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

NCT ID: NCT04661813

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-01-15

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.

Conditions

HIV-1-infection; Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

EXTRA-CVD Virtual Care

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

Group Type: EXPERIMENTAL

EXTRA-CVD Virtual Care

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Metro Health, Michigan

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Chris Todd Longenecker

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris T Longenecker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Allison Webel, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Hayden Bosworth, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Barb Gripshover, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Duke Health

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31419622 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U01HL142099

Identifier Type: NIH

Identifier Source: secondary_id

View Link

03-18-16-S1

Identifier Type: -

Identifier Source: org_study_id