Trial Outcomes & Findings for mVIP (Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV) (NCT NCT02897141)

Last Updated: 2019-03-26

Results Overview

Change in Symptom Status calculates the difference in symptom scores between the intervention and control groups at baseline versus follow-up after 12 weeks. Symptom scores were determined using the Revised Sign and Symptom Check-List for HIV (SSC-HIVrev), where participants who reported experiencing any one of the 13 symptoms in the past 7 days were asked how much it bothered them (a little bit, somewhat, quite a bit, or very much). Instances where the symptom did not bother the individual were coded as "0" whereas instances where the symptom bothered the individual any amount were recoded as "1". The overall difference between groups at baseline and after 12 weeks ("difference of differences") falls within a range of -1 to 1, where lower numbers indicate the symptom bothered the person less, while higher numbers indicate it bothered them more. With the Difference Between Groups, a more negative score (closer to -1) represents a better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2019-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	mVIP Group This group will receive targeted symptom strategies from the University of California, San Francisco (UCSF) symptom management manual based on the symptoms that they report. Health Management App with symptom strategies: The mVIP group will receive a Health Management App with symptom strategies. A mobile app which includes symptom strategies from the UCSF symptom management manual.	Attention Control Group This group will have the Health Management App without symptom strategies pre-loaded on their smartphones. Health Management App without symptom strategies: The attention control group will receive the Health Management App preloaded on their smartphones without symptoms strategies
Overall Study STARTED	40	40
Overall Study COMPLETED	38	39
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

mVIP (Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	mVIP Group n=40 Participants This group will receive targeted symptom strategies from the UCSF symptom management manual based on the symptoms that they report. Health Management App with symptom strategies: The mVIP group will receive a Health Management App with symptom strategies. A mobile app which includes symptom strategies from the UCSF symptom management manual.	Attention Control Group n=40 Participants This group will have the Health Management App without symptom strategies pre-loaded on their smartphones. Health Management App without symptom strategies: The attention control group will receive the Health Management App preloaded on their smartphones without symptoms strategies	Total n=80 Participants Total of all reporting groups
Age, Continuous	50 years STANDARD_DEVIATION 11.7 • n=5 Participants	50.8 years STANDARD_DEVIATION 9 • n=7 Participants	50.4 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	17 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	23 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Race · White, non-hispanic	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black, non-hispanic	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants
Education Less than high school	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Education High school	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Education Some college or associates degree	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Education Bachelors or advanced degree	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Annual income Less than $10,000/year	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Annual income $10,000-$19,999/year	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Annual income $20,000-$59,999/year	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Annual income Don't know or prefer not to answer	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Employment Working (full, part, off-books)	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Employment Unemployed (looking, not looking)	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Employment Retired	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Employment Student	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Employment Disabled	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Employment Unspecified	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Antiretroviral therapy (ART) Use None	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Antiretroviral therapy (ART) Use 2+ pills per day	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Antiretroviral therapy (ART) Use 1 pill per day	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Antiretroviral therapy (ART) Use Prefer not to answer	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Virologically suppressed	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Ever diagnosed with AIDS	17 Participants n=5 Participants	24 Participants n=7 Participants	41 Participants n=5 Participants
Cluster of Differentiation 4 (CD4) count greater than 500	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Possible alcohol use disorder	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Substance use weekly or more often	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Outcome measures

Outcome measures
Measure	Intervention n=40 Participants Participants in the intervention group received self-care strategies for symptoms which they reported experiencing in the past seven days. Three self-care strategies were delivered for each reported symptom, along with short (3-27sec) videos to illustrate the strategy. At the end of the app session, participants were able to view a summary of their strategies.	Control n=40 Participants Participants in the control group were asked the same questions about symptoms experienced in the last seven days (as dictated by the Revised Sign and Symptom Check-List for HIV -- SSC-HIVrev), though they were not given any self-care or symptom management strategies.	Difference Between Groups n=80 Participants This represents the calculated difference between the average score changes from baseline to follow-up (12 weeks) among control and intervention group participants (described in the first two columns).
Change in Symptom Status From Baseline to Week 12 Anxiety	-0.858 score on a scale Standard Error 0.102	-0.318 score on a scale Standard Error 0.118	-0.541 score on a scale Standard Error 0.156
Change in Symptom Status From Baseline to Week 12 Cough of Shortness of Breath	-0.570 score on a scale Standard Error 0.105	-0.421 score on a scale Standard Error 0.122	-0.149 score on a scale Standard Error 0.161
Change in Symptom Status From Baseline to Week 12 Depression	-0.540 score on a scale Standard Error 0.106	-0.007 score on a scale Standard Error 0.123	-0.533 score on a scale Standard Error 0.163
Change in Symptom Status From Baseline to Week 12 Diarrhea	-0.240 score on a scale Standard Error 0.092	-0.233 score on a scale Standard Error 0.107	-0.007 score on a scale Standard Error 0.141
Change in Symptom Status From Baseline to Week 12 Difficulty falling asleep	-0.506 score on a scale Standard Error 0.106	-0.433 score on a scale Standard Error 0.122	-0.073 score on a scale Standard Error 0.162
Change in Symptom Status From Baseline to Week 12 Difficulty remembering	-0.343 score on a scale Standard Error 0.095	-0.169 score on a scale Standard Error 0.110	-0.174 score on a scale Standard Error 0.145
Change in Symptom Status From Baseline to Week 12 Dizziness	-0.319 score on a scale Standard Error 0.083	-0.181 score on a scale Standard Error 0.095	-0.138 score on a scale Standard Error 0.126
Change in Symptom Status From Baseline to Week 12 Fatigue	-0.566 score on a scale Standard Error 0.115	-0.563 score on a scale Standard Error 0.132	-0.003 score on a scale Standard Error 0.175
Change in Symptom Status From Baseline to Week 12 Fever, chills, sweats	-0.360 score on a scale Standard Error 0.086	-0.084 score on a scale Standard Error 0.099	-0.275 score on a scale Standard Error 0.132
Change in Symptom Status From Baseline to Week 12 Nausea or vomiting	-0.122 score on a scale Standard Error 0.066	-0.185 score on a scale Standard Error 0.077	0.063 score on a scale Standard Error 0.101
Change in Symptom Status From Baseline to Week 12 Neuropathy	-0.713 score on a scale Standard Error 0.103	-0.228 score on a scale Standard Error 0.119	-0.485 score on a scale Standard Error 0.157
Change in Symptom Status From Baseline to Week 12 Skin problems	-0.219 score on a scale Standard Error 0.091	-0.089 score on a scale Standard Error 0.105	-0.130 score on a scale Standard Error 0.139
Change in Symptom Status From Baseline to Week 12 Weight loss or wasting	-0.254 score on a scale Standard Error 0.070	-0.004 score on a scale Standard Error 0.081	-0.250 score on a scale Standard Error 0.107

SECONDARY outcome

Timeframe: Baseline and 12 weeks

36-Item Short Form Survey (RAND-36) is a widely-used 36-item tool to measure health-related quality of life, where each item in the scale is scored as 0, 25, 50, 75, or 100. Scoring is a two-step process. First, precoded numeric values are recoded per the scoring key so that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores, where a lower score may indicate a better outcome for some of the scales, while it may indicate a better outcome for others.

Outcome measures

Outcome measures
Measure	Intervention n=38 Participants Participants in the intervention group received self-care strategies for symptoms which they reported experiencing in the past seven days. Three self-care strategies were delivered for each reported symptom, along with short (3-27sec) videos to illustrate the strategy. At the end of the app session, participants were able to view a summary of their strategies.	Control n=39 Participants Participants in the control group were asked the same questions about symptoms experienced in the last seven days (as dictated by the Revised Sign and Symptom Check-List for HIV -- SSC-HIVrev), though they were not given any self-care or symptom management strategies.	Difference Between Groups This represents the calculated difference between the average score changes from baseline to follow-up (12 weeks) among control and intervention group participants (described in the first two columns).
Change in Quality of Life -- RAND-36 Physical Functioning Scale	66.22 score on a scale Standard Deviation 31.39	65.11 score on a scale Standard Deviation 28.97	—
Change in Quality of Life -- RAND-36 Role limitations due to physical health scale	55.41 score on a scale Standard Deviation 41.72	61.54 score on a scale Standard Deviation 41.30	—
Change in Quality of Life -- RAND-36 Role limitations due to emotional problems scale	62.16 score on a scale Standard Deviation 43.86	66.66 score on a scale Standard Deviation 41.43	—
Change in Quality of Life -- RAND-36 Energy/fatigue scale	51.35 score on a scale Standard Deviation 18.24	56.54 score on a scale Standard Deviation 19.67	—
Change in Quality of Life -- RAND-36 Emotional well-being scale	68.11 score on a scale Standard Deviation 15.42	73.23 score on a scale Standard Deviation 19.03	—
Change in Quality of Life -- RAND-36 Social functioning scale	66.89 score on a scale Standard Deviation 20.88	65.06 score on a scale Standard Deviation 26.47	—
Change in Quality of Life -- RAND-36 Pain scale	69.12 score on a scale Standard Deviation 20.41	63.14 score on a scale Standard Deviation 27.98	—
Change in Quality of Life -- RAND-36 General health scale	60.95 score on a scale Standard Deviation 21.34	60 score on a scale Standard Deviation 21.28	—
Change in Quality of Life -- RAND-36 Physical health summary scale	63.18 score on a scale Standard Deviation 23.80	63.03 score on a scale Standard Deviation 21.78	—
Change in Quality of Life -- RAND-36 Mental health summary scale	61.94 score on a scale Standard Deviation 18.53	65.83 score on a scale Standard Deviation 20.70	—

SECONDARY outcome

Timeframe: 12 weeks

The PROMIS-29 includes seven health related quality of life domains on a 5-point scale from a score of 1 to 5 and the pain domain has two subdomains (interference and intensity) where pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain (10). Raw scores 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 the scoring tables listed in the PROMIS manuals. A higher PROMIS T-score implies more of the concept being measured; for instance, a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates a greater severity of depression.

Outcome measures

Outcome measures
Measure	Intervention n=38 Participants Participants in the intervention group received self-care strategies for symptoms which they reported experiencing in the past seven days. Three self-care strategies were delivered for each reported symptom, along with short (3-27sec) videos to illustrate the strategy. At the end of the app session, participants were able to view a summary of their strategies.	Control n=39 Participants Participants in the control group were asked the same questions about symptoms experienced in the last seven days (as dictated by the Revised Sign and Symptom Check-List for HIV -- SSC-HIVrev), though they were not given any self-care or symptom management strategies.	Difference Between Groups This represents the calculated difference between the average score changes from baseline to follow-up (12 weeks) among control and intervention group participants (described in the first two columns).
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function	44.69 T-score Standard Deviation 9.09	45.70 T-score Standard Deviation 9.18	—
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Anxiety	55.85 T-score Standard Deviation 9.19	55.12 T-score Standard Deviation 10.56	—
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Depression	54.12 T-score Standard Deviation 10.46	50.53 T-score Standard Deviation 9.63	—
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Fatigue	51.76 T-score Standard Deviation 9.08	50.16 T-score Standard Deviation 9.89	—
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Sleep Disturbance	51.21 T-score Standard Deviation 9.64	52.85 T-score Standard Deviation 9.26	—
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Satisfaction with participation in social roles	48.86 T-score Standard Deviation 9.01	49.18 T-score Standard Deviation 8.72	—
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Pain interference	53.60 T-score Standard Deviation 7.90	53.25 T-score Standard Deviation 9.84	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks

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 in which a lower score indicates a better outcome. The scores are then collated to an aggregate score where the minimum value = 13 and the maximum value = 52. A low score indicates greater provider engagement, where as higher scores indicate lower provider engagement (less favorable outcome). The difference in scores at baseline and follow-up at three months was calculated within both the intervention and control groups, and the difference was then taken between the resulting means of those scores.

Outcome measures

Outcome measures
Measure	Intervention n=38 Participants Participants in the intervention group received self-care strategies for symptoms which they reported experiencing in the past seven days. Three self-care strategies were delivered for each reported symptom, along with short (3-27sec) videos to illustrate the strategy. At the end of the app session, participants were able to view a summary of their strategies.	Control n=39 Participants Participants in the control group were asked the same questions about symptoms experienced in the last seven days (as dictated by the Revised Sign and Symptom Check-List for HIV -- SSC-HIVrev), though they were not given any self-care or symptom management strategies.	Difference Between Groups This represents the calculated difference between the average score changes from baseline to follow-up (12 weeks) among control and intervention group participants (described in the first two columns).
Engagement With Healthcare Provider	16.65 score on a scale Standard Deviation 6.09	17.59 score on a scale Standard Deviation 7.56	—

SECONDARY outcome

Timeframe: 12 weeks

Medication adherence was calculated by two scales: the Center for Adherence Support Evaluation (CASE) Adherence Index and the Visual Analogue Scale (VAS). The CASE Adherence Index consists of the composite scores of three questions evaluating self-reported measures of adherence. The minimum score on this scale is 3 while the maximum score on this scale is 16, with higher scores indicating better outcome. Scores greater than 10 indicate "good adherence," while scores less than or equal to 10 indicate poor adherence. The VAS asks subjects to indicate a point on a line that shows their best guess about how much of each drug they have taken from a scale of 0% to 100% in which 0% means they have taken no drug, 50% means they have taken half their drugs, and 100% means they have taken every single dose. Consequently, a higher score (100%) indicates

Outcome measures

Outcome measures
Measure	Intervention n=38 Participants Participants in the intervention group received self-care strategies for symptoms which they reported experiencing in the past seven days. Three self-care strategies were delivered for each reported symptom, along with short (3-27sec) videos to illustrate the strategy. At the end of the app session, participants were able to view a summary of their strategies.	Control n=39 Participants Participants in the control group were asked the same questions about symptoms experienced in the last seven days (as dictated by the Revised Sign and Symptom Check-List for HIV -- SSC-HIVrev), though they were not given any self-care or symptom management strategies.	Difference Between Groups This represents the calculated difference between the average score changes from baseline to follow-up (12 weeks) among control and intervention group participants (described in the first two columns).
Medication Adherence CASE adherence index	12.97 score on a scale Standard Deviation 3.51	12.69 score on a scale Standard Deviation 3.00	—
Medication Adherence Visual analogue scale	85.97 score on a scale Standard Deviation 26.86	87.03 score on a scale Standard Deviation 20.56	—

SECONDARY outcome

Timeframe: 12 weeks

Health Information Technology Usability Evaluation Scale (Health-ITUES) was used to measure usability. Health-ITUES consists of 20 items rated on a 5-point Likert scale from strongly disagree (score of 1) to strongly agree (score of 5) measuring actual usage, intention to use, satisfaction, perceived usefulness, perceived ease of use, perceived performance speed, learnability, competency, flexibility/customizability, memorability, error prevention, information needs, and other outcomes. A higher score (5) indicates higher usability. Overall score was calculated as the mean score from the score for quality of life, perceived usefulness, perceived ease of use, and user control.

Outcome measures

Outcome measures
Measure	Intervention n=38 Participants Participants in the intervention group received self-care strategies for symptoms which they reported experiencing in the past seven days. Three self-care strategies were delivered for each reported symptom, along with short (3-27sec) videos to illustrate the strategy. At the end of the app session, participants were able to view a summary of their strategies.	Control n=39 Participants Participants in the control group were asked the same questions about symptoms experienced in the last seven days (as dictated by the Revised Sign and Symptom Check-List for HIV -- SSC-HIVrev), though they were not given any self-care or symptom management strategies.	Difference Between Groups This represents the calculated difference between the average score changes from baseline to follow-up (12 weeks) among control and intervention group participants (described in the first two columns).
Health-IT Usability Evaluation Scale (Health-ITUES) Overall	4.39 score on a scale Standard Deviation 0.72	4.35 score on a scale Standard Deviation 0.63	—
Health-IT Usability Evaluation Scale (Health-ITUES) Quality of Life	4.50 score on a scale Standard Deviation 0.59	4.35 score on a scale Standard Deviation 0.78	—
Health-IT Usability Evaluation Scale (Health-ITUES) Perceived usefulness	4.23 score on a scale Standard Deviation 0.91	4.26 score on a scale Standard Deviation 0.74	—
Health-IT Usability Evaluation Scale (Health-ITUES) Perceived ease of use	4.64 score on a scale Standard Deviation 0.83	4.67 score on a scale Standard Deviation 0.71	—
Health-IT Usability Evaluation Scale (Health-ITUES) User control	4.32 score on a scale Standard Deviation 0.82	4.05 score on a scale Standard Deviation 0.93	—

Adverse Events

mVIP Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Attention Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rebecca Schnall

Columbia University

Phone: 212-342-6886

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place