This trial is active, not recruiting.

Condition human immunodeficiency virus
Treatment mobile phone application
Sponsor Emory University
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
(Active Comparator)
A prerecorded program of songs on various topics in a mobile phone application (app). It is designed to provide education about non-health related topics and will be equivalent in length to the intervention app.
mobile phone application
The LN is a prerecorded mobile phone application (app). It employs a radio talk show format in which a Disc Jockey entertains HIV medication-, adherence-, and self-management-related questions and comments from callers and poses them to expert care providers, whose responses to these questions are augmented by songs that shed additional light on these issues.
mobile phone application

Primary Outcomes

Increased antiretroviral therapy (ART) adherence rates
time frame: up to 9 months post-baseline

Secondary Outcomes

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

Eligibility Criteria

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)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Emory University.