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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
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Rebecca Schnall, RN, MPH, PhD, Columbia University

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.

Condition or disease Intervention/treatment Phase
HIV (Human Immunodeficiency Virus) AIDS (Acquired Immunodeficiency Syndrome) Behavioral: VIP app without HIV-related symptom strategies. Behavioral: VIP app that delivers HIV-related symptom strategies. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms
Actual Study Start Date : November 16, 2016
Actual Primary Completion Date : April 3, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention
VIP app that delivers 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

Sham Comparator: Control
VIP app without HIV-related symptom strategies
Behavioral: VIP app without HIV-related symptom strategies.
The control group will receive the VIP app without HIV-related symptom strategies




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182738


Locations
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United States, New York
Columbia University School for Nursing
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Rebecca Schnall, PhD Columbia University
  Study Documents (Full-Text)

Documents provided by Rebecca Schnall, RN, MPH, PhD, Columbia University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rebecca Schnall, RN, MPH, PhD, Assistant Professor of Nursing, Columbia University
ClinicalTrials.gov Identifier: NCT03182738    
Other Study ID Numbers: AAAP5958
R01NR015737-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2017    Key Record Dates
Results First Posted: December 13, 2019
Last Update Posted: December 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Rebecca Schnall, RN, MPH, PhD, Columbia University:
HIV/AIDS Health Management App
HIV/AIDS symptoms
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases