18 and older, any sex, with HIV (Human Immunodeficiency Virus) or AIDS (Acquired Immunodeficiency Syndrome). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Symptom Burden ScorePrimary· 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)
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).
Anxiety - period 1
Group
Value
95% CI
Intervention
1.08
± 1.47
Control
1.06
± 1.49
Anxiety - period 2
Group
Value
95% CI
Intervention
0.83
± 1.36
Control
0.71
± 1.37
Anxiety - period 3
Group
Value
95% CI
Intervention
0.80
± 1.34
Control
0.78
± 1.38
Changes in appetite - period 1
Group
Value
95% CI
Intervention
0.85
± 1.36
Control
0.70
± 1.19
Changes in appetite - period 2
Group
Value
95% CI
Intervention
0.79
± 1.34
Control
0.67
± 1.21
Changes in appetite - period 3
Group
Value
95% CI
Intervention
0.76
± 1.36
Control
0.55
± 1.15
Clumsiness or difficulty with balance - period 1
Group
Value
95% CI
Intervention
0.88
± 1.49
Control
0.82
± 1.39
Clumsiness or difficulty with balance - period 2
Group
Value
95% CI
Intervention
0.83
± 1.41
Control
0.66
± 1.28
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29Secondary· Baseline, 3 months, and 6 months
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
Physical Function at Baseline
Group
Value
95% CI
Intervention
43.79
± 9.28
Control
41.43
± 8.18
Physical Function at 3 months
Group
Value
95% CI
Intervention
45.37
± 9.09
Control
41.98
± 8.46
Physical Function at 6 months
Group
Value
95% CI
Intervention
44.35
± 9.29
Control
41.63
± 7.43
Anxiety at Baseline
Group
Value
95% CI
Intervention
56.28
± 9.45
Control
55.56
± 9.67
Anxiety at 3 months
Group
Value
95% CI
Intervention
54.88
± 8.29
Control
55.03
± 9.02
Anxiety at 6 months
Group
Value
95% CI
Intervention
44.35
± 9.29
Control
53.32
± 9.46
Depression at Baseline
Group
Value
95% CI
Intervention
53.58
± 8.56
Control
53.32
± 10.11
Depression at 3 months
Group
Value
95% CI
Intervention
52.12
± 8.64
Control
52.52
± 10.02
Score on Engagement With Health Care Provider ScaleSecondary· Baseline, 3 months, and 6 months
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.
Score at Baseline
Group
Value
95% CI
Intervention
17.78
± 8.07
Control
17.13
± 6.52
Score at 3-months
Group
Value
95% CI
Intervention
20.17
± 8.68
Control
17.33
± 5.43
Score at 6-months
Group
Value
95% CI
Intervention
18.05
± 7.72
Control
18.70
± 8.02
Score of the VASSecondary· Baseline, 3 months, and 6 months
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.
Baseline VAS Score
Group
Value
95% CI
Intervention
88.49
± 17.34
Control
83.91
± 26.45
3-month VAS Score
Group
Value
95% CI
Intervention
86.89
± 24.43
Control
87.30
± 20.99
6-month VAS score
Group
Value
95% CI
Intervention
86.88
± 21.49
Control
88.63
± 20.45
Score on Fried's Frailty PhenotypeSecondary· Baseline, 3 months, and 6 months
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.
Frail at Baseline
Group
Value
95% CI
Intervention
25
Control
26
Frail at 3 months
Group
Value
95% CI
Intervention
19
Control
21
Frail at 6 months
Group
Value
95% CI
Intervention
17
Control
17
Sponsor's own description
The purpose of this study is to use technology to improve symptom status and ultimately improve patient centered outcomes in people living with HIV/AIDS (PLWHA). The primary purpose of the intervention (VIP-HANA) is to improve symptom status. The investigators hypothesize that VIP-HANA will improve symptom frequency and intensity.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Columbia University
Last refreshed: 13 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03182738.