Trial Outcomes & Findings for Assess and Adapt to the Impact of COVID-19 on CVD Self-Management and Prevention Care in Adults Living With HIV (NCT NCT04661813)
NCT ID: NCT04661813
Last Updated: 2024-10-24
Results Overview
Monitored continuously during study enrollment period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
Through completion of study enrollment, an average of 9 months
Results posted on
2024-10-24
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assess and Adapt to the Impact of COVID-19 on CVD Self-Management and Prevention Care in Adults Living With HIV
Baseline characteristics by cohort
| Measure |
EXTRA-CVD Virtual Care
n=74 Participants
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.
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|---|---|
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Age, Continuous
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58 years
n=99 Participants
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|
Sex: Female, Male
Female
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25 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
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|
Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
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45 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
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24 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=99 Participants
|
|
Enrollment site
Site A
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24 Participants
n=99 Participants
|
|
Enrollment site
Site B
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25 Participants
n=99 Participants
|
|
Enrollment site
Site C
|
25 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Through completion of study enrollment, an average of 9 monthsPopulation: Total number of eligible patients based on telephone screen
Monitored continuously during study enrollment period
Outcome measures
| Measure |
EXTRA-CVD Virtual Care
n=103 Participants
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.
|
4 Months
Model-estimated mean home systolic BP through 4 months
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8 Months
Model-estimated mean home systolic BP through 8 months
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12 Months
Model-estimated mean home systolic BP through 12 months
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|---|---|---|---|---|
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Proportion of Eligible Participants Who Agree to Participate
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74 Participants
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—
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—
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—
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PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
Repeated measures analysis across 4 time-points (0-, 4-, 8-, and 12-months)
Outcome measures
| Measure |
EXTRA-CVD Virtual Care
n=64 Participants
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.
|
4 Months
n=57 Participants
Model-estimated mean home systolic BP through 4 months
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8 Months
n=40 Participants
Model-estimated mean home systolic BP through 8 months
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12 Months
n=41 Participants
Model-estimated mean home systolic BP through 12 months
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|---|---|---|---|---|
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Average of Home Blood Pressure Values Assessed Over a 2-week Period at 0-, 4-, 8-, and 12-months.
|
134.3 model estimated mmhg
Standard Error 1.5
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128.9 model estimated mmhg
Standard Error 1.6
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127.6 model estimated mmhg
Standard Error 1.8
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126.5 model estimated mmhg
Standard Error 1.8
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PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
Repeated measures analysis across 4 time-points (0-, 4-, 8-, and 12-months)
Outcome measures
| Measure |
EXTRA-CVD Virtual Care
n=64 Participants
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.
|
4 Months
n=57 Participants
Model-estimated mean home systolic BP through 4 months
|
8 Months
n=40 Participants
Model-estimated mean home systolic BP through 8 months
|
12 Months
n=41 Participants
Model-estimated mean home systolic BP through 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.
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7 days
Interval 4.5 to 10.0
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7 days
Interval 4.0 to 10.0
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7.5 days
Interval 5.0 to 12.5
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7 days
Interval 6.0 to 13.0
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Adverse Events
EXTRA-CVD Virtual Care
Serious events: 10 serious events
Other events: 28 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
EXTRA-CVD Virtual Care
n=74 participants at risk
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.
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|---|---|
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General disorders
Non-study related events
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10.8%
8/74 • Number of events 16 • 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
|
|
Cardiac disorders
Hospitalization for bradycardia and syncope
|
1.4%
1/74 • Number of events 1 • 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
|
|
Cardiac disorders
Emergency room visit for elevated home blood pressure
|
1.4%
1/74 • Number of events 1 • 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
|
Other adverse events
| Measure |
EXTRA-CVD Virtual Care
n=74 participants at risk
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.
|
|---|---|
|
General disorders
Non-study related events
|
33.8%
25/74 • Number of events 40 • 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
|
|
Cardiac disorders
Asymptomatic hypotension
|
1.4%
1/74 • Number of events 1 • 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
|
|
General disorders
Fatigue
|
1.4%
1/74 • Number of events 1 • 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
|
|
Cardiac disorders
Lightheadedness
|
1.4%
1/74 • Number of events 1 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place