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

HIV (Human Immunodeficiency Virus) Clinical Trial

— VIP-HANA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182738
• Other study ID #: AAAP5958
• Secondary ID: R01NR015737-01A1
• Status: Completed
• Phase: N/A
• Start date: November 16, 2016
• Est. completion date: May 31, 2019

Study information

• Verified date: November 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS (Acquired Immunodeficiency Syndrome)
• HIV (Human Immunodeficiency Virus)
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University School for Nursing	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Score on SF-12	12-Item Medical Outcomes Study Short Form (SF-12) is a health survey to measure health-related quality of life.	3 months and 6 months
Other	Score on Engagement With Health Care Provider Scale	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.	Baseline, 3 months, and 6 months
Other	Score of the VAS	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.	Baseline, 3 months, and 6 months
Other	Score on Fried's Frailty Phenotype	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.	Baseline, 3 months, and 6 months
Primary	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	Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29	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.	Baseline, 3 months, and 6 months