MedPath

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

Not Applicable
Completed
Conditions
AIDS (Acquired Immunodeficiency Syndrome)
HIV (Human Immunodeficiency Virus)
Interventions
Behavioral: VIP app that delivers HIV-related symptom strategies.
Behavioral: VIP app without HIV-related symptom strategies.
Registration Number
NCT03182738
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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.
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionVIP app that delivers HIV-related symptom strategies.VIP app that delivers HIV-related symptom strategies
ControlVIP app without HIV-related symptom strategies.VIP app without HIV-related symptom strategies
Primary Outcome Measures
NameTimeMethod
Symptom Burden ScoreBaseline, 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
NameTimeMethod
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29Baseline, 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.

Trial Locations

Locations (1)

Columbia University School for Nursing

🇺🇸

New York, New York, United States

© Copyright 2025. All Rights Reserved by MedPath