mVIP (Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV)

NCT ID: NCT02897141

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-12
• Study Completion Date: 2017-06-08

Brief Summary

The goal of this study is to facilitate the dissemination and implementation of patient centered outcomes research using mHealth technology to improve self-management of adverse symptoms in persons living with HIV/AIDS (PLWH). Symptom management in PLWH is especially important because the US HIV epidemic continues to exact a huge toll, especially among Agency for Healthcare Research and Quality (AHRQ) priority populations including racial, ethnic, and sexual minorities and low-income persons. The incorporation of HIV symptom management strategies into patients' lives through the use of mHealth technologies has the potential to advance the effective dissemination and implementation of patient centered outcomes research findings.

Detailed Description

HIV has changed from an acute illness to a chronic disease. The success of HIV medications and treatments has significantly altered the course of the disease. While AIDS-related illnesses are no longer the primary threat, a new set of HIV-associated complications have emerged, resulting in a chronic disease that for many will span several decades of life. The ability to self-manage adverse symptoms of HIV illness has been shown to improve patient-centered outcomes. In response to this need, a team at University of California, San Francisco (UCSF) developed a paper-based symptom management manual with self-management strategies for 21 common HIV/AIDS adverse symptoms (PCOR evidence). The efficacy of the manual was demonstrated in a 775-person randomized controlled trial (RCT) over three months at 12 sites. However, subsequent use of these strategies has been very limited; mHealth offers an ideal platform for the implementation and dissemination of evidence-based strategies for HIV symptom management. Due to the high incidence of HIV among racial and ethnic minority populations, it is appropriate to develop mHealth tools tailored to the needs of these populations. mHealth technology has the potential to address many of the healthcare needs of persons living with HIV/AIDS (PLWH) including symptom management. In response to these current issues, this study seeks to inform the development and testing of a mHealth application that will incorporate findings from PCOR studies to improve the outcomes of PLWH. To improve outcomes for those most in need, study activities are focused on communities with the greatest burden of HIV in the US, including racial and ethnic minorities and those of low socioeconomic status.

Conditions

HIV (Human Immunodeficiency Virus)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

mVIP group

This group will receive targeted symptom strategies via a Health Management App developed from the UCSF symptom management manual based on the symptoms that they report. This is the intervention app group.

Group Type: EXPERIMENTAL

Health Management App with symptom strategies

Intervention Type: DEVICE

The mVIP group will receive a Health Management App with symptom strategies. A mobile app which includes symptom strategies from the UCSF symptom management manual.

Attention Control Group

This group will received an app without symptom strategies, pre-loaded on their smartphones. This is the control app group.

Group Type: PLACEBO_COMPARATOR

Control App

Intervention Type: DEVICE

The attention control group will receive an app which asked them about their symptoms but did not provide symptoms strategies

Interventions

Health Management App with symptom strategies

The mVIP group will receive a Health Management App with symptom strategies. A mobile app which includes symptom strategies from the UCSF symptom management manual.

Intervention Type: DEVICE

Control App

The attention control group will receive an app which asked them about their symptoms but did not provide symptoms strategies

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with HIV/AIDS

2. Over the age of 18 years

3. Able to provide written informed consent

4. Able to communicate in English

5. Health literacy level of marginal or inadequate (as measured by the Newest Vital Sign (NVS): total score of 3 or lower)

6. Report at least 2 HIV related adverse symptoms in the past week

7. Owner of a smart phone/tablet.

Exclusion Criteria

1. Inability to communicate in English

2. Documented diagnosis of dementia

3. Pregnancy

4. Unable to understand consent procedure

5. Self-reporting no adverse symptoms within the past week. (HIV-related symptoms include: anxiety, constipation, cough, depression, diarrhea, dizziness, fever, forgetfulness, fatigue, nausea, night sweats, neuropathy, shortness of breath, dermatitis, swelling of arms, hand, legs, feet, insomnia, weight loss, oral thrush, and vaginal itching, burning and discharge)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Schnall, RN, MPH, PhD

Assistant Professor of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Schnall, PhD, MPH, RN-BC, FAAN

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University School for Nursing

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21HS023963

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

AAAP1258

Identifier Type: -

Identifier Source: org_study_id