Music for Health Project

Browse trials for

• Acquired Immunodeficiency Syndrome 2,040
• HIV Infections 4,258

Keywords

• HIV/AIDS
• Adherence
• Self-management
• Antiretroviral therapy

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 149 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Study arms

• 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

Interventions

• Behavioralmobile phone application

Primary outcomes

1. Change in Antiretroviral Therapy (ART) Adherence Rates

   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

Secondary outcomes

1. Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses.

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

   Time frame: 3, 6, and 9 months post-baseline

2. Clinical Indicator: Change in Mean CD4 Percentage

   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

3. Clinical Indicator: Number of Participants With Non-detectable Viral Load

   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

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Mar 4, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No