- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00849823
HIV Prevention Program for African American Teen Males
A Brief, Clinic-Based, HIV Prevention Program for African American Teen Males
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Based on the observation that African Americans are vastly more likely than their white and Hispanic counterparts to be infected by the human immunodeficiency virus (HIV), the Centers for Disease Control and Prevention (CDC) has termed AIDS a "health crisis" for African Americans and has called for a heightened national response to this glaring racial disparity. The crisis is especially dramatic in the Southern United States. Thus, the search for effective interventions tailored to this population is a national priority. This study expands upon a previous study conducted among young African American men. In the previous study we developed and tested the efficacy of a brief, clinic-based, program designed to interactively promote safer sex for African American men (18 to 29 years of age) engaging in sex with women. Adjusted findings from the previous study provided relatively robust support for program efficacy, with men who received the intervention program being about two-thirds less likely, than controls, to acquire an STI during a 6-month period. This study expands on the work performed in the previous study by developing and testing a version for younger African American males (i.e., teen males).
The purpose of this study is to test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STI incidence among African American teen (15 to 20 years old) males presenting themselves for STI testing.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Louisiana
-
New Orleans, Louisiana, Estados Unidos, 70118
- Adolescent Medicine Program, LSU School of Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- at least 15, but not more than 23 years of age
- attending the clinic for the expressed purpose of being tested for sexually transmitted infections
- engaging in penetrative sex (penile-vaginal or penile-anal) at least once in the past 2 months
- willingness to return for the two planned follow-up assessments
Exclusion Criteria:
- self-report of being HIV positive
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Male Sexual Health Program
|
An attention equivalent control condition entailing a 60-minute one-to-one session that will didactically teach teens about several aspects of male sexual health.
The content and objectives are related only to knowledge acquisition.
In addition to this program, teens randomized to the control condition will receive standard-of-care services from the clinic.
This involves the provision of free condoms (one size "fits all" condoms) and a brief (nurse-delivered) counseling message to practice safer sex.
|
|
Experimental: Focus on the Future Program
|
A 60-minute, theory-guided program designed to increase the quality and frequency of teens' condom use within the context of making safer choices regarding partners and sexual behaviors.
The program is explicitly designed to increase the quality and frequency of teen's condom use.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Incidence rate of laboratory-confirmed STIs
Periodo de tiempo: 2- and 6-month follow-up, as well as 12-month follow-up medical records review
|
2- and 6-month follow-up, as well as 12-month follow-up medical records review
|
|
Self-report of unprotected penetrative sex (past 30 days)
Periodo de tiempo: 2- and 6-month follow-up
|
2- and 6-month follow-up
|
|
Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days)
Periodo de tiempo: 2 and 6-month follow-up
|
2 and 6-month follow-up
|
|
Self-report of negative experiences with the correct use of condoms (past 30 days)
Periodo de tiempo: 2- and 6-month follow-up
|
2- and 6-month follow-up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ryan Pasternak, MD, MPH, Louisiana State University Health Sciences Center in New Orleans
Publicaciones y enlaces útiles
Publicaciones Generales
- Crosby RA, Mena L, Smith RV. Promoting positive condom use experiences among young black MSM: a randomized controlled trial of a brief, clinic-based intervention. Health Educ Res. 2018 Jun 1;33(3):197-204. doi: 10.1093/her/cyy010.
- Crosby RA, Mena L, Salazar LF, Hardin JW, Brown T, Vickers Smith R. Efficacy of a Clinic-Based Safer Sex Program for Human Immunodeficiency Virus-Uninfected and Human Immunodeficiency Virus-Infected Young Black Men Who Have Sex With Men: A Randomized Controlled Trial. Sex Transm Dis. 2018 Mar;45(3):169-176. doi: 10.1097/OLQ.0000000000000721.
- Crosby R, Salazar LF. Reduction of condom use errors from a brief, clinic-based intervention: a secondary analysis of data from a randomised, controlled trial of young black males. Sex Transm Infect. 2015 Mar;91(2):111-5. doi: 10.1136/sextrans-2013-051492. Epub 2014 Jun 4.
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
Otros números de identificación del estudio
- 080666
- NIH Grant # 1R01MH083621
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. .