Trial Outcomes & Findings for Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms (NCT NCT03182738)
NCT ID: NCT03182738
Last Updated: 2019-12-13
Results Overview
The Symptom Burden Score is an expanded version of the 20-item HIV symptom index. The score is calculated for the 28 most common symptoms in persons living with HIV. Each symptom is given a score ranging from 0 to 4 with the scores indicating the following: 0 (not experienced) , 1 (It doesn't bother me), 2 (It bothers me a little), 3 (It bothers me), or 4 (It bothers me a lot). The higher the score (closer to 4), the greater the symptom burden (worse outcome).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Baseline, 3 months and 6 months; period 1 = 1-6 weeks (baseline), period 2 = 6-18 weeks (3 months), period 3 = >18 weeks (6 months)
Results posted on
2019-12-13
Participant Flow
Participant milestones
| Measure |
Intervention
VIP app that delivers HIV-related symptom strategies
VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
|
Control
VIP app without HIV-related symptom strategies
VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
41
|
45
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
Intervention
VIP app that delivers HIV-related symptom strategies
VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
|
Control
VIP app without HIV-related symptom strategies
VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
3
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms
Baseline characteristics by cohort
| Measure |
Intervention
n=50 Participants
VIP app that delivers HIV-related symptom strategies
VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
|
Control
n=50 Participants
VIP app without HIV-related symptom strategies
VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Age, Continuous
|
51.87 years
STANDARD_DEVIATION 10.41 • n=93 Participants
|
53.66 years
STANDARD_DEVIATION 11.21 • n=4 Participants
|
52.77 years
STANDARD_DEVIATION 10.80 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=93 Participants
|
50 participants
n=4 Participants
|
100 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months and 6 months; period 1 = 1-6 weeks (baseline), period 2 = 6-18 weeks (3 months), period 3 = >18 weeks (6 months)Population: The statistical analysis defined the time points into 3 periods to correlate with the baseline, 3-month, and 6-month visits. Not all participants completed the symptom burden scale and therefore did not align within the 3 designated periods.
The Symptom Burden Score is an expanded version of the 20-item HIV symptom index. The score is calculated for the 28 most common symptoms in persons living with HIV. Each symptom is given a score ranging from 0 to 4 with the scores indicating the following: 0 (not experienced) , 1 (It doesn't bother me), 2 (It bothers me a little), 3 (It bothers me), or 4 (It bothers me a lot). The higher the score (closer to 4), the greater the symptom burden (worse outcome).
Outcome measures
| Measure |
Intervention
n=50 Participants
VIP app that delivers HIV-related symptom strategies
VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
|
Control
n=50 Participants
VIP app without HIV-related symptom strategies
VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies
|
|---|---|---|
|
Symptom Burden Score
Anxiety - period 3
|
0.80 score on a scale
Standard Deviation 1.34
|
0.78 score on a scale
Standard Deviation 1.38
|
|
Symptom Burden Score
Changes in appetite - period 1
|
0.85 score on a scale
Standard Deviation 1.36
|
0.70 score on a scale
Standard Deviation 1.19
|
|
Symptom Burden Score
Difficulty remembering - period 2
|
0.92 score on a scale
Standard Deviation 1.40
|
1.08 score on a scale
Standard Deviation 1.51
|
|
Symptom Burden Score
Lightheadedness or dizziness - period 2
|
0.76 score on a scale
Standard Deviation 1.35
|
0.45 score on a scale
Standard Deviation 1.07
|
|
Symptom Burden Score
Dry eyes - period 1
|
0.78 score on a scale
Standard Deviation 1.30
|
0.63 score on a scale
Standard Deviation 1.17
|
|
Symptom Burden Score
Dry eyes - period 3
|
0.53 score on a scale
Standard Deviation 1.15
|
0.57 score on a scale
Standard Deviation 1.06
|
|
Symptom Burden Score
Difficulty falling asleep - period 1
|
1.41 score on a scale
Standard Deviation 1.63
|
1.52 score on a scale
Standard Deviation 1.69
|
|
Symptom Burden Score
Fatigue - period 3
|
1.31 score on a scale
Standard Deviation 1.53
|
1.07 score on a scale
Standard Deviation 1.40
|
|
Symptom Burden Score
Fever, night sweats, or chills - period 1
|
0.72 score on a scale
Standard Deviation 1.27
|
0.77 score on a scale
Standard Deviation 1.40
|
|
Symptom Burden Score
Fever, night sweats, or chills - period 2
|
0.65 score on a scale
Standard Deviation 1.28
|
0.63 score on a scale
Standard Deviation 1.28
|
|
Symptom Burden Score
Heartburn - period 2
|
0.79 score on a scale
Standard Deviation 1.34
|
0.70 score on a scale
Standard Deviation 1.40
|
|
Symptom Burden Score
Heartburn - period 3
|
0.84 score on a scale
Standard Deviation 1.43
|
0.55 score on a scale
Standard Deviation 1.27
|
|
Symptom Burden Score
Problems achieving an erection - period 1
|
0.72 score on a scale
Standard Deviation 1.37
|
0.23 score on a scale
Standard Deviation 0.83
|
|
Symptom Burden Score
Muscle aches or pain - period 2
|
1.86 score on a scale
Standard Deviation 1.59
|
1.74 score on a scale
Standard Deviation 1.62
|
|
Symptom Burden Score
Muscle aches or pain - period 3
|
1.78 score on a scale
Standard Deviation 1.66
|
1.79 score on a scale
Standard Deviation 1.59
|
|
Symptom Burden Score
Pain or discomfort during sex - period 1
|
0.27 score on a scale
Standard Deviation 0.87
|
0.21 score on a scale
Standard Deviation 0.76
|
|
Symptom Burden Score
Ringing in ears or noise intolerance - period 1
|
0.73 score on a scale
Standard Deviation 1.34
|
0.61 score on a scale
Standard Deviation 1.26
|
|
Symptom Burden Score
Ringing in ears or noise intolerance - period 2
|
0.58 score on a scale
Standard Deviation 1.12
|
0.67 score on a scale
Standard Deviation 1.31
|
|
Symptom Burden Score
Ringing in ears or noise intolerance - period 3
|
0.61 score on a scale
Standard Deviation 1.30
|
0.60 score on a scale
Standard Deviation 1.19
|
|
Symptom Burden Score
Shortness of breath - period 1
|
0.86 score on a scale
Standard Deviation 1.37
|
0.94 score on a scale
Standard Deviation 1.41
|
|
Symptom Burden Score
Shortness of breath - period 2
|
1.00 score on a scale
Standard Deviation 1.48
|
0.81 score on a scale
Standard Deviation 1.39
|
|
Symptom Burden Score
Difficulty with urination - period 2
|
0.55 score on a scale
Standard Deviation 1.19
|
0.28 score on a scale
Standard Deviation 0.89
|
|
Symptom Burden Score
Difficulty with urination - period 3
|
0.48 score on a scale
Standard Deviation 1.05
|
0.30 score on a scale
Standard Deviation 0.91
|
|
Symptom Burden Score
Nausea or vomiting - period 1
|
0.56 score on a scale
Standard Deviation 1.16
|
0.27 score on a scale
Standard Deviation 0.80
|
|
Symptom Burden Score
Nausea or vomiting - period 2
|
0.46 score on a scale
Standard Deviation 1.08
|
0.34 score on a scale
Standard Deviation 0.95
|
|
Symptom Burden Score
Changes in appetite - period 2
|
0.79 score on a scale
Standard Deviation 1.34
|
0.67 score on a scale
Standard Deviation 1.21
|
|
Symptom Burden Score
Depression - period 2
|
1.33 score on a scale
Standard Deviation 1.58
|
1.00 score on a scale
Standard Deviation 1.51
|
|
Symptom Burden Score
Decreased sex drive - period 1
|
0.98 score on a scale
Standard Deviation 1.49
|
1.09 score on a scale
Standard Deviation 1.49
|
|
Symptom Burden Score
Decreased sex drive - period 2
|
0.85 score on a scale
Standard Deviation 1.42
|
0.68 score on a scale
Standard Deviation 1.32
|
|
Symptom Burden Score
Anxiety - period 1
|
1.08 score on a scale
Standard Deviation 1.47
|
1.06 score on a scale
Standard Deviation 1.49
|
|
Symptom Burden Score
Anxiety - period 2
|
0.83 score on a scale
Standard Deviation 1.36
|
0.71 score on a scale
Standard Deviation 1.37
|
|
Symptom Burden Score
Changes in appetite - period 3
|
0.76 score on a scale
Standard Deviation 1.36
|
0.55 score on a scale
Standard Deviation 1.15
|
|
Symptom Burden Score
Clumsiness or difficulty with balance - period 1
|
0.88 score on a scale
Standard Deviation 1.49
|
0.82 score on a scale
Standard Deviation 1.39
|
|
Symptom Burden Score
Clumsiness or difficulty with balance - period 2
|
0.83 score on a scale
Standard Deviation 1.41
|
0.66 score on a scale
Standard Deviation 1.28
|
|
Symptom Burden Score
Clumsiness or difficulty with balance - period 3
|
0.94 score on a scale
Standard Deviation 1.49
|
0.58 score on a scale
Standard Deviation 1.25
|
|
Symptom Burden Score
Difficulty concentrating - period 1
|
0.76 score on a scale
Standard Deviation 1.32
|
1.14 score on a scale
Standard Deviation 1.50
|
|
Symptom Burden Score
Depression - period 3
|
1.32 score on a scale
Standard Deviation 1.56
|
0.91 score on a scale
Standard Deviation 1.46
|
|
Symptom Burden Score
Difficulty concentrating - period 2
|
0.68 score on a scale
Standard Deviation 1.29
|
0.82 score on a scale
Standard Deviation 1.37
|
|
Symptom Burden Score
Difficulty concentrating - period 3
|
0.70 score on a scale
Standard Deviation 1.31
|
0.83 score on a scale
Standard Deviation 1.39
|
|
Symptom Burden Score
Constipation, gas, or bloating - period 1
|
1.28 score on a scale
Standard Deviation 1.53
|
1.21 score on a scale
Standard Deviation 1.47
|
|
Symptom Burden Score
Constipation, gas, or bloating - period 2
|
1.16 score on a scale
Standard Deviation 1.57
|
1.11 score on a scale
Standard Deviation 1.51
|
|
Symptom Burden Score
Constipation, gas, or bloating - period 3
|
1.12 score on a scale
Standard Deviation 1.53
|
0.93 score on a scale
Standard Deviation 1.46
|
|
Symptom Burden Score
Cough - period 1
|
0.77 score on a scale
Standard Deviation 1.35
|
0.90 score on a scale
Standard Deviation 1.36
|
|
Symptom Burden Score
Cough - period 2
|
0.72 score on a scale
Standard Deviation 1.32
|
0.76 score on a scale
Standard Deviation 1.32
|
|
Symptom Burden Score
Cough - period 3
|
0.76 score on a scale
Standard Deviation 1.32
|
0.74 score on a scale
Standard Deviation 1.29
|
|
Symptom Burden Score
Depression - period 1
|
1.36 score on a scale
Standard Deviation 1.48
|
1.36 score on a scale
Standard Deviation 1.62
|
|
Symptom Burden Score
Decreased sex drive - period 3
|
0.85 score on a scale
Standard Deviation 1.41
|
0.58 score on a scale
Standard Deviation 1.28
|
|
Symptom Burden Score
Diarrhea- period 1
|
0.81 score on a scale
Standard Deviation 1.36
|
0.62 score on a scale
Standard Deviation 1.19
|
|
Symptom Burden Score
Diarrhea - period 2
|
0.63 score on a scale
Standard Deviation 1.29
|
0.52 score on a scale
Standard Deviation 1.18
|
|
Symptom Burden Score
Diarrhea - period 3
|
0.62 score on a scale
Standard Deviation 1.28
|
0.37 score on a scale
Standard Deviation 0.99
|
|
Symptom Burden Score
Difficulty remembering - period 1
|
1.01 score on a scale
Standard Deviation 1.45
|
1.15 score on a scale
Standard Deviation 1.53
|
|
Symptom Burden Score
Difficulty remembering - period 3
|
0.83 score on a scale
Standard Deviation 1.36
|
0.97 score on a scale
Standard Deviation 1.44
|
|
Symptom Burden Score
Lightheadedness or dizziness - period 1
|
0.83 score on a scale
Standard Deviation 1.39
|
0.66 score on a scale
Standard Deviation 1.22
|
|
Symptom Burden Score
Lightheadedness or dizziness - period 3
|
0.82 score on a scale
Standard Deviation 1.43
|
0.32 score on a scale
Standard Deviation 0.91
|
|
Symptom Burden Score
Dry eyes - period 2
|
0.63 score on a scale
Standard Deviation 1.22
|
0.64 score on a scale
Standard Deviation 1.18
|
|
Symptom Burden Score
Thirst or dry mouth - period 1
|
1.35 score on a scale
Standard Deviation 1.53
|
1.13 score on a scale
Standard Deviation 1.41
|
|
Symptom Burden Score
Thirst or dry mouth - period 2
|
0.98 score on a scale
Standard Deviation 1.41
|
0.96 score on a scale
Standard Deviation 1.40
|
|
Symptom Burden Score
Thirst or dry mouth - period 3
|
0.97 score on a scale
Standard Deviation 1.40
|
0.97 score on a scale
Standard Deviation 1.39
|
|
Symptom Burden Score
Difficulty falling asleep - period 2
|
1.27 score on a scale
Standard Deviation 1.68
|
1.21 score on a scale
Standard Deviation 1.66
|
|
Symptom Burden Score
Difficulty falling asleep - period 3
|
1.47 score on a scale
Standard Deviation 1.74
|
1.28 score on a scale
Standard Deviation 1.68
|
|
Symptom Burden Score
Fatigue - period 1
|
1.83 score on a scale
Standard Deviation 1.53
|
1.73 score on a scale
Standard Deviation 1.52
|
|
Symptom Burden Score
Fatigue - period 2
|
1.41 score on a scale
Standard Deviation 1.60
|
1.32 score on a scale
Standard Deviation 1.51
|
|
Symptom Burden Score
Fever, night sweats, or chills - period 3
|
0.70 score on a scale
Standard Deviation 1.30
|
0.60 score on a scale
Standard Deviation 1.22
|
|
Symptom Burden Score
Heartburn - period 1
|
0.96 score on a scale
Standard Deviation 1.42
|
0.81 score on a scale
Standard Deviation 1.44
|
|
Symptom Burden Score
Problems achieving an erection - period 2
|
0.59 score on a scale
Standard Deviation 1.25
|
0.24 score on a scale
Standard Deviation 0.88
|
|
Symptom Burden Score
Problems achieving an erection - period 3
|
0.62 score on a scale
Standard Deviation 1.30
|
0.23 score on a scale
Standard Deviation 0.87
|
|
Symptom Burden Score
Muscle aches or pain - period 1
|
2.17 score on a scale
Standard Deviation 1.54
|
2.12 score on a scale
Standard Deviation 1.59
|
|
Symptom Burden Score
Neuropathy - period 1
|
1.94 score on a scale
Standard Deviation 1.65
|
1.67 score on a scale
Standard Deviation 1.63
|
|
Symptom Burden Score
Neuropathy - period 2
|
1.77 score on a scale
Standard Deviation 1.68
|
1.66 score on a scale
Standard Deviation 1.63
|
|
Symptom Burden Score
Neuropathy - period 3
|
1.86 score on a scale
Standard Deviation 1.64
|
1.56 score on a scale
Standard Deviation 1.63
|
|
Symptom Burden Score
Pain or discomfort during sex - period 2
|
0.36 score on a scale
Standard Deviation 1.06
|
0.18 score on a scale
Standard Deviation 0.74
|
|
Symptom Burden Score
Pain or discomfort during sex - period 3
|
0.38 score on a scale
Standard Deviation 1.04
|
0.12 score on a scale
Standard Deviation 0.60
|
|
Symptom Burden Score
Shortness of breath - period 3
|
0.73 score on a scale
Standard Deviation 1.29
|
0.72 score on a scale
Standard Deviation 1.30
|
|
Symptom Burden Score
Speech difficulties - period 1
|
0.27 score on a scale
Standard Deviation 0.87
|
0.34 score on a scale
Standard Deviation 0.97
|
|
Symptom Burden Score
Speech difficulties - period 2
|
0.34 score on a scale
Standard Deviation 0.95
|
0.25 score on a scale
Standard Deviation 0.82
|
|
Symptom Burden Score
Speech difficulties - period 3
|
0.42 score on a scale
Standard Deviation 1.06
|
0.21 score on a scale
Standard Deviation 0.73
|
|
Symptom Burden Score
Difficulty staying asleep - period 1
|
1.44 score on a scale
Standard Deviation 1.61
|
1.48 score on a scale
Standard Deviation 1.66
|
|
Symptom Burden Score
Difficulty staying asleep - period 2
|
1.49 score on a scale
Standard Deviation 1.73
|
1.19 score on a scale
Standard Deviation 1.61
|
|
Symptom Burden Score
Difficulty staying asleep - period 3
|
1.53 score on a scale
Standard Deviation 1.69
|
1.22 score on a scale
Standard Deviation 1.64
|
|
Symptom Burden Score
Difficulty with urination - period 1
|
0.45 score on a scale
Standard Deviation 1.09
|
0.32 score on a scale
Standard Deviation 0.96
|
|
Symptom Burden Score
Nausea or vomiting - period 3
|
0.41 score on a scale
Standard Deviation 1.02
|
0.19 score on a scale
Standard Deviation 0.69
|
|
Symptom Burden Score
Unplanned changes in weight - period 1
|
0.71 score on a scale
Standard Deviation 1.39
|
0.90 score on a scale
Standard Deviation 1.52
|
|
Symptom Burden Score
Unplanned changes in weight - period 2
|
0.41 score on a scale
Standard Deviation 1.02
|
0.19 score on a scale
Standard Deviation 0.69
|
|
Symptom Burden Score
Unplanned changes in weight - period 3
|
0.73 score on a scale
Standard Deviation 1.38
|
0.57 score on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsPopulation: Not all participants completed the scale at 3 months and 6 months because they did not show up to their 3-month and 6-month follow-up visit. Some participants also did not answer all of the questions within the scale to produce a valid t-score, and were thus excluded from the analysis.
The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Each of the 7 domains has four 5-level items (i.e., 16 decrements each). In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain. Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. T-scores can be estimated using scoring tables listed in the PROMIS manuals. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms.
Outcome measures
| Measure |
Intervention
n=50 Participants
VIP app that delivers HIV-related symptom strategies
VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
|
Control
n=50 Participants
VIP app without HIV-related symptom strategies
VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies
|
|---|---|---|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Anxiety at 6 months
|
44.35 T-Score
Standard Deviation 9.29
|
53.32 T-Score
Standard Deviation 9.46
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Depression at Baseline
|
53.58 T-Score
Standard Deviation 8.56
|
53.32 T-Score
Standard Deviation 10.11
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Sleep Disturbance at 3 months
|
52.69 T-Score
Standard Deviation 8.95
|
51.52 T-Score
Standard Deviation 9.58
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Satisfaction with Social Role at Baseline
|
47.31 T-Score
Standard Deviation 9.97
|
45.05 T-Score
Standard Deviation 8.64
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Fatigue at Baseline
|
53.81 T-Score
Standard Deviation 9.40
|
52.99 T-Score
Standard Deviation 9.00
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Fatigue at 3 months
|
51.75 T-Score
Standard Deviation 9.93
|
52.63 T-Score
Standard Deviation 10.21
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Fatigue at 6 months
|
54.23 T-Score
Standard Deviation 9.28
|
51.46 T-Score
Standard Deviation 8.45
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Sleep Disturbance at Baseline
|
54.98 T-Score
Standard Deviation 8.79
|
54.66 T-Score
Standard Deviation 8.63
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Sleep Disturbance at 6 months
|
52.54 T-Score
Standard Deviation 8.28
|
50.29 T-Score
Standard Deviation 9.30
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Satisfaction with Social Role at 3 months
|
48.00 T-Score
Standard Deviation 9.88
|
45.99 T-Score
Standard Deviation 9.52
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Satisfaction with Social Role at 6 months
|
48.47 T-Score
Standard Deviation 8.47
|
46.15 T-Score
Standard Deviation 8.10
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Pain Interference at Baseline
|
59.12 T-Score
Standard Deviation 7.70
|
59.56 T-Score
Standard Deviation 8.59
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Pain Interference at 3 months
|
56.56 T-Score
Standard Deviation 10.73
|
57.52 T-Score
Standard Deviation 9.45
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Pain Interference at 6 months
|
57.43 T-Score
Standard Deviation 9.53
|
56.94 T-Score
Standard Deviation 7.28
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Physical Function at Baseline
|
43.79 T-Score
Standard Deviation 9.28
|
41.43 T-Score
Standard Deviation 8.18
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Physical Function at 3 months
|
45.37 T-Score
Standard Deviation 9.09
|
41.98 T-Score
Standard Deviation 8.46
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Physical Function at 6 months
|
44.35 T-Score
Standard Deviation 9.29
|
41.63 T-Score
Standard Deviation 7.43
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Anxiety at Baseline
|
56.28 T-Score
Standard Deviation 9.45
|
55.56 T-Score
Standard Deviation 9.67
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Anxiety at 3 months
|
54.88 T-Score
Standard Deviation 8.29
|
55.03 T-Score
Standard Deviation 9.02
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Depression at 3 months
|
52.12 T-Score
Standard Deviation 8.64
|
52.52 T-Score
Standard Deviation 10.02
|
|
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Depression at 6 months
|
52.62 T-Score
Standard Deviation 7.89
|
52.34 T-Score
Standard Deviation 8.54
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months and 6 months12-Item Medical Outcomes Study Short Form (SF-12) is a health survey to measure health-related quality of life.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, and 6 monthsPopulation: Not all participants completed the scale at 3 months and 6 months because they did not show up to their 3-month and 6-month follow-up visit. Some participants also did not answer all of the questions within the scale to produce a score between 13 and 52, and were thus excluded from the analysis.
Engagement with Health Care Provide scale is a 13-item scale in which subjects rate their interactions with their health care providers on a four-point scale with 1=always true and 4=never true. A total score can be calculated to create a possible range of 13-52. A low score (closer to 13) indicates greater provider engagement between the patient and provider.
Outcome measures
| Measure |
Intervention
n=50 Participants
VIP app that delivers HIV-related symptom strategies
VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
|
Control
n=50 Participants
VIP app without HIV-related symptom strategies
VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies
|
|---|---|---|
|
Score on Engagement With Health Care Provider Scale
Score at Baseline
|
17.78 score on a scale
Standard Deviation 8.07
|
17.13 score on a scale
Standard Deviation 6.52
|
|
Score on Engagement With Health Care Provider Scale
Score at 3-months
|
20.17 score on a scale
Standard Deviation 8.68
|
17.33 score on a scale
Standard Deviation 5.43
|
|
Score on Engagement With Health Care Provider Scale
Score at 6-months
|
18.05 score on a scale
Standard Deviation 7.72
|
18.70 score on a scale
Standard Deviation 8.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, and 6 monthsPopulation: Not all participants completed the scale at 3 months and 6 months because they did not show up to their 3-month and 6-month follow-up visit. Some participants also did not answer the question and left it blank, thus excluded from the analysis.
The Visual Analogue Scale (VAS) measures adherence to antiretroviral therapy (ART). VAS asks subjects to indicate a point on a line that shows their best guess about how much of each drug they have taken. 0% means they have taken no drug, 50% means they have taken half their drugs, and 100% means they have taken every single dose.
Outcome measures
| Measure |
Intervention
n=50 Participants
VIP app that delivers HIV-related symptom strategies
VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
|
Control
n=50 Participants
VIP app without HIV-related symptom strategies
VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies
|
|---|---|---|
|
Score of the VAS
3-month VAS Score
|
86.89 percentage of medication
Standard Deviation 24.43
|
87.30 percentage of medication
Standard Deviation 20.99
|
|
Score of the VAS
6-month VAS score
|
86.88 percentage of medication
Standard Deviation 21.49
|
88.63 percentage of medication
Standard Deviation 20.45
|
|
Score of the VAS
Baseline VAS Score
|
88.49 percentage of medication
Standard Deviation 17.34
|
83.91 percentage of medication
Standard Deviation 26.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, and 6 monthsPopulation: Not all participants showed up to their 3-month and 6-month follow-up visit and therefore did not complete any of the frailty measures. These individuals were excluded from the analysis.
Fried's frailty phenotype is a combination of five scores: weight loss in the last year, exhaustion, physical activity, walk time for a 15 foot interval, and grip strength. The frailty condition is defined as meeting the definition of frailty for at least 3 of the listed scores.
Outcome measures
| Measure |
Intervention
n=50 Participants
VIP app that delivers HIV-related symptom strategies
VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
|
Control
n=50 Participants
VIP app without HIV-related symptom strategies
VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies
|
|---|---|---|
|
Score on Fried's Frailty Phenotype
Frail at Baseline
|
25 Participants
|
26 Participants
|
|
Score on Fried's Frailty Phenotype
Frail at 3 months
|
19 Participants
|
21 Participants
|
|
Score on Fried's Frailty Phenotype
Frail at 6 months
|
17 Participants
|
17 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rebecca Schnall
Columbia University School of Nursing
Phone: 212-342-6886
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place