Trial Outcomes & Findings for A Nurse-led Intervention to Extend the Veteran HIV Treatment Cascade for Cardiovascular Disease Prevention (NCT NCT04545489)
NCT ID: NCT04545489
Last Updated: 2025-10-30
Results Overview
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
305 participants
Primary outcome timeframe
Baseline
Results posted on
2025-10-30
Participant Flow
While 305 participants were consented and randomized to an arm, 4 withdrew and did not complete the baseline assessment. 301 is the number that completed baseline assessment and will therefore be used as the baseline analytic population for the study.
Participant milestones
| Measure |
Intervention Group
Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
|
Education Control Group
Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
149
|
|
Overall Study
COMPLETED
|
119
|
123
|
|
Overall Study
NOT COMPLETED
|
33
|
26
|
Reasons for withdrawal
| Measure |
Intervention Group
Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
|
Education Control Group
Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
4
|
|
Overall Study
Lost to Follow-up
|
17
|
18
|
|
Overall Study
12month BP not collected
|
4
|
4
|
Baseline Characteristics
A Nurse-led Intervention to Extend the Veteran HIV Treatment Cascade for Cardiovascular Disease Prevention
Baseline characteristics by cohort
| Measure |
Intervention Group
n=152 Participants
Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
|
Education Control Group
n=149 Participants
Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
118 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
152 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
|
Education
High school or less
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Education
Some college or trade school
|
69 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Education
College graduate or higher
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Employment
Employed
|
61 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Employment
Unemployed
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Employment
Retired
|
56 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The randomized participants who completed the baseline assessment
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Outcome measures
| Measure |
Intervention Group
n=152 Participants
Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
|
Education Control Group
n=149 Participants
Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
|
|---|---|---|
|
Mean Systolic Blood Pressure
|
134.6 mmHg
Standard Deviation 17.3
|
133.3 mmHg
Standard Deviation 15.5
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Enrolled participants who attended the in-person 4 month outcome assessment visit and had BP taken by study personnel.
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Outcome measures
| Measure |
Intervention Group
n=123 Participants
Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
|
Education Control Group
n=115 Participants
Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
|
|---|---|---|
|
Mean Systolic Blood Pressure
|
129.7 mmHg
Standard Deviation 14.6
|
129.6 mmHg
Standard Deviation 14.3
|
PRIMARY outcome
Timeframe: 8 monthsPopulation: Enrolled participants who attended the in-person 8 month outcome assessment visit and had BP taken by study personnel.
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Outcome measures
| Measure |
Intervention Group
n=107 Participants
Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
|
Education Control Group
n=109 Participants
Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
|
|---|---|---|
|
Mean Systolic Blood Pressure
|
130.4 mmHg
Standard Deviation 14.7
|
130.5 mmHg
Standard Deviation 16.6
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Enrolled participants who attended the in-person 12 month outcome assessment visit and had BP taken by study personnel.
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Outcome measures
| Measure |
Intervention Group
n=119 Participants
Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
|
Education Control Group
n=123 Participants
Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
|
|---|---|---|
|
Mean Systolic Blood Pressure
|
130.5 mmHg
Standard Deviation 13.4
|
130.6 mmHg
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: The number of enrolled participants who visited the lab during their outcome assessment period and had blood lipids measured.
Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
Outcome measures
| Measure |
Intervention Group
n=151 Participants
Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
|
Education Control Group
n=148 Participants
Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
|
|---|---|---|
|
Non-HDL Cholesterol
|
118.0 mg/dL
Standard Deviation 42.6
|
120.9 mg/dL
Standard Deviation 38.3
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: The number of enrolled participants who visited the lab during their 4 month outcome assessment period and had blood lipids drawn.
Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
Outcome measures
| Measure |
Intervention Group
n=125 Participants
Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
|
Education Control Group
n=120 Participants
Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
|
|---|---|---|
|
Non-HDL Cholesterol
|
114.1 mg/dL
Standard Deviation 51.0
|
115.4 mg/dL
Standard Deviation 34.8
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: The number of enrolled participants who visited the lab during their 8 month outcome assessment period and had blood lipids drawn.
Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
Outcome measures
| Measure |
Intervention Group
n=108 Participants
Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
|
Education Control Group
n=113 Participants
Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
|
|---|---|---|
|
Non-HDL Cholesterol
|
111.7 mg/dL
Standard Deviation 42.9
|
116.4 mg/dL
Standard Deviation 37.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of enrolled participants who visited the lab during their 12 month outcome assessment period and had blood lipids drawn.
Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
Outcome measures
| Measure |
Intervention Group
n=123 Participants
Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
|
Education Control Group
n=127 Participants
Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
|
|---|---|---|
|
Non-HDL Cholesterol
|
110.8 mg/dL
Standard Deviation 39.7
|
115.2 mg/dL
Standard Deviation 38.6
|
Adverse Events
Intervention Group
Serious events: 18 serious events
Other events: 0 other events
Deaths: 3 deaths
Education Control Group
Serious events: 16 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intervention Group
n=152 participants at risk
Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
|
Education Control Group
n=149 participants at risk
Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
|
|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/152 • 12 months
|
1.3%
2/149 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Acute knee pain
|
0.66%
1/152 • Number of events 1 • 12 months
|
0.00%
0/149 • 12 months
|
|
Cardiac disorders
Chest pain hospitalization
|
1.3%
2/152 • Number of events 2 • 12 months
|
1.3%
2/149 • Number of events 2 • 12 months
|
|
Cardiac disorders
Congestive Heart Failure Exacerbation
|
2.0%
3/152 • Number of events 8 • 12 months
|
0.00%
0/149 • 12 months
|
|
Infections and infestations
COVID hospitalization
|
0.66%
1/152 • Number of events 2 • 12 months
|
0.00%
0/149 • 12 months
|
|
Cardiac disorders
Defibrillator placement
|
0.00%
0/152 • 12 months
|
0.67%
1/149 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Elective surgery
|
1.3%
2/152 • Number of events 2 • 12 months
|
1.3%
2/149 • Number of events 2 • 12 months
|
|
General disorders
Falls
|
0.66%
1/152 • Number of events 2 • 12 months
|
0.00%
0/149 • 12 months
|
|
Hepatobiliary disorders
Gallbladder-related hospitalization
|
0.00%
0/152 • 12 months
|
0.67%
1/149 • Number of events 1 • 12 months
|
|
Social circumstances
Inpatient rehab
|
0.00%
0/152 • 12 months
|
0.67%
1/149 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.00%
0/152 • 12 months
|
0.67%
1/149 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Lithotripsy
|
0.66%
1/152 • Number of events 1 • 12 months
|
0.00%
0/149 • 12 months
|
|
Hepatobiliary disorders
Liver biopsy
|
0.00%
0/152 • 12 months
|
0.67%
1/149 • Number of events 1 • 12 months
|
|
General disorders
Orthostasis
|
0.00%
0/152 • 12 months
|
0.67%
1/149 • Number of events 1 • 12 months
|
|
Infections and infestations
Osteomyelitis
|
0.66%
1/152 • Number of events 1 • 12 months
|
0.00%
0/149 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.3%
2/152 • Number of events 3 • 12 months
|
0.00%
0/149 • 12 months
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/152 • 12 months
|
0.67%
1/149 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Psychiatric admission
|
0.00%
0/152 • 12 months
|
0.67%
1/149 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal failure/injury
|
1.3%
2/152 • Number of events 2 • 12 months
|
0.67%
1/149 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/152 • 12 months
|
1.3%
2/149 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
UTI
|
0.00%
0/152 • 12 months
|
0.67%
1/149 • Number of events 1 • 12 months
|
|
Cardiac disorders
Stent placement
|
0.66%
1/152 • Number of events 1 • 12 months
|
0.00%
0/149 • 12 months
|
|
General disorders
Death
|
2.0%
3/152 • Number of events 3 • 12 months
|
0.67%
1/149 • Number of events 1 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place