- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05968755
Aprovechamiento de Chatbot para mejorar la PrEP en el sur de los Estados Unidos
Aprovechamiento de la tecnología Chatbot para mejorar el conocimiento y la aceptación de la PrEP entre los HSH negros en el sur de los Estados Unidos
The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and uptake among Black men who have sex with men (MSM) in the Southern United States.
Descripción general del estudio
Estado
Descripción detallada
In the United States (US), the epicenter of the HIV epidemic is in the South. The HIV-related death rate in the US South is high, but engagement with quality HIV prevention services and care is low. Although only 38% of the US population lives in the South, the region accounts for 51% of new HIV infections. Gay, bisexual, and other men who have sex with men (MSM) account for 60% of new infections among African Americans in the South. Black MSM are one of the most vulnerable groups to HIV transmission in the US. HIV testing and PrEP uptake in Black MSM, however, remain low (10%) due to multiple factors including stigma, sexual-orientation based discrimination and low PrEP awareness among Black MSM. Innovative strategies that motivate and provide guidance for PrEP among Black MSM in the US South are therefore urgently needed. Chatbot technology should be tested and implemented to help improve PrEP awareness and uptake in the US South. In this project, the investigators aim to develop and pilot test to assess the acceptability and feasibility of a chatbot for PrEP awareness and uptake relative to treatment as usual (control).
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Zhao Ni
- Número de teléfono: 203-737-3039
- Correo electrónico: Zhao.ni@yale.edu
Ubicaciones de estudio
-
-
Florida
-
Miami, Florida, Estados Unidos, 33127
- Reclutamiento
- Care 4 U Community Health Center
-
Contacto:
- Chief Operating Officer
- Número de teléfono: 305-835-0101
- Correo electrónico: aichite@care4uchc.org
-
Pembroke Pines, Florida, Estados Unidos, 33027
- Reclutamiento
- Community Care Resources of FL (CCRSFL)
-
Contacto:
- Executive Director
- Número de teléfono: 877-287-2520
- Correo electrónico: victoria@ccrsfl.com
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30318
- Reclutamiento
- NAESM, Inc
-
Contacto:
- Research Coordinator
- Número de teléfono: 404-691-8880
- Correo electrónico: ak@naesminc.org
-
-
North Carolina
-
Charlotte, North Carolina, Estados Unidos, 28202
- Reclutamiento
- RAO Community Health
-
Contacto:
- Director of Programs
- Número de teléfono: 704-237-8793
- Correo electrónico: zharris@raoassist.org
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Being cisgender Black male
- Being aged ≥ 18 years
- Having Internet access
- Speaking English
- Self-reporting condomless sex with another man in the past 6 months
- Living in the U.S. South
- HIV negative or untested.
Exclusion Criteria:
- Not residing in a U.S. Census Bureau-defined Southern state: AL, AR, DE, FL, GA, KY, LA, MD, MS, NC, OK, SC, TN, TX, VA, WV.
- Having received antiretroviral therapy (ART) treatment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Grupo de intervención
|
Participants in the intervention group will have access to a theory-informed (Self-Determination Theory) chatbot and receive an automated personalized question message (root-node message) from the chatbot. The root-node messages are questions written into the chatbot algorithms to initiate interactive communication with participants. In each round of the interactive communication, the chatbot will provide automated personalized PrEP-related information, autonomous motivation, and psychological needs based on Self-Determination Theory constructs. |
|
Comparador de placebos: Grupo de control
|
Participants in the control group will received general education messages from a research assistant including healthy diet, exercise, and COVID-19 prevention. The frequency of contact will be pre-specified by participants in interviews prior to the RCT. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline PrEP awareness in 90 days
Periodo de tiempo: At the baseline, 30, 60, and 90 days
|
PrEP awareness will be measured as the proportion of participants who are aware of PrEP. Specifically, the investigators will collect PrEP awareness by asking participants standardized questions through a Qualtrics survey. |
At the baseline, 30, 60, and 90 days
|
|
Change from baseline PrEP uptake in 90 days
Periodo de tiempo: At the baseline, 30, 60, and 90 days
|
PrEP uptake will be measured as the mean of the frequency of taking PrEP medication. Specifically, the investigators will collect PrEP uptake by asking participants through a Qualtrics survey if they have been taken PrEP at baseline and every 30 days. If participants respond that they have taken PrEP, the investigators will ask them the date and frequency of taking it and ask them to upload a photo of their PrEP for verification to reduce social desirability bias in responses. |
At the baseline, 30, 60, and 90 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Usability score
Periodo de tiempo: At 90 days
|
The usability score will be measured by the System Usability Scale, which is 5-point Likert scale consisted of 10 questions. Participants' scores range from 0 to 100. A score of 68 is average, below 68 is poor, above 68 is good, and above 80.3 is excellent. |
At 90 days
|
|
Recommendation score
Periodo de tiempo: At 90 days
|
The recommendation score will be calculated by a Net Promote Score, which measures MSM's likelihood to recommend the chatbot to other MSM friends. The score ranges from 0 to 10. The higher the score, the better the recommendation score. |
At 90 days
|
|
Acceptability score
Periodo de tiempo: At 90 days
|
Acceptability, defined as the extent to which the chatbot is suitable and satisfactory to MSM, will be measured using the standardized Customer Satisfaction Scale "How would you rate your overall satisfaction with the chatbot?" and a 5-point Likert question "How would you rate the likelihood of continuing to use the chatbot?" |
At 90 days
|
|
Practicality score
Periodo de tiempo: At 90 days
|
Practicality defined as the extent to which the chatbot provides real-time Self-Determination theory inputs, will be measured using a 5-point Likert question "How would you rate the overall quality of the chatbot?" |
At 90 days
|
|
Demand score
Periodo de tiempo: At 90 days
|
Demand, defined as the level of integration to which the chatbot fits into the MSM-preferred online platform, will be measured by the number of actual use documented on developer's platform. |
At 90 days
|
|
Adaptation score
Periodo de tiempo: At 90 days
|
Adaptation, defined as the extent to which the chatbot can be integrated into other social-networking apps, will be measured by asking "How likely would you use the chatbot if embedded on other apps?" |
At 90 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Zhao Ni, Yale University
Publicaciones y enlaces útiles
Publicaciones Generales
- Centers for Disease Control and Prevention. HIV and African American Gay and Bisexual Men. [cited 2022 August 4]; Available from: https://www.cdc.gov/hiv/group/msm/bmsm.html.
- Adeagbo O, Harrison S, Qiao S, Li X. Pre-Exposure Prophylaxis (PrEP) Uptake among Black Men Who Have Sex with Men (BMSM) in the Southern U.S. Int J Environ Res Public Health. 2021 Sep 15;18(18):9715. doi: 10.3390/ijerph18189715.
- Watson RJ, Eaton LA, Maksut JL, Rucinski KB, Earnshaw VA. Links Between Sexual Orientation and Disclosure Among Black MSM: Sexual Orientation and Disclosure Matter for PrEP Awareness. AIDS Behav. 2020 Jan;24(1):39-44. doi: 10.1007/s10461-019-02696-1.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- 2000035242
- 000 (Otro identificador: CTGTY)
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.
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. .