A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention

Hypertension Clinical Trial

— EXTRA-CVD  

Official title:

A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03643705
• Other study ID #: 03-18-16
• Secondary ID: U01HL142099
• Status: Completed
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: January 15, 2023

Study information

• Verified date: March 2024
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Strategies to improve uptake of cardiovascular disease preventive therapies among people living with HIV (PLHIV) are urgently needed. This study tests an innovative prevention nurse intervention to extend the HIV/AIDS treatment cascade for the treatment of hypertension and hyperlipidemia among PLHIV on suppressive antiretroviral therapy. This intervention may be scalable as an extension of ongoing HIV/AIDS treatment cascade initiatives in HIV specialty clinics nationwide.

Description:

People living with HIV (PLHIV) are at increased risk for atherosclerotic cardiovascular disease (ASCVD); however, uptake of evidence based therapies to prevent ASCVD is sub-optimal. Reasons for under treatment may include low perceived risk, competing priorities for HIV specialist providers, and poor trust and communication with non-HIV primary care providers. This project proposes a nurse-led intervention to extend the HIV/AIDS treatment cascade-a widely adopted framework developed to improve access to high quality HIV care-for CVD prevention, specifically to improve control of blood pressure and hyperlipidemia in PLHIV on antiretroviral therapy who have suppressed HIV viral load. The study will be conducted in three racially and ethnically diverse clinic contexts [University Hospitals (Cleveland, OH), MetroHealth (Cleveland, OH) and Duke Health (Durham, NC)] that are broadly representative of HIV specialty care in the US. Using a mixed-methods clinical effectiveness trial design, this project will test the 12-month efficacy of a multi-component intervention among n=300 HIV+ adults on suppressive ART with hypertension and hyperlipidemia. Participants will be randomized 1:1 to intervention vs. education control. Control participants will receive general prevention education. The intervention will consist of four evidence-based components derived from prior studies in the general population: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home BP monitoring, and (4) electronic medical records (EMR) support tools. These components will be further adapted to the HIV specialty clinic context with key stakeholder input and using data from a mixed-methods study of current ASCVD preventive care practices at the three HIV clinic sites. A process evaluation of the prevention nurse intervention will be conducted, which will assess fidelity, dose, recruitment, reach, and context. Two key contextual process measures of interest will be changes in perceived ASCVD risk and changes in trust and communication between PLHIV participants and their HIV and non-HIV providers. If proven effective to reduce both blood pressure and cholesterol as postulated, this nurse-led intervention will have substantial clinical impact among high-risk PLHIV, potentially reducing ASCVD events by more than a quarter. This model is potentially scalable as an extension of HIV treatment cascade initiatives nationwide.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years

2. Laboratory confirmed HIV+ diagnosis

3. Undetectable HIV viral load: defined as the most recent HIV viral load <200 copies/mL, checked within the past year (assessed via chart abstraction)

4. Hypertension: defined as systolic blood pressure >130 mmHg on = 2 occasions in the past 12 months or on an antihypertensive medication (assessed via chart abstraction)

5. Hyperlipidemia: defined as a non-high-density lipoprotein cholesterol level >130mg/dL or on cholesterol lowering medication

Exclusion Criteria:

1. On lipid-lowering medication solely for cardiovascular disease prevention with evidence of pre-medication non-high-density lipoprotein cholesterol which was already below 100mg/dL

2. On anti-hypertensive medications solely for a non-hypertension indication (e.g. systolic heart failure)

3. Severely hearing or speech impaired, or other disability that would limit participation in the intervention components

4. In a nursing home and/or receiving in-patient psychiatric care

5. Terminal illness with life expectancy < 4 months

6. No reliable access to a telephone

7. Pregnant, breast-feeding, or planning a pregnancy during the study period

8. Planning to move out of the area in the next 12 months

9. Non-English Speaking

Related Conditions & MeSH terms

• Cardiovascular Diseases
• HIV/AIDS
• Hyperlipidemias
• Hypertension

Intervention

Other:
• Multi-component intervention
4 components as described
• General prevention education
General education as described

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Duke Health	Durham	North Carolina

Sponsors (6)

Lead Sponsor	Collaborator
Case Western Reserve University	Duke University, MetroHealth Medical Center, National Heart, Lung, and Blood Institute (NHLBI), University Hospitals Cleveland Medical Center, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	% of Subjects in Each Hypertension Cascade Category	Ordinal 3-level variable across 4 time points (0, 4, 8, and 12 months). The hypertension cascade tool is reported as mutually exclusive categories as follows: 1=untreated hypertension; 2=hypertension treated; 3=blood pressure target achieved. NOTE: This differs from our protocol specified 4-level variable because the numbers in the first two categories were too small. Therefore, undiagnosed and diagnosed were collapsed into one "untreated" category.	12 months
Other	% of Subjects in Each Hyperlipidemia Cascade Category	Ordinal 3-level variable across 4 time points (0, 4, 8, and 12 months). The cholesterol cascade is reported as mutually exclusive categories as follows: 1=untreated hyperlipidemia; 2=hyperlipidemia treated; 3=non-HDL cholesterol target achieved. NOTE: This differs from our protocol specified 4-level variable because the numbers in the first two categories were too small. Therefore, undiagnosed and diagnosed were collapsed into one "untreated" category.	12 months
Primary	Systolic Blood Pressure	Repeated measures across 4 time points (0, 4, 8, and 12 months)	12 months
Secondary	Non High Density Lipoprotein (Non-HDL) Cholesterol	Repeated measures across 4 time points (0, 4, 8, and 12 months)	12 months