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Incentives to Promote Medication Adherence Among HIV-Infected Youth

20 de junio de 2016 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

25

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38105
        • St. Jude Children's Research Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

16 años a 24 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Youth with HIV who meet eligibility criteria.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Study Participants
All participants who meet eligibility requirements and who consent to participation will use an incentive intervention model.
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of dosages taken within 2 hours of prescribed time per month
Periodo de tiempo: Monthly through week 48
Data collected by a real-time medication monitor that records pillbox opening times.
Monthly through week 48
Pharmacy pill count
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility - Accrual percentage
Periodo de tiempo: End of study (week 48)
Number of people enrolled in study/number approached for enrollment.
End of study (week 48)
Feasibility - Drop out rate
Periodo de tiempo: End of study (week 48)
Number of people ending protocol early/ total enrollment
End of study (week 48)
Feasibility - Participant reported device concerns
Periodo de tiempo: 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
Periodo de tiempo: End of study (week 48)
Number of devices requiring replacement due to loss/theft/breakage
End of study (week 48)
Feasibility - Contact failure rate
Periodo de tiempo: 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
Periodo de tiempo: End of study (week 48)
Hours spent providing remote incentives
End of study (week 48)
Feasibility - Adverse effects of incentives
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

St. Jude Children's Research Hospital

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2014

Finalización primaria (Actual)

1 de junio de 2016

Finalización del estudio (Actual)

1 de junio de 2016

Fechas de registro del estudio

Enviado por primera vez

30 de julio de 2014

Primero enviado que cumplió con los criterios de control de calidad

30 de julio de 2014

Publicado por primera vez (Estimar)

1 de agosto de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

21 de junio de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

20 de junio de 2016

Última verificación

1 de junio de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • INMED

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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