Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil
Randomized Clinical Trial of a Brazilian HIV Prevention Intervention for the Severely Mentally Ill
Descripción general del estudio
Estado
Condiciones
Descripción detallada
HIV is a virus that weakens a person's immune system and can cause AIDS. It is most commonly transmitted through unprotected sexual contact. People with a mental illness who are sexually active may be at risk of HIV infection, but most interventions for reducing risk of HIV infection do not target this particular population. This study will test an intervention aimed at reducing behaviors with a high risk of causing HIV infection in sexually active people with a mental illness.
Participation in this study will last 15 months. At study entry, participants will complete a baseline interview with a research assistant. This interview will evaluate sexual activity, knowledge of HIV, the participant's psychiatric diagnosis and symptoms, attitude toward condoms, and stigma related to mental illness experienced by the participant.
Participants will then be randomly assigned to either an HIV risk reduction group or a general health group. Both of these groups will meet once a week for 8 weeks. Those in the HIV risk reduction group will learn information and take part in activities aimed at reducing behaviors that place people at a high risk of being infected with HIV. Those in the general health group will learn about long-term serious medical conditions, such as diabetes and high blood pressure, that may be common in people with a mental illness.
Participants will complete two follow-up visits after their 8-week intervention, one the week after and one 3 months after. Participants will then complete a "booster" of three weekly group sessions covering the same information from their 8-week intervention. More follow-up visits will occur 1 week and 6 months after participants complete the booster sessions. All follow-up visits will involve an interview similar to the one held at study entry. Additionally, feedback forms will be completed at the first interview at study entry, after the eight group sessions, after the three booster sessions, and at the last interview.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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RJ
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Rio de Janeiro, RJ, Brasil
- Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
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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:
- Being treated as a patient in one of the study psychiatric clinics
- Sexually active in the past 3 months
Exclusion Criteria:
- Primary alcohol or other drug use disorder
- Acutely psychotic or actively suicidal at the time of the screening interview
- Developmental disability as a primary diagnosis
- Unable to speak Portuguese
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 1
Participants will complete HIV risk reduction group meetings.
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Eight weekly 2-hour HIV risk reduction intervention sessions, with three weekly 2-hour booster sessions completed 6 months after the initial intervention.
Specific goals of the intervention are to (1) increase information about HIV risk behaviors and safer sex options; (2) increase identification of personal risk of HIV and enhance the motivation to engage in safer sex behaviors; and (3) enhance skills to achieve safer sex, particularly negotiating safer sex, using condoms, and communicating within a relationship.
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Comparador activo: 2
Participants will complete health promotion group meetings.
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Eight weekly 2-hour health promotion intervention sessions with three weekly 2-hour booster sessions completed 6 months after the initial intervention.
Specific goals of the intervention are to (1) increase information about health issues specific to psychiatric patients, (2) increase identification of personal health risks and enhance motivation to engage in healthier behaviors, and (3) enhance skills to achieve healthier behaviors.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Sexual Risk Behavior Assessment Schedule (SERBAS)
Periodo de tiempo: Measured at baseline and 3, 6, and 12 months post-intervention
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Measured at baseline and 3, 6, and 12 months post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Brief HIV Knowledge Questionnaire (Brief HIV-KQ)
Periodo de tiempo: Measured at baseline and 3, 6, and 12 months post-intervention
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Measured at baseline and 3, 6, and 12 months post-intervention
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Brief Psychiatric Rating Scale (BPRS)
Periodo de tiempo: Measured at baseline and 3, 6, and 12 months post-intervention
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Measured at baseline and 3, 6, and 12 months post-intervention
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Stigma and Discrimination Questionnaire
Periodo de tiempo: Measured at baseline and 3, 6, and 12 months post-intervention
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Measured at baseline and 3, 6, and 12 months post-intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Milton L. Wainberg, MD, Columbia University and New York State Psychiatric Institute
Publicaciones y 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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones transmitidas por la sangre
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Atributos de la enfermedad
- Enfermedades de virus lentos
- Infecciones por VIH
- Infecciones
- Enfermedades contagiosas
- Síndrome de inmunodeficiencia adquirida
Otros números de identificación del estudio
- #5264
- DAHBR 9A-ASPI
- R01MH065163 (Subvención/contrato del NIH de EE. UU.)
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