HIV/AIDS, Hypertension, Hyperlipidemias
Conditions
Keywords
Implementation Science, Cardiovascular Disease, Prevention
Brief 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 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.
Interventions
4 components as described
OTHERGeneral prevention education
General education as described
Sponsors
Duke University
University Hospitals Cleveland Medical Center
MetroHealth Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
University of Washington
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Laboratory 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 blood pressure \>130 mmHg on ≥ 2 occasions in the past 12 months or on an antihypertensive medication (assessed via chart abstraction) 5. Hyperlipidemia: defined as a non-high-density lipoprotein cholesterol level \>130mg/dL or on cholesterol lowering medication
Exclusion criteria
1. 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 2. On anti-hypertensive medications solely for a non-hypertension indication (e.g. systolic heart failure) 3. Severely hearing or speech impaired, or other disability that would limit participation in the intervention components 4. In a nursing home and/or receiving in-patient psychiatric care 5. Terminal illness with life expectancy \< 4 months 6. No reliable access to a telephone 7. Pregnant, breast-feeding, or planning a pregnancy during the study period 8. Planning to move out of the area in the next 12 months 9. Non-English Speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 12 months | Repeated measures across 4 time points (0, 4, 8, and 12 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non High Density Lipoprotein (Non-HDL) Cholesterol | 12 months | Repeated measures across 4 time points (0, 4, 8, and 12 months) |
Other
| Measure | Time frame | Description |
|---|---|---|
| % of Subjects in Each Hypertension Cascade Category | 12 months | Ordinal 3-level variable across 4 time points (0, 4, 8, and 12 months). The hypertension cascade tool is reported as mutually exclusive categories as follows: 1=untreated hypertension; 2=hypertension treated; 3=blood pressure target achieved. NOTE: This differs from our protocol specified 4-level variable because the numbers in the first two categories were too small. Therefore, undiagnosed and diagnosed were collapsed into one untreated category. |
| % of Subjects in Each Hyperlipidemia Cascade Category | 12 months | Ordinal 3-level variable across 4 time points (0, 4, 8, and 12 months). The cholesterol cascade is reported as mutually exclusive categories as follows: 1=untreated hyperlipidemia; 2=hyperlipidemia treated; 3=non-HDL cholesterol target achieved. NOTE: This differs from our protocol specified 4-level variable because the numbers in the first two categories were too small. Therefore, undiagnosed and diagnosed were collapsed into one untreated category. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nurse Intervention 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.
Multi-component intervention: 4 components as described | 149 |
| Education Control 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.
General prevention education: General education as described | 148 |
| Total | 297 |
Baseline characteristics
| Characteristic | Nurse Intervention | Education Control | Total |
|---|---|---|---|
| Age, Continuous | 59 years | 59.5 years | 59 years |
| Number of Participants Enrolled at Each Site Site A | 49 Participants | 50 Participants | 99 Participants |
| Number of Participants Enrolled at Each Site Site B | 50 Participants | 50 Participants | 100 Participants |
| Number of Participants Enrolled at Each Site Site C | 50 Participants | 48 Participants | 98 Participants |
| Race/Ethnicity, Customized Black | 79 Participants | 97 Participants | 176 Participants |
| Race/Ethnicity, Customized Multiracial | 6 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Other race | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized White | 60 Participants | 41 Participants | 101 Participants |
| Region of Enrollment United States | 149 Participants | 148 Participants | 297 Participants |
| Sex/Gender, Customized Female | 35 Participants | 27 Participants | 62 Participants |
| Sex/Gender, Customized Male | 113 Participants | 120 Participants | 233 Participants |
| Sex/Gender, Customized Transgender Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 149 | 2 / 148 |
| other Total, other adverse events | 44 / 149 | 45 / 148 |
| serious Total, serious adverse events | 30 / 149 | 22 / 148 |
Outcome results
Primary
Systolic Blood Pressure
Repeated measures across 4 time points (0, 4, 8, and 12 months)
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nurse Intervention | Systolic Blood Pressure | Baseline | 134.9 model estimated mmhg | Standard Error 1 |
| Nurse Intervention | Systolic Blood Pressure | 4 months | 129.9 model estimated mmhg | Standard Error 1.5 |
| Nurse Intervention | Systolic Blood Pressure | 8 months | 129.3 model estimated mmhg | Standard Error 1.6 |
| Nurse Intervention | Systolic Blood Pressure | 12 months | 129.7 model estimated mmhg | Standard Error 1.5 |
| Education Control | Systolic Blood Pressure | 12 months | 133.9 model estimated mmhg | Standard Error 1.4 |
| Education Control | Systolic Blood Pressure | Baseline | 134.9 model estimated mmhg | Standard Error 1 |
| Education Control | Systolic Blood Pressure | 8 months | 133.0 model estimated mmhg | Standard Error 1.4 |
| Education Control | Systolic Blood Pressure | 4 months | 136.3 model estimated mmhg | Standard Error 1.5 |
Secondary
Non High Density Lipoprotein (Non-HDL) Cholesterol
Repeated measures across 4 time points (0, 4, 8, and 12 months)
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nurse Intervention | Non High Density Lipoprotein (Non-HDL) Cholesterol | Baseline | 139.9 model estimated mg/dL | Standard Error 2.5 |
| Nurse Intervention | Non High Density Lipoprotein (Non-HDL) Cholesterol | 4 months | 127.4 model estimated mg/dL | Standard Error 3.5 |
| Nurse Intervention | Non High Density Lipoprotein (Non-HDL) Cholesterol | 8 months | 120.9 model estimated mg/dL | Standard Error 3.5 |
| Nurse Intervention | Non High Density Lipoprotein (Non-HDL) Cholesterol | 12 months | 114.7 model estimated mg/dL | Standard Error 3.5 |
| Education Control | Non High Density Lipoprotein (Non-HDL) Cholesterol | 12 months | 132.1 model estimated mg/dL | Standard Error 3.3 |
| Education Control | Non High Density Lipoprotein (Non-HDL) Cholesterol | Baseline | 139.9 model estimated mg/dL | Standard Error 2.5 |
| Education Control | Non High Density Lipoprotein (Non-HDL) Cholesterol | 8 months | 131.9 model estimated mg/dL | Standard Error 3.3 |
| Education Control | Non High Density Lipoprotein (Non-HDL) Cholesterol | 4 months | 135.7 model estimated mg/dL | Standard Error 3.4 |
Other Pre-specified
% of Subjects in Each Hyperlipidemia Cascade Category
Ordinal 3-level variable across 4 time points (0, 4, 8, and 12 months). The cholesterol cascade is reported as mutually exclusive categories as follows: 1=untreated hyperlipidemia; 2=hyperlipidemia treated; 3=non-HDL cholesterol target achieved. NOTE: This differs from our protocol specified 4-level variable because the numbers in the first two categories were too small. Therefore, undiagnosed and diagnosed were collapsed into one untreated category.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nurse Intervention | % of Subjects in Each Hyperlipidemia Cascade Category | At treatment goal Baseline | 42.0 model estimated % |
| Nurse Intervention | % of Subjects in Each Hyperlipidemia Cascade Category | Treated 8 months | 9.0 model estimated % |
| Nurse Intervention | % of Subjects in Each Hyperlipidemia Cascade Category | Treated 4 months | 15.7 model estimated % |
| Nurse Intervention | % of Subjects in Each Hyperlipidemia Cascade Category | At treatment goal 8 months | 85.1 model estimated % |
| Nurse Intervention | % of Subjects in Each Hyperlipidemia Cascade Category | Treated Baseline | 20.5 model estimated % |
| Nurse Intervention | % of Subjects in Each Hyperlipidemia Cascade Category | Untreated 12 months | 5.3 model estimated % |
| Nurse Intervention | % of Subjects in Each Hyperlipidemia Cascade Category | At treatment goal 4 months | 66.3 model estimated % |
| Nurse Intervention | % of Subjects in Each Hyperlipidemia Cascade Category | At treatment goal 12 months | 91.1 model estimated % |
| Nurse Intervention | % of Subjects in Each Hyperlipidemia Cascade Category | Untreated 4 months | 18.1 model estimated % |
| Nurse Intervention | % of Subjects in Each Hyperlipidemia Cascade Category | Untreated 8 months | 5.9 model estimated % |
| Nurse Intervention | % of Subjects in Each Hyperlipidemia Cascade Category | Treated 12 months | 3.6 model estimated % |
| Nurse Intervention | % of Subjects in Each Hyperlipidemia Cascade Category | Untreated Baseline | 37.5 model estimated % |
| Education Control | % of Subjects in Each Hyperlipidemia Cascade Category | Treated 12 months | 14.1 model estimated % |
| Education Control | % of Subjects in Each Hyperlipidemia Cascade Category | Treated Baseline | 20.5 model estimated % |
| Education Control | % of Subjects in Each Hyperlipidemia Cascade Category | At treatment goal Baseline | 42.0 model estimated % |
| Education Control | % of Subjects in Each Hyperlipidemia Cascade Category | Untreated 4 months | 27.5 model estimated % |
| Education Control | % of Subjects in Each Hyperlipidemia Cascade Category | Treated 4 months | 18.0 model estimated % |
| Education Control | % of Subjects in Each Hyperlipidemia Cascade Category | At treatment goal 4 months | 54.5 model estimated % |
| Education Control | % of Subjects in Each Hyperlipidemia Cascade Category | Untreated 8 months | 16.3 model estimated % |
| Education Control | % of Subjects in Each Hyperlipidemia Cascade Category | Treated 8 months | 16.3 model estimated % |
| Education Control | % of Subjects in Each Hyperlipidemia Cascade Category | At treatment goal 8 months | 67.4 model estimated % |
| Education Control | % of Subjects in Each Hyperlipidemia Cascade Category | Untreated 12 months | 27.1 model estimated % |
| Education Control | % of Subjects in Each Hyperlipidemia Cascade Category | At treatment goal 12 months | 58.7 model estimated % |
| Education Control | % of Subjects in Each Hyperlipidemia Cascade Category | Untreated Baseline | 37.5 model estimated % |
Other Pre-specified
% of Subjects in Each Hypertension Cascade Category
Ordinal 3-level variable across 4 time points (0, 4, 8, and 12 months). The hypertension cascade tool is reported as mutually exclusive categories as follows: 1=untreated hypertension; 2=hypertension treated; 3=blood pressure target achieved. NOTE: This differs from our protocol specified 4-level variable because the numbers in the first two categories were too small. Therefore, undiagnosed and diagnosed were collapsed into one untreated category.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nurse Intervention | % of Subjects in Each Hypertension Cascade Category | Untreated 8 months | 3.2 model estimated % |
| Nurse Intervention | % of Subjects in Each Hypertension Cascade Category | Untreated Baseline | 10.8 model estimated % |
| Nurse Intervention | % of Subjects in Each Hypertension Cascade Category | Untreated 12 months | 5.7 model estimated % |
| Nurse Intervention | % of Subjects in Each Hypertension Cascade Category | Treated Baseline | 47.3 model estimated % |
| Nurse Intervention | % of Subjects in Each Hypertension Cascade Category | At treatment goal 4 months | 57.9 model estimated % |
| Nurse Intervention | % of Subjects in Each Hypertension Cascade Category | At treatment goal Baseline | 42.0 model estimated % |
| Nurse Intervention | % of Subjects in Each Hypertension Cascade Category | Treated 12 months | 34.4 model estimated % |
| Nurse Intervention | % of Subjects in Each Hypertension Cascade Category | Untreated 4 months | 7.8 model estimated % |
| Nurse Intervention | % of Subjects in Each Hypertension Cascade Category | At treatment goal 8 months | 63.6 model estimated % |
| Nurse Intervention | % of Subjects in Each Hypertension Cascade Category | Treated 4 months | 34.3 model estimated % |
| Nurse Intervention | % of Subjects in Each Hypertension Cascade Category | At treatment goal 12 months | 59.9 model estimated % |
| Nurse Intervention | % of Subjects in Each Hypertension Cascade Category | Treated 8 months | 33.2 model estimated % |
| Education Control | % of Subjects in Each Hypertension Cascade Category | At treatment goal 12 months | 39.8 model estimated % |
| Education Control | % of Subjects in Each Hypertension Cascade Category | At treatment goal 4 months | 44.4 model estimated % |
| Education Control | % of Subjects in Each Hypertension Cascade Category | Treated 8 months | 45.3 model estimated % |
| Education Control | % of Subjects in Each Hypertension Cascade Category | At treatment goal 8 months | 47.0 model estimated % |
| Education Control | % of Subjects in Each Hypertension Cascade Category | Untreated 12 months | 11.6 model estimated % |
| Education Control | % of Subjects in Each Hypertension Cascade Category | Treated 12 months | 48.6 model estimated % |
| Education Control | % of Subjects in Each Hypertension Cascade Category | Treated 4 months | 45.7 model estimated % |
| Education Control | % of Subjects in Each Hypertension Cascade Category | Untreated Baseline | 10.8 model estimated % |
| Education Control | % of Subjects in Each Hypertension Cascade Category | Treated Baseline | 47.3 model estimated % |
| Education Control | % of Subjects in Each Hypertension Cascade Category | At treatment goal Baseline | 42.0 model estimated % |
| Education Control | % of Subjects in Each Hypertension Cascade Category | Untreated 4 months | 9.9 model estimated % |
| Education Control | % of Subjects in Each Hypertension Cascade Category | Untreated 8 months | 7.7 model estimated % |