Music for Health Project (MFH)

Emory University

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Behavioral: mobile phone application

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01786148

IRB00055077

1R01NR012923 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The project has two primary aims and one exploratory aim. 1.0 Revise and adapt the Live Network (LN) program and manual for rural persons living with HIV/AIDS (PLWHA) and develop into a mobile application.

2.0 Conduct a randomized controlled trial to test the efficacy of the program. When compared with an educational music control condition at 3, 6, and 9 months post-baseline, those randomized to the LN will have: H1: Significantly higher mean antiretroviral therapy (ART) adherence rates (measured by pill counts, self report).

H2: Significantly higher mean levels of ART drug levels in hair sample analyses.

H3: Significantly better clinical indicators: higher mean CD4 lymphocyte counts and percents, a larger proportion achieving virologic suppression (proportion with HIV RNA PCR <50 copies/ml), and smaller proportion with evidence of drug resistance, all as measured by medical record review.

3.0 Explore: a) the effects of LN on symptoms and symptom management; b) the roles of self-efficacy, outcome expectancies, and personal goal setting as mediators, and depression and health literacy as moderators of adherence.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 2 patient groups

Educational music mobile app

Active Comparator group

Description:

A prerecorded program of songs on various topics in a mobile phone application (app). It is designed to provide education about non-health related topics and will be equivalent in length to the intervention app.

Treatment:

Behavioral: mobile phone application

Live Network mobile phone App

Experimental group

Description:

The LN is a prerecorded mobile phone application (app). It employs a radio talk show format in which a Disc Jockey entertains HIV medication-, adherence-, and self-management-related questions and comments from callers and poses them to expert care providers, whose responses to these questions are augmented by songs that shed additional light on these issues.

Treatment:

Behavioral: mobile phone application