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Supporting Treatment Adherence Readiness Through Training (START) (START)

5 de octubre de 2020 actualizado por: RAND

Controlled Evaluation of the Adherence Readiness Program for ART Adherence

Multi-site, randomized controlled trial of the Adherence Readiness Program (ARP) adherence intervention for HIV clients starting or restarting antiretroviral therapy (ART) for the purpose of achieving and sustaining optimal levels of ART adherence and virologic suppression. Eligible participants will be randomized to receive either the ARP intervention or usual care (no intervention) and followed for 24 months.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

This study will evaluate the effects of the Adherence Readiness Program (ARP) intervention on the primary outcomes of dose-taking HIV antiretroviral (ART) adherence and undetectable HIV viral load in a multi-site randomized controlled trial. The ARP is based on the Information Motivation Behavioral skills (IMB) model of behavior change and includes (1) brief pill taking practice trials for enhancing pre-treatment adherence counseling and providing a behavioral criterion for determining adherence readiness and the start of treatment, and (2) a performance driven dose regulation mechanism to tailor the amount of counseling (from pre-treatment through the full course of treatment) to the individual needs of the patient and conserve limited resources. Participants will be randomized to receive either the ARP (adherence counseling sessions) or usual care. Primary assessments will be administered at screening and every 6 months after ART initiation over a 24-month follow-up, making it one of the few studies to examine intervention effects longer than one year. Secondary outcomes include dose-timing adherence and CD4 count. If effective, the ARP will provide clinicians with an intervention that (1) informs providers and patients when the patient is ready to adhere well and start treatment, (2) enhances adherence readiness from the outset of treatment through the full course of therapy, and (3) tailors the amount of adherence support based on individual patient need and performance, thus more efficiently using clinic resources, fostering better acceptance from providers and patients, and increasing the likelihood of successful program adoption and dissemination. This emphasis on efficient use of resources will be complemented by a cost-effectiveness analysis to further inform policy decisions regarding the transportability of the intervention and its potential for more wide scale use and sustainability if effective.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

240

Fase

  • No aplica

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

    • California
      • Long Beach, California, Estados Unidos
        • CaRe Clinic
      • Los Angeles, California, Estados Unidos
        • T.H.E. Clinic
      • Los Angeles, California, Estados Unidos
        • UCLA CARE Center

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. The patient's provider views the patient as medically appropriate to begin (ART naïve) or restart ART (has been off ART for at least 2 months), and either

    • plans to start the patient on ART
    • would like to start the patient on ART but the provider or patient is uncertain about the patient's readiness to adhere well.

    Patients who are currently on ART are also eligible if they meet the following criteria, which are specific only to this type of patient:

    i) the patient has 2 or more HIV viral load tests in the past year > 1000 copies/ml ii) the patient has had no HIV viral load tests that were undetectable in the past year iii) the patient has a genotype in the past year that does not show resistance as a reason for virologic failure (detectable viral load) iv) primary care provider views the patient as a good candidate for the study, with the understanding that the patient will interrupt ART if assigned to the intervention.

    Criteria i to iii are intended to define a subgroup of nonadherent patients who are taking very little of their ART medications, as evidenced by the combination of consistently high viral load and no drug resistance. If the patient was taking at least a moderate level of drug and still had consistently high viral load, than they would have evidence of drug resistance. Providers are generally comfortable with this type of patient stopping their medication in order to facilitate the pre-treatment, adherence readiness assessment and training phase of the intervention prior to restarting the patient on treatment.

  2. The patient's health status is stable. There is no current acute OI or medical condition that calls for immediate ART, as determined by the patient's provider.
  3. Most recent HIV viral load is detectable.
  4. If CD4 < 200, the patient is on or will be prescribed prophylactic medication
  5. Patient is 18 or older.
  6. Patient is able and willing to give informed consent.
  7. English speaking.

Exclusion Criteria:

1. Patient just tested HIV+ and their provider suspects the patient may be acutely or recently infected (within past 6 months).

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

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: ARP intervention
Adherence counseling intervention
The ARP consists of pre-treatment (including practice trials to determine readiness for and timing of ART initiation), early-treatment, and ongoing maintenance training (using a performance-based, dose regulation mechanism to tailor the amount and intensity) phases
Sin intervención: usual care
no intervention, standard care practices regarding adherence support

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HIV virologic suppression
Periodo de tiempo: Month 24
undetectable HIV viral load at time of assessment
Month 24
log change in HIV viral load (log change in HIV RNA levels)
Periodo de tiempo: Month 24
log change in HIV RNA levels from baseline to Month 24.
Month 24
optimal dose-taking adherence (whether at least 85% of prescribed doses were taken)
Periodo de tiempo: Month 24
binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 24
Month 24
percent dose-taking adherence
Periodo de tiempo: Month 24
percent of prescribed doses taken between baseline and Month 24
Month 24
HIV virologic suppression
Periodo de tiempo: Month 6
undetectable HIV viral load at time of assessment
Month 6
log change in HIV viral load (log change in HIV RNA levels)
Periodo de tiempo: Month 6
log change in HIV RNA levels from baseline to Month 6
Month 6
optimal dose-taking adherence (whether at least 85% of prescribed doses were taken)
Periodo de tiempo: month 6
binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 6
month 6
percent dose-taking adherence
Periodo de tiempo: month 6
percent of prescribed doses taken between baseline and Month 6
month 6

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
dose-timing adherence
Periodo de tiempo: Month 24
percent of prescribed doses taken within correct time-window between baseline and Month 24
Month 24
dose-timing adherence
Periodo de tiempo: Month 6
percent of prescribed doses taken within correct time-window between baseline and Month 6
Month 6
optimal dose-timing adherence
Periodo de tiempo: Month 24
binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 24
Month 24
optimal dose-timing adherence
Periodo de tiempo: Month 6
binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 6
Month 6
change in CD4 count
Periodo de tiempo: Month 24
change in CD4 count from baseline to Month 24
Month 24
change in CD4 count
Periodo de tiempo: Month 6
change in CD4 count from baseline to Month 6
Month 6
clinic attendance (number of missed clinic appointments)
Periodo de tiempo: Month 24
number of missed clinic appointments between baseline and Month 24
Month 24
clinic attendance (number of missed clinic appointments)
Periodo de tiempo: Month 6
number of missed clinic appointments between baseline and Month 6
Month 6

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Glenn Wagner, PhD, RAND

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.

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 (Actual)

1 de febrero de 2015

Finalización primaria (Actual)

30 de marzo de 2020

Finalización del estudio (Actual)

30 de marzo de 2020

Fechas de registro del estudio

Enviado por primera vez

22 de diciembre de 2014

Primero enviado que cumplió con los criterios de control de calidad

31 de diciembre de 2014

Publicado por primera vez (Estimar)

1 de enero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de octubre de 2020

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

5 de octubre de 2020

Última verificación

1 de octubre de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • MH104086

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

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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