Clinical Trials Directory

Trials / Completed

CompletedNCT01786148

Music for Health Project

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
149 (actual)
Sponsor
Emory University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALmobile phone application

Timeline

Start date
2014-06-01
Primary completion
2017-04-19
Completion
2017-06-30
First posted
2013-02-07
Last updated
2019-11-29
Results posted
2019-11-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01786148. Inclusion in this directory is not an endorsement.