Clinical trial NCT03182738: Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms
Official title: Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV (Human Immunodeficiency Virus)
AIDS (Acquired Immunodeficiency Syndrome)
Keywords: HIV/AIDS Health Management App
HIV/AIDS symptoms
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Symptom Burden Score
timeFrame: 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:
measure: Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
measure: Change in Score on SF-12
timeFrame: 3 months and 6 months
measure: Score on Engagement With Health Care Provider Scale
timeFrame: Baseline, 3 months, and 6 months
measure: Score of the VAS
timeFrame: Baseline, 3 months, and 6 months
measure: Score on Fried's Frailty Phenotype
timeFrame: Baseline, 3 months, and 6 months
Locations:
city: New York
country: United States
facility: Columbia University School for Nursing
state: New York
Study officials:
affiliation: Columbia University
name: Rebecca Schnall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.