Trial Outcomes & Findings for A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention (NCT NCT03643705)
NCT ID: NCT03643705
Last Updated: 2024-10-16
Results Overview
Repeated measures across 4 time points (0, 4, 8, and 12 months)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
298 participants
Primary outcome timeframe
12 months
Results posted on
2024-10-16
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
148
|
|
Overall Study
COMPLETED
|
114
|
129
|
|
Overall Study
NOT COMPLETED
|
35
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention
Baseline characteristics by cohort
| Measure |
Nurse Intervention
n=149 Participants
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
|
Education Control
n=148 Participants
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
|
Total
n=297 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
59.5 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
113 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
79 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
60 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
149 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Number of Participants Enrolled at Each Site
Site A
|
49 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Number of Participants Enrolled at Each Site
Site B
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Number of Participants Enrolled at Each Site
Site C
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsRepeated measures across 4 time points (0, 4, 8, and 12 months)
Outcome measures
| Measure |
Nurse Intervention
n=149 Participants
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
|
Education Control
n=148 Participants
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
|
|---|---|---|
|
Systolic Blood Pressure
Baseline
|
134.9 model estimated mmhg
Standard Error 1.0
|
134.9 model estimated mmhg
Standard Error 1.0
|
|
Systolic Blood Pressure
4 months
|
129.9 model estimated mmhg
Standard Error 1.5
|
136.3 model estimated mmhg
Standard Error 1.5
|
|
Systolic Blood Pressure
8 months
|
129.3 model estimated mmhg
Standard Error 1.6
|
133.0 model estimated mmhg
Standard Error 1.4
|
|
Systolic Blood Pressure
12 months
|
129.7 model estimated mmhg
Standard Error 1.5
|
133.9 model estimated mmhg
Standard Error 1.4
|
SECONDARY outcome
Timeframe: 12 monthsRepeated measures across 4 time points (0, 4, 8, and 12 months)
Outcome measures
| Measure |
Nurse Intervention
n=149 Participants
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
|
Education Control
n=148 Participants
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
|
|---|---|---|
|
Non High Density Lipoprotein (Non-HDL) Cholesterol
Baseline
|
139.9 model estimated mg/dL
Standard Error 2.5
|
139.9 model estimated mg/dL
Standard Error 2.5
|
|
Non High Density Lipoprotein (Non-HDL) Cholesterol
4 months
|
127.4 model estimated mg/dL
Standard Error 3.5
|
135.7 model estimated mg/dL
Standard Error 3.4
|
|
Non High Density Lipoprotein (Non-HDL) Cholesterol
8 months
|
120.9 model estimated mg/dL
Standard Error 3.5
|
131.9 model estimated mg/dL
Standard Error 3.3
|
|
Non High Density Lipoprotein (Non-HDL) Cholesterol
12 months
|
114.7 model estimated mg/dL
Standard Error 3.5
|
132.1 model estimated mg/dL
Standard Error 3.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsOrdinal 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.
Outcome measures
| Measure |
Nurse Intervention
n=149 Participants
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
|
Education Control
n=148 Participants
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
|
|---|---|---|
|
% of Subjects in Each Hypertension Cascade Category
Untreated Baseline
|
10.8 model estimated %
|
10.8 model estimated %
|
|
% of Subjects in Each Hypertension Cascade Category
Treated Baseline
|
47.3 model estimated %
|
47.3 model estimated %
|
|
% of Subjects in Each Hypertension Cascade Category
At treatment goal Baseline
|
42.0 model estimated %
|
42.0 model estimated %
|
|
% of Subjects in Each Hypertension Cascade Category
Untreated 4 months
|
7.8 model estimated %
|
9.9 model estimated %
|
|
% of Subjects in Each Hypertension Cascade Category
Treated 4 months
|
34.3 model estimated %
|
45.7 model estimated %
|
|
% of Subjects in Each Hypertension Cascade Category
At treatment goal 4 months
|
57.9 model estimated %
|
44.4 model estimated %
|
|
% of Subjects in Each Hypertension Cascade Category
Untreated 8 months
|
3.2 model estimated %
|
7.7 model estimated %
|
|
% of Subjects in Each Hypertension Cascade Category
Treated 8 months
|
33.2 model estimated %
|
45.3 model estimated %
|
|
% of Subjects in Each Hypertension Cascade Category
At treatment goal 8 months
|
63.6 model estimated %
|
47.0 model estimated %
|
|
% of Subjects in Each Hypertension Cascade Category
Untreated 12 months
|
5.7 model estimated %
|
11.6 model estimated %
|
|
% of Subjects in Each Hypertension Cascade Category
Treated 12 months
|
34.4 model estimated %
|
48.6 model estimated %
|
|
% of Subjects in Each Hypertension Cascade Category
At treatment goal 12 months
|
59.9 model estimated %
|
39.8 model estimated %
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsOrdinal 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.
Outcome measures
| Measure |
Nurse Intervention
n=149 Participants
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
|
Education Control
n=148 Participants
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
|
|---|---|---|
|
% of Subjects in Each Hyperlipidemia Cascade Category
Untreated Baseline
|
37.5 model estimated %
|
37.5 model estimated %
|
|
% of Subjects in Each Hyperlipidemia Cascade Category
Treated Baseline
|
20.5 model estimated %
|
20.5 model estimated %
|
|
% of Subjects in Each Hyperlipidemia Cascade Category
At treatment goal Baseline
|
42.0 model estimated %
|
42.0 model estimated %
|
|
% of Subjects in Each Hyperlipidemia Cascade Category
Untreated 4 months
|
18.1 model estimated %
|
27.5 model estimated %
|
|
% of Subjects in Each Hyperlipidemia Cascade Category
Treated 4 months
|
15.7 model estimated %
|
18.0 model estimated %
|
|
% of Subjects in Each Hyperlipidemia Cascade Category
At treatment goal 4 months
|
66.3 model estimated %
|
54.5 model estimated %
|
|
% of Subjects in Each Hyperlipidemia Cascade Category
Untreated 8 months
|
5.9 model estimated %
|
16.3 model estimated %
|
|
% of Subjects in Each Hyperlipidemia Cascade Category
Treated 8 months
|
9.0 model estimated %
|
16.3 model estimated %
|
|
% of Subjects in Each Hyperlipidemia Cascade Category
At treatment goal 8 months
|
85.1 model estimated %
|
67.4 model estimated %
|
|
% of Subjects in Each Hyperlipidemia Cascade Category
Untreated 12 months
|
5.3 model estimated %
|
27.1 model estimated %
|
|
% of Subjects in Each Hyperlipidemia Cascade Category
Treated 12 months
|
3.6 model estimated %
|
14.1 model estimated %
|
|
% of Subjects in Each Hyperlipidemia Cascade Category
At treatment goal 12 months
|
91.1 model estimated %
|
58.7 model estimated %
|
Adverse Events
Nurse Intervention
Serious events: 30 serious events
Other events: 44 other events
Deaths: 2 deaths
Education Control
Serious events: 22 serious events
Other events: 45 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Nurse Intervention
n=149 participants at risk
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
|
Education Control
n=148 participants at risk
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
|
|---|---|---|
|
General disorders
Non-study related events
|
17.4%
26/149 • Number of events 43 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
14.9%
22/148 • Number of events 47 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
|
Vascular disorders
Emergency room visit or hospitalization for high home blood pressure
|
2.0%
3/149 • Number of events 3 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
0.00%
0/148 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
|
Cardiac disorders
Emergency room visit for chest pain
|
0.67%
1/149 • Number of events 1 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
0.00%
0/148 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
Other adverse events
| Measure |
Nurse Intervention
n=149 participants at risk
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
|
Education Control
n=148 participants at risk
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
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury due to antihypertensive medication
|
0.67%
1/149 • Number of events 1 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
0.00%
0/148 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
|
Musculoskeletal and connective tissue disorders
myalgias
|
0.67%
1/149 • Number of events 1 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
0.00%
0/148 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
|
Immune system disorders
possible angioedema
|
0.67%
1/149 • Number of events 1 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
0.00%
0/148 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
|
General disorders
non study related events
|
27.5%
41/149 • Number of events 41 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
30.4%
45/148 • Number of events 45 • 12 months
Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place