N/A
N=74
Assess and Adapt to the Impact of COVID-19 on CVD Self-Management and Prevention Care in Adults Living With HIV
HIV-1-infection · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT04661813 ↗Enrolled (actual)
74
Serious AEs
13.5%
Results posted
Jun 2024
Primary outcome: Primary: Proportion of Eligible Participants Who Agree to Participate — 74 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EXTRA-CVD Virtual Care (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 Proportion of Eligible Participants Who Agree to Participate |
74 | — |
| PRIMARY Average of Home Blood Pressure Values Assessed Over a 2-week Period at 0-, 4-, 8-, and 12-months. |
134.3; 128.9; 127.6; 126.5 | — |
| PRIMARY Number of Days With at Least 1 Home Blood Pressure Measurement Assessed Over a 2-week Period at 0-, 4-, 8-, and 12-months. |
7; 7; 7.5; 7 | — |
Summary
Social distancing measures put in place to combat the COVID-19 disease pandemic may increase social isolation and impact cardiovascular disease prevention behaviors among people living with HIV (PLWH). This study builds on a previously developed nurse-led intervention to improve blood pressure and cholesterol care for PLWH. The investigators will adapt the intervention to be administered virtually in order to facilitate cardiovascular prevention care within the US health care system which has sustained long-term changes as a result of the COVID-19 pandemic. The implementation and effectiveness of the intervention will be tested in a 12-month single arm intervention study.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- 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), and
Exclusion Criteria
- 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, and
- 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 (NCT04661813). 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.