N/A
N=297
A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention
HIV/AIDS · Hypertension · Hyperlipidemias
Bottom Line
View on ClinicalTrials.gov: NCT03643705 ↗Enrolled (actual)
297
Serious AEs
17.5%
Results posted
Apr 2024
Primary outcome: Primary: Systolic Blood Pressure — 134.9; 134.9; 129.9; 136.3 model estimated mmhg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multi-component intervention (Other); General prevention education (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure |
134.9; 134.9; 129.9; 136.3; 129.3; 133.0 | — |
| SECONDARY Non High Density Lipoprotein (Non-HDL) Cholesterol |
139.9; 139.9; 127.4; 135.7; 120.9; 131.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Laboratory confirmed HIV+ diagnosis
- Undetectable HIV viral load: defined as the most recent HIV viral load 130 mmHg on ≥ 2 occasions in the past 12 months or on an antihypertensive medication (assessed via chart abstraction)
- Hyperlipidemia: defined as a non-high-density lipoprotein cholesterol level >130mg/dL or on cholesterol lowering medication
Exclusion Criteria
- 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
- On anti-hypertensive medications solely for a non-hypertension indication (e.g. systolic heart failure)
- Severely hearing or speech impaired, or other disability that would limit participation in the intervention components
- In a nursing home and/or receiving in-patient psychiatric care
- Terminal illness with life expectancy < 4 months
- No reliable access to a telephone
- Pregnant, breast-feeding, or planning a pregnancy during the study period
- Planning to move out of the area in the next 12 months
- Non-English Speaking
Data sourced from ClinicalTrials.gov (NCT03643705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.