HIV (Human Immunodeficiency Virus)mVIPNCT02897141
mVIP (Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV)
A study testing Health Management App with symptom strategies in people with HIV (Human Immunodeficiency Virus), run by Columbia University at 1 site in United States.
Trial summary
The goal of this study is to facilitate the dissemination and implementation of patient centered outcomes research using mHealth technology to improve self-management of adverse symptoms in persons living with HIV/AIDS (PLWH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV (Human Immunodeficiency Virus)
- What is being tested?
- Health Management App with symptom strategies
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2016to 8 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with HIV/AIDS
- Over the age of 18 years
- Able to provide written informed consent
- Able to communicate in English
- Health literacy level of marginal or inadequate (as measured by the Newest Vital Sign (NVS): total score of 3 or lower)
- Report at least 2 HIV related adverse symptoms in the past week
- Owner of a smart phone/tablet.
Who cannot join
- Inability to communicate in English
- Documented diagnosis of dementia
- Pregnancy
- Unable to understand consent procedure
- Self-reporting no adverse symptoms within the past week. (HIV-related symptoms include: anxiety, constipation, cough, depression, diarrhea, dizziness, fever, forgetfulness, fatigue, nausea, night sweats, neuropathy, shortness of breath, dermatitis, swelling of arms, hand, legs, feet, insomnia, weight loss, oral thrush, and vaginal itching, burning and discharge)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University School for Nursing
New York, New York, 10032
About this study
Official title: Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV
The goal of this study is to facilitate the dissemination and implementation of patient centered outcomes research using mHealth technology to improve self-management of adverse symptoms in persons living with HIV/AIDS (PLWH). Symptom management in PLWH is especially important because the US HIV epidemic continues to exact a huge toll, especially among Agency for Healthcare Research and Quality (AHRQ) priority populations including racial, ethnic, and sexual minorities and low-income persons. The incorporation of HIV symptom management strategies into patients' lives through the use of mHealth technologies has the potential to advance the effective dissemination and implementation of patient centered outcomes research findings.
Read the detailed description
HIV has changed from an acute illness to a chronic disease. The success of HIV medications and treatments has significantly altered the course of the disease. While AIDS-related illnesses are no longer the primary threat, a new set of HIV-associated complications have emerged, resulting in a chronic disease that for many will span several decades of life. The ability to self-manage adverse symptoms of HIV illness has been shown to improve patient-centered outcomes. In response to this need, a team at University of California, San Francisco (UCSF) developed a paper-based symptom management manual with self-management strategies for 21 common HIV/AIDS adverse symptoms (PCOR evidence). The efficacy of the manual was demonstrated in a 775-person randomized controlled trial (RCT) over three months at 12 sites. However, subsequent use of these strategies has been very limited; mHealth offers an ideal platform for the implementation and dissemination of evidence-based strategies for HIV symptom management. Due to the high incidence of HIV among racial and ethnic minority populations, it is appropriate to develop mHealth tools tailored to the needs of these populations. mHealth technology has the potential to address many of the healthcare needs of persons living with HIV/AIDS (PLWH) including symptom management. In response to these current issues, this study seeks to inform the development and testing of a mHealth application that will incorporate findings from PCOR studies to improve the outcomes of PLWH. To improve outcomes for those most in need, study activities are focused on communities with the greatest burden of HIV in the US, including racial and ethnic minorities and those of low socioeconomic status.
- Conditions
- HIV (Human Immunodeficiency Virus)
- Being tested
- Health Management App with symptom strategies, Control App
- Keywords
- HIV, Health Management App, HIV symptoms
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Management App with symptom strategiesDevice
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.
Control AppDevice
The attention control group will receive an app which asked them about their symptoms but did not provide symptoms strategies
| Study group | Role | What they receive |
|---|---|---|
| mVIP group | Experimental | This group will receive targeted symptom strategies via a Health Management App developed from the UCSF symptom management manual based on the symptoms that they report. This is the intervention app group. Receives: Device: Health Management App with symptom strategies |
| Attention Control Group | Placebo comparator | This group will received an app without symptom strategies, pre-loaded on their smartphones. This is the control app group. Receives: Device: Control App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptom Status From Baseline to Week 12
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.
Measured: Baseline and 12 weeks
Secondary outcomes (5)
Change in Quality of Life -- RAND-36
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.
Measured: Baseline and 12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
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.
Measured: 12 weeks
Engagement With Healthcare Provider
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.
Measured: Baseline and 12 weeks
Medication Adherence
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
Measured: 12 weeks
Health-IT Usability Evaluation Scale (Health-ITUES)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start12 Dec 2016
- Primary completion8 Jun 2017
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Schnall, RN, MPH, PhD, Columbia University
- Investigators
- Rebecca Schnall, PhD, MPH, RN-BC, FAAN, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897141
- Sponsor's protocol ID
- AAAP1258
- Other IDs
- R21HS023963
- Acronym
- mVIP
- Status last verified
- Mar 2019
- First submitted
- 7 Sep 2016
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV
- ClinicalTrials.gov ID
- NCT02897141
- Acronym / sponsor ID
- mVIP / AAAP1258
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- HIV, Health Management App, HIV symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Posted 10 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to facilitate the dissemination and implementation of patient centered outcomes research using mHealth technology to improve self-management of adverse symptoms in persons living with HIV/AIDS (PLWH). Symptom management in PLWH is especially important because the US HIV epidemic continues to exact a huge toll, especially among Agency for Healthcare Research and Quality (AHRQ) priority populations including racial, ethnic, and sexual minorities and low-income persons. The incorporation of HIV symptom management strategies into patients' lives through the use of mHealth technologies has the potential to advance the effective dissemination and implementation of patient centered outcomes research findings.
Detailed description
HIV has changed from an acute illness to a chronic disease. The success of HIV medications and treatments has significantly altered the course of the disease. While AIDS-related illnesses are no longer the primary threat, a new set of HIV-associated complications have emerged, resulting in a chronic disease that for many will span several decades of life. The ability to self-manage adverse symptoms of HIV illness has been shown to improve patient-centered outcomes. In response to this need, a team at University of California, San Francisco (UCSF) developed a paper-based symptom management manual with self-management strategies for 21 common HIV/AIDS adverse symptoms (PCOR evidence). The efficacy of the manual was demonstrated in a 775-person randomized controlled trial (RCT) over three months at 12 sites. However, subsequent use of these strategies has been very limited; mHealth offers an ideal platform for the implementation and dissemination of evidence-based strategies for HIV symptom management. Due to the high incidence of HIV among racial and ethnic minority populations, it is appropriate to develop mHealth tools tailored to the needs of these populations. mHealth technology has the potential to address many of the healthcare needs of persons living with HIV/AIDS (PLWH) including symptom management. In response to these current issues, this study seeks to inform the development and testing of a mHealth application that will incorporate findings from PCOR studies to improve the outcomes of PLWH. To improve outcomes for those most in need, study activities are focused on communities with the greatest burden of HIV in the US, including racial and ethnic minorities and those of low socioeconomic status.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mVIP group | Experimental | Device: Health Management App with symptom strategiesThis group will receive targeted symptom strategies via a Health Management App developed from the UCSF symptom management manual based on the symptoms that they report. This is the intervention app group. |
| Attention Control Group | Placebo comparator | Device: Control AppThis group will received an app without symptom strategies, pre-loaded on their smartphones. This is the control app group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with HIV/AIDS
- Over the age of 18 years
- Able to provide written informed consent
- Able to communicate in English
- Health literacy level of marginal or inadequate (as measured by the Newest Vital Sign (NVS): total score of 3 or lower)
Key exclusion criteria (5 listed)
- Inability to communicate in English
- Documented diagnosis of dementia
- Pregnancy
- Unable to understand consent procedure
- Self-reporting no adverse symptoms within the past week. (HIV-related symptoms include: anxiety, constipation, cough, depression, diarrhea, dizziness, fever, forgetfulness, fatigue, nausea, night sweats, neuropathy, shortness of breath, dermatitis, swelling of arms, hand, legs, feet, insomnia, weight loss, oral thrush, and vaginal itching, burning and discharge)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Management App with symptom strategiesThe mVIP group will receive a Health Management App with symptom strategies. A mobile app which includes symptom strategies from the UCSF symptom management manual. | Device | mVIP group |
| Control AppThe attention control group will receive an app which asked them about their symptoms but did not provide symptoms strategies | Device | Attention Control Group |
Primary outcome
Change in Symptom Status From Baseline to Week 12
Time frame: Baseline and 12 weeks
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.
5 secondary outcomes
Change in Quality of Life -- RAND-36
Time frame: Baseline and 12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Time frame: 12 weeks
Engagement With Healthcare Provider
Time frame: Baseline and 12 weeks
Medication Adherence
Time frame: 12 weeks
Health-IT Usability Evaluation Scale (Health-ITUES)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Schnall, PhD, MPH, RN-BC, FAAN principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Management App with symptom strategies in people with HIV (Human Immunodeficiency Virus), run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptom Status From Baseline to Week 12 (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.