- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01694121
Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men (MENCount)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
District of Columbia
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Washington, District of Columbia, Estados Unidos, 20052
- George Washington University
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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: Black men aged 18 and older, reporting heterosexual risk for HIV [unprotected sex with a woman and 2+ female sex partners in the past 6 months] and either current unemployment or homeless in the past 6 months.
Exclusion Criteria: planned to leave Washington D.C., Maryland, or Virginia in the next 6 months, were cognitively impaired (based on Folstein Mini-Mental Exam at recruitment or baseline testing), and/or had self-reported health status that prohibited them from participating in the program
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: MEN Count
3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing.
|
The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period.
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Comparador activo: Comparison
An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle.
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general health intervention for men, not inclusive of HIV or relationship health
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up
Periodo de tiempo: 12 month follow-up
|
Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement.
Very low sexual risk was defined as having one partner and consistent condom use.
Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use.
Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex.
High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex.
Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each.
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12 month follow-up
|
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Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up
Periodo de tiempo: 6 month follow-up
|
Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement.
Very low sexual risk was defined as having one partner and consistent condom use.
Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use.
Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex.
High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex.
Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each.
|
6 month follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Non-viral STI - 12 Month Follow-up
Periodo de tiempo: 12 month follow-up
|
HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time
|
12 month follow-up
|
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Non-viral STI - 6 Month Follow-up
Periodo de tiempo: 6 month follow-up
|
HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time
|
6 month follow-up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anita Raj, PhD, UCSD
- Investigador principal: Lisa Bowleg, PhD, George Washington University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- R01MH096657 (Subvención/contrato del NIH de EE. UU.)
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