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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; HIV-1-infection
• Intervention / Treatment: Other: EXTRA-CVD Virtual Care

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Health
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXTRA-CVD Virtual Care; An adapted version of a "Nurse-led intervention to EXtend the HIV TReatment CascAde for CardioVascular Disease prevention" (EXTRA-CVD).	Other: EXTRA-CVD Virtual Care; The original EXTRA-CVD intervention was developed to improve blood pressure and cholesterol control among People Living with HIV. The intervention will be adapted to the post-COVID healthcare delivery landscape as a "virtual" intervention delivered by phone, teleconference, internet support groups, and nurse care coordination.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Duke University; University of Washington; University Hospitals Cleveland Medical Center; Metro Health, Michigan
• Investigators: Principal Investigator: Chris T Longenecker, MD, University of Washington; Principal Investigator: Hayden Bosworth, PhD, Duke University; Principal Investigator: Barb Gripshover, MD, Case Western Reserve University; Principal Investigator: Allison Webel, RN, PhD, University of Washington

Publications and helpful links

General Publications

• 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.

Helpful Links

• Primary study website

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 03-18-16-S1; U01HL142099 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In collaboration with the National Institutes of Health funding body, we will develop a process to facilitate providing other investigators with access to appropriately de-identified study data. We will make the following available upon request after the primary manuscript is published: de-identified data set, trial description information, data collection forms, and data structure.
• IPD Sharing Time Frame: After publication of the primary manuscript
• IPD Sharing Access Criteria: Data will be made available upon request or on a data share site after publication of the primary manuscript.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No