Music for Health Project (MFH)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Human Immunodeficiency Virus |
Behavioral: mobile phone application |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | An Audio Music Self-Management Program to Improve ART Adherence in Rural GA |
- Increased antiretroviral therapy (ART) adherence rates [ Time Frame: up to 9 months post-baseline ] [ Designated as safety issue: No ]
- Significantly higher mean levels of ART drug levels in hair sample analyses. [ Time Frame: 3, 6, and 9 months post-baseline ] [ Designated as safety issue: No ]
- Mediators and Moderators [ Time Frame: 3, 6, 9 months post baseline ] [ Designated as safety issue: No ]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.
- Clinical indicators [ Time Frame: 3, 6, and 9 months post-baseline ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 240 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Educational music mobile app
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.
|
Behavioral: mobile phone application |
|
Experimental: Live Network mobile phone App
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.
|
Behavioral: mobile phone application |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 1) HIV infection; 2) initiating ART for the first time (except women who may have had ART during pregnancy) or changing ART regimen within the past 3 months due to side effects or virologic resistance; 3) ≥18 years of age; 4) English speaking; and 5) willing to use smart phone and app, complete 4 assessments, monthly PC, and collection of hair samples, be randomly assigned to either condition, and participate in study activities.
Exclusion Criteria:
- be a history of, or self-identified bilateral hearing loss, cognitive impairment (inability to comprehend the informed consent), or psychotic symptoms (Brief Symptom Inventory; BSI).
Contacts and Locations| Contact: Marcia M Holstad, DSN | 404-727-1307 | nurmmcd@emory.edu |
| Contact: Derek Jobe, BS | 404-727-2589 | djobe@emory.edu |
| United States, Georgia | |
| Emory University | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: Marcia M Holstad, DSN | |
| Principal Investigator: | Marcia M Holstad, DSN | Emory University |
More Information
No publications provided
| Responsible Party: | Marcia McDonnell Holstad, DSN, FNP-BC, Associate Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT01786148 History of Changes |
| Other Study ID Numbers: | 1R01NR012923, 1R01NR012923 |
| Study First Received: | February 5, 2013 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
HIV/AIDS Adherence Self-management Antiretroviral therapy |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013