Integration of Hypertension Management Into HIV Care in Nigeria

Hypertension Clinical Trial

— TASSH NIMR  

Official title:

Integration of Hypertension Management Into HIV Care in Nigeria: A Task Strengthening Strategy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04704336
• Other study ID #: 20-00009
• Secondary ID: R01HL147811-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: December 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 830
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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>180/100 mm Hg;
• history of chronic kidney disease, heart disease, diabetes or stroke, pregnancy
• Inability to provide informed consent.
• Refusal to participate in the study.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Hypertension
• Immunologic Deficiency Syndromes

Intervention

Behavioral:
• Task-shifting strategy for HTN control (TASSH) protocol
The TASSH protocol include the following 4 steps: 1). Identify HIV patients with uncontrolled HTN: trained HIV nurses will take patients' medical history (whether or not they have a diagnosis of diabetes, heart attack, stroke, heart failure, smoking). 2) Next, they will measure the patients' weight, height, waist circumference and BP with a valid automated device following standard procedures and then conduct lab tests with point-of-care testing on blood glucose, lipids and urine dip stick. 3) Initiate lifestyle counseling and medication treatment every 1-3 months: The nurses will next counsel eligible patients on lifestyle behaviors for 20 to 30 minutes (increased intake of fruits and vegetables, moderate physical activity and reduce salt intake). 4). Refer patients with complicated HTN to physicians for further care

Locations

Country	Name	City	State
Nigeria	Nigerian Institute of Medical Research (NIMR)	Yaba	Lagos
United States	Saint Louis University (SLU)	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic Blood Pressure	The primary outcome is change in systolic blood pressure (SBP) from baseline to 12 months. Following the research investigators' existing TASSH protocol, the SBP reduction in patients will assessed as mean change in systolic BP from baseline to 12 months. Blood pressure will be taken with valid automated BP device from the existing TASSH protocol.	baseline, 6 months, 12 months, 18 months and 24 months
Secondary	The rate of adoption of TASSH across participating primary health centers (PHCs) at 12- and 24 months respectively.	Rate of adoption of TASSH is defined as the proportion of patients who were correctly diagnosed with hypertension, received lifestyle counseling and antihypertensive treatment from HIV nurses at 12 months. In order to assess this measure, the nurses will complete a questionnaire inquiring about the number of patients with uncontrolled HTN who received lifestyle counseling and medication treatment. For this purpose, all nurses will be required to keep an attendance log sheet for their patients' visits.	12 months
Secondary	The rate of sustainability of TASSH across participating primary health centers (PHCs) at 12- and 24 months respectively.	Sustainability of TASSH is defined as the maintenance of TASSH uptake at the HIV clinics at 24 months (one year after the end of the intervention). Sustainability will be assessed with a quantitative measure similar to adoption (as defined above) and qualitatively, based on interviews with nurses and clinic leadership at 24 months. For this purpose, two research coordinators will conduct the interviews with two nurses and one key leadership personnel at each primary health center (PHCs). The interviews will be guided by Consolidated Framework for Implementation Research (CFIR) and inquire about attitudes regarding the implementation of TASSH, barriers, facilitators, and implications for scalability.	24 months
Secondary	Change in Implementation Climate of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months.	Implementation Climate will be assessed with the Implementation Climate Scale. It measures shared perceptions of policies, practices, procedures, and behaviors that are expected, supported, and rewarded to facilitate effective evidence-based practice (EBP) implementation. It has a Cronbach's alpha of .91. The six subscales of EBP Implementation Climate are: focus on EBP (a=.91), educational support for EBP (a=.84), recognition for EBP (a=.88), rewards for EBP (a=.81), selection for EBP (a=.89), and selection for openness (a=.91).	12 months and 24 months
Secondary	Change in Implementation Leadership of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months.	Implementation Leadership will be assessed with the Implementation Leadership Scale (ILS). It is a 12-item measure with four subscales: Proactive Leadership (a=.95), Knowledgeable Leadership (a=.96), Supportive Leadership (a=.95), and perseverant leadership (a=.96) and a total score (a=.98).	12 months and 24 months
Secondary	Change in Proficiency of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months.	Organizational Culture domain of the Organizational Social Context Scale is a 15-item Proficiency subscale used to evaluate the practice capacity proficiency level of the primary health centers (PHCs). Proficient Organizational Cultures are those characterized by shared norms and expectations that the nurses are skilled service providers, and have current knowledge of the TASSH protocol. Items are completed using a 5-point rating scale ranging from 1 (never) to 5 (always) with measures such as responsiveness (e.g., 'members of my organizational unit are expected to be responsive to the needs of each patient') and competence (e.g., 'members of my organizational unit are expected to have up-to-date knowledge'). Alpha reliability for the proficient culture scale is .89.	12 months and 24 months
Secondary	Change in Organizational Readiness of Mediators of TASSH across the primary health centers (PHCs) at 12 and 24 months.	Organizational Readiness to Change is assessed with the 12-item Evidence Scale, which evaluates the strength of the evidence for the proposed change/innovation. It will be used to evaluate intervention process measures focused on CFIR's Evidence Strength & Quality and Relative Advantage construct. Each item measures the extent to which a respondent agrees or disagrees with the item statement on a 5-point Likert- type scale (1 = strongly disagree; 5 = strongly agree) and the Cronbach a=0.74.	12 months and 24 months
Secondary	Change in implementation process across the primary health centers (PHCs) at 12 and 24 months.	External change agent support is a 3-item tool that evaluates support provided by external facilitators, the expectations about performance and improvement, and the ways to achieve the goal of the project. Items are scored on a 5-point Likert scale and the Cronbach a=0.77.	12 months and 24 months
Secondary	Change in Organizational capacity to change across the primary health centers (PHCs) at 12 and 24 months.	Organizational Readiness to Change (Facilitation Scale-8-items), which evaluates organizational capacity to facilitate change will be used to evaluate implementation process measures focused on CFIR Engaging construct. Each item measures the extent to which a respondent agrees or disagrees with the item statement on a 5-point Likert-type scale (1 = strongly disagree; 5 = strongly agree). It has Cronbach a=0.95.	12 months and 24 months