- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00653991
The SOLVE-IT National Randomized Trial (SOLVE-IT)
SOLVE IT: Real Risk Reduction for MSM
Descripción general del estudio
Descripción detallada
HIV and sexually transmitted diseases (STDs) are a major public health concern worldwide. Although prevalent across all groups of people, HIV/STDs have had a remarkable effect on men who have sex with men (MSM), who accounted for 71% of all HIV infections among American males in 2005. After years of decline, the number of HIV diagnoses appears to have increased for MSM, especially within the black MSM population. Thus, new approaches geared for HIV prevention and education and built on past HIV prevention methods are needed. New technologies, such as interactive computer games, delivered in a modern and appealing manner may gain or recapture the attention of MSM who have disregarded more traditional HIV prevention and educational services. Socially Optimized Learning in a Virtual Environment (SOLVE)-IT is an interactive virtual environment computer game, designed specifically for MSMs, that simulates the emotional, interpersonal, and contextual narrative of an actual sexual encounter and provides challenging decision-making opportunities. By promoting development of self-regulatory and behavioral skills, SOLVE-IT may be an effective approach to reduce sexual risk behaviors. This study will evaluate the effectiveness of SOLVE-IT in reducing risky sexual behaviors among MSM.
Participation in this study will last 6 months from the beginning of treatment. All participants will first undergo baseline assessments that will include questionnaires about sexual behavior, drug use, health history, feelings, and beliefs. Participants will then be assigned randomly to receive SOLVE-IT immediately or after a 6-month waitlist period. SOLVE-IT will include two 1-hour sessions conducted on a computer over the Internet, occurring at baseline and 6 months later. During sessions, participants will play an interactive computer game that presents dating or sexual scenarios and allows participants to choose how the scenarios unfold. Participants will repeat baseline questionnaires at Months 3 and 6 of follow-up. Participants in the waitlist group will be offered to receive SOLVE-IT after completion of the Month 6 follow-up.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90007
- University of Southern California (University Village)
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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:
- Self-identifies as Latino, black, or Caucasian
- Men who have sex with men
- Not HIV infected
- Engaged in unprotected anal sex at least twice in the 90 days before study entry with a nonprimary male partner
- Has broadband access during course of study
- Lives in United States
- Biological male
Exclusion Criteria:
- History of nonprescription drug injection use
- Has participated in SOLVE-IT at any phase
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 |
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Experimental: SOLVE-IT
Participants will receive the intervention SOLVE-IT.
The SOLVE-IT intervention is a videogame designed to optimize self-regulation, reduce shame, and reduce risky choices for young men who have sex with men (YMSM).
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SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM.
Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context.
Otros nombres:
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Comparador activo: Waitlist Control
Participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for YMSM, after a 6-month waitlist period.
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SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM.
Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months
Periodo de tiempo: Measured at baseline and 3 month follow-up
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Counts of unprotected anal intercourse (one each for insertive and receptive; UAI) in the past 3 months with a non-primary partner were reported by participants at baseline, and 3 month follow-up.
Reports of insertive and receptive anal intercourse per time period were summed.
Change in unprotected anal intercourse was calculated at 3 months using residualized change scores (regressing 3-month reported UAI (Y) on baseline UAI.
Negative numbers reflect a reduction in UAI over time).
Although raw counts of UAI are heavily tailed, residualized change scores yield a normal distribution.
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Measured at baseline and 3 month follow-up
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Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months
Periodo de tiempo: Measured at baseline and 6 month follow-up
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Counts of unprotected anal intercourse (one each for insertive and receptive) in the past 3 months with a non-primary partner were reported by participants at baseline, and 6 month follow-up.
Reports of insertive and receptive anal intercourse per time period were summed.
Change in unprotected anal intercourse from baseline, was calculated at 6 months using residualized change scores (regressing 6-month reported UAI (Y) on baseline UAI.
Negative numbers reflect a reduction in UAI over time).
Raw counts of UAI are heavily tailed, but residualized change scores are normally distributed.
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Measured at baseline and 6 month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Shame Residualized Change
Periodo de tiempo: Measured at baseline and Immediate post
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Measures of reported shame (five items from an existing subscale of Watson and Clark's (1994) Positive and Negative Affect Schedule- Expanded Form-- designed to assess State Shame): ashamed, blameworthy, angry at self, disgusted with self, dissatisfied with self.
Participants indicate to what extent they experienced emotions that were part of this sub scale, responding on a scale from 1 (very slightly or not at all) to 5(extremely).
Values reported represent the mean value per participant on the State Shame subscale; values per participant on this subscale therefore ranged from 1 to 5. Higher scores represent a higher level of reported state shame.
Scores on this scale are heavily tailed.
Therefore, we have consistently used residualized change scores: This is calculated from baseline to immediate post; negative numbers for residualized change mean reduced shame baseline to immediate post.
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Measured at baseline and Immediate post
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lynn C. Miller, PhD, University of Southern California
Publicaciones y enlaces útiles
Publicaciones Generales
- Read SJ, Miller, LC, Appleby PR, Nwosu ME, Reynaldo S, Lauren A, Putcha A. Socially optimized learning in a virtual environment: Reducing risky sexual behavior among men who have sex with men. Human Communication Research 32(1):1-34, 2006.
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
- R01MH082671 (Subvención/contrato del NIH de EE. UU.)
- DAHBR 9A-ASPQ (NIMH)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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. .
Ensayos clínicos sobre Infecciones por VIH
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Icahn School of Medicine at Mount SinaiIRRASReclutamientoHemorragia Intraventricular (HIV)Estados Unidos
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Yale UniversityTerminadoPrecocidad | Recién nacidos de muy bajo peso al nacer | Hemorragia Intraventricular (HIV) | Sangrado en el cerebroEstados Unidos
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Ensayos clínicos sobre SOLVE-IT
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Oslo University HospitalCentre for Appearance Research, University of the West of England, UKInscripción por invitaciónQuemaduras | Labio y paladar hendido | Anomalías craneofaciales | Condición de piel | Otras condiciones que conducen a una diferencia visibleNoruega
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Philips Clinical & Medical Affairs GlobalTerminadoEnfermedad Arterial Periférica | Isquemia Crítica de las ExtremidadesAustria
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Liverpool School of Tropical MedicineKenya Medical Research Institute; LVCT HealthAún no reclutandoEl embarazo | Sistemas de Salud | Sistemas electrónicos de información de salud comunitaria | Aceptación de la clínica prenatal
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University of Alabama at BirminghamReclutamientoDemencia | Comportamiento resistente al cuidadoEstados Unidos
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Oregon Health and Science UniversityTexas A&M University; University of North Carolina, GreensboroActivo, no reclutandoActividad físicaEstados Unidos
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TakedaReclutamientoSíndrome del cazadorCanadá, Francia
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Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd...Beijing Tiantan HospitalReclutamientoAccidente cerebrovascular isquémicoPorcelana