此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

利用聊天机器人改善美国南部的 PrEP

2026年9月18日 更新者:Yale University

利用聊天机器人技术提高美国南部黑人 MSM 的 PrEP 意识和接受度

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.

研究概览

详细说明

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).

研究类型

介入性

注册 (估计的)

145

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Florida
      • Miami、Florida、美国、33127
        • 招聘中
        • Care 4 U Community Health Center
        • 接触:
      • Pembroke Pines、Florida、美国、33027
        • 招聘中
        • Community Care Resources of FL (CCRSFL)
        • 接触:
    • Georgia
      • Atlanta、Georgia、美国、30318
        • 招聘中
        • NAESM, Inc
        • 接触:
          • Research Coordinator
          • 电话号码:404-691-8880
          • 邮箱:ak@naesminc.org
    • North Carolina
      • Charlotte、North Carolina、美国、28202
        • 招聘中
        • RAO Community Health
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

男性

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:干预组

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.

安慰剂比较:控制组

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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from baseline PrEP awareness in 90 days
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Usability score
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Zhao Ni、Yale University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月13日

初级完成 (估计的)

2027年3月31日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2023年5月22日

首先提交符合 QC 标准的

2023年7月27日

首次发布 (实际的)

2023年8月1日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月18日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2000035242
  • 000 (其他标识符:CTGTY)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅