthening strategy for hypertension control (TASSH) for the care of patients living with HIV (PWH) within primary health centers (PHCs) in Lagos, Nigeria.

Full description

Although access to antiretroviral therapy has led to increased survival among people living with HIV (PWH) in Africa, this population now has higher cardiovascular disease (CVD) - mortality than the general population largely due to an increased burden of hypertension. In Nigeria, the acute shortage of physicians limits the capacity to control hypertension among PWH at the primary care level where the majority receive treatment. This study proposes the use of practice facilitation (PF) - which will provide external expertise on practice redesign and a tailored approach to delivery of the evidence-based task strengthening strategy - to integrate hypertension into the HIV care model. Using a clinical-effectiveness implementation design, we will evaluate the effect of a PF strategy for integrating an evidence-based intervention for hypertension (HTN) control into HIV care among 960 patients with uncontrolled HTN in 30 primary health centers (PHCs) in Nigeria. Study is in 3 phases: 1) a pre-implementation phase that will develop a tailored PF intervention for integrating TASSH into HIV clinics; 2) an implementation phase that will compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and 3) a post- implementation phase to evaluate the effect of PF vs. self-directed condition on the adoption and sustainability of TASSH. The PF intervention comprises: (a) an advisory board to provide leadership support for implementing TASSH in HIV clinics; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses

Enrollment: 830 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be an adult aged 18 years and older.
• Attends one of the 30 HIV clinics.
• Have a diagnosis of HTN with uncontrolled blood pressure, i.e. BP is 140-179/90-100 mm Hg.
• Ability to provide consent.

Exclusion criteria

• BP>180/110 mm Hg;
• history of chronic kidney disease, heart disease, diabetes or stroke, pregnancy
• Inability to provide informed consent.
• Refusal to participate in the study.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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830 participants in 2 patient groups

Self-directed without Practice Facilitation (PF)

No Intervention group

Description:

Participants will be identified from HIV clinics during routine visits and provided standard of care.

With Practice Facilitation (PF)

Experimental group

Description:

Participants will be identified from HIV clinics during routine visits and will receive the task-shifting strategy for HTN control (TASSH) protocol.

Treatment:

Behavioral: Task-shifting strategy for HTN control (TASSH) protocol