Music for Health Project (MFH)

November 12, 2019 updated by: Marcia McDonnell Holstad, DSN, FNP-BC, Emory University

An Audio Music Self-Management Program to Improve ART Adherence in Rural GA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Educational music mobile app
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
Experimental: Live Network mobile phone App
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Antiretroviral Therapy (ART) Adherence Rates
Time Frame: Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses.
Time Frame: 3, 6, and 9 months post-baseline
No data available due to inability of the lab to accurately extract drug from hair.
3, 6, and 9 months post-baseline
Clinical Indicator: Change in Mean CD4 Percentage
Time Frame: Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
CD4 count is a test that measures the number of CD4 cells in your blood. CD4 cells, also known as T cell lymphocytes, are white blood cells that fight infection and play an important role in your immune system. A CD4 count is used to check the health of the immune system in people infected with HIV (human immunodeficiency virus). The count measures the number of CD4 cells in a small sample of blood. The percent of CD4 cells measure the percentage of all lymphocytes that are CD4 cells. The study assesses the percentage of CD4 lymphocytes over time.
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
Time Frame: Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
Change in number of participants with viral load presented as number of copies if <50 copies versus ≥ 50 copies. Subjects were coded as having non-detectable viral loads if the "load" was < 50 copies. The analyses performed reflects the number of subjects with non-detectable load (<50) at Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention.
Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Marcia M Holstad, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

April 19, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00055077
  • 1R01NR012923 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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