Clinical trial NCT02897141: mVIP (Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV)
Official title: Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV (Human Immunodeficiency Virus)
Keywords: HIV
Health Management App
HIV symptoms
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 80
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 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.

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)

Primary outcomes:
measure: Change in Symptom Status From Baseline to Week 12
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Quality of Life -- RAND-36
timeFrame: Baseline and 12 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-29
timeFrame: 12 weeks
measure: Engagement With Healthcare Provider
timeFrame: Baseline and 12 weeks
measure: Medication Adherence
timeFrame: 12 weeks
measure: Health-IT Usability Evaluation Scale (Health-ITUES)
timeFrame: 12 weeks
Other outcomes:
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, MPH, RN-BC, FAAN
role: PRINCIPAL_INVESTIGATOR
References: