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Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms (VIP-HANA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03182738
Recruitment Status : Completed
First Posted : June 9, 2017
Results First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Rebecca Schnall, RN, MPH, PhD, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions HIV (Human Immunodeficiency Virus)
AIDS (Acquired Immunodeficiency Syndrome)
Interventions Behavioral: VIP app without HIV-related symptom strategies.
Behavioral: VIP app that delivers HIV-related symptom strategies.
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 50 50
Completed 41 45
Not Completed 9 5
Reason Not Completed
Lost to Follow-up             9             3
Pregnancy             0             1
Withdrawal by Subject             0             1
Arm/Group Title Intervention Control Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
  90.0%
44
  88.0%
89
  89.0%
>=65 years
5
  10.0%
6
  12.0%
11
  11.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
51.87  (10.41) 53.66  (11.21) 52.77  (10.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
17
  34.0%
27
  54.0%
44
  44.0%
Male
33
  66.0%
23
  46.0%
56
  56.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Hispanic or Latino
10
  20.0%
20
  40.0%
30
  30.0%
Not Hispanic or Latino
40
  80.0%
30
  60.0%
70
  70.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   2.0%
1
   1.0%
Black or African American
35
  70.0%
31
  62.0%
66
  66.0%
White
5
  10.0%
5
  10.0%
10
  10.0%
More than one race
2
   4.0%
1
   2.0%
3
   3.0%
Unknown or Not Reported
8
  16.0%
12
  24.0%
20
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 100 participants
50 50 100
1.Primary Outcome
Title Symptom Burden Score
Hide Description 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).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: score on a scale
Anxiety - period 1 Number Analyzed 50 participants 50 participants
1.08  (1.47) 1.06  (1.49)
Anxiety - period 2 Number Analyzed 42 participants 46 participants
0.83  (1.36) 0.71  (1.37)
Anxiety - period 3 Number Analyzed 40 participants 44 participants
0.80  (1.34) 0.78  (1.38)
Changes in appetite - period 1 Number Analyzed 50 participants 50 participants
0.85  (1.36) 0.70  (1.19)
Changes in appetite - period 2 Number Analyzed 42 participants 46 participants
0.79  (1.34) 0.67  (1.21)
Changes in appetite - period 3 Number Analyzed 40 participants 44 participants
0.76  (1.36) 0.55  (1.15)
Clumsiness or difficulty with balance - period 1 Number Analyzed 50 participants 50 participants
0.88  (1.49) 0.82  (1.39)
Clumsiness or difficulty with balance - period 2 Number Analyzed 42 participants 46 participants
0.83  (1.41) 0.66  (1.28)
Clumsiness or difficulty with balance - period 3 Number Analyzed 40 participants 44 participants
0.94  (1.49) 0.58  (1.25)
Difficulty concentrating - period 1 Number Analyzed 50 participants 50 participants
0.76  (1.32) 1.14  (1.50)
Difficulty concentrating - period 2 Number Analyzed 42 participants 46 participants
0.68  (1.29) 0.82  (1.37)
Difficulty concentrating - period 3 Number Analyzed 40 participants 44 participants
0.70  (1.31) 0.83  (1.39)
Constipation, gas, or bloating - period 1 Number Analyzed 50 participants 50 participants
1.28  (1.53) 1.21  (1.47)
Constipation, gas, or bloating - period 2 Number Analyzed 42 participants 46 participants
1.16  (1.57) 1.11  (1.51)
Constipation, gas, or bloating - period 3 Number Analyzed 40 participants 44 participants
1.12  (1.53) 0.93  (1.46)
Cough - period 1 Number Analyzed 50 participants 50 participants
0.77  (1.35) 0.90  (1.36)
Cough - period 2 Number Analyzed 42 participants 46 participants
0.72  (1.32) 0.76  (1.32)
Cough - period 3 Number Analyzed 40 participants 44 participants
0.76  (1.32) 0.74  (1.29)
Depression - period 1 Number Analyzed 50 participants 50 participants
1.36  (1.48) 1.36  (1.62)
Depression - period 2 Number Analyzed 42 participants 46 participants
1.33  (1.58) 1.00  (1.51)
Depression - period 3 Number Analyzed 40 participants 44 participants
1.32  (1.56) 0.91  (1.46)
Decreased sex drive - period 1 Number Analyzed 50 participants 50 participants
0.98  (1.49) 1.09  (1.49)
Decreased sex drive - period 2 Number Analyzed 42 participants 46 participants
0.85  (1.42) 0.68  (1.32)
Decreased sex drive - period 3 Number Analyzed 40 participants 44 participants
0.85  (1.41) 0.58  (1.28)
Diarrhea- period 1 Number Analyzed 50 participants 50 participants
0.81  (1.36) 0.62  (1.19)
Diarrhea - period 2 Number Analyzed 42 participants 46 participants
0.63  (1.29) 0.52  (1.18)
Diarrhea - period 3 Number Analyzed 40 participants 44 participants
0.62  (1.28) 0.37  (0.99)
Difficulty remembering - period 1 Number Analyzed 50 participants 50 participants
1.01  (1.45) 1.15  (1.53)
Difficulty remembering - period 2 Number Analyzed 42 participants 46 participants
0.92  (1.40) 1.08  (1.51)
Difficulty remembering - period 3 Number Analyzed 40 participants 44 participants
0.83  (1.36) 0.97  (1.44)
Lightheadedness or dizziness - period 1 Number Analyzed 50 participants 50 participants
0.83  (1.39) 0.66  (1.22)
Lightheadedness or dizziness - period 2 Number Analyzed 42 participants 46 participants
0.76  (1.35) 0.45  (1.07)
Lightheadedness or dizziness - period 3 Number Analyzed 40 participants 44 participants
0.82  (1.43) 0.32  (0.91)
Dry eyes - period 1 Number Analyzed 50 participants 50 participants
0.78  (1.30) 0.63  (1.17)
Dry eyes - period 2 Number Analyzed 42 participants 46 participants
0.63  (1.22) 0.64  (1.18)
Dry eyes - period 3 Number Analyzed 40 participants 44 participants
0.53  (1.15) 0.57  (1.06)
Thirst or dry mouth - period 1 Number Analyzed 50 participants 50 participants
1.35  (1.53) 1.13  (1.41)
Thirst or dry mouth - period 2 Number Analyzed 42 participants 46 participants
0.98  (1.41) 0.96  (1.40)
Thirst or dry mouth - period 3 Number Analyzed 40 participants 44 participants
0.97  (1.40) 0.97  (1.39)
Difficulty falling asleep - period 1 Number Analyzed 50 participants 50 participants
1.41  (1.63) 1.52  (1.69)
Difficulty falling asleep - period 2 Number Analyzed 42 participants 46 participants
1.27  (1.68) 1.21  (1.66)
Difficulty falling asleep - period 3 Number Analyzed 40 participants 44 participants
1.47  (1.74) 1.28  (1.68)
Fatigue - period 1 Number Analyzed 50 participants 50 participants
1.83  (1.53) 1.73  (1.52)
Fatigue - period 2 Number Analyzed 42 participants 46 participants
1.41  (1.60) 1.32  (1.51)
Fatigue - period 3 Number Analyzed 40 participants 44 participants
1.31  (1.53) 1.07  (1.40)
Fever, night sweats, or chills - period 1 Number Analyzed 50 participants 50 participants
0.72  (1.27) 0.77  (1.40)
Fever, night sweats, or chills - period 2 Number Analyzed 42 participants 46 participants
0.65  (1.28) 0.63  (1.28)
Fever, night sweats, or chills - period 3 Number Analyzed 40 participants 44 participants
0.70  (1.30) 0.60  (1.22)
Heartburn - period 1 Number Analyzed 50 participants 50 participants
0.96  (1.42) 0.81  (1.44)
Heartburn - period 2 Number Analyzed 42 participants 46 participants
0.79  (1.34) 0.70  (1.40)
Heartburn - period 3 Number Analyzed 40 participants 44 participants
0.84  (1.43) 0.55  (1.27)
Problems achieving an erection - period 1 Number Analyzed 50 participants 50 participants
0.72  (1.37) 0.23  (0.83)
Problems achieving an erection - period 2 Number Analyzed 42 participants 46 participants
0.59  (1.25) 0.24  (0.88)
Problems achieving an erection - period 3 Number Analyzed 40 participants 44 participants
0.62  (1.30) 0.23  (0.87)
Muscle aches or pain - period 1 Number Analyzed 50 participants 50 participants
2.17  (1.54) 2.12  (1.59)
Muscle aches or pain - period 2 Number Analyzed 42 participants 46 participants
1.86  (1.59) 1.74  (1.62)
Muscle aches or pain - period 3 Number Analyzed 40 participants 44 participants
1.78  (1.66) 1.79  (1.59)
Neuropathy - period 1 Number Analyzed 50 participants 50 participants
1.94  (1.65) 1.67  (1.63)
Neuropathy - period 2 Number Analyzed 42 participants 46 participants
1.77  (1.68) 1.66  (1.63)
Neuropathy - period 3 Number Analyzed 40 participants 44 participants
1.86  (1.64) 1.56  (1.63)
Pain or discomfort during sex - period 1 Number Analyzed 50 participants 50 participants
0.27  (0.87) 0.21  (0.76)
Pain or discomfort during sex - period 2 Number Analyzed 42 participants 46 participants
0.36  (1.06) 0.18  (0.74)
Pain or discomfort during sex - period 3 Number Analyzed 40 participants 44 participants
0.38  (1.04) 0.12  (0.60)
Ringing in ears or noise intolerance - period 1 Number Analyzed 50 participants 50 participants
0.73  (1.34) 0.61  (1.26)
Ringing in ears or noise intolerance - period 2 Number Analyzed 42 participants 46 participants
0.58  (1.12) 0.67  (1.31)
Ringing in ears or noise intolerance - period 3 Number Analyzed 40 participants 44 participants
0.61  (1.30) 0.60  (1.19)
Shortness of breath - period 1 Number Analyzed 50 participants 50 participants
0.86  (1.37) 0.94  (1.41)
Shortness of breath - period 2 Number Analyzed 42 participants 46 participants
1.00  (1.48) 0.81  (1.39)
Shortness of breath - period 3 Number Analyzed 40 participants 44 participants
0.73  (1.29) 0.72  (1.30)
Speech difficulties - period 1 Number Analyzed 50 participants 50 participants
0.27  (0.87) 0.34  (0.97)
Speech difficulties - period 2 Number Analyzed 42 participants 46 participants
0.34  (0.95) 0.25  (0.82)
Speech difficulties - period 3 Number Analyzed 40 participants 44 participants
0.42  (1.06) 0.21  (0.73)
Difficulty staying asleep - period 1 Number Analyzed 50 participants 50 participants
1.44  (1.61) 1.48  (1.66)
Difficulty staying asleep - period 2 Number Analyzed 42 participants 46 participants
1.49  (1.73) 1.19  (1.61)
Difficulty staying asleep - period 3 Number Analyzed 40 participants 44 participants
1.53  (1.69) 1.22  (1.64)
Difficulty with urination - period 1 Number Analyzed 50 participants 50 participants
0.45  (1.09) 0.32  (0.96)
Difficulty with urination - period 2 Number Analyzed 42 participants 46 participants
0.55  (1.19) 0.28  (0.89)
Difficulty with urination - period 3 Number Analyzed 40 participants 44 participants
0.48  (1.05) 0.30  (0.91)
Nausea or vomiting - period 1 Number Analyzed 50 participants 50 participants
0.56  (1.16) 0.27  (0.80)
Nausea or vomiting - period 2 Number Analyzed 42 participants 46 participants
0.46  (1.08) 0.34  (0.95)
Nausea or vomiting - period 3 Number Analyzed 40 participants 44 participants
0.41  (1.02) 0.19  (0.69)
Unplanned changes in weight - period 1 Number Analyzed 50 participants 50 participants
0.71  (1.39) 0.90  (1.52)
Unplanned changes in weight - period 2 Number Analyzed 42 participants 46 participants
0.41  (1.02) 0.19  (0.69)
Unplanned changes in weight - period 3 Number Analyzed 40 participants 44 participants
0.73  (1.38) 0.57  (1.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "neuropathy" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "neuropathy" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.02
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.32
Estimation Comments

The parameter was estimated using a difference in change in "neuropathy" score from period 1 to period 2 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "problems maintaining an erection" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "problems maintaining an erection" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.11
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.29
Estimation Comments

The parameter was estimated using a difference in change in "problems maintaining an erection" score from period 1 to period 2 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "dry mouth" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "dry mouth" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.02
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.29
Estimation Comments

The parameter was estimated using a difference in change in "dry mouth" score from period 1 to period 2 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "ringing in ear" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "ringing in ear" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.01
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.29
Estimation Comments

The parameter was estimated using a difference in change in "ringing in ear" score from period 1 to period 2 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "vomit" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "vomit" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.01
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.28
Estimation Comments

The parameter was estimated using a difference in change in "vomit" score from period 1 to period 2 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "dry eyes" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "dry eyes" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.02
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.24
Estimation Comments

The parameter was estimated using a difference in change in "dry eyes" score from period 1 to period 2 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "heartburn" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "heartburn" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.11
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.19
Estimation Comments

The parameter was estimated using a difference in change in "heartburn" score from period 1 to period 2 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "diarrhea" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "diarrhea" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.21
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.16
Estimation Comments

The parameter was estimated using a difference in change in "diarrhea" score from period 1 to period 2 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "constipation" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "constipation" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.33
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.14
Estimation Comments

The parameter was estimated using a difference in change in "constipation" score from period 1 to period 2 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "appetite change" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "appetite change" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.46
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.10
Estimation Comments

The parameter was estimated using a difference in change in "appetite change" score from period 1 to period 2 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "difficulty remembering" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "difficulty remembering" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.46
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.10
Estimation Comments

The parameter was estimated using a difference in change in "difficulty remembering" score from period 1 to period 2 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "fatigue" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "fatigue" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.58
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.07
Estimation Comments

The parameter was estimated using a difference in change in "fatigue" score from period 1 to period 2 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "cough" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "cough" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.92
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.01
Estimation Comments The parameter was estimated using a difference in change in "cough" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "urination" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "urination" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.84
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.02
Estimation Comments The parameter was estimated using a difference in change in "urination" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "clumsy" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "clumsy" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.83
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.03
Estimation Comments The parameter was estimated using a difference in change in "clumsy" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "fever" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "fever" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.72
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.04
Estimation Comments The parameter was estimated using a difference in change in "fever" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "pain during sex" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "pain during sex" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.48
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.06
Estimation Comments The parameter was estimated using a difference in change in "pain during sex" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "dizziness" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "dizziness" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.54
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.08
Estimation Comments The parameter was estimated using a difference in change in "dizziness" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "muscle aches" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "muscle aches" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.56
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.09
Estimation Comments The parameter was estimated using a difference in change in "muscle aches" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "speech difficulties" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "speech difficulties" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.22
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.10
Estimation Comments The parameter was estimated using a difference in change in "speech difficulties" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "decreased sex drive" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "decreased sex drive" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.40
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.11
Estimation Comments The parameter was estimated using a difference in change in "decreased sex drive" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "anxiety" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "anxiety" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.35
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.13
Estimation Comments The parameter was estimated using a difference in change in "anxiety" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "difficulty concentrating" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "difficulty concentrating" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.11
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.17
Estimation Comments The parameter was estimated using a difference in change in "difficulty concentrating" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "shortness of breath" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "shortness of breath" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.11
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.20
Estimation Comments The parameter was estimated using a difference in change in "shortness of breath" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "difficulty falling asleep" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "difficulty falling asleep" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.15
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.20
Estimation Comments The parameter was estimated using a difference in change in "difficulty falling asleep" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "unplanned changes in weight" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "unplanned changes in weight" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.08
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.22
Estimation Comments The parameter was estimated using a difference in change in "unplanned changes in weight" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "depression" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "depression" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.02
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.34
Estimation Comments The parameter was estimated using a difference in change in "depression" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "difficulty staying asleep" score from period 1 to period 2 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "difficulty staying asleep" score from period 1 to period 2 between the two arms.
Statistical Test of Hypothesis P-Value 0.01
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.36
Estimation Comments The parameter was estimated using a difference in change in "difficulty staying asleep" score from period 1 to period 2 between the two arms.
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "dry mouth" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "dry mouth" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.08
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.27
Estimation Comments

The parameter was estimated using a difference in change in "dry mouth" score from period 1 to period 3 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "ringing in ear" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "ringing in ear" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.08
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.24
Estimation Comments

The parameter was estimated using a difference in change in "ringing in ear" score from period 1 to period 3 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "dry eyes" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "dry eyes" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.08
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.24
Estimation Comments

The parameter was estimated using a difference in change in "dry eyes" score from period 1 to period 3 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "maintaining an erection" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "maintaining an erection" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.71
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.13
Estimation Comments

The parameter was estimated using a difference in change in "maintaining an erection" score from period 1 to period 3 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "vomit" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "vomit" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.41
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.11
Estimation Comments

The parameter was estimated using a difference in change in "vomit" score from period 1 to period 3 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "neuropathy" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "neuropathy" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.84
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.08
Estimation Comments

The parameter was estimated using a difference in change in "neuropathy" score from period 1 to period 3 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "urination" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "urination" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.71
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.07
Estimation Comments

The parameter was estimated using a difference in change in "urination" score from period 1 to period 3 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "appetite change" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "appetite change" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.88
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.05
Estimation Comments

The parameter was estimated using a difference in change in "appetite change" score from period 1 to period 3 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "shortness of breath" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "shortness of breath" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.93
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.03
Estimation Comments

The parameter was estimated using a difference in change in "shortness of breath" score from period 1 to period 3 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "difficulty remembering" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "difficulty remembering" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.93
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.03
Estimation Comments

The parameter was estimated using a difference in change in "difficulty remembering" score from period 1 to period 3 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "muscle aches" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "muscle aches" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.94
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.03
Estimation Comments

The parameter was estimated using a difference in change in "muscle aches" score from period 1 to period 3 between the two arms.

Negative estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "diarrhea" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "diarrhea" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.97
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.004
Estimation Comments The parameter was estimated using a difference in change in "diarrhea" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "fatigue" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "fatigue" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.95
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.01
Estimation Comments The parameter was estimated using a difference in change in "fatigue" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "anxiety" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "anxiety" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.95
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.01
Estimation Comments The parameter was estimated using a difference in change in "anxiety" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "constipation" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "constipation" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.93
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.03
Estimation Comments The parameter was estimated using a difference in change in "constipation" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "fever" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "fever" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.84
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.06
Estimation Comments The parameter was estimated using a difference in change in "fever" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "cough" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "cough" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.84
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.07
Estimation Comments The parameter was estimated using a difference in change in "cough" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "heartburn" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "heartburn" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.54
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.11
Estimation Comments The parameter was estimated using a difference in change in "heartburn" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "pain during sex" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "pain during sex" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.13
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.14
Estimation Comments The parameter was estimated using a difference in change in "pain during sex" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "clumsy" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "clumsy" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.18
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.18
Estimation Comments The parameter was estimated using a difference in change in "clumsy" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "difficulty falling asleep" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "difficulty falling asleep" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.29
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.19
Estimation Comments The parameter was estimated using a difference in change in "difficulty falling asleep" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "difficulty concentrating" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "difficulty concentrating" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.12
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.20
Estimation Comments The parameter was estimated using a difference in change in "difficulty concentrating" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "decreased sex drive" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "decreased sex drive" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.10
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.24
Estimation Comments The parameter was estimated using a difference in change in "decreased sex drive" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "speech difficulties" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "speech difficulties" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.01
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.25
Estimation Comments The parameter was estimated using a difference in change in "speech difficulties" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "unplanned changes in weight" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "unplanned changes in weight" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.08
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.26
Estimation Comments The parameter was estimated using a difference in change in "unplanned changes in weight" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "dizziness" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "dizziness" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.08
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.27
Estimation Comments The parameter was estimated using a difference in change in "dizziness" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "difficulty staying asleep" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "difficulty staying asleep" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.09
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.27
Estimation Comments The parameter was estimated using a difference in change in "difficulty staying asleep" score from period 1 to period 3 between the two arms.
Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in mean "depression" score from period 1 to period 3 between the two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean "depression" score from period 1 to period 3 between the two arms.
Statistical Test of Hypothesis P-Value 0.05
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.38
Estimation Comments The parameter was estimated using a difference in change in "depression" score from period 1 to period 3 between the two arms.
2.Secondary Outcome
Title Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Hide Description 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.
Time Frame Baseline, 3 months, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: T-Score
Physical Function at Baseline Number Analyzed 50 participants 49 participants
43.79  (9.28) 41.43  (8.18)
Physical Function at 3 months Number Analyzed 43 participants 46 participants
45.37  (9.09) 41.98  (8.46)
Physical Function at 6 months Number Analyzed 41 participants 45 participants
44.35  (9.29) 41.63  (7.43)
Anxiety at Baseline Number Analyzed 50 participants 50 participants
56.28  (9.45) 55.56  (9.67)
Anxiety at 3 months Number Analyzed 43 participants 46 participants
54.88  (8.29) 55.03  (9.02)
Anxiety at 6 months Number Analyzed 41 participants 45 participants
44.35  (9.29) 53.32  (9.46)
Depression at Baseline Number Analyzed 50 participants 50 participants
53.58  (8.56) 53.32  (10.11)
Depression at 3 months Number Analyzed 43 participants 46 participants
52.12  (8.64) 52.52  (10.02)
Depression at 6 months Number Analyzed 41 participants 44 participants
52.62  (7.89) 52.34  (8.54)
Fatigue at Baseline Number Analyzed 50 participants 50 participants
53.81  (9.40) 52.99  (9.00)
Fatigue at 3 months Number Analyzed 43 participants 46 participants
51.75  (9.93) 52.63  (10.21)
Fatigue at 6 months Number Analyzed 41 participants 45 participants
54.23  (9.28) 51.46  (8.45)
Sleep Disturbance at Baseline Number Analyzed 50 participants 50 participants
54.98  (8.79) 54.66  (8.63)
Sleep Disturbance at 3 months Number Analyzed 43 participants 46 participants
52.69  (8.95) 51.52  (9.58)
Sleep Disturbance at 6 months Number Analyzed 41 participants 45 participants
52.54  (8.28) 50.29  (9.30)
Satisfaction with Social Role at Baseline Number Analyzed 50 participants 50 participants
47.31  (9.97) 45.05  (8.64)
Satisfaction with Social Role at 3 months Number Analyzed 43 participants 46 participants
48.00  (9.88) 45.99  (9.52)
Satisfaction with Social Role at 6 months Number Analyzed 41 participants 45 participants
48.47  (8.47) 46.15  (8.10)
Pain Interference at Baseline Number Analyzed 50 participants 50 participants
59.12  (7.70) 59.56  (8.59)
Pain Interference at 3 months Number Analyzed 43 participants 46 participants
56.56  (10.73) 57.52  (9.45)
Pain Interference at 6 months Number Analyzed 41 participants 45 participants
57.43  (9.53) 56.94  (7.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 3 months between two arms.
Statistical Test of Hypothesis P-Value 0.83
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -2.09
Estimation Comments The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 3 months between two arms.
Statistical Test of Hypothesis P-Value 0.83
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.94
Estimation Comments The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 3 months between two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 3 months between two arms.
Statistical Test of Hypothesis P-Value 0.83
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.79
Estimation Comments The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 3 months between two arms
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 3 months between two arms.
Statistical Test of Hypothesis P-Value 0.83
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.78
Estimation Comments The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.
Statistical Test of Hypothesis P-Value 0.98
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.04
Estimation Comments

The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.

Positive estimation parameter value indicates intervention arm better than control arm

Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 3 months between two arms.
Statistical Test of Hypothesis P-Value 0.83
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.55
Estimation Comments

The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.

Positive estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.
Statistical Test of Hypothesis P-Value 0.83
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.84
Estimation Comments

The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.

Positive estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 6 months between two arms.
Statistical Test of Hypothesis P-Value 0.96
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value -0.43
Estimation Comments The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 6 months between two arms.
Statistical Test of Hypothesis P-Value 0.96
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.07
Estimation Comments

The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.

Positive estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.
Statistical Test of Hypothesis P-Value 0.96
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.23
Estimation Comments [Not Specified]
Other Statistical Analysis

The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.

Positive estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 6 months between two arms.
Statistical Test of Hypothesis P-Value 0.96
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.77
Estimation Comments

The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.

Positive estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 6 months between two arms.
Statistical Test of Hypothesis P-Value 0.96
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 1.05
Estimation Comments

The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.

Positive estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 6 months between two arms.
Statistical Test of Hypothesis P-Value 0.96
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 1.50
Estimation Comments

The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.

Positive estimation parameter value indicates intervention arm better than control arm.

Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.
Type of Statistical Test Superiority
Comments Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.
Statistical Test of Hypothesis P-Value 0.64
Comments Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).
Method Linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 2.04
Estimation Comments

The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.

Positive estimation parameter value indicates intervention arm better than control arm.

3.Other Pre-specified Outcome
Title Change in Score on SF-12
Hide Description 12-Item Medical Outcomes Study Short Form (SF-12) is a health survey to measure health-related quality of life.
Time Frame 3 months and 6 months
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Score on Engagement With Health Care Provider Scale
Hide Description 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.
Time Frame Baseline, 3 months, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: score on a scale
Score at Baseline Number Analyzed 50 participants 47 participants
17.78  (8.07) 17.13  (6.52)
Score at 3-months Number Analyzed 42 participants 43 participants
20.17  (8.68) 17.33  (5.43)
Score at 6-months Number Analyzed 39 participants 44 participants
18.05  (7.72) 18.70  (8.02)
5.Other Pre-specified Outcome
Title Score of the VAS
Hide Description 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.
Time Frame Baseline, 3 months, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: percentage of medication
Baseline VAS Score Number Analyzed 45 participants 48 participants
88.49  (17.34) 83.91  (26.45)
3-month VAS Score Number Analyzed 38 participants 44 participants
86.89  (24.43) 87.30  (20.99)
6-month VAS score Number Analyzed 40 participants 42 participants
86.88  (21.49) 88.63  (20.45)
6.Other Pre-specified Outcome
Title Score on Fried's Frailty Phenotype
Hide Description 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.
Time Frame Baseline, 3 months, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Frail at Baseline Number Analyzed 50 participants 50 participants
25
  50.0%
26
  52.0%
Frail at 3 months Number Analyzed 43 participants 46 participants
19
  44.2%
21
  45.7%
Frail at 6 months Number Analyzed 41 participants 45 participants
17
  41.5%
17
  37.8%
Time Frame Adverse event data was collected over a 1 year time period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Control
Hide Arm/Group Description

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

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

All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rebecca Schnall
Organization: Columbia University School of Nursing
Phone: 212-342-6886
EMail: rb897@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Rebecca Schnall, RN, MPH, PhD, Columbia University
ClinicalTrials.gov Identifier: NCT03182738    
Other Study ID Numbers: AAAP5958
R01NR015737-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 11, 2017
First Posted: June 9, 2017
Results First Submitted: October 27, 2019
Results First Posted: December 13, 2019
Last Update Posted: December 13, 2019