N/A
N=149
Music for Health Project
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT01786148 ↗Enrolled (actual)
149
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Change in Antiretroviral Therapy (ART) Adherence Rates — 27.04; 26.25; 26.14; 26.48 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mobile phone application (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Antiretroviral Therapy (ART) Adherence Rates |
27.04; 26.25; 26.14; 26.48; 26.60; 27.81 | — |
| SECONDARY Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses. |
— | — |
| SECONDARY Clinical Indicator: Change in Mean CD4 Percentage |
21.87; 26.07; 21.68; 25.91; 27.08; 26.23 | — |
| SECONDARY Clinical Indicator: Number of Participants With Non-detectable Viral Load |
25; 21; 49; 35; 40; 38 | — |
Summary
The overall goal of this project is to use technology to improve adherence to antiretroviral therapy (ART)and increase access to ART adherence care for those HIV+ persons living in rural areas. The LIVE Network audio music program mobile application (app) is innovative, practical, portable, and could be rapidly scaled up to address the adherence self-management needs of rural groups nationwide. If successful, the impact on HIV care will be immense and could transform the delivery of HIV self-management and adherence education by overcoming barriers of geographic isolation, transportation, stigma and confidentiality in this vulnerable group.
Eligibility Criteria
Inclusion Criteria
- HIV+ individuals initiating ART for the first time (except women who may have had ART during pregnancy); or HIV+ individuals changing ART regimen within the past 3 months due to side effects or virologic resistance; or HIV+ individuals with a detectable viral load ≥ 40copies/ml; or HIV+ individuals on ART medication
- English speaking
- Willing to complete 4 assessments
- Willing to complete monthly, unannounced pill counts
- Willing to allow collection of hair samples
- Willing to be randomly assigned to either condition
- Willing to participate in study activities that include using smart phone and mobile app
Exclusion Criteria
- Have a history of bilateral hearing loss (health care provider diagnosed or self-identified)
- Homeless
- Have a cognitive impairment (inability to comprehend the informed consent)
- Display psychotic symptoms, as determined by the Brief Symptom Inventory (BSI)
Data sourced from ClinicalTrials.gov (NCT01786148). 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.