- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00891358
Empowerment Intervention for Young Women - Phase I
A Secondary Prevention Empowerment Intervention for Young Women Living With HIV
This study will begin to develop a culturally appropriate secondary prevention intervention for young HIV+ women through focus groups.
Using three intervention sites, focus groups will guide the development of the intervention's framework and content areas. An intervention will be developed/adapted through the data collected in the focus groups and review of relevant interventions. The intervention aims to address the following concerns: 1) reducing the risk of young women infected with HIV transmitting the virus to their sexual partners, and 2) preventing young women infected with HIV from re-infection with a new viral strain or co-infection with another sexually transmitted disease.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will develop/adapt a culturally appropriate secondary prevention intervention for young HIV+ women through focus groups. Using three intervention sites, focus groups will guide the development of the intervention's framework and content areas. An initial list of content areas and potential activities for presentation to the focus groups will be developed by the protocol team by reviewing existing HIV prevention interventions that have been implemented with adolescents and young adults, as well as interventions that have targeted HIV+ populations.
Three focus groups will be convened (1 per selected ATN site) with young women living with HIV to solicit information on their intervention needs. All focus groups will be digitally recorded and transcribed. Executive summaries of the groups will focus on the major themes elicited by probes that explore the proposed content and structure of the interventions. The summaries will be generated by members of the Protocol Team and based on a review and integration of data from a) focus group flip charts; b) digitally recorded comments from participants; c) digitally recorded oral summaries by moderators offered during the focus groups; and d) thematic notes taken by the assistant moderator during the focus groups. Based on the outcome of the focus groups, intervention modules will be developed and modified in collaboration with the Youth Advisory Team.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Tampa, Florida, Estados Unidos, 33606
- USF College of Medicine
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
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Maryland
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Baltimore, Maryland, Estados Unidos, 20723
- University of Maryland Medical School
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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:
- Female at birth and currently female;
- Receives services at one of the selected ATN sites or their community partners;
- HIV-infected as documented by medical record review or verbal verification with referring professional;
- Between the ages of 16-24 (inclusive) at the time of informed consent/assent;
- Ability to understand both written and spoken English; and
- Gives informed consent/assent for study participation.
Exclusion Criteria:
- Presence of active, serious psychiatric symptoms (hallucinations, thought disorder) that would impair a participant's ability to meet the study requirements;
- Visibly distraught (suicidal, homicidal, exhibiting violent behavior);
- If other serious conditions are present during screening, the Protocol Team must be consulted to determine whether enrollment may interfere with the evaluation of the protocol objectives and for permission to proceed with the enrollment; or
Intoxicated or under the influence of alcohol or other substances at the time of study enrollment*.
- Participants cannot be visibly under the influence at the time of consent, enrollment, or during the focus group. Intoxication at the time of the focus group will exclude participation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Focus Group
Participants in focus groups will meet and discuss their intervention needs.
|
Using three intervention sites, focus groups will guide the development of the intervention's framework and content areas. An initial list of content areas and potential activities for presentation to the focus groups will be developed by the protocol team by reviewing existing HIV prevention interventions that have been implemented with adolescents and young adults, as well as interventions that have targeted HIV+ populations. The three focus groups will be convened (1 per selected ATN site) with young women living with HIV to solicit information on their intervention needs. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Use of focus groups for development/adaptation of a secondary prevention empowerment intervention to reduce sexual risk behavior among young women living with HIV.
Periodo de tiempo: 6-8 weeks
|
6-8 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Sybil Hosek, PhD, John Stroger Hospital of Cook County; Adolescent Trials Network
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Infecciones por VIH
Otros números de identificación del estudio
- ATN 073
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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