Depression and ART Adherence in HIV+ Latinos
15 de marzo de 2018 actualizado por: Jane Simoni, University of Washington
Addressing Depression and ART Adherence in HIV+ Latinos on the U.S.-Mexico Border
The current HIV treatment adherence project was designed to adapt culturally and then pilot test an empirically supported cognitive-behavioral therapy program for adherence and symptoms of depression (CBT-AD)with HIV+ Latinos living on the U.S.-Mexico Border.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Additionally, the investigators will assess the feasibility and efficacy of a novel medication monitoring and reminder system (MedSignals®) in the form of an electronic pillbox with monitoring and reminding functions that is available in a Spanish-language version.
Our hypotheses are grounded in a conceptual model proposing that the CBT-AD intervention will improve problem-solving ability and decrease depressive symptomatology, which will directly improve biomedical outcomes of HIV-1 RNA viral load and CD4 as well as indirectly improve biomedical outcomes through increased motivation, improved memory, and better medication adherence.
Evaluating and implementing generalizable and sustainable mental health and adherence interventions such as the ones proposed are urgently needed in the region to improve HIV treatment outcomes and thwart the development and transmission of drug resistant virus.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
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
-
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Texas
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El Paso, Texas, Estados Unidos, 79925
- Centro de Salud Familiar La Fe CARE Center
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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:
- HIV+ participants (a) currently receiving HIV care at La Fe CARE Center (study site);
- 18 years of age or older;
- Latino (i.e., self-identified as being of Mexican heritage);
- English- or Spanish-speaking
- capable of giving informed consent;
- currently on a prescribed antiretroviral regimen;
- suboptimally adherent (i.e., demonstrated either by a VL load taken in the last 12 months that is above the undetectable threshold of 50 mL copies or self-reporting a missed dose in the last two weeks);
- exhibiting some depressive symptomatology (i.e., scoring on the Beck Depression Inventory-1A 10 or above), and (i) male or female (including transgender Female-to-Male and Male-To-Female.
Exclusion Criteria:
- actively psychotic or so cognitively impaired that they cannot participate,
- so physically ill as to be unable to come to the clinic to participate in the intervention, OR
- Report The use of crack, cocaine, heroin, OR methamphetamines to any extent in the past 40 days.
- Those who are planning on being away from the area for any extended period during the study (as in the case of seasonal workers) or whom
- have household members already enrolled in the study will also be excluded. We did choose to restrict study eligibility to individuals of Mexican descent.
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cognitive-Behavioral Therapy (CBT-AD)
This arm type is a cognitive-behavioral therapy program intervention for issues of medication adherence and depression.
The intervention is a therapy program intervention involves 10-weekly or biweekly sessions, with 2 booster session, and focused on psychoeducation, behavioral activation, cognitive restructuring, and problem-solving.
A letter was sent to their medical provider indicating that mild symptoms of depression were detected and that they were enrolled in this intervention, but no details were provided regarding their assignment to one of two conditions/arms.
|
CBT-AD is a therapy program intervention that uses one-on-one and face-to-face patient-therapist sessions.
Otros nombres:
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Sin intervención: Control-Standard Care
Those randomized to the control condition are not involved in the CBT-AD therapy intervention.
They receive standard care as usual.
A letter was sent to their medical provider indicating that mild symptoms of depression were detected and that they were enrolled in this intervention, but no details were provided regarding their assignment to one of two conditions/arms.
The participants in the control arm are followed and matched to a participant in the intervention arm.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a
Periodo de tiempo: MADRS and BDI-1a scores at 6 and 9-month follow-up
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MADRS and BDI-1a scores at 6 and 9-month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Self-Report Adherence
Periodo de tiempo: Self-reported adherence at 6 and 9-month follow-up
|
Self-reported adherence was assessed with the visual analog scale (VAS).
The VAS is a 10cm line that is shown to patients who then mark on the line (from 0 to 100% in 1cm intervals) how much medication they have taken.
Higher scores indicate better adherence.
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Self-reported adherence at 6 and 9-month follow-up
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MedSignals Electronic Pill-box for Adherence
Periodo de tiempo: 6 and 9 month follow-up adherence scores
|
The MedSignals electronic pill-box is a storage bin that allows participants to store medications.
In the treatment condition, the pill-box provides audio commands to alarm participants that it is time to take their medication.
The pill-box stores adherence data (time, number of openings).
In the control condition, the pill-box does not alarm participants but serves in the same capacity otherwise.
All data is uploaded electronically.
Higher numbers indicate better adherence that correspond to pill-box openings corresponding to the designated time of taking their medication.
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6 and 9 month follow-up adherence scores
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jane M Simoni, Ph.D., University of Washington
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 2008
Finalización primaria (Actual)
1 de agosto de 2011
Finalización del estudio (Actual)
1 de enero de 2012
Fechas de registro del estudio
Enviado por primera vez
25 de julio de 2011
Primero enviado que cumplió con los criterios de control de calidad
5 de agosto de 2011
Publicado por primera vez (Estimar)
8 de agosto de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de marzo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
15 de marzo de 2018
Última verificación
1 de marzo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 35279
- R34MH084674 (Subvención/contrato del NIH de EE. UU.)
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
producto fabricado y exportado desde los EE. UU.
No
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