HIV/AIDSEXTRA-CVDNCT03643705
A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention
A study testing Multi-component intervention and General prevention education in people with HIV/AIDS and Hypertension, run by Case Western Reserve University at 3 sites in United States.
Trial summary
Strategies to improve uptake of cardiovascular disease preventive therapies among people living with HIV (PLHIV) are urgently needed. This study tests an innovative prevention nurse intervention to extend the HIV/AIDS treatment cascade for the treatment of hypertension and hyperlipidemia among PLHIV on suppressive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Hypertension, Hyperlipidemias
- What is being tested?
- Multi-component intervention and General prevention education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Sep 2019to 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
- Laboratory 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 blood pressure >130 mmHg on ≥ 2 occasions in the past 12 months or on an antihypertensive medication (assessed via chart abstraction)
- Hyperlipidemia: defined as a non-high-density lipoprotein cholesterol level >130mg/dL or on cholesterol lowering medication
Who cannot join
- On lipid-lowering medication solely for cardiovascular disease prevention with evidence of pre-medication non-high-density lipoprotein cholesterol which was already below 100mg/dL
- 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
- In a nursing home and/or receiving in-patient psychiatric care
- Terminal illness with life expectancy < 4 months
- No reliable access to a telephone
Show all 9Show fewer
- 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
About this study
Strategies to improve uptake of cardiovascular disease preventive therapies among people living with HIV (PLHIV) are urgently needed. This study tests an innovative prevention nurse intervention to extend the HIV/AIDS treatment cascade for the treatment of hypertension and hyperlipidemia among PLHIV on suppressive antiretroviral therapy. This intervention may be scalable as an extension of ongoing HIV/AIDS treatment cascade initiatives in HIV specialty clinics nationwide.
Read the detailed description
People living with HIV (PLHIV) are at increased risk for atherosclerotic cardiovascular disease (ASCVD); however, uptake of evidence based therapies to prevent ASCVD is sub-optimal. Reasons for under treatment may include low perceived risk, competing priorities for HIV specialist providers, and poor trust and communication with non-HIV primary care providers. This project proposes a nurse-led intervention to extend the HIV/AIDS treatment cascade-a widely adopted framework developed to improve access to high quality HIV care-for CVD prevention, specifically to improve control of blood pressure and hyperlipidemia in PLHIV on antiretroviral therapy who have suppressed HIV viral load. The study will be conducted in three racially and ethnically diverse clinic contexts [University Hospitals (Cleveland, OH), MetroHealth (Cleveland, OH) and Duke Health (Durham, NC)] that are broadly representative of HIV specialty care in the US. Using a mixed-methods clinical effectiveness trial design, this project will test the 12-month efficacy of a multi-component intervention among n=300 HIV+ adults on suppressive ART with hypertension and hyperlipidemia. Participants will be randomized 1:1 to intervention vs. education control. Control participants will receive general prevention education. The intervention will consist of four evidence-based components derived from prior studies in the general population: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home BP monitoring, and (4) electronic medical records (EMR) support tools. These components will be further adapted to the HIV specialty clinic context with key stakeholder input and using data from a mixed-methods study of current ASCVD preventive care practices at the three HIV clinic sites. A process evaluation of the prevention nurse intervention will be conducted, which will assess fidelity, dose, recruitment, reach, and context. Two key contextual process measures of interest will be changes in perceived ASCVD risk and changes in trust and communication between PLHIV participants and their HIV and non-HIV providers. If proven effective to reduce both blood pressure and cholesterol as postulated, this nurse-led intervention will have substantial clinical impact among high-risk PLHIV, potentially reducing ASCVD events by more than a quarter. This model is potentially scalable as an extension of HIV treatment cascade initiatives nationwide.
- Conditions
- HIV/AIDS, Hypertension, Hyperlipidemias
- Being tested
- Multi-component intervention, General prevention education
- Keywords
- Implementation Science, Cardiovascular Disease, Prevention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hypertension, Hyperlipidemias, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component interventionOther
4 components as described
General prevention educationOther
General education as described
| Study group | Role | What they receive |
|---|---|---|
| Nurse Intervention | Experimental | This multi-component intervention will consist of four evidence-based components delivered at 4 in-person visits (0, 4, 8, and 12 months) and by telephone contact: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home blood pressure monitoring, and (4) electronic medical records support tools. Receives: Other: Multi-component intervention |
| Education Control | Active comparator | Participants in the education control arm will receive general prevention education delivered at 4 in-person visits (0, 4, 8, and 12 months), which will consist of evidence-based material on diet, exercise, smoking, sexually transmitted infections, and cancer prevention. Receives: Other: General prevention education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Repeated measures across 4 time points (0, 4, 8, and 12 months)
Measured: 12 months
Secondary outcomes (1)
Non High Density Lipoprotein (Non-HDL) Cholesterol
Repeated measures 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.
- First posted23 Aug 2018
- Study start20 Sep 2019
- 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 (4)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, University Hospitals Cleveland Medical Center, MetroHealth Medical Center, National Heart, Lung, and Blood Institute (NHLBI), University of Washington
- Responsible party
- Principal investigator, Chris Todd Longenecker, University of Washington
- Investigators
- Chris T Longenecker, MD, Principal investigator, University of WashingtonAllison R Webel, RN PhD, Principal investigator, University of WashingtonHayden Bosworth, PhD, Principal investigator, Duke UniversityBarb Gripshover, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643705
- Sponsor's protocol ID
- 03-18-16
- Other IDs
- U01HL142099
- Acronym
- EXTRA-CVD
- Status last verified
- Sep 2024
- First submitted
- 20 Aug 2018
- Last updated
- 16 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
Longenecker CT, Jones KA, Hileman CO, Okeke NL, Gripshover BM, Aifah A, Bloomfield GS, Muiruri C, Smith VA, Vedanthan R, Webel AR, Bosworth HB. Nurse-Led Strategy to Improve Blood Pressure and Cholesterol Level Among People With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e2356445. doi: 10.1001/jamanetworkopen.2023.56445.
PubMed 38441897Schexnayder J, Longenecker CT, Muiruri C, Bosworth HB, Gebhardt D, Gonzales SE, Hanson JE, Hileman CO, Okeke NL, Sico IP, Vedanthan R, Webel AR. Understanding constraints on integrated care for people with HIV and multimorbid cardiovascular conditions: an application of the Theoretical Domains Framework. Implement Sci Commun. 2021 Feb 12;2(1):17. doi: 10.1186/s43058-021-00114-z.
PubMed 33579396Webel AR, Schexnayder J, Rentrope CR, Bosworth HB, Hileman CO, Okeke NL, Vedanthan R, Longenecker CT. The influence of healthcare financing on cardiovascular disease prevention in people living with HIV. BMC Public Health. 2020 Nov 23;20(1):1768. doi: 10.1186/s12889-020-09896-8.
PubMed 33228623Okeke 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention
- ClinicalTrials.gov ID
- NCT03643705
- Acronym / sponsor ID
- EXTRA-CVD / 03-18-16
- Conditions
- HIV/AIDS, Hypertension, Hyperlipidemias
- Keywords
- Implementation Science, Cardiovascular Disease, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Duke University, University Hospitals Cleveland Medical Center, MetroHealth Medical Center, National Heart, Lung, and Blood Institute (NHLBI), University of Washington
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Posted 23 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Strategies to improve uptake of cardiovascular disease preventive therapies among people living with HIV (PLHIV) are urgently needed. This study tests an innovative prevention nurse intervention to extend the HIV/AIDS treatment cascade for the treatment of hypertension and hyperlipidemia among PLHIV on suppressive antiretroviral therapy. This intervention may be scalable as an extension of ongoing HIV/AIDS treatment cascade initiatives in HIV specialty clinics nationwide.
Detailed description
People living with HIV (PLHIV) are at increased risk for atherosclerotic cardiovascular disease (ASCVD); however, uptake of evidence based therapies to prevent ASCVD is sub-optimal. Reasons for under treatment may include low perceived risk, competing priorities for HIV specialist providers, and poor trust and communication with non-HIV primary care providers. This project proposes a nurse-led intervention to extend the HIV/AIDS treatment cascade-a widely adopted framework developed to improve access to high quality HIV care-for CVD prevention, specifically to improve control of blood pressure and hyperlipidemia in PLHIV on antiretroviral therapy who have suppressed HIV viral load. The study will be conducted in three racially and ethnically diverse clinic contexts [University Hospitals (Cleveland, OH), MetroHealth (Cleveland, OH) and Duke Health (Durham, NC)] that are broadly representative of HIV specialty care in the US. Using a mixed-methods clinical effectiveness trial design, this project will test the 12-month efficacy of a multi-component intervention among n=300 HIV+ adults on suppressive ART with hypertension and hyperlipidemia. Participants will be randomized 1:1 to intervention vs. education control. Control participants will receive general prevention education. The intervention will consist of four evidence-based components derived from prior studies in the general population: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home BP monitoring, and (4) electronic medical records (EMR) support tools. These components will be further adapted to the HIV specialty clinic context with key stakeholder input and using data from a mixed-methods study of current ASCVD preventive care practices at the three HIV clinic sites. A process evaluation of the prevention nurse intervention will be conducted, which will assess fidelity, dose, recruitment, reach, and context. Two key contextual process measures of interest will be changes in perceived ASCVD risk and changes in trust and communication between PLHIV participants and their HIV and non-HIV providers. If proven effective to reduce both blood pressure and cholesterol as postulated, this nurse-led intervention will have substantial clinical impact among high-risk PLHIV, potentially reducing ASCVD events by more than a quarter. This model is potentially scalable as an extension of HIV treatment cascade initiatives nationwide.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse Intervention | Experimental | Other: Multi-component interventionThis multi-component intervention will consist of four evidence-based components delivered at 4 in-person visits (0, 4, 8, and 12 months) and by telephone contact: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home blood pressure monitoring, and (4) electronic medical records support tools. |
| Education Control | Active comparator | Other: General prevention educationParticipants in the education control arm will receive general prevention education delivered at 4 in-person visits (0, 4, 8, and 12 months), which will consist of evidence-based material on diet, exercise, smoking, sexually transmitted infections, and cancer prevention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Laboratory 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 blood pressure >130 mmHg on ≥ 2 occasions in the past 12 months or on an antihypertensive medication (assessed via chart abstraction)
- Hyperlipidemia: defined as a non-high-density lipoprotein cholesterol level >130mg/dL or on cholesterol lowering medication
Key exclusion criteria (9 listed)
- On lipid-lowering medication solely for cardiovascular disease prevention with evidence of pre-medication non-high-density lipoprotein cholesterol which was already below 100mg/dL
- 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
- In a nursing home and/or receiving in-patient psychiatric care
- Terminal illness with life expectancy < 4 months
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 |
|---|---|---|
| Multi-component intervention4 components as described | Other | Nurse Intervention |
| General prevention educationGeneral education as described | Other | Education Control |
Primary outcome
Systolic Blood Pressure
Time frame: 12 months
Repeated measures across 4 time points (0, 4, 8, and 12 months)
1 secondary outcome
Non High Density Lipoprotein (Non-HDL) Cholesterol
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38441897Longenecker CT, Jones KA, Hileman CO, Okeke NL, Gripshover BM, Aifah A, Bloomfield GS, Muiruri C, Smith VA, Vedanthan R, Webel AR, Bosworth HB. Nurse-Led Strategy to Improve Blood Pressure and Cholesterol Level Among People With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e2356445. doi: 10.1001/jamanetworkopen.2023.56445.
- Derived from this study: PubMed 33579396Schexnayder J, Longenecker CT, Muiruri C, Bosworth HB, Gebhardt D, Gonzales SE, Hanson JE, Hileman CO, Okeke NL, Sico IP, Vedanthan R, Webel AR. Understanding constraints on integrated care for people with HIV and multimorbid cardiovascular conditions: an application of the Theoretical Domains Framework. Implement Sci Commun. 2021 Feb 12;2(1):17. doi: 10.1186/s43058-021-00114-z.
- Derived from this study: PubMed 33228623Webel AR, Schexnayder J, Rentrope CR, Bosworth HB, Hileman CO, Okeke NL, Vedanthan R, Longenecker CT. The influence of healthcare financing on cardiovascular disease prevention in people living with HIV. BMC Public Health. 2020 Nov 23;20(1):1768. doi: 10.1186/s12889-020-09896-8.
- Derived from this study: 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.
- 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 R 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 Multi-component intervention and General prevention education in people with HIV/AIDS 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 5 inclusion and 9 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 16 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 23 Apr 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?
Systolic Blood Pressure (time frame: 12 months). 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 NCT03643705, which also lists 4 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 16 Oct 2024.