Music for Health Project

NCT01786148 | Completed Results

• 2 other identifiers: IRB000550771R01NR012923
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus

Keywords

HIV/AIDS; Adherence; Self-management; Antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

• Change in Antiretroviral Therapy (ART) Adherence Rates

  Adherence rate was measured with the Antiretroviral General Adherence Scale (AGAS) which measures the general ease and ability to take one's medication as prescribed in the past 30 days. It includes 5 items scored 1 to 6, with the possible scores for this instrument ranging from 5 to 30, and higher scores reflect better adherence.

  Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline

Secondary Outcomes (3)

• Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses.

  3, 6, and 9 months post-baseline

• Clinical Indicator: Change in Mean CD4 Percentage

  Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention

• Clinical Indicator: Number of Participants With Non-detectable Viral Load

  Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention

Study Arms (2)

Educational music mobile app

ACTIVE COMPARATOR

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.

Behavioral: mobile phone application

Live Network mobile phone App

EXPERIMENTAL

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.

Behavioral: mobile phone application

Interventions

mobile phone application BEHAVIORAL

Educational music mobile app; Live Network mobile phone App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Marcia McDonnell Holstad
• Organization: Emory University

nurmmcd@emory.edu

404-727-1307

Study Officials

• Marcia M Holstad, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 7, 2013
• Study Start: June 1, 2014
• Primary Completion: April 19, 2017
• Study Completion: June 30, 2017
• Last Updated: November 29, 2019
• Results First Posted: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)