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

• ClinicalTrials.gov Identifier: NCT03182738
• Recruitment Status: Completed
• First Posted: June 9, 2017
• Results First Posted: December 13, 2019
• Last Update Posted: December 13, 2019
• Sponsor: Columbia University
• Collaborator: National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): Rebecca Schnall, RN, MPH, PhD, Columbia University

Tracking Information

• First Submitted Date: May 11, 2017
• First Posted Date: June 9, 2017
• Results First Submitted Date: October 27, 2019
• Results First Posted Date: December 13, 2019
• Last Update Posted Date: December 13, 2019
• Actual Study Start Date: November 16, 2016
• Actual Primary Completion Date: April 3, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2019)

Symptom Burden Score [ 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) ]

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).

Original Primary Outcome Measures (submitted: June 8, 2017)

Decrease symptom frequency and intensity in the intervention group as compared to the control group. [ Time Frame: Six Months ]

The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Each of the 7 domains has four 5-level items (i.e., 16 decrements each). In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain. Raw scores 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 more severe depressive symptoms.

Current Secondary Outcome Measures (submitted: November 21, 2019)

Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 [ Time Frame: Baseline, 3 months, and 6 months ]

The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Each of the 7 domains has four 5-level items (i.e., 16 decrements each). In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain. Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which 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.

• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: November 21, 2019)

• Change in Score on SF-12 [ Time Frame: 3 months and 6 months ]
  12-Item Medical Outcomes Study Short Form (SF-12) is a health survey to measure health-related quality of life.
• Score on Engagement With Health Care Provider Scale [ Time Frame: Baseline, 3 months, and 6 months ]
  Engagement with Health Care Provide scale is a 13-item scale in which subjects rate their interactions with their health care providers on a four-point scale with 1=always true and 4=never true. A total score can be calculated to create a possible range of 13-52. A low score (closer to 13) indicates greater provider engagement between the patient and provider.
• Score of the VAS [ Time Frame: Baseline, 3 months, and 6 months ]
  The Visual Analogue Scale (VAS) measures adherence to antiretroviral therapy (ART). VAS asks subjects to indicate a point on a line that shows their best guess about how much of each drug they have taken. 0% means they have taken no drug, 50% means they have taken half their drugs, and 100% means they have taken every single dose.
• Score on Fried's Frailty Phenotype [ Time Frame: Baseline, 3 months, and 6 months ]
  Fried's frailty phenotype is a combination of five scores: weight loss in the last year, exhaustion, physical activity, walk time for a 15 foot interval, and grip strength. The frailty condition is defined as meeting the definition of frailty for at least 3 of the listed scores.

Original Other Pre-specified Outcome Measures (submitted: June 8, 2017)

• Quality of Life [ Time Frame: Six Months ]
  12-Item Medical Outcomes Study Short Form (SF-12) is a health survey to measure health-related quality of life.
• Improve engagement with healthcare provider. [ Time Frame: Six Months ]
  Engagement with Health Care Provide scale is a 13-item scale in which subjects rate their interactions with their health care providers on a four-point scale with 1=always true and 4=never true. A low score indicates greater provider engagement.
• Improve adherence to antiretroviral therapy (ART). [ Time Frame: Six Months ]
  The Visual Analogue Scale (VAS) measures adherence to antiretroviral therapy (ART). VAS asks subjects to indicate a point on a line that shows their best guess about how much of each drug they have taken. 0% means they have taken no drug, 50% means they have taken half their drugs, and 100% means they have taken every single dose.
• Decrease frailty as measured by Fried's frailty phenotype [ Time Frame: Six Months ]

Descriptive Information

• Brief Title: Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms
• Official Title: Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms
• Brief Summary: The purpose of this study is to use technology to improve symptom status and ultimately improve patient centered outcomes in people living with HIV/AIDS (PLWHA). The primary purpose of the intervention (VIP-HANA) is to improve symptom status. The investigators hypothesize that VIP-HANA will improve symptom frequency and intensity.

Detailed Description

As PLWHA age, they are developing chronic illnesses and co-morbid conditions that are often seen in older HIV negative patients. HANA conditions (e.g., cardiovascular disease, liver disease, diabetes, and asthma) are becoming more common as PLWHA age.

An individual's ability to identify and self-manage symptoms of HIV illness has been shown to improve patient outcomes and quality of life. The investigators will develop and pilot test the Video Information Provider (VIP), a web application (app) that delivered HIV-related symptom self-care strategies for PLWHA for 13 common (non-HANA) HIV/AIDS symptoms. There is a need to identify the symptom experience of PLWHA with HANA conditions.

The aim is to compare the efficacy of VIP-HANA to a control arm for ameliorating symptom frequency and intensity and secondary health outcomes in 100 PLWHA with HANA conditions over 6 months.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Supportive Care

Condition

• HIV (Human Immunodeficiency Virus)
• AIDS (Acquired Immunodeficiency Syndrome)

Intervention

• Behavioral: VIP app without HIV-related symptom strategies.
  The control group will receive the VIP app without HIV-related symptom strategies
• Behavioral: VIP app that delivers HIV-related symptom strategies.
  The Intervention group will receive the VIP app that delivers HIV-related symptom strategies

Study Arms

• Experimental: Intervention
  VIP app that delivers HIV-related symptom strategies
  Intervention: Behavioral: VIP app that delivers HIV-related symptom strategies.
• Sham Comparator: Control
  VIP app without HIV-related symptom strategies
  Intervention: Behavioral: VIP app without HIV-related symptom strategies.

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 8, 2017): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 31, 2019
• Actual Primary Completion Date: April 3, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. HIV+
2. Age 18 or over
3. Able to read and respond in English
4. Reside within the US
5. Willing to participate in an online survey.

Exclusion Criteria:

1. HIV-negative
2. under age 18
3. Unwilling to provide key data (i.e., age, information about symptoms) on the online survey.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03182738
• Other Study ID Numbers: AAAP5958; R01NR015737-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Rebecca Schnall, RN, MPH, PhD, Columbia University
• Original Responsible Party: Rebecca Schnall, Columbia University, Assistant Professor of Nursing
• Current Study Sponsor: Columbia University
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Rebecca Schnall, PhD; Columbia University

• PRS Account: Columbia University
• Verification Date: November 2019