Daily, Weekly, or Event-driven Doxycycline for STI Prevention Among Men Who Have Sex With Men (MSM) Engaging in Chemsex: The DOSE Non-inferiority Trial (DOSE)
The goal of this clinical trial is to learn if three different dosing strategies of doxycycline (daily, weekly, and on-demand) works to prevent sexually transmitted infections (gonorrhea, chlamydia, and syphilis) among men who use methamphetamine and who have sex with other men. The main question it aims to answer is:
Does daily, weekly, and on-demand doxycycline dosing strategies lower the incidence of quarterly STIs (gonorrhea, chlamydia, and syphilis)?
Participants will:
Take doxycycline either on-demand (within 72 hours after sex), daily, or weekly doxycycline for one year Visit the clinic once every 3 months to complete questionnaires, undergo HIV/STI testing, and collect samples. Additional visits may be needed to receive STI treatment.
Complete text surveys once every month
Descripción general del estudio
Estado
Descripción detallada
This study will evaluate the acceptability, effectiveness, and adherence of alternative doxycycline dosing strategies to optimize STI prophylaxis in this high-risk population. We will accomplish this through the following independent, yet interrelated Aims: 1) Determine effectiveness of fixed-dose daily, fixed-dose weekly, and event-driven dosing of doxycycline for STI prophylaxis; 2) Assess acceptability and preferences for doxycycline as STI prophylaxis through either fixed dose (daily or weekly) or event-driven (post-exposure) dosing strategies through individual interviews; 3) Evaluate and compare adherence and tolerability of daily, weekly, and event-driven doxycycline dosing strategies. We will conduct an open-label, non-inferior, randomized control trial (RCT) comparing fixed-dose daily, fixed-dose weekly, and event-driven doxycycline dosing strategies on quarterly incidence of STIs among MSM who use MA. We will screen 900 individuals to recruit a cohort of 300 MSM who self-report MA use in conjunction with condomless anal intercourse in the past month. At the Enrollment visit, participants will receive HIV, syphilis, and gonorrhea/chlamydia (GC/CT) testing as well as complete demographic and behavioral questionnaires. Enrolled participants will be randomly assigned 1:1:1 to either fixed-dose daily doxycycline (100mg daily; n=100), fixed-dose weekly doxycycline (200mg weekly; n=100), or event-driven doxyPEP (200mg taken up to 72 hours after a potential STI exposure; n=100; standard of care). All participants will participate in Quarterly follow-up visits where they will be assessed for HIV, bacterial STIs (GC/CT and syphilis), adherence to doxycycline, sexual behaviors/practices, substance use, nasal Staph aureus colonization and doxycycline resistance over 12 months. The primary outcome for this study will be quarterly incidence of, GC, CT, and/or early syphilis (defined as newly positive rapid plasma reagin [RPR] or four-fold rise in RPR titers), by arm.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: UCLA Vine Street Clinic
- Número de teléfono: (323) 461-3106
- Correo electrónico: uclavsc@mednet.ucla.edu
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90038
- UCLA Vine Street Clinic
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Contacto:
- UCLA Vine Street Clinic
- Número de teléfono: (323) 461-3106
- Correo electrónico: uclavsc@mednet.ucla.edu
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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:
- Born male
- Age ≥ 18 years old
- Reports receiving an STI diagnosis (i.e., GC, CT, and/or syphilis) in the past 12 months
- Reports MA use in conjunction with CAI with a male partner in the 30 days prior to screening
- Not planning to relocate out of the study area in the 12-month follow-up period
- Willingness to engage in up to one year of repeated antibiotic exposure
- Willing and able to give written informed consent
Exclusion Criteria:
- Reported allergy to tetracyclines
- Current or anticipated use of a medication that interacts with doxycycline (prohibited medications listed below)
- Current or planned use of doxycycline for a prolonged period (> 2 weeks, with the exception of pre-enrollment doxyPEP)
- Prolonged antibiotic use (> 2 weeks, with the exception of pre-enrollment doxyPEP) in the 30 days prior to study enrollment
- Co-enrollment in any other concurrent study that may interfere with this study, such as an STI prevention trial, unless approved by the PI or designee
- Any other medical or psychiatric condition that, in the opinion of the PI or designee, may interfere with study participation or participant safety
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 |
|---|---|
|
Experimental: On-demand doxycycline
Participants randomized to on-demand doxycycline will be instructed to take doxycycline hyclate 200mg once as needed within 24 and up to 72 hours after sex (not to exceed 200mg in 24 hours). |
Participants randomized to receive on-demand doxycycline hyclate 200mg will be instructed to take doxycycline hyclate 200mg once as needed within 24 hours and up to 72 hours after sex (not to exceed 200mg in 24 hours) |
|
Experimental: Weekly doxycycline
Participants randomized to receive fixed dose weekly doxycycline hyclate 200mg will be instructed to take doxycycline hyclate 200mg once weekly, regardless of sexual exposure. |
Participants randomized to receive weekly doxycycline hyclate 100mg will be instructed to take doxycycline hyclate 100mg once weekly |
|
Experimental: Daily doxycycline
Participants randomized to receive fixed dose daily doxycycline hyclate 100mg will be instructed to take doxycycline hyclate 100mg once daily, regardless of sexual exposure. |
Participants randomized to receive fixed dose daily doxycycline hyclate 100mg will be instructed to take doxycycline hyclate 100mg once daily |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Quarterly incidence of chlamydia, gonorrhea, and/or early syphilis infection
Periodo de tiempo: Quarterly incidence of C. trachomatis, N. gonorrhoeae, and/or early syphilis infection by laboratory-based diagnosis (over 1 year time period)
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Quarterly incidence of C. trachomatis, N. gonorrhoeae, and/or early syphilis infection by laboratory-based diagnosis (over 1 year time period)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Cherie Blair, MD, PhD, University of California, Los Angeles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- Enfermedades urogenitales
- Enfermedades Genitales
- Procesos Patológicos
- Atributos de la enfermedad
- Infecciones
- Enfermedades contagiosas
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por bacterias gramnegativas
- Infecciones por espiroquetas
- Infecciones por clamidias
- Enfermedades De Transmisión Sexual Bacterianas
- Infecciones por Neisseriaceae
- Infecciones treponémicas
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de transmisión sexual
- Infecciones por clamidia
- Gonorrea
- Sífilis
Otros números de identificación del estudio
- 26-1595
- 1R01DA066392-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
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