Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms
VIP-HANA
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 16, 2016
CompletedFirst Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedResults Posted
Study results publicly available
December 13, 2019
CompletedDecember 13, 2019
November 1, 2019
2.4 years
May 11, 2017
October 27, 2019
November 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptom Burden Score
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).
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)
Secondary Outcomes (1)
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Baseline, 3 months, and 6 months
Other Outcomes (4)
Change in Score on SF-12
3 months and 6 months
Score on Engagement With Health Care Provider Scale
Baseline, 3 months, and 6 months
Score of the VAS
Baseline, 3 months, and 6 months
- +1 more other outcomes
Study Arms (2)
Intervention
EXPERIMENTALVIP app that delivers HIV-related symptom strategies
Control
SHAM COMPARATORVIP app without HIV-related symptom strategies
Interventions
The control group will receive the VIP app without HIV-related symptom strategies
The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
Eligibility Criteria
You may qualify if:
- HIV+
- Age 18 or over
- Able to read and respond in English
- Reside within the US
- Willing to participate in an online survey.
You may not qualify if:
- HIV-negative
- under age 18
- Unwilling to provide key data (i.e., age, information about symptoms) on the online survey.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Institute of Nursing Research (NINR)collaborator
Study Sites (1)
Columbia University School for Nursing
New York, New York, 10032, United States
Related Publications (2)
Gordian-Arroyo A, Reame N, Gutierrez J, Liu J, Ganzhorn S, Igwe KC, Laing K, Schnall R. Do correlates of white matter features differ between older men and women living with human immunodeficiency virus? Menopause. 2023 Feb 1;30(2):149-155. doi: 10.1097/GME.0000000000002102. Epub 2022 Nov 20.
PMID: 36696639DERIVEDCho 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.
PMID: 32538796DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Rebecca Schnall
- Organization
- Columbia University School of Nursing
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Schnall, PhD
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Nursing
Study Record Dates
First Submitted
May 11, 2017
First Posted
June 9, 2017
Study Start
November 16, 2016
Primary Completion
April 3, 2019
Study Completion
May 31, 2019
Last Updated
December 13, 2019
Results First Posted
December 13, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share