HIV-1-infectionAAIM-HighNCT04661813

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

A study testing EXTRA-CVD Virtual Care in people with HIV-1-infection and Hypertension, run by Case Western Reserve University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1-infection, Hypertension
What is being tested?: EXTRA-CVD Virtual Care
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 3 sitesUnited States
Study dates: 1 Mar 2021to 15 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

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.

Read the 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
Being tested: EXTRA-CVD Virtual Care
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EXTRA-CVD Virtual CareOther
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.

Study groups in NCT04661813
Study group	Role	What they receive
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). Receives: Other: EXTRA-CVD Virtual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Eligible Participants Who Agree to Participate
Monitored continuously during study enrollment period
Measured: 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)
Measured: 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)
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202115 Jan 2023

First posted10 Dec 2020
Study start1 Mar 2021
Primary completion15 Jan 2023
Study completion15 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV-1-infectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Model description: Single arm hybrid type 3 implementation study
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04661813
Sponsor's protocol ID: 03-18-16-S1
Other IDs: U01HL142099
Acronym: AAIM-High
Status last verified: Oct 2024
First submitted: 29 Oct 2020
Last updated: 24 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

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.
PubMed 31419622
Cutshaw MK, Jones KA, Okeke NL, Hileman CO, Gripshover BM, Aifah A, Bloomfield GS, Muiruri C, Smith VA, Vedanthan R, Webel AR, Bosworth HB, Longenecker CT. Virtual adaptation of a nurse-driven strategy to improve blood pressure control among people with HIV. HIV Res Clin Pract. 2025 Dec;26(1):2477396. doi: 10.1080/25787489.2025.2477396. Epub 2025 Mar 18.
PubMed 40099639

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1-infection trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assess and Adapt to the Impact of COVID-19 on CVD Self-Management and Prevention Care in Adults Living With HIV
ClinicalTrials.gov ID: NCT04661813
Acronym / sponsor ID: AAIM-High / 03-18-16-S1
Conditions: HIV-1-infection, Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Case Western Reserve UniversityUniversity, hospital or other
Collaborators: Duke University, Metro Health, Michigan, National Heart, Lung, and Blood Institute (NHLBI), University Hospitals Cleveland Medical Center, University of Washington
Study start: 1 Mar 2021 (actual)
Primary completion: 15 Jan 2023 (actual)
Study completion: 15 Jan 2023 (actual)
First posted: 10 Dec 2020 (actual)
Results: Posted 26 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single arm hybrid type 3 implementation study

Arm	Type	Receives
EXTRA-CVD Virtual Care	Experimental	Other: EXTRA-CVD Virtual CareAn adapted version of a "Nurse-led intervention to EXtend the HIV TReatment CascAde for CardioVascular Disease prevention" (EXTRA-CVD).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EXTRA-CVD Virtual CareThe 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.	Other	EXTRA-CVD Virtual Care

Primary outcome

Proportion of Eligible Participants Who Agree to Participate
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Repeated measures analysis across 4 time-points (0-, 4-, 8-, and 12-months)

Results and safety

Results posted to the registry on 26 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EXTRA-CVD Virtual Care	74	55

Primary outcome: Proportion of Eligible Participants Who Agree to Participate

Time frame: Through completion of study enrollment, an average of 9 months. Count of participants. Unit: Participants

Measure	EXTRA-CVD Virtual Care n = 103
Value	74

Population analysed: Total number of eligible patients based on telephone screen

Primary outcome: Average of Home Blood Pressure Values Assessed Over a 2-week Period at 0-, 4-, 8-, and 12-months.

Time frame: 12 months. Mean (Standard Error). Unit: model estimated mmhg

Measure	Baseline n = 64	4 Months n = 57	8 Months n = 40	12 Months n = 41
Value	134.3 (1.5)	128.9 (1.6)	127.6 (1.8)	126.5 (1.8)

Population analysed: Only participants who recorded blood pressure measurements at home during the 2-week period prior to their visit are included in the analysis. This explains why the number of participants analyzed is lower than the overall total number of study participants.

Primary outcome: Number of Days With at Least 1 Home Blood Pressure Measurement Assessed Over a 2-week Period at 0-, 4-, 8-, and 12-months.

Time frame: 12 months. Median (Inter-Quartile Range). Unit: days

Measure	Baseline n = 64	4 Months n = 57	8 Months n = 40	12 Months n = 41
Value	7 (4.5 to 10)	7 (4 to 10)	7.5 (5 to 12.5)	7 (6 to 13)

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EXTRA-CVD Virtual Care	10 of 74 (13.5%)	28 of 74 (37.8%)	3 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31419622Okeke 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.
Derived from this study: PubMed 40099639Cutshaw MK, Jones KA, Okeke NL, Hileman CO, Gripshover BM, Aifah A, Bloomfield GS, Muiruri C, Smith VA, Vedanthan R, Webel AR, Bosworth HB, Longenecker CT. Virtual adaptation of a nurse-driven strategy to improve blood pressure control among people with HIV. HIV Res Clin Pract. 2025 Dec;26(1):2477396. doi: 10.1080/25787489.2025.2477396. Epub 2025 Mar 18.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chris T Longenecker, MD principal investigator

University of Washington

Allison Webel, RN, PhD principal investigator

University of Washington

Hayden Bosworth, PhD principal investigator

Duke University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EXTRA-CVD Virtual Care in people with HIV-1-infection and Hypertension, run by Case Western Reserve University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Eligible Participants Who Agree to Participate (time frame: Through completion of study enrollment, an average of 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04661813, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.