HIV-1-infection, Hypertension
Conditions
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.
Interventions
OTHEREXTRA-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.
Sponsors
Duke University
Metro Health, Michigan
National Heart, Lung, and Blood Institute (NHLBI)
University Hospitals Cleveland Medical Center
University of Washington
Case Western Reserve University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Single arm hybrid type 3 implementation study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eligible Participants Who Agree to Participate | 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. | 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. | 12 months | Repeated measures analysis across 4 time-points (0-, 4-, 8-, and 12-months) |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 74 |
| Total | 74 |
Baseline characteristics
| Characteristic | EXTRA-CVD Virtual Care |
|---|---|
| Age, Continuous | 58 years |
| Enrollment site Site A | 24 Participants |
| Enrollment site Site B | 25 Participants |
| Enrollment site Site C | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 74 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 74 |
| other Total, other adverse events | 28 / 74 |
| serious Total, serious adverse events | 10 / 74 |
Outcome results
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)
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EXTRA-CVD Virtual Care | 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 |
| 4 Months | Average of Home Blood Pressure Values Assessed Over a 2-week Period at 0-, 4-, 8-, and 12-months. | 128.9 model estimated mmhg | Standard Error 1.6 |
| 8 Months | Average of Home Blood Pressure Values Assessed Over a 2-week Period at 0-, 4-, 8-, and 12-months. | 127.6 model estimated mmhg | Standard Error 1.8 |
| 12 Months | Average of Home Blood Pressure Values Assessed Over a 2-week Period at 0-, 4-, 8-, and 12-months. | 126.5 model estimated mmhg | Standard Error 1.8 |
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)
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EXTRA-CVD Virtual Care | Number of Days With at Least 1 Home Blood Pressure Measurement Assessed Over a 2-week Period at 0-, 4-, 8-, and 12-months. | 7 days |
| 4 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. | 7 days |
| 8 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. | 7.5 days |
| 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. | 7 days |
Primary
Proportion of Eligible Participants Who Agree to Participate
Monitored continuously during study enrollment period
Time frame: Through completion of study enrollment, an average of 9 months
Population: Total number of eligible patients based on telephone screen
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EXTRA-CVD Virtual Care | Proportion of Eligible Participants Who Agree to Participate | 74 Participants |