Trial Outcomes & Findings for VA Video Connect in HIV Care (NCT NCT04055207)

NCT ID: NCT04055207

Last Updated: 2026-08-26

Results Overview

Completion of at least 1 visit with a primary care or Infectious Disease provider in each 6 months of the year at least 60 days apart.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

306 participants

Primary outcome timeframe

From enrollment to the end of follow-up at 12 months

Results posted on

2026-08-26

Participant Flow

Participants were enrolled at completion of a scheduled medical visit. The first participant was enrolled on July 1, 2021 and the last participant was enrolled on May 24, 2022.

Of 472 randomized scheduled clinic appointments, 306 appointments were completed and enrolled in the study.

Participant milestones

Participant milestones
Measure
VVC Option
Option to receive VA Video Connect (VVC) delivery of HIV care. VVC: Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Usual Care
All HIV care available at MEDVAMC will be delivered as usual.
Overall Study
STARTED
154
152
Overall Study
COMPLETED
149
148
Overall Study
NOT COMPLETED
5
4

Reasons for withdrawal

Reasons for withdrawal
Measure
VVC Option
Option to receive VA Video Connect (VVC) delivery of HIV care. VVC: Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Usual Care
All HIV care available at MEDVAMC will be delivered as usual.
Overall Study
Death
3
4
Overall Study
Moved to a different clinic
2
0

Baseline Characteristics

One participant had missing data and was excluded from the analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
VVC Option
n=154 Participants
Option to receive VA Video Connect (VVC) delivery of HIV care. VVC: Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Usual Care
n=152 Participants
All HIV care available at MEDVAMC will be delivered as usual.
Total
n=306 Participants
Total of all reporting groups
Age, Continuous
57.36 years
STANDARD_DEVIATION 12.59 • n=154 Participants
58.16 years
STANDARD_DEVIATION 12.93 • n=152 Participants
57.76 years
STANDARD_DEVIATION 12.74 • n=306 Participants
Sex/Gender, Customized
Female
4 Participants
n=154 Participants
4 Participants
n=152 Participants
8 Participants
n=306 Participants
Sex/Gender, Customized
Male
150 Participants
n=154 Participants
147 Participants
n=152 Participants
297 Participants
n=306 Participants
Sex/Gender, Customized
Transgender
0 Participants
n=154 Participants
1 Participants
n=152 Participants
1 Participants
n=306 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants
n=154 Participants
17 Participants
n=152 Participants
30 Participants
n=306 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
139 Participants
n=154 Participants
133 Participants
n=152 Participants
272 Participants
n=306 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=154 Participants
2 Participants
n=152 Participants
4 Participants
n=306 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=154 Participants
0 Participants
n=152 Participants
0 Participants
n=306 Participants
Race (NIH/OMB)
Asian
0 Participants
n=154 Participants
1 Participants
n=152 Participants
1 Participants
n=306 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=154 Participants
2 Participants
n=152 Participants
3 Participants
n=306 Participants
Race (NIH/OMB)
Black or African American
102 Participants
n=154 Participants
92 Participants
n=152 Participants
194 Participants
n=306 Participants
Race (NIH/OMB)
White
50 Participants
n=154 Participants
53 Participants
n=152 Participants
103 Participants
n=306 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=154 Participants
0 Participants
n=152 Participants
0 Participants
n=306 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=154 Participants
4 Participants
n=152 Participants
5 Participants
n=306 Participants
Region of Enrollment
United States
154 Participants
n=154 Participants
152 Participants
n=152 Participants
306 Participants
n=306 Participants
Rural zip code
Rural
14 Participants
n=153 Participants • One participant had missing data and was excluded from the analysis.
13 Participants
n=152 Participants • One participant had missing data and was excluded from the analysis.
27 Participants
n=305 Participants • One participant had missing data and was excluded from the analysis.
Rural zip code
Not rural
139 Participants
n=153 Participants • One participant had missing data and was excluded from the analysis.
139 Participants
n=152 Participants • One participant had missing data and was excluded from the analysis.
278 Participants
n=305 Participants • One participant had missing data and was excluded from the analysis.
OEF/OIF Status
OEF/OIF
67 Participants
n=153 Participants • 3 participants were missing data and were excluded from the analysis
63 Participants
n=150 Participants • 3 participants were missing data and were excluded from the analysis
130 Participants
n=303 Participants • 3 participants were missing data and were excluded from the analysis
OEF/OIF Status
Not OEF/OIF
86 Participants
n=153 Participants • 3 participants were missing data and were excluded from the analysis
87 Participants
n=150 Participants • 3 participants were missing data and were excluded from the analysis
173 Participants
n=303 Participants • 3 participants were missing data and were excluded from the analysis
Drive time to MEDVAMC
37.43 minutes
STANDARD_DEVIATION 29.33 • n=148 Participants • 11 participants with missing data were excluded from this analysis
37.49 minutes
STANDARD_DEVIATION 31.36 • n=147 Participants • 11 participants with missing data were excluded from this analysis
37.46 minutes
STANDARD_DEVIATION 30.30 • n=295 Participants • 11 participants with missing data were excluded from this analysis
Alcohol Use Disorders Identification Test (AUDIT-C )
1.61 Score on screening tool
STANDARD_DEVIATION 2.26 • n=137 Participants • 46 participants who were missing AUDIT-C scores were excluded from this analysis.
1.61 Score on screening tool
STANDARD_DEVIATION 2.00 • n=123 Participants • 46 participants who were missing AUDIT-C scores were excluded from this analysis.
1.61 Score on screening tool
STANDARD_DEVIATION 2.14 • n=260 Participants • 46 participants who were missing AUDIT-C scores were excluded from this analysis.
Alcohol Use Disorders Identification Test (AUDIT-C )
Low-risk (0-4)
119 Participants
n=137 Participants • 46 participants who were missing AUDIT-C scores were excluded from this analysis.
103 Participants
n=123 Participants • 46 participants who were missing AUDIT-C scores were excluded from this analysis.
222 Participants
n=260 Participants • 46 participants who were missing AUDIT-C scores were excluded from this analysis.
Alcohol Use Disorders Identification Test (AUDIT-C )
Positive/Moderate or higher risk (>=5)
18 Participants
n=137 Participants • 46 participants who were missing AUDIT-C scores were excluded from this analysis.
20 Participants
n=123 Participants • 46 participants who were missing AUDIT-C scores were excluded from this analysis.
38 Participants
n=260 Participants • 46 participants who were missing AUDIT-C scores were excluded from this analysis.
Patient Health Questionnaire-2 (PHQ-2)
0.5 Scale score
STANDARD_DEVIATION 1.27 • n=98 Participants • 116 participants who were missing PHQ-2 scores were excluded from this analysis
0.62 Scale score
STANDARD_DEVIATION 1.45 • n=92 Participants • 116 participants who were missing PHQ-2 scores were excluded from this analysis
0.56 Scale score
STANDARD_DEVIATION 1.36 • n=190 Participants • 116 participants who were missing PHQ-2 scores were excluded from this analysis
Patient Health Questionnaire-2 (PHQ-2)
Score 0-2
89 Participants
n=98 Participants • 116 participants who were missing PHQ-2 scores were excluded from this analysis
85 Participants
n=92 Participants • 116 participants who were missing PHQ-2 scores were excluded from this analysis
174 Participants
n=190 Participants • 116 participants who were missing PHQ-2 scores were excluded from this analysis
Patient Health Questionnaire-2 (PHQ-2)
Score 3-6 (likely MDD)
9 Participants
n=98 Participants • 116 participants who were missing PHQ-2 scores were excluded from this analysis
7 Participants
n=92 Participants • 116 participants who were missing PHQ-2 scores were excluded from this analysis
16 Participants
n=190 Participants • 116 participants who were missing PHQ-2 scores were excluded from this analysis
CD4 Cell count
<200
3 Participants
n=46 Participants • 215 participants were missing CD4 cell count data and were excluded from this analysis
2 Participants
n=45 Participants • 215 participants were missing CD4 cell count data and were excluded from this analysis
5 Participants
n=91 Participants • 215 participants were missing CD4 cell count data and were excluded from this analysis
CD4 Cell count
200-499
9 Participants
n=46 Participants • 215 participants were missing CD4 cell count data and were excluded from this analysis
15 Participants
n=45 Participants • 215 participants were missing CD4 cell count data and were excluded from this analysis
24 Participants
n=91 Participants • 215 participants were missing CD4 cell count data and were excluded from this analysis
CD4 Cell count
>=500
34 Participants
n=46 Participants • 215 participants were missing CD4 cell count data and were excluded from this analysis
28 Participants
n=45 Participants • 215 participants were missing CD4 cell count data and were excluded from this analysis
62 Participants
n=91 Participants • 215 participants were missing CD4 cell count data and were excluded from this analysis
HIV Viral Load
<200 (suppressed)
136 Participants
n=152 Participants • 6 participants were missing HIV viral load data and were excluded from this analysis
133 Participants
n=148 Participants • 6 participants were missing HIV viral load data and were excluded from this analysis
269 Participants
n=300 Participants • 6 participants were missing HIV viral load data and were excluded from this analysis
HIV Viral Load
>=200
16 Participants
n=152 Participants • 6 participants were missing HIV viral load data and were excluded from this analysis
15 Participants
n=148 Participants • 6 participants were missing HIV viral load data and were excluded from this analysis
31 Participants
n=300 Participants • 6 participants were missing HIV viral load data and were excluded from this analysis
Antiretroviral Therapy (ART) Medication adherence
91.06 Percent adherence
STANDARD_DEVIATION 12.90 • n=151 Participants • 7 participants were missing medication data at baseline and were excluded from this analysis
91.36 Percent adherence
STANDARD_DEVIATION 14.40 • n=148 Participants • 7 participants were missing medication data at baseline and were excluded from this analysis
91.21 Percent adherence
STANDARD_DEVIATION 13.64 • n=299 Participants • 7 participants were missing medication data at baseline and were excluded from this analysis
Constancy Retention in Care
123 Participants
n=154 Participants
118 Participants
n=152 Participants
241 Participants
n=306 Participants
Completed visits for adherence counseling
3.84 Number of visits
STANDARD_DEVIATION 2.25 • n=154 Participants
3.88 Number of visits
STANDARD_DEVIATION 2.00 • n=152 Participants
3.86 Number of visits
STANDARD_DEVIATION 2.13 • n=306 Participants
Adherence Retention in Care
78.56 Percent visits attended
STANDARD_DEVIATION 21.61 • n=154 Participants • One participant was missing visit data in the 12 months prior to baseline.
76.72 Percent visits attended
STANDARD_DEVIATION 22.26 • n=151 Participants • One participant was missing visit data in the 12 months prior to baseline.
77.65 Percent visits attended
STANDARD_DEVIATION 21.92 • n=305 Participants • One participant was missing visit data in the 12 months prior to baseline.

PRIMARY outcome

Timeframe: From enrollment to the end of follow-up at 12 months

Population: The full 306 participants were included in all analyses.

Completion of at least 1 visit with a primary care or Infectious Disease provider in each 6 months of the year at least 60 days apart.

Outcome measures

Outcome measures
Measure
VVC Option
n=154 Participants
Option to receive VA Video Connect (VVC) delivery of HIV care. VVC: Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Usual Care
n=152 Participants
All HIV care available at MEDVAMC will be delivered as usual.
Constancy Retention in Care Measure
99 Participants
94 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Only participants with adherence retention in care data available at baseline and the 12 month follow-up were included in descriptive and completer analyses. The 305 participants with baseline data were included in ITT analyses.

Percentage of scheduled HIV clinic appointments attended over 12 months

Outcome measures

Outcome measures
Measure
VVC Option
n=152 Participants
Option to receive VA Video Connect (VVC) delivery of HIV care. VVC: Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Usual Care
n=150 Participants
All HIV care available at MEDVAMC will be delivered as usual.
Adherence Retention in Care Measure
61.74 percentage of HIV clinic visits attended
Standard Deviation 31.35
66.49 percentage of HIV clinic visits attended
Standard Deviation 27.88

SECONDARY outcome

Timeframe: 12 months

Population: The full 306 participants were included in all analyses.

Number of completed visits for counseling, mental health, and social services during the year.

Outcome measures

Outcome measures
Measure
VVC Option
n=154 Participants
Option to receive VA Video Connect (VVC) delivery of HIV care. VVC: Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Usual Care
n=152 Participants
All HIV care available at MEDVAMC will be delivered as usual.
Completed Visits for Adherence Counseling
2.55 number of visits
Standard Deviation 1.88
2.73 number of visits
Standard Deviation 1.64

SECONDARY outcome

Timeframe: 12 months

Population: Only participants with viral load data available in the medical record at baseline and 12 month follow-up period were included in analyses.

Number of Veterans with HIV on ART whose most recent viral load during the 12-month period was \<200c/mL

Outcome measures

Outcome measures
Measure
VVC Option
n=126 Participants
Option to receive VA Video Connect (VVC) delivery of HIV care. VVC: Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Usual Care
n=135 Participants
All HIV care available at MEDVAMC will be delivered as usual.
HIV Suppression
121 Participants
128 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Only participants with medication data available at baseline and 12 month follow-up period were included in analyses.

The percentage of ART medication dispensed was calculated by dividing the total number of ART medication pills dispensed during each 365-day observation period (i.e., baseline and 12-month follow-up) by 365 and then multiplying by 100, yielding a percentage (0-100%). This pharmacy dispensing measure serves as a proxy for medication adherence, with higher percentages indicating greater medication availability.

Outcome measures

Outcome measures
Measure
VVC Option
n=151 Participants
Option to receive VA Video Connect (VVC) delivery of HIV care. VVC: Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Usual Care
n=145 Participants
All HIV care available at MEDVAMC will be delivered as usual.
Percent ART Medication Dispensed (as a Proxy for Medication Adherence)
90.30 mean percentage ART medication dispensed
Standard Deviation 14.91
91.32 mean percentage ART medication dispensed
Standard Deviation 13.35

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: With 91 participants at baseline, 61 at 12 month follow-up and 17 at both assessment timepoints, imputations were not appropriate and statistical comparisons between VVC and UC arms could not be conducted.

Last recorded value in medical record during 12 month period

Outcome measures

Outcome measures
Measure
VVC Option
n=10 Participants
Option to receive VA Video Connect (VVC) delivery of HIV care. VVC: Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Usual Care
n=7 Participants
All HIV care available at MEDVAMC will be delivered as usual.
CD4 Cell Count Greater Than or Equal to 200
< 200
0 Participants
0 Participants
CD4 Cell Count Greater Than or Equal to 200
> = 200
10 Participants
7 Participants

Adverse Events

VVC Option

Serious events: 42 serious events
Other events: 62 other events
Deaths: 3 deaths

Usual Care

Serious events: 38 serious events
Other events: 61 other events
Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure
VVC Option
n=154 participants at risk
Option to receive VA Video Connect (VVC) delivery of HIV care. VVC: Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Usual Care
n=152 participants at risk
All HIV care available at MEDVAMC will be delivered as usual.
Blood and lymphatic system disorders
Hospital Admission
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
1.3%
2/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Cardiac disorders
Hospital admission
2.6%
4/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
2.0%
3/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Endocrine disorders
Hospital Admission
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.00%
0/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Gastrointestinal disorders
Hospital Admission
1.9%
3/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
1.3%
2/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
General disorders
Hospital Admission
2.6%
4/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
1.3%
2/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Hepatobiliary disorders
Hospital Admission
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Infections and infestations
Hospital Admission
2.6%
4/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
1.3%
2/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Injury, poisoning and procedural complications
Hospital Admission
0.00%
0/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Metabolism and nutrition disorders
Hospital Admission
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.00%
0/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospital Admission
0.00%
0/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
1.3%
2/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Nervous system disorders
Hospital Admission
1.9%
3/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
1.3%
2/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Psychiatric disorders
Hospital Admission
0.00%
0/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
2.6%
4/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Renal and urinary disorders
Hospital Admission
2.6%
4/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
2.6%
4/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Respiratory, thoracic and mediastinal disorders
Hospital Admission
1.3%
2/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.00%
0/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Skin and subcutaneous tissue disorders
Hospital Admission
0.00%
0/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Surgical and medical procedures
Hospital Admission
5.2%
8/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
5.3%
8/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Vascular disorders
Hospital Admission
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.00%
0/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Cardiac disorders
Emergency Room Visit
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Endocrine disorders
Emergency Room Visit
0.00%
0/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Infections and infestations
Emergency Room Visit
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.00%
0/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Injury, poisoning and procedural complications
Emergency Room Visit
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Nervous system disorders
Emergency Room Visit
1.3%
2/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team

Other adverse events

Other adverse events
Measure
VVC Option
n=154 participants at risk
Option to receive VA Video Connect (VVC) delivery of HIV care. VVC: Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Usual Care
n=152 participants at risk
All HIV care available at MEDVAMC will be delivered as usual.
Musculoskeletal and connective tissue disorders
Emergency Room Visit
5.8%
9/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
5.9%
9/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Nervous system disorders
Emergency Room Visit
0.00%
0/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
2.6%
4/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Psychiatric disorders
Emergency Room Visit
1.3%
2/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Renal and urinary disorders
Emergency Room Visit
1.9%
3/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
2.0%
3/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Respiratory, thoracic and mediastinal disorders
Emergency Room Visit
7.8%
12/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
8.6%
13/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Skin and subcutaneous tissue disorders
Emergency Room Visit
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
1.3%
2/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Surgical and medical procedures
Emergency Room Visit
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.00%
0/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Vascular disorders
Emergency Room Visit
1.9%
3/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Renal and urinary disorders
Hospital Admission
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.00%
0/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Surgical and medical procedures
Hospital Admission
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Immune system disorders
Emergency Room Visit
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.00%
0/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Infections and infestations
Emergency Room Visit
4.5%
7/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
2.6%
4/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Injury, poisoning and procedural complications
Emergency Room Visit
2.6%
4/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
1.3%
2/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Psychiatric disorders
Psychosis leading to ART medication noncompliance
0.00%
0/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Psychiatric disorders
Crisis Call
1.3%
2/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
2.0%
3/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Respiratory, thoracic and mediastinal disorders
Illness
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.00%
0/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Surgical and medical procedures
Invasive Procedure
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.00%
0/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Cardiac disorders
Emergency Room Visit
1.3%
2/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Endocrine disorders
Emergency Room Visit
0.00%
0/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Eye disorders
Emergency Room Visit
0.65%
1/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
0.66%
1/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
Gastrointestinal disorders
Emergency Room Visit
1.3%
2/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
2.0%
3/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
General disorders
Emergency Room Visit
5.2%
8/154 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team
7.2%
11/152 • From enrollment to end of follow-up period, up to 12 months
Adverse event information was collected via chart review of participant medical records by the study team

Additional Information

Jan Lindssay

Michael E. DeBakey VA Medical Center

Phone: 713-440-4682

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place