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

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ClinicalTrials.gov Identifier: NCT03182738

Recruitment Status : Completed

First Posted : June 9, 2017

Results First Posted : December 13, 2019

Last Update Posted : December 13, 2019

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Intervention	Control
Arm/Group Description	VIP app that delivers HIV-related s...	VIP app without HIV-related symptom...
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

Baseline Characteristics

Arm/Group Title		Intervention	Control	Total
Arm/Group Description		VIP app that delivers HIV-related s...	VIP app without HIV-related symptom...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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
United States		50	50	100

Outcome Measures

1.Primary Outcome


Title	Symptom Burden Score
Description	The Symptom Burden Score is an expanded version of the 20-item HIV sym...
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)

Outcome Measure Data

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
Arm/Group Description:		VIP app that delivers HIV-related s...	VIP app without HIV-related symptom...
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
Anxiety - period 1		1.08 (1.47)	1.06 (1.49)
Anxiety - period 2	Number Analyzed	42 participants	46 participants
Anxiety - period 2		0.83 (1.36)	0.71 (1.37)
Anxiety - period 3	Number Analyzed	40 participants	44 participants
Anxiety - period 3		0.80 (1.34)	0.78 (1.38)
Changes in appetite - period 1	Number Analyzed	50 participants	50 participants
Changes in appetite - period 1		0.85 (1.36)	0.70 (1.19)
Changes in appetite - period 2	Number Analyzed	42 participants	46 participants
Changes in appetite - period 2		0.79 (1.34)	0.67 (1.21)
Changes in appetite - period 3	Number Analyzed	40 participants	44 participants
Changes in appetite - period 3		0.76 (1.36)	0.55 (1.15)
Clumsiness or difficulty with balance - period 1	Number Analyzed	50 participants	50 participants
Clumsiness or difficulty with balance - period 1		0.88 (1.49)	0.82 (1.39)
Clumsiness or difficulty with balance - period 2	Number Analyzed	42 participants	46 participants
Clumsiness or difficulty with balance - period 2		0.83 (1.41)	0.66 (1.28)
Clumsiness or difficulty with balance - period 3	Number Analyzed	40 participants	44 participants
Clumsiness or difficulty with balance - period 3		0.94 (1.49)	0.58 (1.25)
Difficulty concentrating - period 1	Number Analyzed	50 participants	50 participants
Difficulty concentrating - period 1		0.76 (1.32)	1.14 (1.50)
Difficulty concentrating - period 2	Number Analyzed	42 participants	46 participants
Difficulty concentrating - period 2		0.68 (1.29)	0.82 (1.37)
Difficulty concentrating - period 3	Number Analyzed	40 participants	44 participants
Difficulty concentrating - period 3		0.70 (1.31)	0.83 (1.39)
Constipation, gas, or bloating - period 1	Number Analyzed	50 participants	50 participants
Constipation, gas, or bloating - period 1		1.28 (1.53)	1.21 (1.47)
Constipation, gas, or bloating - period 2	Number Analyzed	42 participants	46 participants
Constipation, gas, or bloating - period 2		1.16 (1.57)	1.11 (1.51)
Constipation, gas, or bloating - period 3	Number Analyzed	40 participants	44 participants
Constipation, gas, or bloating - period 3		1.12 (1.53)	0.93 (1.46)
Cough - period 1	Number Analyzed	50 participants	50 participants
Cough - period 1		0.77 (1.35)	0.90 (1.36)
Cough - period 2	Number Analyzed	42 participants	46 participants
Cough - period 2		0.72 (1.32)	0.76 (1.32)
Cough - period 3	Number Analyzed	40 participants	44 participants
Cough - period 3		0.76 (1.32)	0.74 (1.29)
Depression - period 1	Number Analyzed	50 participants	50 participants
Depression - period 1		1.36 (1.48)	1.36 (1.62)
Depression - period 2	Number Analyzed	42 participants	46 participants
Depression - period 2		1.33 (1.58)	1.00 (1.51)
Depression - period 3	Number Analyzed	40 participants	44 participants
Depression - period 3		1.32 (1.56)	0.91 (1.46)
Decreased sex drive - period 1	Number Analyzed	50 participants	50 participants
Decreased sex drive - period 1		0.98 (1.49)	1.09 (1.49)
Decreased sex drive - period 2	Number Analyzed	42 participants	46 participants
Decreased sex drive - period 2		0.85 (1.42)	0.68 (1.32)
Decreased sex drive - period 3	Number Analyzed	40 participants	44 participants
Decreased sex drive - period 3		0.85 (1.41)	0.58 (1.28)
Diarrhea- period 1	Number Analyzed	50 participants	50 participants
Diarrhea- period 1		0.81 (1.36)	0.62 (1.19)
Diarrhea - period 2	Number Analyzed	42 participants	46 participants
Diarrhea - period 2		0.63 (1.29)	0.52 (1.18)
Diarrhea - period 3	Number Analyzed	40 participants	44 participants
Diarrhea - period 3		0.62 (1.28)	0.37 (0.99)
Difficulty remembering - period 1	Number Analyzed	50 participants	50 participants
Difficulty remembering - period 1		1.01 (1.45)	1.15 (1.53)
Difficulty remembering - period 2	Number Analyzed	42 participants	46 participants
Difficulty remembering - period 2		0.92 (1.40)	1.08 (1.51)
Difficulty remembering - period 3	Number Analyzed	40 participants	44 participants
Difficulty remembering - period 3		0.83 (1.36)	0.97 (1.44)
Lightheadedness or dizziness - period 1	Number Analyzed	50 participants	50 participants
Lightheadedness or dizziness - period 1		0.83 (1.39)	0.66 (1.22)
Lightheadedness or dizziness - period 2	Number Analyzed	42 participants	46 participants
Lightheadedness or dizziness - period 2		0.76 (1.35)	0.45 (1.07)
Lightheadedness or dizziness - period 3	Number Analyzed	40 participants	44 participants
Lightheadedness or dizziness - period 3		0.82 (1.43)	0.32 (0.91)
Dry eyes - period 1	Number Analyzed	50 participants	50 participants
Dry eyes - period 1		0.78 (1.30)	0.63 (1.17)
Dry eyes - period 2	Number Analyzed	42 participants	46 participants
Dry eyes - period 2		0.63 (1.22)	0.64 (1.18)
Dry eyes - period 3	Number Analyzed	40 participants	44 participants
Dry eyes - period 3		0.53 (1.15)	0.57 (1.06)
Thirst or dry mouth - period 1	Number Analyzed	50 participants	50 participants
Thirst or dry mouth - period 1		1.35 (1.53)	1.13 (1.41)
Thirst or dry mouth - period 2	Number Analyzed	42 participants	46 participants
Thirst or dry mouth - period 2		0.98 (1.41)	0.96 (1.40)
Thirst or dry mouth - period 3	Number Analyzed	40 participants	44 participants
Thirst or dry mouth - period 3		0.97 (1.40)	0.97 (1.39)
Difficulty falling asleep - period 1	Number Analyzed	50 participants	50 participants
Difficulty falling asleep - period 1		1.41 (1.63)	1.52 (1.69)
Difficulty falling asleep - period 2	Number Analyzed	42 participants	46 participants
Difficulty falling asleep - period 2		1.27 (1.68)	1.21 (1.66)
Difficulty falling asleep - period 3	Number Analyzed	40 participants	44 participants
Difficulty falling asleep - period 3		1.47 (1.74)	1.28 (1.68)
Fatigue - period 1	Number Analyzed	50 participants	50 participants
Fatigue - period 1		1.83 (1.53)	1.73 (1.52)
Fatigue - period 2	Number Analyzed	42 participants	46 participants
Fatigue - period 2		1.41 (1.60)	1.32 (1.51)
Fatigue - period 3	Number Analyzed	40 participants	44 participants
Fatigue - period 3		1.31 (1.53)	1.07 (1.40)
Fever, night sweats, or chills - period 1	Number Analyzed	50 participants	50 participants
Fever, night sweats, or chills - period 1		0.72 (1.27)	0.77 (1.40)
Fever, night sweats, or chills - period 2	Number Analyzed	42 participants	46 participants
Fever, night sweats, or chills - period 2		0.65 (1.28)	0.63 (1.28)
Fever, night sweats, or chills - period 3	Number Analyzed	40 participants	44 participants
Fever, night sweats, or chills - period 3		0.70 (1.30)	0.60 (1.22)
Heartburn - period 1	Number Analyzed	50 participants	50 participants
Heartburn - period 1		0.96 (1.42)	0.81 (1.44)
Heartburn - period 2	Number Analyzed	42 participants	46 participants
Heartburn - period 2		0.79 (1.34)	0.70 (1.40)
Heartburn - period 3	Number Analyzed	40 participants	44 participants
Heartburn - period 3		0.84 (1.43)	0.55 (1.27)
Problems achieving an erection - period 1	Number Analyzed	50 participants	50 participants
Problems achieving an erection - period 1		0.72 (1.37)	0.23 (0.83)
Problems achieving an erection - period 2	Number Analyzed	42 participants	46 participants
Problems achieving an erection - period 2		0.59 (1.25)	0.24 (0.88)
Problems achieving an erection - period 3	Number Analyzed	40 participants	44 participants
Problems achieving an erection - period 3		0.62 (1.30)	0.23 (0.87)
Muscle aches or pain - period 1	Number Analyzed	50 participants	50 participants
Muscle aches or pain - period 1		2.17 (1.54)	2.12 (1.59)
Muscle aches or pain - period 2	Number Analyzed	42 participants	46 participants
Muscle aches or pain - period 2		1.86 (1.59)	1.74 (1.62)
Muscle aches or pain - period 3	Number Analyzed	40 participants	44 participants
Muscle aches or pain - period 3		1.78 (1.66)	1.79 (1.59)
Neuropathy - period 1	Number Analyzed	50 participants	50 participants
Neuropathy - period 1		1.94 (1.65)	1.67 (1.63)
Neuropathy - period 2	Number Analyzed	42 participants	46 participants
Neuropathy - period 2		1.77 (1.68)	1.66 (1.63)
Neuropathy - period 3	Number Analyzed	40 participants	44 participants
Neuropathy - period 3		1.86 (1.64)	1.56 (1.63)
Pain or discomfort during sex - period 1	Number Analyzed	50 participants	50 participants
Pain or discomfort during sex - period 1		0.27 (0.87)	0.21 (0.76)
Pain or discomfort during sex - period 2	Number Analyzed	42 participants	46 participants
Pain or discomfort during sex - period 2		0.36 (1.06)	0.18 (0.74)
Pain or discomfort during sex - period 3	Number Analyzed	40 participants	44 participants
Pain or discomfort during sex - period 3		0.38 (1.04)	0.12 (0.60)
Ringing in ears or noise intolerance - period 1	Number Analyzed	50 participants	50 participants
Ringing in ears or noise intolerance - period 1		0.73 (1.34)	0.61 (1.26)
Ringing in ears or noise intolerance - period 2	Number Analyzed	42 participants	46 participants
Ringing in ears or noise intolerance - period 2		0.58 (1.12)	0.67 (1.31)
Ringing in ears or noise intolerance - period 3	Number Analyzed	40 participants	44 participants
Ringing in ears or noise intolerance - period 3		0.61 (1.30)	0.60 (1.19)
Shortness of breath - period 1	Number Analyzed	50 participants	50 participants
Shortness of breath - period 1		0.86 (1.37)	0.94 (1.41)
Shortness of breath - period 2	Number Analyzed	42 participants	46 participants
Shortness of breath - period 2		1.00 (1.48)	0.81 (1.39)
Shortness of breath - period 3	Number Analyzed	40 participants	44 participants
Shortness of breath - period 3		0.73 (1.29)	0.72 (1.30)
Speech difficulties - period 1	Number Analyzed	50 participants	50 participants
Speech difficulties - period 1		0.27 (0.87)	0.34 (0.97)
Speech difficulties - period 2	Number Analyzed	42 participants	46 participants
Speech difficulties - period 2		0.34 (0.95)	0.25 (0.82)
Speech difficulties - period 3	Number Analyzed	40 participants	44 participants
Speech difficulties - period 3		0.42 (1.06)	0.21 (0.73)
Difficulty staying asleep - period 1	Number Analyzed	50 participants	50 participants
Difficulty staying asleep - period 1		1.44 (1.61)	1.48 (1.66)
Difficulty staying asleep - period 2	Number Analyzed	42 participants	46 participants
Difficulty staying asleep - period 2		1.49 (1.73)	1.19 (1.61)
Difficulty staying asleep - period 3	Number Analyzed	40 participants	44 participants
Difficulty staying asleep - period 3		1.53 (1.69)	1.22 (1.64)
Difficulty with urination - period 1	Number Analyzed	50 participants	50 participants
Difficulty with urination - period 1		0.45 (1.09)	0.32 (0.96)
Difficulty with urination - period 2	Number Analyzed	42 participants	46 participants
Difficulty with urination - period 2		0.55 (1.19)	0.28 (0.89)
Difficulty with urination - period 3	Number Analyzed	40 participants	44 participants
Difficulty with urination - period 3		0.48 (1.05)	0.30 (0.91)
Nausea or vomiting - period 1	Number Analyzed	50 participants	50 participants
Nausea or vomiting - period 1		0.56 (1.16)	0.27 (0.80)
Nausea or vomiting - period 2	Number Analyzed	42 participants	46 participants
Nausea or vomiting - period 2		0.46 (1.08)	0.34 (0.95)
Nausea or vomiting - period 3	Number Analyzed	40 participants	44 participants
Nausea or vomiting - period 3		0.41 (1.02)	0.19 (0.69)
Unplanned changes in weight - period 1	Number Analyzed	50 participants	50 participants
Unplanned changes in weight - period 1		0.71 (1.39)	0.90 (1.52)
Unplanned changes in weight - period 2	Number Analyzed	42 participants	46 participants
Unplanned changes in weight - period 2		0.41 (1.02)	0.19 (0.69)
Unplanned changes in weight - period 3	Number Analyzed	40 participants	44 participants
Unplanned changes in weight - period 3		0.73 (1.38)	0.57 (1.22)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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
Description	The PROMIS-29 includes seven health related quality of life domains (P...
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

Outcome Measure Data

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
Arm/Group Description:		VIP app that delivers HIV-related s...	VIP app without HIV-related symptom...
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
Physical Function at Baseline		43.79 (9.28)	41.43 (8.18)
Physical Function at 3 months	Number Analyzed	43 participants	46 participants
Physical Function at 3 months		45.37 (9.09)	41.98 (8.46)
Physical Function at 6 months	Number Analyzed	41 participants	45 participants
Physical Function at 6 months		44.35 (9.29)	41.63 (7.43)
Anxiety at Baseline	Number Analyzed	50 participants	50 participants
Anxiety at Baseline		56.28 (9.45)	55.56 (9.67)
Anxiety at 3 months	Number Analyzed	43 participants	46 participants
Anxiety at 3 months		54.88 (8.29)	55.03 (9.02)
Anxiety at 6 months	Number Analyzed	41 participants	45 participants
Anxiety at 6 months		44.35 (9.29)	53.32 (9.46)
Depression at Baseline	Number Analyzed	50 participants	50 participants
Depression at Baseline		53.58 (8.56)	53.32 (10.11)
Depression at 3 months	Number Analyzed	43 participants	46 participants
Depression at 3 months		52.12 (8.64)	52.52 (10.02)
Depression at 6 months	Number Analyzed	41 participants	44 participants
Depression at 6 months		52.62 (7.89)	52.34 (8.54)
Fatigue at Baseline	Number Analyzed	50 participants	50 participants
Fatigue at Baseline		53.81 (9.40)	52.99 (9.00)
Fatigue at 3 months	Number Analyzed	43 participants	46 participants
Fatigue at 3 months		51.75 (9.93)	52.63 (10.21)
Fatigue at 6 months	Number Analyzed	41 participants	45 participants
Fatigue at 6 months		54.23 (9.28)	51.46 (8.45)
Sleep Disturbance at Baseline	Number Analyzed	50 participants	50 participants
Sleep Disturbance at Baseline		54.98 (8.79)	54.66 (8.63)
Sleep Disturbance at 3 months	Number Analyzed	43 participants	46 participants
Sleep Disturbance at 3 months		52.69 (8.95)	51.52 (9.58)
Sleep Disturbance at 6 months	Number Analyzed	41 participants	45 participants
Sleep Disturbance at 6 months		52.54 (8.28)	50.29 (9.30)
Satisfaction with Social Role at Baseline	Number Analyzed	50 participants	50 participants
Satisfaction with Social Role at Baseline		47.31 (9.97)	45.05 (8.64)
Satisfaction with Social Role at 3 months	Number Analyzed	43 participants	46 participants
Satisfaction with Social Role at 3 months		48.00 (9.88)	45.99 (9.52)
Satisfaction with Social Role at 6 months	Number Analyzed	41 participants	45 participants
Satisfaction with Social Role at 6 months		48.47 (8.47)	46.15 (8.10)
Pain Interference at Baseline	Number Analyzed	50 participants	50 participants
Pain Interference at Baseline		59.12 (7.70)	59.56 (8.59)
Pain Interference at 3 months	Number Analyzed	43 participants	46 participants
Pain Interference at 3 months		56.56 (10.73)	57.52 (9.45)
Pain Interference at 6 months	Number Analyzed	41 participants	45 participants
Pain Interference at 6 months		57.43 (9.53)	56.94 (7.28)

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

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

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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
Description	12-Item Medical Outcomes Study Short Form (SF-12) is a health survey t...
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
Description	Engagement with Health Care Provide scale is a 13-item scale in which ...
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

Outcome Measure Data

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
Arm/Group Description:		VIP app that delivers HIV-related s...	VIP app without HIV-related symptom...
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
Score at Baseline		17.78 (8.07)	17.13 (6.52)
Score at 3-months	Number Analyzed	42 participants	43 participants
Score at 3-months		20.17 (8.68)	17.33 (5.43)
Score at 6-months	Number Analyzed	39 participants	44 participants
Score at 6-months		18.05 (7.72)	18.70 (8.02)

5.Other Pre-specified Outcome


Title	Score of the VAS
Description	The Visual Analogue Scale (VAS) measures adherence to antiretroviral t...
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

Outcome Measure Data

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
Arm/Group Description:		VIP app that delivers HIV-related s...	VIP app without HIV-related symptom...
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
Baseline VAS Score		88.49 (17.34)	83.91 (26.45)
3-month VAS Score	Number Analyzed	38 participants	44 participants
3-month VAS Score		86.89 (24.43)	87.30 (20.99)
6-month VAS score	Number Analyzed	40 participants	42 participants
6-month VAS score		86.88 (21.49)	88.63 (20.45)

6.Other Pre-specified Outcome


Title	Score on Fried's Frailty Phenotype
Description	Fried's frailty phenotype is a combination of five scores: weight loss...
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

Outcome Measure Data

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
Arm/Group Description:		VIP app that delivers HIV-related s...	VIP app without HIV-related symptom...
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
Frail at Baseline		25 50.0%	26 52.0%
Frail at 3 months	Number Analyzed	43 participants	46 participants
Frail at 3 months		19 44.2%	21 45.7%
Frail at 6 months	Number Analyzed	41 participants	45 participants
Frail at 6 months		17 41.5%	17 37.8%

Adverse Events

Time Frame	Adverse event data was collected over a 1 year time period.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	VIP app that delivers HIV-related s...	VIP app without HIV-related symptom...
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%)
Serious Adverse Events Serious Adverse Events
	Intervention	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/50 (0.00%)	0/50 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cho H, Porras T, Flynn G, Schnall R. Usability of a Consumer Health Informatics Tool Following Completion of a Clinical Trial: Focus Group Study. J Med Internet Res. 2020 Jun 15;22(6):e17708. doi: 10.2196/17708.

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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

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