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Incentives to Promote Medication Adherence Among HIV-Infected Youth

20. Juni 2016 aktualisiert von: St. Jude Children's Research Hospital

Investigation of Incentives to Promote Medication Adherence Among HIV-Infected Youth on Antiretroviral Therapy

Medication adherence is one of the most salient predictors of patient outcomes in the era following development of effective treatment for HIV infection. Evolving strategies to improve adherence, specifically incentive interventions and real-time medication monitoring, have shown some success in limited studies. Further investigation into incentive interventions for HIV-infected adolescents with poor medication adherence is necessary.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

PRIMARY OBJECTIVE:

  • To describe the effects of a novel incentive intervention model on HIV-infected youths' patterns of antiretroviral medication adherence.

SECONDARY OBJECTIVES:

  • To evaluate the feasibility of an outpatient incentive intervention model.
  • To assess participant satisfaction with the incentive intervention model.
  • To evaluate the effect of an outpatient incentive intervention model on targeted health behaviors (numbers of missed appointments and STI diagnoses).
  • To measure the effect of the incentive intervention on HIV viral load and CD4+ count.
  • To determine the overall and per patient cost of the incentive intervention model.
  • To describe associations between adherence measures: real-time medication monitor data, pharmacy pill count, pharmacy prescription pick-up data, medication possession ratio, and self-report.

Upon enrollment, participants will receive education and a real-time medication monitor. Participants will be followed monthly in the clinic and will be prescribed thirty-day supplies of medication. During weeks 1-4 participants will establish a baseline with the real-time medication monitor. During weeks 5-28, participants will receive remote incentives based on their level of medication adherence as measured by the real-time medication monitor. Additional lottery-style incentives will occur at regular follow-up visits. No incentives will be applied during weeks 29-48. Participants will complete the protocol at the week 48 visit.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

25

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Tennessee
      • Memphis, Tennessee, Vereinigte Staaten, 38105
        • St. Jude Children's Research Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

16 Jahre bis 24 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Youth with HIV who meet eligibility criteria.

Beschreibung

Inclusion Criteria:

  • ≥16 and ≤ 24 years old
  • Documented diagnosis of HIV
  • Adolescent is aware of his/her HIV diagnosis
  • Adolescent understands either written or spoken English.
  • Adolescent is willing and able to provide informed consent or assent.
  • Adolescent has access to a phone and the internet at the time of enrollment.

  • Adolescent meets the definition of inadequate ARV adherence, which is any of the following in the previous 12 months:

    • < 80% adherent to any ARV by pharmacy pill count
    • ≥ 7 days delay in scheduled ARV prescription pick-up
    • Detectable viral load after being on ARVs for at least 12 weeks

Exclusion Criteria:

  • Adolescent has a documented diagnosis of mental retardation or a significant motor or sensory impairment that would preclude participation.
  • Adolescent has a documented acute psychiatric illness, including suicidal ideation, homicidal ideation or active psychosis.
  • Adolescent was diagnosed with HIV in the previous 6 months.
  • Adolescent has a planned transition to alternative care setting prior to study completion (e.g. relocation, pregnancy or planned pregnancy, transition to adult care).
  • Concurrent enrollment on a research study with an intervention targeted at increasing adherence to antiretroviral regimens.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Interessent

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Study Participants
All participants who meet eligibility requirements and who consent to participation will use an incentive intervention model.
Verhalten: Incentive intervention model
All participants will receive a real-time electronic medication monitor to monitor daily pill-taking behavior. Participants with qualifying levels of adherence will receive a weekly incentive during the intervention period. At all clinic visits participants will participate in a lottery incentive to reinforce clinic attendance and negative STI screening tests.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of dosages taken within 2 hours of prescribed time per month
Zeitfenster: Monthly through week 48
Data collected by a real-time medication monitor that records pillbox opening times.
Monthly through week 48
Pharmacy pill count
Zeitfenster: Monthly from 6 months prior to study start through week 48
Pharmacy pill count data is collected at each participant encounter, approximately once per month.
Monthly from 6 months prior to study start through week 48

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility - Accrual percentage
Zeitfenster: End of study (week 48)
Number of people enrolled in study/number approached for enrollment.
End of study (week 48)
Feasibility - Drop out rate
Zeitfenster: End of study (week 48)
Number of people ending protocol early/ total enrollment
End of study (week 48)
Feasibility - Participant reported device concerns
Zeitfenster: End of study (week 48)
Problems with the Wisepill devices as spontaneously reported by participants or as assessed at routine follow-up.
End of study (week 48)
Feasibility - Device replacement rate
Zeitfenster: End of study (week 48)
Number of devices requiring replacement due to loss/theft/breakage
End of study (week 48)
Feasibility - Contact failure rate
Zeitfenster: End of study (week 48)
Number of failed attempts to contact participants/total number of contact attempts made
End of study (week 48)
Feasibility - Staff hours per week
Zeitfenster: End of study (week 48)
Hours spent providing remote incentives
End of study (week 48)
Feasibility - Adverse effects of incentives
Zeitfenster: End of study (week 48)
Unexpected risks/harms of providing incentives as self-reported by participants.
End of study (week 48)
Percentage of participants who are satisfied with the incentive intervention
Zeitfenster: Enrollment (week 0) and end of study (week 48)
To assess participant satisfaction with the incentive intervention model. Patient satisfaction, assessed by ACASI survey, will be summarized and tabulated for baseline (week 0) and follow-up (week 48) measurements.
Enrollment (week 0) and end of study (week 48)
Effect of incentives on missed appointment rate
Zeitfenster: Enrollment (week 0) and end of study (week 48)
Descriptive statistics of numbers of missed appointments such as mean, interquartile range and median, during each study phase will be computed and compared
Enrollment (week 0) and end of study (week 48)
Effect of incentives on STI rates
Zeitfenster: Enrollment (week 0) and end of study (week 48)
Descriptive statistics of numbers of STI rates such as mean, interquartile range and median, during each study phase will be computed and compared
Enrollment (week 0) and end of study (week 48)
Change in biological parameters
Zeitfenster: At weeks 0, 12, 24, 36 and 48
To measure the effect of the incentive intervention on HIV viral load and CD4+ count. HIV viral load and CD4+ count measured at week 0, 12, 24, 36 and 48 will be summarized and plotted by descriptive statistics, such as mean and standard deviation. Mixed effects models will be applied to explore the effect of the intervention on HIV viral load and CD4+ count.
At weeks 0, 12, 24, 36 and 48
Overall cost of incentive intervention
Zeitfenster: End of study (week 48)
To determine the overall and per patient cost of the incentive intervention model the accumulated overall and per patient cost till week 48 will be summarized and tabulated.
End of study (week 48)
Association between adherence measures
Zeitfenster: End of study (week 48)
To describe associations between adherence measures: Wisepill data, pharmacy pill count, pharmacy prescription pick-up data, medication possession ratio, and self-report. Associations of Wisepill adherence rates with pill count and pick up rates will be described by Pearson or Spearman's correlation coefficients and intraclass correlation coefficients as appropriate.
End of study (week 48)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

St. Jude Children's Research Hospital

Ermittler

  • Hauptermittler: Ronald Dallas, PhD, St. Jude Children's Research Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2014

Primärer Abschluss (Tatsächlich)

1. Juni 2016

Studienabschluss (Tatsächlich)

1. Juni 2016

Studienanmeldedaten

Zuerst eingereicht

30. Juli 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Juli 2014

Zuerst gepostet (Schätzen)

1. August 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

21. Juni 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Juni 2016

Zuletzt verifiziert

1. Juni 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • INMED

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