Completado

C3Prevention of HIV Infection in High-Risk Social Networks of African American MSM

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

Social Network Intervention

+ Counsel, Test, and Treat

Conductual
Quiénes están siendo reclutados

Enfermedades Urogenitales+4

+ Enfermedades Genitales

+ Enfermedades Transmisibles

A partir de 18 años
+9 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Prevención

Intervencional
Inicio del estudio: agosto de 2011
Ver detalles del protocolo

Resumen

Patrocinador PrincipalMedical College of Wisconsin
Última actualización: 15 de febrero de 2018
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de agosto de 2011

Fecha en la que se inscribió al primer participante.

During the formative research phase, investigators will undertake formative studies to locate, understand, and characterize high-risk social networks of African American MSM in the community; gain community participation, involvement, and input; and undertake interviews with key informants and community members to gain information needed to pilot test study recruitment procedures, measures, and intervention content. During a 4-year main outcome trial phase, the investigators will enroll 24 separate sociocentric ("bounded") social networks composed predominantly of Black MSM. Each sociocentric network will consist of the ring of friends surrounding an initial high-risk index as well as all friends surrounding persons in this second ring and then friends surrounding a successive third snowball ring of enrollees. Each 3-ring sociocentric network is expected to consist of approximately 40 unique members (n=24 networks, each with 40 members = approximately 960 individual participants). All participants will be assessed at baseline to measure sexual practices, substance use, and other risk characteristics over the past 3 months; asked to provide biological specimens to be tested for HIV and other sexually transmitted diseases (STDs); and counseled in HIV/STD risk reduction. STDs will be treated and those with HIV will be referred for treatment. The investigators will identify the individuals in intervention condition networks with the greatest number of reciprocal interconnections and the most favorable sociometric standing in the network. These individuals--expected to constitute approximately 20% of the sociocentric network and designated as network leaders--will be recruited to attend a 9-session program that provides training and guidance in how to deliver on-going, theoretically-based, and culturally tailored risk reduction advice and counseling to other members within the same network. Six and 18 months following the intervention, all participants will be reassessed on risk behavior and STD/HIV laboratory measures as well as measures of intervention exposure, with positive STD and HIV cases respectively treated or referred to care at each assessment point. Outcome analyses will test whether there is greater reduction in high-risk sexual practices, substance use associated with risky sex, and HIV/STD incidence within social networks in the intervention condition. The primary trial endpoints are reductions in prevalence and frequency of unprotected anal intercourse with nonexclusive partners, increased condom use, and lower incidence on a composite biological measure of new HIV/STD disease during the followup period.

NCT01825252
Patrocinador PrincipalMedical College of Wisconsin
Última actualización: 15 de febrero de 2018
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 856 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.



Elegibilidad

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

Hombre

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 no permitidos

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

Condiciones

Patología

Enfermedades UrogenitalesEnfermedades GenitalesEnfermedades TransmisiblesInfeccionesProcesos PatológicosCondiciones Patológicas, Signos y SíntomasEnfermedades de Transmisión Sexual

Criterios

5 criterios de inclusión requeridos para participar
are age 18 or older

can complete study measures and participate in study activities in English

except for the initial index, were named as part of a friendship circle of an already-enrolled participant

provide written informed consent and do not exhibit intoxication, drug use,or psychiatric impairment that leads the research staff member to question capacity to provide informed consent

Mostrar Más Criterios

4 criterios de exclusión impiden participar
are age 17 or younger

cannot complete study measures or adequately comprehend study activities conducted in English; or

exhibit intoxication, drug use, or psychiatric impairment such that they are unable to provide written informed consent

live in a location distant from the study city

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
Approximately 20% of people in this condition will be trained to have discussions endorsing less risky behaviors with their social network members.

Grupo II

Comparador Activo
People in this arm will only receive standard-of-care counseling, testing, and treatment for HIV and STDs.

Objetivos del Estudio

Objetivos Primarios

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

AIDS TaskForce of Greater Cleveland

Cleveland, United StatesAbrir AIDS TaskForce of Greater Cleveland en Google Maps

Medical College of Wisconsin

Milwaukee, United States
Completado2 Centros de Estudio