Music for Health Project
This trial is active, not recruiting.
|Condition||human immunodeficiency virus|
|Treatment||mobile phone application|
|Collaborator||National Institute of Nursing Research (NINR)|
|Start date||June 2014|
|End date||March 2017|
|Trial size||149 participants|
|Trial identifier||NCT01786148, 1R01NR012923, IRB00055077|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Primary purpose||supportive care|
Increased antiretroviral therapy (ART) adherence rates
time frame: up to 9 months post-baseline
Significantly higher mean levels of ART drug levels in hair sample analyses.
time frame: 3, 6, and 9 months post-baseline
Mediators and Moderators
time frame: 3, 6, 9 months post baseline
Male or female participants at least 18 years old.
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)
|Official title||An Audio Music Self-Management Program to Improve ART Adherence in Rural GA|
|Principal investigator||Marcia M Holstad, DSN|
|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.|
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