Music for Health Project

Human Immunodeficiency Virus Clinical Trial

— MFH  

Official title:

An Audio Music Self-Management Program to Improve ART Adherence in Rural GA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786148
• Other study ID #: IRB00055077
• Secondary ID: 1R01NR012923
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: November 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: June 30, 2017
• Est. primary completion date: April 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• mobile phone application

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline
Secondary	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.	3, 6, and 9 months post-baseline
Secondary	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.	Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
Secondary	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.	Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention