Clinical trial NCT03643705: A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention
Official title: A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Hypertension
Hyperlipidemias
Keywords: Implementation Science
Cardiovascular Disease
Prevention
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Duke University
name: University Hospitals Cleveland Medical Center
name: MetroHealth Medical Center
name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Washington
First posted: 2018-08-23
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 12 months
Secondary outcomes:
measure: Non High Density Lipoprotein (Non-HDL) Cholesterol
timeFrame: 12 months
Other outcomes:
measure: % of Subjects in Each Hypertension Cascade Category
timeFrame: 12 months
measure: % of Subjects in Each Hyperlipidemia Cascade Category
timeFrame: 12 months
Locations:
city: Durham
country: United States
facility: Duke Health
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: University of Washington
name: Chris T Longenecker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Allison R Webel, RN PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Hayden Bosworth, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Barb Gripshover, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schexnayder J, Longenecker CT, Muiruri C, Bosworth HB, Gebhardt D, Gonzales SE, Hanson JE, Hileman CO, Okeke NL, Sico IP, Vedanthan R, Webel AR. Understanding constraints on integrated care for people with HIV and multimorbid cardiovascular conditions: an application of the Theoretical Domains Framework. Implement Sci Commun. 2021 Feb 12;2(1):17. doi: 10.1186/s43058-021-00114-z.
citation: Webel AR, Schexnayder J, Rentrope CR, Bosworth HB, Hileman CO, Okeke NL, Vedanthan R, Longenecker CT. The influence of healthcare financing on cardiovascular disease prevention in people living with HIV. BMC Public Health. 2020 Nov 23;20(1):1768. doi: 10.1186/s12889-020-09896-8.
citation: Okeke NL, Webel AR, Bosworth HB, Aifah A, Bloomfield GS, Choi EW, Gonzales S, Hale S, Hileman CO, Lopez-Kidwell V, Muiruri C, Oakes M, Schexnayder J, Smith V, Vedanthan R, Longenecker CT. Rationale and design of a nurse-led intervention to extend the HIV treatment cascade for cardiovascular disease prevention trial (EXTRA-CVD). Am Heart J. 2019 Oct;216:91-101. doi: 10.1016/j.ahj.2019.07.005. Epub 2019 Jul 18.