Completado

Proyecto PACToEnhanced Access to HIV Care for Drug Users in San Juan, Puerto Rico

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Enhanced HIV Care Access and Retention Intervention

+ HIV Testing Campaign

+ Treatment Re-engagement Campaign

Conductual
Quiénes están siendo reclutados

Infecciones Transmitidas por la Sangre+14

+ Enfermedades Urogenitales

+ Enfermedades Genitales

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional
Inicio del estudio: diciembre de 2013
Ver detalles del protocolo

Resumen

Patrocinador PrincipalColumbia University
Última actualización: 28 de marzo de 2022
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 20 de diciembre de 2013

Fecha en la que se inscribió al primer participante.

Recent scientific advances demonstrate that for people living with HIV, antiretroviral therapy (ART) is the most effective strategy to improve immune function, reduce morbidity, improve quality of life, prolong survival, and prevent HIV transmission. Translating this knowledge into practice, however, requires prompt diagnosis and linkage to care, entry into care with timely ART initiation, and engagement in care, support for ART adherence, and retention to promote durable viral suppression. Addressing failures in this cascade of care, often referred to as the "Seek, Test, Treat, and Retain (STTR)" paradigm, has become a major part of the National HIV/AIDS strategy in the United States. To date, much of the research and discussion surrounding this strategy has focused on expanding HIV testing to improve the early identification of new cases. There has been less attention focused on linkage to, engagement in, and retention in care. Specifically, little attention has focused on identifying HIV-positive individuals who, despite being aware of their diagnosis, have never been in HIV care, are intermittent users of care, or have dropped out of care. HIV-infected injection drug users (IDUs) are a particularly difficult subpopulation to link to and retain in HIV care. They face a myriad of challenges that can impede retention in care including substance use disorders (both alcohol and drugs), mental health problems and poverty-related issues such as unstable housing and food insecurity. If IDUs adhere to their treatment regimens, however, studies have demonstrated they realize similar survival benefits from antiretroviral therapy as persons without a history of injection drug use. In contrast to the majority of communities in the U.S., in Puerto Rico, drug use, particularly injection drug use, continues to fuel a fast-growing HIV epidemic. Puerto Rico has an estimated incidence rate of 45 HIV cases per 100,000 population, twice the rate for the 50 U.S. states, and almost 40% of new infections are associated with injection drug use. In contrast, only 12% of new infections in the 50 U.S. states are among IDUs. The overall goal of this project is to implement and evaluate a community-level, structured enhanced approach, the Enhanced HIV Care Access and Retention Intervention, for substance users in San Juan, Puerto Rico. It will bring HIV care directly to five San Juan zones in which a high proportion of HIV-infected substance users reside. The significance of the study is threefold.f care, or have dropped out of care.

NCT01792752
Patrocinador PrincipalColumbia University
Última actualización: 28 de marzo de 2022
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 2082 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Infecciones Transmitidas por la SangreEnfermedades UrogenitalesEnfermedades GenitalesTrastornos MentalesEnfermedades TransmisiblesSíndromes de Deficiencia InmunológicaEnfermedades del sistema inmunitarioInfeccionesInfecciones por RetroviridaeInfecciones por virus de ARNEnfermedades de Transmisión SexualEnfermedades por virus lentoEnfermedades ViralesEnfermedades de transmisión sexual, viralesInfecciones por VIHUso indebido de drogasSíndrome de Inmunodeficiencia Adquirida

Criterios

HIV Testing Campaign Inclusion Criteria: be 18 years of age or older report having injected drugs (opioid or stimulants) at least once in the past 30 days provide written informed consent HIV Care Cohort Inclusion Criteria: be 18 years of age or older test HIV-seropositive through rapid testing (confirmed with Western Blot or immunofluorescence assay) report having injected drugs more than once per week for the past 30 days self-report that they have not been in HIV care for the past 6 months agree to have their blood drawn for CD4 and HIV plasma RNA testing live in one of the San Juan neighborhoods targeted for intervention provide basic contact information for follow-up sign a HIPAA Authorization/medical record release form provide written informed consent Assessment Cohort Inclusion Criteria: be 18 years of age or older test HIV-seropositive through rapid testing (confirmed with Western Blot or immunofluorescence assay) report having injected drugs more than once per week for the past 30 days self-report that they have not been in HIV care for the past 6 months agree to have their blood drawn for CD4 and HIV plasma RNA testing live in one of the San Juan neighborhoods targeted for intervention provide basic contact information for follow-up sign a HIPAA Authorization/medical record release form provide written informed consent Exclusion Criteria (for all study components mentioned above): do not meet any one or more of the above-described inclusion criteria have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent are terminated via Site PI decision

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Through the Enhanced HIV Care Access and Retention Intervention, the five neighborhoods will receive the 4 components of the intervention: 1) HIV Testing Campaign; 2) Treatment Re-engagement Campaign; 3) Patient Navigator Linkage to Care and Substance Abuse Treatment Team; and 4) Mobile Care Clinic. The neighborhoods will receive the intervention at different times throughout the study period, but once the intervention is initiated in a neighborhood it will continue being implemented in that neighborhood until the end of the study period.

Grupo II

Sin Intervención
The neighborhood(s) not receiving the intervention will act as a control while the intervention is initiated and implemented in other neighborhoods. All neighborhoods will receive the intervention but at different times throughout the study period. Once the intervention is initiated in a neighborhood, that neighborhood will continue receiving the intervention until the end of the study period.

Objetivos 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 2 ubicaciones

Puerto Rico Department of Health

Rio Piedras, Puerto RicoAbrir Puerto Rico Department of Health en Google Maps

Iniciativa Comunitaria de Investigacion, Inc.

San Juan, Puerto Rico
Completado2 Centros de Estudio