Assess and Adapt to the Impact of COVID-19 on CVD Self-Management and Prevention Care in Adults Living With HIV

Not Applicable

Completed

• Conditions: Hypertension; HIV-1-infection
• Interventions: Other: EXTRA-CVD Virtual Care

• Registration Number: NCT04661813
• Lead Sponsor: Case Western Reserve University

Brief 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.

Detailed Description

Social distancing in the context of the SARS-CoV-2 coronavirus and COVID-19 disease pandemic may amplify isolation and loneliness due to the requirement to limit in-person interactions with loved ones, friends, community members, healthcare providers, etc. Social isolation increases susceptibility to illness, stress, hypertension, depression, and mortality and decreases engagement in self-management and physical activity. People living with HIV (PLWH) are at increased risk for cardiovascular disease (CVD) and are particularly vulnerable to the stress and social isolation caused by the public health measures to combat COVID-19. Using mixed-methods and a human-centered design approach, the investigators will adapt a nurse-led intervention to EXtend the HIV/AIDS TReatment cAscade for CVD prevention (EXTRA-CVD) so that it is better suited to a post-COVID healthcare environment. This hybrid type 3 implementation study will evaluate the implementation of a virtually enhanced EXTRA-CVD intervention to improve BP control in PLWH from 3 HIV-specialty clinics in the United States \[University Hospitals, MetroHealth (both Cleveland, OH) and Duke Health (Durham, NC)\]. The study will enroll adult PLWH participants (n=75) on suppressive ART with high blood pressure whom are otherwise ineligible for the parent trial (EXTRA-CVD; NCT03643705) because they do not also have high cholesterol or because they are unwilling or unable to participate in the in-person trial. Primary outcomes will be: reach (% agreeing to participate), effectiveness (change in home systolic BP), and adoption (frequency of home BP use). Additional implementation measures including feasibility, acceptability, and intention to maintain blood pressure self-monitoring will be assessed qualitatively. This study will increase the impact and scalability of the EXTRA-CVD intervention without compromising the integrity or feasibility of the parent trial.

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Study Start: 2021-03-01
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Results First Submitted: 2024-04-15
• Results First Submitted QC: 2024-06-04
• Results First Posted: 2024-06-26
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. Age ≥18 years
2. 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 BP >130 mmHg on ≥ 2 occasions in the past 12 months or on an antihypertensive medication (assessed via chart abstraction), and

Exclusion Criteria

1. On anti-hypertensive medications solely for a non-hypertension indication (e.g. systolic heart failure),
2. Severely hearing or speech impaired, or other disability that would limit participation in the intervention components, and
3. In a nursing home and/or receiving in-patient psychiatric care.
4. Terminal illness with life expectancy < 4 months
5. No reliable access to a telephone
6. Pregnant, breast-feeding, or planning a pregnancy during the study period
7. Planning to move out of the area in the next 12 months
8. Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EXTRA-CVD Virtual Care	EXTRA-CVD Virtual Care	An adapted version of a "Nurse-led intervention to EXtend the HIV TReatment CascAde for CardioVascular Disease prevention" (EXTRA-CVD).

Primary Outcome Measures

Name	Time	Method
Proportion of Eligible Participants Who Agree to Participate	Through completion of study enrollment, an average of 9 months	Monitored continuously during study enrollment period
Average of Home Blood Pressure Values Assessed Over a 2-week Period at 0-, 4-, 8-, and 12-months.	12 months	Repeated measures analysis across 4 time-points (0-, 4-, 8-, and 12-months)
Number of Days With at Least 1 Home Blood Pressure Measurement Assessed Over a 2-week Period at 0-, 4-, 8-, and 12-months.	12 months	Repeated measures analysis across 4 time-points (0-, 4-, 8-, and 12-months)

Trial Locations

Locations (3)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Duke Health; 🇺🇸 Durham, North Carolina, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States