N/A
Completed N=80
mVIP (Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV)
Source: ClinicalTrials.gov NCT02897141 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Change in Symptom Status From Baseline to Week 12 — -0.858; -0.318; -0.541; -0.570 score on a scale — p=0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Symptom Status From Baseline to Week 12 |
-0.858; -0.318; -0.541; -0.570; -0.421; -0.149 | 0.001 sig |
| SECONDARY Change in Quality of Life -- RAND-36 |
66.22; 65.11; 55.41; 61.54; 62.16; 66.66 | 0.001 sig |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS)-29 |
44.69; 45.70; 55.85; 55.12; 54.12; 50.53 | 0.529 |
| SECONDARY Engagement With Healthcare Provider |
16.65; 17.59 | 0.252 |
| SECONDARY Medication Adherence |
12.97; 12.69; 85.97; 87.03 | 0.017 sig |
| SECONDARY Health-IT Usability Evaluation Scale (Health-ITUES) |
4.39; 4.35; 4.50; 4.35; 4.23; 4.26 | 0.743 |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with HIV/AIDS
- Over the age of 18 years
- Able to provide written informed consent
- Able to communicate in English
- Health literacy level of marginal or inadequate (as measured by the Newest Vital Sign (NVS): total score of 3 or lower)
- Report at least 2 HIV related adverse symptoms in the past week
- Owner of a smart phone/tablet.
Exclusion Criteria
- Inability to communicate in English
- Documented diagnosis of dementia
- Pregnancy
- Unable to understand consent procedure
- 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)
Data sourced from ClinicalTrials.gov (NCT02897141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.