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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL142099 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| Metro Health, Michigan | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University Hospitals Cleveland Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Health | Durham | North Carolina | 27710 | United States | ||
| University Hospitals Cleveland Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31419622 | Background | 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. | |
| 40099639 | Derived | 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. |
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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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After publication of the primary manuscript
Data will be made available upon request or on a data share site after publication of the primary manuscript.
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81 participants consented to participate in the study. Of these, 7 participants withdrew prior to completion of the entry visit data collection, leaving 74 participants who actually started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | EXTRA-CVD Virtual Care | An adapted version of a "Nurse-led intervention to EXtend the HIV TReatment CascAde for CardioVascular Disease prevention" (EXTRA-CVD). 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EXTRA-CVD Virtual Care | An adapted version of a "Nurse-led intervention to EXtend the HIV TReatment CascAde for CardioVascular Disease prevention" (EXTRA-CVD). 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Eligible Participants Who Agree to Participate | Monitored continuously during study enrollment period | Total number of eligible patients based on telephone screen | Posted | Count of Participants | Participants | Through completion of study enrollment, an average of 9 months |
|
12 months
Adverse events data were collected by study nurses through a combination of chart review and participant self report at baseline, 0-, 4-, 8-, and 12-months. The numbers reported here reflect the total number of AEs over the 12 month study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EXTRA-CVD Virtual Care | An adapted version of a "Nurse-led intervention to EXtend the HIV TReatment CascAde for CardioVascular Disease prevention" (EXTRA-CVD). 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-study related events | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-study related events | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chris Longenecker | University of Washington | 2066161159 | ctlongen@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2022 | Oct 22, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| University of Washington | OTHER |
Single arm hybrid type 3 implementation study
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|
| Cleveland |
| Ohio |
| 44106 |
| United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Enrollment site | Site specific information is reported anonymously. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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) | 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. | Posted | Mean | Standard Error | model estimated mmhg | 12 months |
|
|
|
| Primary | 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) | 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. | Posted | Median | Inter-Quartile Range | days | 12 months |
|
|
|
| 3 |
| 74 |
| 10 |
| 74 |
| 28 |
| 74 |
| Hospitalization for bradycardia and syncope | Cardiac disorders | Systematic Assessment |
|
| Emergency room visit for elevated home blood pressure | Cardiac disorders | Systematic Assessment |
|
| Asymptomatic hypotension | Cardiac disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment | Fatigue, anorexia and malaise after starting lisinopril and hydrochlorothiazide |
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| Lightheadedness | Cardiac disorders | Systematic Assessment | Lightheadedness with new amlodipine dose |
|
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