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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | mobile 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.