Music for Health Project (MFH)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Emory University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marcia McDonnell Holstad, DSN, FNP-BC, Emory University
ClinicalTrials.gov Identifier:
NCT01786148
First received: February 5, 2013
Last updated: April 30, 2014
Last verified: April 2014

February 5, 2013
April 30, 2014
May 2014
March 2016   (final data collection date for primary outcome measure)
Increased antiretroviral therapy (ART) adherence rates [ Time Frame: up to 9 months post-baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01786148 on ClinicalTrials.gov Archive Site
  • Significantly higher mean levels of ART drug levels in hair sample analyses. [ Time Frame: 3, 6, and 9 months post-baseline ] [ Designated as safety issue: No ]
  • Mediators and Moderators [ Time Frame: 3, 6, 9 months post baseline ] [ Designated as safety issue: No ]
    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.
Same as current
Clinical indicators [ Time Frame: 3, 6, and 9 months post-baseline ] [ Designated as safety issue: No ]
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.
Same as current
 
Music for Health Project
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Human Immunodeficiency Virus
Behavioral: mobile phone application
  • 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.
    Intervention: 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.
    Intervention: Behavioral: mobile phone application
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
240
March 2016
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1) HIV infection; 2) initiating ART for the first time (except women who may have had ART during pregnancy) or changing ART regimen within the past 3 months due to side effects or virologic resistance; 3) ≥18 years of age; 4) English speaking; and 5) willing to use smart phone and app, complete 4 assessments, monthly PC, and collection of hair samples, be randomly assigned to either condition, and participate in study activities.

Exclusion Criteria:

  • be a history of, or self-identified bilateral hearing loss, cognitive impairment (inability to comprehend the informed consent), or psychotic symptoms (Brief Symptom Inventory; BSI).
Both
18 Years and older
No
Contact: Marcia M Holstad, DSN 404-727-1307 nurmmcd@emory.edu
Contact: Derek Jobe, BS 404-727-2589 djobe@emory.edu
United States
 
NCT01786148
IRB00055077, 1R01NR012923
No
Marcia McDonnell Holstad, DSN, FNP-BC, Emory University
Emory University
National Institute of Nursing Research (NINR)
Principal Investigator: Marcia M Holstad, DSN Emory University
Emory University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP