Music for Health Project (MFH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Human Immunodeficiency Virus
Behavioral: mobile phone application

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: An Audio Music Self-Management Program to Improve ART Adherence in Rural GA

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Increased antiretroviral therapy (ART) adherence rates [ Time Frame: up to 9 months post-baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 240
Study Start Date: June 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786148

Contacts
Contact: Marcia M Holstad, DSN 404-727-1307 nurmmcd@emory.edu
Contact: Derek Jobe, BS 404-727-2589 djobe@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Marcia M Holstad, DSN         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Marcia M Holstad, DSN Emory University
  More Information

No publications provided

Responsible Party: Marcia McDonnell Holstad, DSN, FNP-BC, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT01786148     History of Changes
Other Study ID Numbers: IRB00055077, 1R01NR012923
Study First Received: February 5, 2013
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
HIV/AIDS
Adherence
Self-management
Antiretroviral therapy

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014