HIV Prevention Toolkit for HIV-negative Male Couples (MCAP)
28 de marzo de 2019 actualizado por: Daniel J Feaster, University of Miami
Development of a HIV Prevention Toolkit for At-risk HIV-negative Male Couples
Though technology is integrated into the lives of our target population, use of any particular technology will depend on the content delivered, aesthetic appeal, and overall design.
Based on the completion and analysis of data from Phase 1, the investigators were able to obtain feedback on HIV-negative male couples' attitudes toward the original content in the prevention toolkit modules.
The research team, along with the web-developers, used this feedback to specifically tailor the content of the modules to fit the unique needs of the intervention's target population: at risk HIV-negative male couples.
For Phase 2, the investigators conducted focus groups at each site to help identify strengths and potential areas for improvement of the prevention toolkit, which will be incorporated before piloting it in the intervention for Phase 3 of this project.
After assessing the acceptability of the prevention toolkit, including the content of modules, aesthetic appeal, and overall design with HIV-negative male couples target population, the research team will pilot test whether the RCT with the prevention toolkit will help reduce HIV risk through formation and adherence to a sexual agreement, reduction in occurrences of condomless anal sex with casual sex partners, and increase testing behaviors among at-risk HIV-negative male couples.
The interactive website, herein referred to as the "HIV prevention toolkit" will contain unique modules about sexual agreements and effective HIV prevention strategies.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
298
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Florida
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Miami, Florida, Estados Unidos, 33136
- Clinical Research Building
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
Eligible male couples:
- are identified as two men (i.e., main partners) who had been in a sexual relationship together for > 6 months;
- are at least 18 years of age;
- are self-reported as being HIV-negative;
- had been practicing CAS in their relationship for > 6 months;
- report no recent history (< 1 year) of intimate partner violence (IPV) or coercion;
- have had no current sexual agreement; and
- own a smartphone and have an alternate method to access the Internet (e.g., computer).
Exclusion Criteria:
- Interested participants, including both men of a male couple, who did not meet the inclusion criteria above will be excluded from participating in Phase 3 of this study.
- Individuals who participated in Phase 1 or 2 will be were excluded from participating in Phase 3 of this study.
- Adults who are unable to consent;
- Individuals who are not yet adults;
- Pregnant and non-pregnant women, and prisoners.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Control group
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
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Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center.
As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
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Comparador activo: Intervention group
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center.
As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
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Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center.
As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Formation of a Sexual Agreement at 6 Months
Periodo de tiempo: 6 month
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Self-reports of yes/no to forming a sexual agreement via electronic survey
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6 month
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Adherence to a Sexual Agreement at 6 Months
Periodo de tiempo: 6 month
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Self-report of yes/no of adhering to a sexual agreement
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6 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Formation of a Sexual Agreement at 3 Months
Periodo de tiempo: 3 month
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Self-reports of yes/no to forming a sexual agreement via electronic survey
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3 month
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Adherence to a Sexual Agreement
Periodo de tiempo: 3 month
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Self-reports of yes/no to adhering to a sexual agreement via electronic survey
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3 month
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Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3
Periodo de tiempo: 3 month
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Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey
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3 month
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Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6
Periodo de tiempo: month 6
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Self-reports of yes/no any anal sex with casual male sex partner, measured at month 6 via electronic survey (about the previous 3 months, i.e., timeframe between months 3-6).
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month 6
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Test for HIV During Past 3 Months (Months 0-3)
Periodo de tiempo: 3 month
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Self-reports of yes/no via electronic survey taken at 3 month.
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3 month
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Test for HIV During the Last 3 Months (Months 3-6)
Periodo de tiempo: month 6
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Self-reports of yes/no any test for HIV at month 6 assessment, collected via electronic survey for timeframe between months 3 and 6.
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month 6
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jason W Mitchell, PhD, University of Miami
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2015
Finalización primaria (Actual)
1 de septiembre de 2016
Finalización del estudio (Actual)
1 de septiembre de 2016
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2015
Primero enviado que cumplió con los criterios de control de calidad
7 de julio de 2015
Publicado por primera vez (Estimar)
10 de julio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
28 de marzo de 2019
Última verificación
1 de marzo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 20140561
- R34MH102098 (Subvención/contrato del NIH de 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. .