Trial Outcomes & Findings for Music for Health Project (NCT NCT01786148)
NCT ID: NCT01786148
Last Updated: 2019-11-29
Results Overview
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.
COMPLETED
NA
149 participants
Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline
2019-11-29
Participant Flow
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
Participant milestones
| Measure |
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.
mobile phone application
|
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.
mobile phone application
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
72
|
|
Overall Study
COMPLETED
|
55
|
50
|
|
Overall Study
NOT COMPLETED
|
22
|
22
|
Reasons for withdrawal
| Measure |
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.
mobile phone application
|
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.
mobile phone application
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
13
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
7
|
|
Overall Study
Incarceration
|
1
|
1
|
Baseline Characteristics
Music for Health Project
Baseline characteristics by cohort
| Measure |
Live Network Mobile Phone App
n=72 Participants
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
n=149 Participants
Total of all reporting groups
|
Educational Music Mobile App
n=77 Participants
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
|
|---|---|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
39.4 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
54 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=5 Participants
|
|
Consider Yourself to be
Straight/Heterosexual
|
29 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
42 Participants
n=5 Participants
|
|
Consider Yourself to be
Gay/Homosexual
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
28 Participants
n=5 Participants
|
|
Consider Yourself to be
Bisexual
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
|
Consider Yourself to be
None of the above
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baselinePopulation: 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.
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.
Outcome measures
| Measure |
Educational Music Mobile App
n=64 Participants
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
|
Live Network Mobile Phone App
n=60 Participants
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
|
|---|---|---|
|
Change in Antiretroviral Therapy (ART) Adherence Rates
Baseline
|
27.04 score on a scale
Standard Deviation 4.23
|
26.25 score on a scale
Standard Deviation 5.18
|
|
Change in Antiretroviral Therapy (ART) Adherence Rates
3 months
|
26.14 score on a scale
Standard Deviation 4.81
|
26.48 score on a scale
Standard Deviation 5.39
|
|
Change in Antiretroviral Therapy (ART) Adherence Rates
6 months
|
26.60 score on a scale
Standard Deviation 5.48
|
27.81 score on a scale
Standard Deviation 3.90
|
|
Change in Antiretroviral Therapy (ART) Adherence Rates
9 months
|
26.45 score on a scale
Standard Deviation 5.90
|
26.38 score on a scale
Standard Deviation 5.99
|
SECONDARY outcome
Timeframe: 3, 6, and 9 months post-baselinePopulation: Data were not collected.
No data available due to inability of the lab to accurately extract drug from hair.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-interventionPopulation: Population includes participants with a valid CD4 sample analyzed.
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.
Outcome measures
| Measure |
Educational Music Mobile App
n=60 Participants
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
|
Live Network Mobile Phone App
n=51 Participants
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
|
|---|---|---|
|
Clinical Indicator: Change in Mean CD4 Percentage
Baseline
|
21.87 percentage of CD4
Standard Deviation 12.66
|
26.07 percentage of CD4
Standard Deviation 14.26
|
|
Clinical Indicator: Change in Mean CD4 Percentage
3 months post-intervention
|
21.68 percentage of CD4
Standard Deviation 12.37
|
25.91 percentage of CD4
Standard Deviation 12.32
|
|
Clinical Indicator: Change in Mean CD4 Percentage
6 months post-intervention
|
27.08 percentage of CD4
Standard Deviation 12.90
|
26.23 percentage of CD4
Standard Deviation 13.27
|
|
Clinical Indicator: Change in Mean CD4 Percentage
9 months post-intervention
|
26.13 percentage of CD4
Standard Deviation 11.92
|
24.08 percentage of CD4
Standard Deviation 14.08
|
|
Clinical Indicator: Change in Mean CD4 Percentage
9 to 12 months post-intervention
|
24.80 percentage of CD4
Standard Deviation 11.40
|
26.39 percentage of CD4
Standard Deviation 10.49
|
SECONDARY outcome
Timeframe: Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-interventionPopulation: Only number of participants with available lab tests are included in this analysis.
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.
Outcome measures
| Measure |
Educational Music Mobile App
n=64 Participants
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
|
Live Network Mobile Phone App
n=56 Participants
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
|
|---|---|---|
|
Clinical Indicator: Number of Participants With Non-detectable Viral Load
Baseline
|
25 Participants
|
21 Participants
|
|
Clinical Indicator: Number of Participants With Non-detectable Viral Load
3 months post-intervention
|
49 Participants
|
35 Participants
|
|
Clinical Indicator: Number of Participants With Non-detectable Viral Load
6 months post-intervention
|
40 Participants
|
38 Participants
|
|
Clinical Indicator: Number of Participants With Non-detectable Viral Load
9 months post-intervention
|
27 Participants
|
33 Participants
|
|
Clinical Indicator: Number of Participants With Non-detectable Viral Load
9 to 12 months post-intervention
|
26 Participants
|
27 Participants
|
Adverse Events
Educational Music Mobile App
Live Network Mobile Phone App
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place