Clinical trial NCT01786148: Music for Health Project
Official title: An Audio Music Self-Management Program to Improve ART Adherence in Rural GA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: HIV/AIDS
Adherence
Self-management
Antiretroviral therapy
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-02-07
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Antiretroviral Therapy (ART) Adherence Rates
timeFrame: Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline
Secondary outcomes:
measure: Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses.
timeFrame: 3, 6, and 9 months post-baseline
measure: Clinical Indicator: Change in Mean CD4 Percentage
timeFrame: Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
measure: Clinical Indicator: Number of Participants With Non-detectable Viral Load
timeFrame: Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Marcia M Holstad, PhD
role: PRINCIPAL_INVESTIGATOR
References: