MFH: Music for Health Project

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01786148
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 149
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 4

Study Details

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	Phase
Human Immunodeficiency Virus	Behavioral: mobile phone application	N/A

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
• 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: Jun 1, 2014
• Actual Primary Completion Date: Apr 19, 2017
• Actual Study Completion Date: Jun 30, 2017

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. Change in Antiretroviral Therapy (ART) Adherence Rates [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.

Secondary Outcome Measures

1. Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses. [3, 6, and 9 months post-baseline]

   No data available due to inability of the lab to accurately extract drug from hair.

2. 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]

   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.

3. 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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 4, 2016

More Information

Publications

None provided.

• Responsible Party: Marcia McDonnell Holstad, DSN, FNP-BC, Associate Professor, Emory University
• ClinicalTrials.gov Identifier: NCT01786148
• Other Study ID Numbers: IRB00055077; 1R01NR012923
• First Posted: Feb 7, 2013
• Last Update Posted: Nov 29, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Marcia McDonnell Holstad, DSN, FNP-BC, Associate Professor, Emory University: HIV/AIDS; Adherence; Self-management; Antiretroviral therapy
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections

Study Results

Participant Flow

Recruitment Details	Participants were enrolled in the trial starting in June 2014 and randomized either to Educational music mobile app or to the Live Network mobile phone app

Arm/Group Title	Educational Music Mobile App	Live Network Mobile Phone App
Arm/Group Description	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. mobile phone application	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. mobile phone application
Period Title: Overall Study
STARTED	77	72
COMPLETED	55	50
NOT COMPLETED	22	22

Baseline Characteristics

Arm/Group Title	Educational Music Mobile App	Live Network Mobile Phone App	Total
Arm/Group Description	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. mobile phone application	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. mobile phone application	Total of all reporting groups
Overall Participants	77	72	149
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.4 (11.6)	37.3 (11.1)	39.4 (11.6)
Sex: Female, Male (Count of Participants)
Female	28 36.4%	23 31.9%	51 34.2%
Male	49 63.6%	49 68.1%	98 65.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.3%	1 1.4%	2 1.3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	61 79.2%	54 75%	115 77.2%
White	8 10.4%	15 20.8%	23 15.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	7 9.1%	2 2.8%	9 6%
Consider Yourself to be (Count of Participants)
Straight/Heterosexual	42 54.5%	29 40.3%	71 47.7%
Gay/Homosexual	28 36.4%	27 37.5%	55 36.9%
Bisexual	5 6.5%	12 16.7%	17 11.4%
None of the above	2 2.6%	4 5.6%	6 4%

Outcome Measures

1. Primary Outcome

Title	Change in Antiretroviral Therapy (ART) Adherence Rates
Description	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.
Time Frame	Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline

Outcome Measure Data

Analysis Population Description

Population included only subjects that were able to complete 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. The possible scores for this instrument range from 5 to 30, and higher scores reflect better adherence.

Arm/Group Title	Educational Music Mobile App	Live Network Mobile Phone App
Arm/Group Description	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. mobile phone application	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. mobile phone application
Measure Participants	64	60
Baseline	27.04 (4.23)	26.25 (5.18)
3 months	26.14 (4.81)	26.48 (5.39)
6 months	26.60 (5.48)	27.81 (3.90)
9 months	26.45 (5.90)	26.38 (5.99)

2. Secondary Outcome

Title	Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses.
Description	No data available due to inability of the lab to accurately extract drug from hair.
Time Frame	3, 6, and 9 months post-baseline

Outcome Measure Data

Analysis Population Description

Data were not collected.

Arm/Group Title	Educational Music Mobile App	Live Network Mobile Phone App
Arm/Group Description	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. mobile phone application	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. mobile phone application
Measure Participants	0	0

3. Secondary Outcome

Title	Clinical Indicator: Change in Mean CD4 Percentage
Description	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.
Time Frame	Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention

Outcome Measure Data

Analysis Population Description

Population includes participants with a valid CD4 sample analyzed.

Arm/Group Title	Educational Music Mobile App	Live Network Mobile Phone App
Arm/Group Description	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. mobile phone application	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. mobile phone application
Measure Participants	60	51
Baseline	21.87 (12.66)	26.07 (14.26)
3 months post-intervention	21.68 (12.37)	25.91 (12.32)
6 months post-intervention	27.08 (12.90)	26.23 (13.27)
9 months post-intervention	26.13 (11.92)	24.08 (14.08)
9 to 12 months post-intervention	24.80 (11.40)	26.39 (10.49)

4. Secondary Outcome

Title	Clinical Indicator: Number of Participants With Non-detectable Viral Load
Description	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.
Time Frame	Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention

Outcome Measure Data

Analysis Population Description

Only number of participants with available lab tests are included in this analysis.

Arm/Group Title	Educational Music Mobile App	Live Network Mobile Phone App
Arm/Group Description	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. mobile phone application	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. mobile phone application
Measure Participants	64	56
Baseline	25 32.5%	21 29.2%
3 months post-intervention	49 63.6%	35 48.6%
6 months post-intervention	40 51.9%	38 52.8%
9 months post-intervention	27 35.1%	33 45.8%
9 to 12 months post-intervention	26 33.8%	27 37.5%

Adverse Events

Time Frame	9 months post-baseline
Arm/Group Title	Educational Music Mobile App		Live Network Mobile Phone App
Arm/Group Description	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. mobile phone application		The Live Network (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. mobile phone application
All Cause Mortality
	Educational Music Mobile App		Live Network Mobile Phone App
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		1/72 (1.4%)
Serious Adverse Events
	Educational Music Mobile App		Live Network Mobile Phone App
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/72 (0%)
Other (Not Including Serious) Adverse Events
	Educational Music Mobile App		Live Network Mobile Phone App
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/72 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.