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Psychosocial Stress and Aging in HIV

14 de abril de 2022 actualizado por: Wake Forest University Health Sciences

The Syndemic of Stress and Aging in an HIV-infected Population

This study will begin to assess the association between perceived stress and enhanced aging in persons living with HIV (PLWH). The investigators suspect this relationship may be mediated by increased aging within the immune system and subsequent low-level inflammation that commonly leads to multiple illnesses and frailty as one ages. The findings from this study will identify potential diagnostic and therapeutic targets to improve the health of aging PLWH which could also apply to HIV-uninfected populations.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

While life expectancy has increased markedly for people living with HIV (PLWH), gains in expected years of life have come at a cost - earlier onset and greater frequency of age-associated comorbid conditions, such as osteoporosis, metabolic syndrome, and cardiovascular disease. Accumulated multi-morbidity is the likely cause of much higher than age-expected rates of frailty in PLWH. Perceived stress is prevalent in PLWH and, when present, associated with worse clinical outcomes, including poor engagement in HIV care, rapid progression to AIDS, and higher AIDS-related mortality. Stress is a well-documented risk factor for many illnesses that demonstrate early onset in PLWH, and perceived stress has been hypothesized to be a cause of aging itself. Nonetheless, the role of perceived stress in early-onset aging and age-related illness in PLWH is essentially unexplored. Investigating the interrelatedness of aging, perceived stress, and HIV may elucidate mechanism(s) that underlie a phenotype of premature aging and functional decline in HIV patients with implications for understanding fundamental mechanisms of stress and aging in HIV uninfected populations. The proposed randomized controlled study will estimate correlations between perceived stress and both aging and HIV-specific outcomes and will measure feasibility of a cell phone-delivered stress reduction intervention. Participants will complete structured interviews to measure cumulative life stress, perceived stress, intimate partner violence exposure (as a traumatic stressor), functional status, frailty, and potential covariates across the age spectrum in PLWH. Stress measures will be correlated with biomarkers known to be associated with functional decline in aging, HIV-uninfected populations. The findings from this exploratory R03, led by a New Investigator, will measure feasibility of mobile technology for stress reduction interventions and estimate correlations between perceived stress and markers of aging and HIV disease. The results will be used to determine sample sizes necessary to perform definitive studies to assess the link between perceived stress and a phenotype of premature aging, as well as interventional studies of stress modification to mitigate the onset of early multi-morbidity and functional decline. These findings can be applicable to both HIV-infected and HIV-uninfected populations.

Tipo de estudio

Intervencionista

Inscripción (Actual)

42

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

    • North Carolina
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Wake Forest University Health Sciences

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

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • HIV positive serostatus
  • Wake Forest ID clinic patient for at least 12 months
  • prescribed ART for at least 6 months
  • English fluency (cell phone app and some interview tools are only available in English)
  • consistent access to a smartphone

Exclusion Criteria:

  • ART-naive
  • unable to perform functional measures
  • recent (within 30 days) acute illness requiring medical therapy or hospitalization
  • immunosuppressive agents (e.g. > 20 mg/d prednisone or equivalent, chemotherapy, biologic immune-modulating agents) in the last 6 months
  • cancer requiring treatment within 3 years (except for non-melanoma skin cancer)
  • use of non-steroidal anti-inflammatory drugs more frequently than once per week within the last 30 days.

Criteria iii-vi are necessary because of their effects on biomarkers of aging

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: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Usual care
Participants randomized to this arm will have no change to their usual care
Experimental: Cell phone app
Participants randomized to this arm will use a stress reduction cell phone app called "Breathe2Relax" to assess feasibility and acceptability
The app teaches diaphragmatic breathing and has audiovisual coaching
Otros nombres:
  • aplicación de teléfono celular

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation of perceived stress with HIV virologic suppression
Periodo de tiempo: 12 weeks
Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with HIV viral load
12 weeks
Correlation of perceived stress with immune senescence
Periodo de tiempo: 12 weeks
Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with biomarkers of immune senescence, including IL-6, soluble CD-14, telomere length, and DNA methylation
12 weeks
Correlation of perceived stress with inflammation
Periodo de tiempo: 12 weeks
Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with biomarkers of inflammation (C-reactive protein, salivary cortisol)
12 weeks
Correlation of perceived stress with frailty phenotype
Periodo de tiempo: 12 weeks
Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with each participant's Fried Frailty Index score (comprised of 5 items, including weight loss, exhaustion, 4 meter walk time, physical activity, and grip strength).
12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility of a stress-reduction cell phone app
Periodo de tiempo: 12 weeks
This outcome will measure the accrual, adherence and retention of using a stress-reduction cell phone application in people aging with HIV through the randomized pilot study.
12 weeks
The effect of a cell phone app on stress-reduction
Periodo de tiempo: 12 weeks
The study will collect preliminary data on the efficacy of a cell phone-based stress reduction intervention versus usual care for improving markers of inflammation and aging, as well as HIV-specific outcomes.
12 weeks
Acceptability of a stress-reduction cell phone app
Periodo de tiempo: 12 weeks
An exit survey will measure the acceptability of using a stress-reduction cell phone application in people aging with HIV.
12 weeks

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Katherine R Schafer, MD, Associate professor

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 mayo de 2016

Finalización primaria (Actual)

14 de noviembre de 2017

Finalización del estudio (Actual)

14 de noviembre de 2017

Fechas de registro del estudio

Enviado por primera vez

4 de noviembre de 2016

Primero enviado que cumplió con los criterios de control de calidad

11 de noviembre de 2016

Publicado por primera vez (Estimar)

16 de noviembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de abril de 2022

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

14 de abril de 2022

Última verificación

1 de julio de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IRB00033537
  • 1R03AG048033-01A1 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

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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