- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06004011
Responsabilidades basadas en roles de AYAHIV para la fuerza laboral centrada en oncología (ARROW)
Prestación integrada de intervenciones de control del cáncer para adolescentes y adultos jóvenes que viven con el VIH en Zambia
Adolescents and young adults living with HIV experience higher premature mortality from cancer than their uninfected peers. In Zambia, because of multilevel barriers, interventions for early diagnosis and optimized treatment to reduce this cancer mortality are underutilized for this disproportionally impacted cohort. In this study, the investigators will test peer-to-peer education and support strategies to increase use of early diagnosis services in HIV treatment facilities and improve compliance with cancer treatment in the cancer center.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Zambia is a global epicenter for HIV with a large number of adolescents and young adults living with HIV (AYAHIV). Compared with their uninfected peers, AYAHIV are at increased risk of developing cancer, most frequently Kaposi sarcoma (KS), non-Hodgkin's lymphoma (NHL), and cervical cancer (CC). To reduce this premature mortality, evidence-based strategies should be implemented to both diagnose cancers at an earlier stage and help AYAHIV complete recommended cancer treatment. The investigators will use theory-informed multilevel strategies to create the AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW) program to increase uptake of services for early diagnosis and improve compliance with cancer treatment for KS, NHL, and CC. Our overall approach is based on the evidence-based strategy of peer support for engagement and learning. At the individual level, the investigators will address barriers by embedding peer counselors to support AYAHIV. At the provider level, the investigators will create a peer-to-peer learning network to build linkages between those specializing in pediatric and adult HIV treatment and cancer care. At the health care system level, the investigators will bring together health care administrators and Zambian Ministry of Health policy makers to review barriers and to develop and implement collaborative solutions. The investigators will use implementation science methods to evaluate effectiveness, implementation outcomes, and cost-effectiveness of the ARROW program compared with a one-time education campaign by pursuing the following aims:
Aim 1. Conduct randomized trials to compare the ARROW program with the one-time education campaign in increasing services received by AYAHIV to facilitate early diagnosis (physical exam for KS and NHL, CC screening, and timely diagnostic testing) and in improving adherence to cancer treatment.
Aim 2. Use mixed methods to assess implementation outcomes of the ARROW program compared with one-time education based on acceptability, feasibility, appropriateness, fidelity, and sustainability.
Aim 3. Perform economic evaluations to assess cost-effectiveness and return-on-investment scenarios.
Successful completion of these aims will yield a set of data-driven strategies that can be scaled up to reduce premature cancer mortality among AYAHIV. To support future implementation efforts, the investigators will generate incremental cost-effectiveness estimates, conduct policy simulations, evaluate implementation outcomes, and assess challenges and facilitators to optimize the ARROW program. The model tested in Zambia can serve as a blueprint for other Sub-Saharan African countries to ensure AYAHIV receive optimal services to facilitate early diagnosis and ensure completion of guideline-recommended treatments. The ARROW program will also provide a framework for implementing expanded services, such as preventive services and survivorship care, to further reduce the burden of cancer AYAHIV face.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sujha Subramanian
- Número de teléfono: 3022225034
- Correo electrónico: sujha.subramanian@implenomics.com
Ubicaciones de estudio
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Lusaka, Zambia
- Reclutamiento
- Public Health Facilities
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Contacto:
- Ronald Mungoni
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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:
- 15 to 39 years of age at the time of study enrolment, on antiretroviral medication (ART) for at least 6 months and with no pending plans to move from current residence during the 3-year study duration
Exclusion Criteria:
- pregnant at study enrolment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ARROW strategies
The ARROW strategies which use peer-peer support at the patient level (through peer counselors), at the provider level (through peer lead education sessions) and at the health system level (through a health collaborative forum) to deliver high quality screenings and ensure cancer treatment completion. |
ARROW strategies are peer-to-peer support at the patient, provider and health system levels |
|
Comparador activo: One-time education
The comparator arm participants will receive one-time education and usual care services. |
The comparison group will receive a one-time education campaign that will provide informational brochures to adolescents and young adults living with HIV and HIV providers |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion who complete screening/physical examination
Periodo de tiempo: 12 months after study enrollment
|
Number who complete screening/physician exams |
12 months after study enrollment
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Proportion who complete recommended cancer treatment modalities
Periodo de tiempo: 12 months after diagnosis
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Number who complete treatment |
12 months after diagnosis
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion who complete recommended follow-up supplemental diagnostic procedures
Periodo de tiempo: 3 months from receipt of follow-up referral
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Number who complete follow-up |
3 months from receipt of follow-up referral
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Proportion who initiate cancer treatment
Periodo de tiempo: 3 months from diagnosis
|
Number who initiate treatment |
3 months from diagnosis
|
|
Proportion alive at 12 months
Periodo de tiempo: 12 months after diagnosis
|
Number alive at 12 months |
12 months after diagnosis
|
Colaboradores e Investigadores
Patrocinador
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
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades del sistema inmunológico
- Infecciones
- Enfermedades virales
- Neoplasias por tipo histológico
- Enfermedades uterinas
- Enfermedades Genitales Femeninas
- Infecciones por virus de ADN
- Neoplasias Genitales Femeninas
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Enfermedades del cuello uterino
- Linfoma
- Neoplasias Uterinas
- Sarcoma
- Neoplasias De Tejidos Conectivos Y Blandos
- Infecciones por herpesviridae
- Neoplasias De Tejido Vascular
- Enfermedades hemic y linfáticas
- Neoplasias del cuello uterino
- Linfoma No Hodgkin
- Sarcoma de Kaposi
Otros números de identificación del estudio
- Imp001
Información sobre medicamentos y dispositivos, documentos del estudio
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