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- Ensaio Clínico NCT05968755
Aproveitando o chatbot para melhorar a PrEP no sul dos Estados Unidos
Aproveitando a tecnologia Chatbot para melhorar a conscientização e a aceitação da PrEP entre HSH negros no sul dos 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.
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Zhao Ni
- Número de telefone: 203-737-3039
- E-mail: Zhao.ni@yale.edu
Locais de estudo
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Florida
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Miami, Florida, Estados Unidos, 33127
- Recrutamento
- Care 4 U Community Health Center
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Contato:
- Chief Operating Officer
- Número de telefone: 305-835-0101
- E-mail: aichite@care4uchc.org
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Pembroke Pines, Florida, Estados Unidos, 33027
- Recrutamento
- Community Care Resources of FL (CCRSFL)
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Contato:
- Executive Director
- Número de telefone: 877-287-2520
- E-mail: victoria@ccrsfl.com
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Georgia
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Atlanta, Georgia, Estados Unidos, 30318
- Recrutamento
- NAESM, Inc
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Contato:
- Research Coordinator
- Número de telefone: 404-691-8880
- E-mail: ak@naesminc.org
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28202
- Recrutamento
- RAO Community Health
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Contato:
- Director of Programs
- Número de telefone: 704-237-8793
- E-mail: zharris@raoassist.org
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Grupo de intervenção
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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. |
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Comparador de Placebo: Grupo de controle
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline PrEP awareness in 90 days
Prazo: At the baseline, 30, 60, and 90 days
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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
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Change from baseline PrEP uptake in 90 days
Prazo: At the baseline, 30, 60, and 90 days
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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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Usability score
Prazo: At 90 days
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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
|
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Recommendation score
Prazo: 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
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Acceptability score
Prazo: At 90 days
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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
|
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Practicality score
Prazo: At 90 days
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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
|
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Demand score
Prazo: At 90 days
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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
|
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Adaptation score
Prazo: 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
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 2000035242
- 000 (Outro identificador: CTGTY)
Plano para dados de participantes individuais (IPD)
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