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Music for Health Project (MFH)

12. november 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

149

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Adfærdsmæssigt: mobile phone application
Eksperimentel: 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.
Adfærdsmæssigt: mobile phone application

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Antiretroviral Therapy (ART) Adherence Rates
Tidsramme: Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline
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.
Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses.
Tidsramme: 3, 6, and 9 months post-baseline
No data available due to inability of the lab to accurately extract drug from hair.
3, 6, and 9 months post-baseline
Clinical Indicator: Change in Mean CD4 Percentage
Tidsramme: Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
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.
Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
Clinical Indicator: Number of Participants With Non-detectable Viral Load
Tidsramme: Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention
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.
Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Emory University

Samarbejdspartnere

National Institute of Nursing Research (NINR)

Efterforskere

  • Ledende efterforsker: Marcia M Holstad, PhD, Emory University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2014

Primær færdiggørelse (Faktiske)

19. april 2017

Studieafslutning (Faktiske)

30. juni 2017

Datoer for studieregistrering

Først indsendt

5. februar 2013

Først indsendt, der opfyldte QC-kriterier

6. februar 2013

Først opslået (Skøn)

7. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00055077
  • 1R01NR012923 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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