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Juntas Adelante: A Peer-Coaching Intervention to Promote Chemoprophylaxis for HIV Prevention Among Latina Transgender Women in the Washington DC Metropolitan Area.

2 de septiembre de 2026 actualizado por: Ana María del Río-González, George Washington University

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:

  1. Is the Juntas Adelante intervention acceptable and feasible to implement with this population?
  2. 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

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:

  1. 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.
  2. 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

Intervencionista

Inscripción (Actual)

39

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

    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20037
        • The George Washington University

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

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

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: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervención

The Juntas Adelante intervention includes two components:

  1. 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. Sessions occur via Zoom, and are scheduled at the convenience of participants. In addition to HIV and STI prevention, participants may bring other topics they want to discuss during the coaching sessions.
  2. 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PrEP initiation/persistence and/or PEP use
Periodo de tiempo: "Final follow up, 3 months after last coaching session"

Our primary outcome is PrEP initiation/persistence or PEP use at the 3-month follow up, defined as the combination of any:

  1. PrEP Initiation: Participants who reported having never used PrEP at baseline AND report starting PrEP between baseline and 3-month follow up OR participants who reported having ever used PrEP but were not currently using at baseline AND report re-starting PrEP between baseline and 3-month follow up.
  2. PrEP Persistence: Participants who reported using PrEP at baseline AND continued using at 3-month follow up. For daily oral PrEP, persistence is defined as still taking PrEP at 3 month follow-up. Persistence for long-acting injectable PrEP will be defined as receiving at least 1 injection since baseline visit.
  3. PEP Use: Any instance of PEP use by a non-PrEP user between baseline and 3-month follow up.
"Final follow up, 3 months after last coaching session"

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.
Whether participant knows about PrEP for HIV prevention, evaluated by comparing baseline to 3-month follow-up surveys.
Baseline survey to final follow-up 3 months after last coaching session.
Change in PEP awareness
Periodo de tiempo: Baseline survey to final follow-up 3 months after last coaching session.
Whether participant knows about PEP for HIV prevention, evaluated by comparing baseline to 3-month follow-up surveys.
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.
Whether participant knows about (awareness) or has used Doxy-PEP for STI prevention, evaluated by comparing baseline to 3-month follow-up surveys.
Baseline survey to final follow-up 3 months after last coaching session.
Change in U=U awareness
Periodo de tiempo: Baseline survey to final follow-up 3 months after last coaching session.
Whether participant knows about Undetectable equals Untransmittable as a treatment-as-prevention message, evaluated by comparing baseline to 3-month follow-up surveys.
Baseline survey to final follow-up 3 months after last coaching session.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este 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 (Actual)

1 de octubre de 2024

Finalización primaria (Actual)

5 de agosto de 2026

Finalización del estudio (Actual)

5 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

2 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de septiembre de 2026

Publicado por primera vez (Actual)

9 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

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)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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