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

NCT04661813 | Completed Results DMC

• 2 other identifiers: 03-18-16-S1U01HL142099
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV-1-infection; Hypertension

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

EXTRA-CVD Virtual Care

EXPERIMENTAL

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

Interventions

EXTRA-CVD Virtual Care OTHER

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.

EXTRA-CVD Virtual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Confirmed HIV+ diagnosis
• Undetectable HIV viral load: defined as the most recent HIV viral load \<200 copies/mL, checked within the past year (assessed via chart abstraction)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• Duke University: collaborator
• Metro Health, Michigan: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University Hospitals Cleveland Medical Center: collaborator
• University of Washington: collaborator

Study Sites (3)

Duke Health

Durham, North Carolina, 27710, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (1)

• 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.

  PMID: 31419622 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Chris Longenecker
• Organization: University of Washington

ctlongen@uw.edu

2066161159

Study Officials

• Chris T Longenecker, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Allison Webel, RN, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Hayden Bosworth, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Barb Gripshover, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Single arm hybrid type 3 implementation study

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: December 10, 2020
• Study Start: March 1, 2021
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: October 24, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication of the primary manuscript
• Access Criteria: Data will be made available upon request or on a data share site after publication of the primary manuscript.

Locations

US (3)