Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03643705 |
Other study ID # |
03-18-16 |
Secondary ID |
U01HL142099 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.