- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04325555
Pre-exposure Prophylaxis: A Miracle Drug or a Moral Hazard
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Abu Dhabi, Emiratos Árabes Unidos, 00000
- New York University Abu Dhabi
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 18 years or above
- living in the London, New York, Toronto or Sydney metro area
- self-reported sex at birth is male
- reported ever having sex with a male
Exclusion Criteria:
- not meeting the inclusion criteria
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Respondents on PrEP
On PrEP status will be operationalized in multiple ways, and sensitivity analyses will be conducted using multiple definitions as a result of the self-reported nature of the study.
A comparison group will be constructed by matching on a variety of characteristics, when this method is applied. Most importantly, age, and STD testing frequency among others, which influence the likelihood of being on PrEP and via that avenue sexual practices, as well as the likelihood of detecting STDs (i.e., ascertainment bias). In other models adjustments will be made for these factors. |
The investigators measure self-reported PrEP status as exposure, i.e., PrEP status is not confirmed via matched medical records or any other type of information directly collected form subjects.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Syphilis diagnosis
Periodo de tiempo: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Self-reported diagnosis of syphilis
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All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Chlamydia diagnosis
Periodo de tiempo: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Self-reported diagnosis of chlamydia
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All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Gonorrhea diagnosis
Periodo de tiempo: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Self-reported diagnosis of gonorrhea
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All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Sexually transmitted diseases
Periodo de tiempo: All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Self-reported diagnosis of any STD
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All diagnosis data is collected in a time-stamped fashion between January 2015 and December 2019; diagnosis is reported within the year, but not in a specific month/day
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Percent of time that condoms were used in sexual intercourse
Periodo de tiempo: 12 months
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Self-reported condom adherence
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12 months
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Number of ongoing sexual relationships
Periodo de tiempo: Through study completion, approximately 2 months
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Self-reported number of concurrent sexual partners
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Through study completion, approximately 2 months
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Number of sexual partners over the past 12 months
Periodo de tiempo: 12 months
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Self-reported number of sexual partners over the past 12 months
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12 months
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Selecting a potential date with many recent partners
Periodo de tiempo: Through study completion, approximately 2 months
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The likelihood of selecting a potential date with 6 or more recent sexual partners in the conjoint experiment. Both AMCEs (average marginal component effects) and marginal means will be computed, see statistical analysis plan. As part of a conjoint experiment the investigators expose participants to a partner selection task. The attributes in the experiment and possible attribute values can be seen below: Race/ethnicity: White/Black/Asian Education: High school/Undergraduate degree/Graduate degree Number of sexual partners (past 3 months): 1/2-5 partners/6 or more Recreational drug use: Never/Sometimes/Often Seeking a...: Committed relationship/Casual relationship Use of condoms: Occasional/Frequent |
Through study completion, approximately 2 months
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Selecting a potential date with frequent recreational drug use
Periodo de tiempo: Through study completion, approximately 2 months
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The likelihood of selecting a potential date with frequent recreational drug use in the conjoint experiment. Both AMCEs (average marginal component effects) and marginal means will be computed, see statistical analysis plan. As part of a conjoint experiment the investigators expose participants to a partner selection task. The attributes in the experiment and possible attribute values can be seen below: Race/ethnicity: White/Black/Asian Education: High school/Undergraduate degree/Graduate degree Number of sexual partners (past 3 months): 1/2-5 partners/6 or more Recreational drug use: Never/Sometimes/Often Seeking a...: Committed relationship/Casual relationship Use of condoms: Occasional/Frequent |
Through study completion, approximately 2 months
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Selecting a potential date with occasional condom adherence
Periodo de tiempo: Through study completion, approximately 2 months
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The likelihood of selecting a potential date with occasional condom use in the conjoint experiment. Both AMCEs (average marginal component effects) and marginal means will be computed, see statistical analysis plan. As part of a conjoint experiment the investigators expose participants to a partner selection task. The attributes in the experiment and possible attribute values can be seen below: Race/ethnicity: White/Black/Asian Education: High school/Undergraduate degree/Graduate degree Number of sexual partners (past 3 months): 1/2-5 partners/6 or more Recreational drug use: Never/Sometimes/Often Seeking a...: Committed relationship/Casual relationship Use of condoms: Occasional/Frequent |
Through study completion, approximately 2 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The likelihood at which a respondent would engage a partner in casual sex with without using condoms
Periodo de tiempo: Through study completion, approximately 2 months
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This is collected as a follow-up question for each profile in the conjoint experiment as detailed above
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Through study completion, approximately 2 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kinga R Makovi, PhD, New York University Abu Dhabi
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 (Actual)
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
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Infecciones
- Enfermedades contagiosas
- Atributos de la enfermedad
- Infecciones por bacterias gramnegativas
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por Neisseriaceae
- Enfermedades De Transmisión Sexual Bacterianas
- Infecciones por espiroquetas
- Infecciones treponémicas
- Gonorrea
- Enfermedades de transmisión sexual
- Sífilis
Otros números de identificación del estudio
- 097-2018
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. .
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