Music for Health Project

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.

• mobile phone application (Behavioral)

Primary outcomes

• 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 outcomes

• 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.
• 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.
• 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.

Sex: All, ages: 18 Years to any

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)

Participant flow

Outcome results

• Change in Antiretroviral Therapy (ART) Adherence Rates (Primary), Mean, score on a scale: Educational Music Mobile App 27.04 +/- 4.23; Live Network Mobile Phone App 26.25 +/- 5.18
• Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses. (Secondary)
• Clinical Indicator: Change in Mean CD4 Percentage (Secondary), Mean, percentage of CD4: Educational Music Mobile App 21.87 +/- 12.66; Live Network Mobile Phone App 26.07 +/- 14.26
• Clinical Indicator: Number of Participants With Non-detectable Viral Load (Secondary), Count of participants, Participants: Educational Music Mobile App 25; Live Network Mobile Phone App 21

Adverse events

Time frame: 9 months post-baseline

• Study Protocol and Statistical Analysis Plan (PDF, 2016-03-04)

• Marcia M Holstad, PhD, Principal investigator, Emory University

NIH grants: R01NR012923