- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05785169
Poner fin a la epidemia del VIH con equidad: una intervención para reducir el impacto del racismo y la discriminación
Poner fin a la epidemia del VIH: una intervención integral para reducir el impacto del racismo estructural y la discriminación en los pacientes y la atención médica
The scope of this study is to engage Ryan White HIV/AIDS Program (RWHAP) funded organizations in the South/East US to co-develop context-responsive programs utilizing evidence-informed interventions to reduce stigma against living with HIV (PLH) who have difficulties accessing and remaining engaged in life-saving treatment. Five RWHAP clinics will be selected for this trial. Clinic members will participate in interactive trainings to raise awareness of and reduce stigma, from the clinic policy level to individual attitudes. Clinic members and select patients will complete self-administered surveys every 6 months over 24 months.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The scope of this study is to engage HIV care clinics in the United States to co-develop context-responsive programs utilizing evidence-informed interventions to reduce processes and practices perceived as stigmatizing by people living with HIV who have difficulties accessing and remaining engaged in life-saving treatment. HIV-related stigma in a clinical setting directly impacts access to and uptake of healthcare, including engagement in HIV care services. The proposed intervention draws on the evidence-based Health Policy Plus (HP+) 'total' facility HIV stigma-reduction intervention that focuses on the clinics' organizational and interpersonal levels to strengthen patient care and engagement in services, and staff wellbeing. We will conduct an implementation trial of our HIV stigma-reduction intervention. Clinics will receive training to support them in 1) identifying/creating organizational-level policies and practices (e.g., clear understanding of what practices can be experienced as stigmatizing) to reduce HIV stigma, and 2) deliver participatory trainings to all staff (e.g., building awareness of the impact of patient perceptions and experiences of HIV-related stigma on health). In Aim 3, we will evaluate outcomes, including at the organization (primary outcome of Stigma Reduction Index - ratings of mission/vision statements, policies around HIV stigma, comfort level in clinics), interpersonal (secondary outcomes of provider/staff attitudes; behavior), and individual patient and/or staff (tertiary outcomes of clinic-level HIV indicators, reports of HIV care practices that can be experienced as stigmatizing, anxiety, depression, and stress) levels. Assessments will take place every 6 months.
The intervention will generate strategies to improve the wellbeing of the healthcare workforce. Ultimately, the study will produce implementation lessons on how to effectuate clinical practice changes to increase access to effective HIV treatment, as well as the wellbeing of the healthcare workforce.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Corina T Lelutiu-Weinberger, PhD
- Número de teléfono: 212-305-5756
- Correo electrónico: cl4265@cumc.columbia.edu
Copia de seguridad de contactos de estudio
- Nombre: Felicia A Browne, ScD
- Número de teléfono: 919-541-6596
- Correo electrónico: fbrowne@rti.org
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10032
- Reclutamiento
- Columbia University School of Nursing
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Contacto:
- Corina Lelutiu-Weinberger, PhD
- Correo electrónico: cl4265@cumc.columbia.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Selected Ryan White Clinics. Selection based on the following:
First, clinic leaders will complete a 15-min Site Characteristics Survey, assessing suitability for participation and clinic comparability. Staff and leadership at Ryan White clinics will next complete an anonymous 15-minute Eligibility Survey.
Within each clinic, both clinic staff and patients will be invited to participate.
Exclusion Criteria:
- Non-Ryan White Clinics
- Clinics not located in the geographical area of interest
- Clinics that are not interested in participating
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention
The intervention will be implemented across six months with a total of five clinics. The intervention consists of a series of interactive trainings that cover stigma and health-related topics, such as roots, manifestations, and consequences of stigma in healthcare, history of HIV stigma, and stress and stigma. These will be split across several sessions, depending on clinics' schedules. At the end of the intervention, each clinic will create a Code of Practice that will be formalized into a manual for each clinic, to guide the implementation and sustainability of stigma reduction efforts. |
The HP+ curriculum includes total-site training and co-facilitation via participatory modules. To change clinic culture, a multi-level approach that includes the whole facility and reaches all parties is required. The intervention aims to modify top-down mechanisms of influence. The training is modeled on these principles and supports the development of multiple stigma-reduction strategies to improve patient and staff wellbeing.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Stigma Index (SI)
Periodo de tiempo: Baseline, 6, 12, 18, and 24 months
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The SI is a rating of clinic mission/vision statements, the anti-stigma policy, and the clinic context. A change in the mean score of SI post-intervention implementation will be measured. Scores range from 0-100, with a higher score indicating increased anti-stigma policies and procedures. |
Baseline, 6, 12, 18, and 24 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Cultural Humility Score
Periodo de tiempo: Baseline, 6, 12, 18, and 24 months
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Cultural humility as measured by the adapted Trauma-Informed, Resilience-Oriented Care (TI-ROC) Cultural Humility Scale, which assess staff's perceptions of colleagues and clinic context. Scores range from 12-60. The negative items are reverse coded such that higher scores indicate higher cultural humility indicating better outcomes. |
Baseline, 6, 12, 18, and 24 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Time to Linkage to Care
Periodo de tiempo: Baseline, 6, 12, 18, and 24 months
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Change in time to linkage to care from diagnosis at the clinics. |
Baseline, 6, 12, 18, and 24 months
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Change in Patients Retained in Care
Periodo de tiempo: Baseline, 6, 12, 18, and 24 months
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Change in the number of patients retained in care at the clinics. |
Baseline, 6, 12, 18, and 24 months
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Change in Number of Patients HIV Virally Suppressed
Periodo de tiempo: Baseline, 6, 12, 18, and 24 months
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Change in the number of patients virally suppressed at the clinics. Viral suppression defined as less than 200 copies/mL. |
Baseline, 6, 12, 18, and 24 months
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Change in Frequency of Perceived HIV and Other Stigmas
Periodo de tiempo: Baseline, 6, 12, 18, and 24 months
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Change in the frequency of perceived stigma-related events by staff and patients attending the clinic as collected by self-administered Experiences of Perceived Stigma survey. |
Baseline, 6, 12, 18, and 24 months
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Change in Depression and Anxiety
Periodo de tiempo: Baseline, 6, 12, 18, and 24 months
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A 4-item scale that assesses depression and anxiety (PHQ-4) over the past week. Scores range from 0-63 with a lower score indicating a better outcome. |
Baseline, 6, 12, 18, and 24 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Corina Lelutiu-Weinberger, PhD, Columbia University
- Investigador principal: Felicia A Browne, ScD, RTI International
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AAAU1559
- 1R01NR020583 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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