iVYiVY: Comprehensive, Tailored, Technology-based Intervention to Improve Virologic Suppression Among Youth and Young Adults Living With HIV
Standard of Care
+ Video-counseling+app
Enfermedades Transmisibles+13
+ Enfermedades Urogenitales
+ Síndrome de Inmunodeficiencia Adquirida
Estudio de Investigación en servicios de salud
Resumen
Fecha de inicio: 29 de noviembre de 2023
Fecha en la que se inscribió al primer participante.In the US, youth and young adults living with HIV (YLWH) have the lowest level of virologic suppression compared to older age groups and experience significant health disparities with regard to HIV treatment initiation and clinical outcomes. Additionally, mental health (MH) and substance use (SU) impact every step of the HIV care continuum from diagnosis to virologic suppression and exacerbate socioeconomic challenges of linkage and sustained access to healthcare. The proposed study aims to address these barriers in a tailored manner using a differentiated care approach that is "youth-friendly". The iVY intervention is grounded in the Information Motivation Behavioral Skills (IMB) Model and developed with and for YLWH using a Human-Centered Design (HCD) approach. The goal is to test the effect of the technology-based intervention with differing levels of resource requirements (i.e., financial and personnel time) in a randomized clinical trial (RCT) with an Adaptive Treatment Strategy (ATS) among YLWH (18-29 years old). Using pre-defined algorithms, ATSs adapt a treatment to an individual's unique and changing needs as opposed to a one-size-fits-all approach. Video-counseling will be delivered by clinical social workers trained to provide MH and SU counseling to YLWH. Video-counseling sessions will focus on the needs of the participant and potential linkage to further MH and SU treatment, as needed. The app will allow for medication management, identification of community resources, and online networking with other YLWH. Therefore, the primary goal of this approach is to address important, distinct, and changing barriers to HIV care engagement (e.g., MH, SU, forgetting, social isolation) among YLWH. HIV virologic suppression (primary outcome) will be evaluated using home-collected Hemaspot test. To increase generalizability and geographic, demographic, and economic diversity and decrease logistics- or stigma-related barriers to research participation, all study activities will be conducted remotely. This study will provide valuable data about the characteristics of virologic responders and non-responders to the intervention, individualization of the intervention based on these variables, and linkage to MH and SU treatment services among those in need.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 200 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Investigación en Servicios de Salud
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 29 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Division of Prevention Science, Center for AIDS Prevention Studies (CAPS)
San Francisco, United StatesAbrir Division of Prevention Science, Center for AIDS Prevention Studies (CAPS) en Google Maps