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Music for Health Project (MFH)

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ClinicalTrials.gov Identifier: NCT01786148
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : July 31, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Audio Music Self-Management Program to Improve ART Adherence in Rural GA
Study Start Date : June 2014
Primary Completion Date : April 19, 2017
Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Increased antiretroviral therapy (ART) adherence rates [ Time Frame: up to 9 months post-baseline ]

Secondary Outcome Measures :
  1. Significantly higher mean levels of ART drug levels in hair sample analyses. [ Time Frame: 3, 6, and 9 months post-baseline ]
  2. Mediators and Moderators [ Time Frame: 3, 6, 9 months post baseline ]
    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:
  1. Clinical indicators [ Time Frame: 3, 6, and 9 months post-baseline ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786148


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Marcia M Holstad, PhD Emory University
More Information

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 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017

Keywords provided by Marcia McDonnell Holstad, DSN, FNP-BC, Emory University:
HIV/AIDS
Adherence
Self-management
Antiretroviral therapy

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