- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07808541
Juntas Adelante: A Peer-Coaching Intervention to Promote Chemoprophylaxis for HIV Prevention Among Latina Transgender Women in the Washington DC Metropolitan Area.
The goal of this clinical trial is to evaluate the impact of the Juntas Adelante intervention on awareness and use of chemoprophylaxis for HIV prevention (Pre- and Post-Exposure prophylaxis, or PrEP and PEP) among Latina Transgender Women in the Washington DC Metropolitan Area. Secondary outcomes included awareness and use of Doxy-PEP (i.e., Doxycycline for prevention of Sexually Transmitted Infections - STI), and awareness of Undetectable = Untransmittable (U=U).
The main questions are:
- Is the Juntas Adelante intervention acceptable and feasible to implement with this population?
- Is participating in the Juntas Adelante intervention associated with increased awareness and use of PrEP and PEP? All participants in the study will view 5 online short videos on HIV and STI prevention and will receive up to two virtual coaching sessions with a peer coach. They will also complete a brief survey after viewing each video (5 total) and three longer surveys/interviews over the course of 3 months.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Using a community-based participatory research (CBPR) approach, we developed Juntas Adelante, an intervention to increase awareness and use of PrEP and PEP for HIV prevention among Latina transgender women in the DC metropolitan area. The Juntas Adelante intervention includes two components:
- Peer coaching sessions: Up to two virtual coaching sessions with another Latina transgender woman (peer coach) who has been trained to encourage dialogue around HIV prevention goals.
- Video mini-series: Five short informational videos covering 5 topics (one per episode): 1) Latina transgender women and HIV (duration: 2:29 min); 2) Post-exposure prophylaxis - PEP (duration: 3:49 min); 3) Pre-exposure prophylaxis - PrEP (duration: 1:58 min); 4) Doxy-PEP (duration: 3:25 min); and 5) Undetectable equals Untransmittable - U=U (duration: 3:47 min). Videos were housed into the Vimeo platform, and were embedded into REDCap surveys for distribution.
Participant recruitment and eligibility: Participants will be recruited via referrals from community members (i.e., members of the Community Council, other study participants). Eligibility criteria include: 1) Male sex assigned at birth, currently identifying as a woman, transgender woman, transgender, or transsexual, irrespective of gender transition stage; 2) identifying as Latina, regardless of country of birth; 3) being 18 years old or older; 4) living in the DC metropolitan area; 5) self-reporting HIV negative status at study enrollment 6) reporting having receptive anal and/or neovaginal sex with at least one cisgender man or transgender woman in the previous 12 months; 7) not currently using PrEP or report less than 3 months of use; 8) have access to a cellphone with internet capabilities, and 9) not planning to move from the DC metropolitan area in the next 12 months.
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 D.C., District of Columbia, Estados Unidos, 20037
- The George Washington University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Male sex assigned at birth, currently identifying as a woman, transgender woman, transgender, or transsexual, irrespective of gender transition stage;
- Identifying as Latina, regardless of country of birth;
- Being 18 years old or older;
- Living in the DC metropolitan area;
- Self-reporting HIV negative status at study enrollment
- Reporting having receptive anal and/or neovaginal sex with at least one cisgender man or transgender woman in the previous 12 months;
- Not currently using PrEP or report less than 3 months of use;
- Must have access to a cellphone with internet capabilities,
- Not planning to move from the DC metropolitan area in the next 12 months
Exclusion Criteria:
- Not meeting all of the inclusion criteria.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervención
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The Juntas Adelante intervention includes two components:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PrEP initiation/persistence and/or PEP use
Periodo de tiempo: "Final follow up, 3 months after last coaching session"
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Our primary outcome is PrEP initiation/persistence or PEP use at the 3-month follow up, defined as the combination of any:
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"Final follow up, 3 months after last coaching session"
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in PrEP awareness
Periodo de tiempo: Baseline survey to final follow-up 3 months after last coaching session.
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Whether participant knows about PrEP for HIV prevention, evaluated by comparing baseline to 3-month follow-up surveys.
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Baseline survey to final follow-up 3 months after last coaching session.
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Change in PEP awareness
Periodo de tiempo: Baseline survey to final follow-up 3 months after last coaching session.
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Whether participant knows about PEP for HIV prevention, evaluated by comparing baseline to 3-month follow-up surveys.
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Baseline survey to final follow-up 3 months after last coaching session.
|
|
Change in Doxy-PEP awareness and use
Periodo de tiempo: Baseline survey to final follow-up 3 months after last coaching session.
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Whether participant knows about (awareness) or has used Doxy-PEP for STI prevention, evaluated by comparing baseline to 3-month follow-up surveys.
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Baseline survey to final follow-up 3 months after last coaching session.
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Change in U=U awareness
Periodo de tiempo: Baseline survey to final follow-up 3 months after last coaching session.
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Whether participant knows about Undetectable equals Untransmittable as a treatment-as-prevention message, evaluated by comparing baseline to 3-month follow-up surveys.
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Baseline survey to final follow-up 3 months after last coaching session.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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
Palabras clave
Otros números de identificación del estudio
- IRBPH 2024.16
- U01PS005218 (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.
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