Music for Health Project (MFH)
12 november 2019 bijgewerkt door: Marcia McDonnell Holstad, DSN, FNP-BC, Emory University
An Audio Music Self-Management Program to Improve ART Adherence in Rural GA
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
149
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Emory University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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.
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Experimenteel: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Antiretroviral Therapy (ART) Adherence Rates
Tijdsspanne: Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline
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Adherence rate was measured with the Antiretroviral General Adherence Scale (AGAS) which measures the general ease and ability to take one's medication as prescribed in the past 30 days.
It includes 5 items scored 1 to 6, with the possible scores for this instrument ranging from 5 to 30, and higher scores reflect better adherence.
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Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses.
Tijdsspanne: 3, 6, and 9 months post-baseline
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No data available due to inability of the lab to accurately extract drug from hair.
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3, 6, and 9 months post-baseline
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Clinical Indicator: Change in Mean CD4 Percentage
Tijdsspanne: Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
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CD4 count is a test that measures the number of CD4 cells in your blood.
CD4 cells, also known as T cell lymphocytes, are white blood cells that fight infection and play an important role in your immune system.
A CD4 count is used to check the health of the immune system in people infected with HIV (human immunodeficiency virus).
The count measures the number of CD4 cells in a small sample of blood.
The percent of CD4 cells measure the percentage of all lymphocytes that are CD4 cells.
The study assesses the percentage of CD4 lymphocytes over time.
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Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
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Clinical Indicator: Number of Participants With Non-detectable Viral Load
Tijdsspanne: Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
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Change in number of participants with viral load presented as number of copies if <50 copies versus ≥ 50 copies.
Subjects were coded as having non-detectable viral loads if the "load" was < 50 copies.
The analyses performed reflects the number of subjects with non-detectable load (<50) at Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention.
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Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Marcia M Holstad, PhD, Emory University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2014
Primaire voltooiing (Werkelijk)
19 april 2017
Studie voltooiing (Werkelijk)
30 juni 2017
Studieregistratiedata
Eerst ingediend
5 februari 2013
Eerst ingediend dat voldeed aan de QC-criteria
6 februari 2013
Eerst geplaatst (Schatting)
7 februari 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 november 2019
Laatste update ingediend die voldeed aan QC-criteria
12 november 2019
Laatst geverifieerd
1 november 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- Langzame virusziekten
- HIV-infecties
- Verworven Immunodeficiëntie Syndroom
Andere studie-ID-nummers
- IRB00055077
- 1R01NR012923 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .