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

NCT ID: NCT03182738

Last Updated: 2019-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-16

Study Completion Date

2019-05-31

Brief Summary

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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

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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.

Conditions

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HIV (Human Immunodeficiency Virus) AIDS (Acquired Immunodeficiency Syndrome)

Keywords

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HIV/AIDS Health Management App HIV/AIDS symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention

VIP app that delivers HIV-related symptom strategies

Group Type EXPERIMENTAL

VIP app that delivers HIV-related symptom strategies.

Intervention Type BEHAVIORAL

The Intervention group will receive the VIP app that delivers HIV-related symptom strategies

Control

VIP app without HIV-related symptom strategies

Group Type SHAM_COMPARATOR

VIP app without HIV-related symptom strategies.

Intervention Type BEHAVIORAL

The control group will receive the VIP app without HIV-related symptom strategies

Interventions

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VIP app without HIV-related symptom strategies.

The control group will receive the VIP app without HIV-related symptom strategies

Intervention Type BEHAVIORAL

VIP app that delivers HIV-related symptom strategies.

The Intervention group will receive the VIP app that delivers HIV-related symptom strategies

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Schnall, RN, MPH, PhD

Assistant Professor of Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca Schnall, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University School for Nursing

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36696639 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32538796 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01NR015737-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAP5958

Identifier Type: -

Identifier Source: org_study_id