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HC-HMP: Healthy Choices Implementation Trial (HC-HMP)

2026年10月28日 更新者:Florida State University

Scaling Up Integrated Youth Alcohol and HIV Prevention Interventions: The Healthy Choices Implementation Trial

This study is a national, fully virtual Type 3 hybrid implementation-effectiveness clinical trial using the Multiphase Optimization Strategy (MOST) to evaluate implementation strategies designed to optimize delivery of the Healthy Choices (HC) behavioral intervention through the HealthMpowerment (HMP) digital health platform. A total of 360 emerging adults ages 18-29 who are eligible for antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) and report recent alcohol use will be randomized using a factorial design to combinations of three implementation strategies: a personalized video introduction to an HC peer counselor, tailored digital messaging, and asynchronous support from an HC counselor. All participants receive HC-HMP. The primary implementation outcome is HC direct-to-consumer fidelity, measured by the number of HC counseling sessions completed. Secondary outcomes include HMP fidelity assessed using platform-generated paradata, alcohol use, and HIV transmission risk. Participants complete assessments at baseline, 3 months, and 6 months.

研究概览

研究类型

介入性

注册 (估计的)

360

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

研究联系人备份

学习地点

    • Florida
      • Tallahassee、Florida、美国、32310
        • Florida State University, Center for Translational Behavioral Science
        • 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 至 29年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 18-29 years
  • Resident of the United States
  • Able to read and understand English
  • Self-reported as eligible for HIV pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART)
  • Self-reported alcohol use within the past 30 days
  • Regular access to an internet-connected smartphone capable of supporting the HMP mobile application (Android version 7.0 or higher or iPhone iOS version 16.4 or higher)

Exclusion Criteria:

  • Pregnant at the time of screening
  • Currently incarcerated
  • Unable to provide legally effective informed consent
  • Self-reported unmanaged moderate-to-severe mental health symptoms or concerns that would interfere with safe study participation, including active psychosis
  • Active heavy illegal drug use that is unmanaged/not currently in treatment, as defined by the study eligibility screener
  • Moderate-to-severe suicide risk, including suicidal ideation with plan, as defined by study eligibility and safety procedures

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:卫生服务研究
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Factorial Condition 1

Participants receive HC-HMP without any of the three implementation strategies (Video Introduction, Tailored Digital Messaging, or Asynchronous Support).

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

实验性的:Factorial Condition 2

Participants receive HC-HMP with the Low-Touch implementation strategy (Video Introduction) and without the Medium-Touch or High-Touch implementation strategies.

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy receive a brief, personalized video introduction to an HC peer counselor designed to foster early trust and empathy and support participant autonomy.

实验性的:Factorial Condition 3

Participants receive HC-HMP with the Medium-Touch implementation strategy (Tailored Digital Messaging) and without the Low-Touch or High-Touch implementation strategies.

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy receive tailored motivational and self-management messages designed to support participation in Healthy Choices and engagement with relevant intervention content. Message timing and content may be adapted based on participant engagement.

实验性的:Factorial Condition 4

Participants receive HC-HMP with the High-Touch implementation strategy (Asynchronous Support) and without the Low-Touch or Medium-Touch implementation strategies.

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy have access for three months to individualized asynchronous messaging with an HC counselor through the HMP platform. The support is designed to address barriers to participation and support engagement with HC and HMP resources.

实验性的:Factorial Condition 5

Participants receive HC-HMP with the Low-Touch (Video Introduction) and Medium-Touch (Tailored Digital Messaging) implementation strategies and without the High-Touch implementation strategy.

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy receive a brief, personalized video introduction to an HC peer counselor designed to foster early trust and empathy and support participant autonomy.

Participants randomized to this strategy receive tailored motivational and self-management messages designed to support participation in Healthy Choices and engagement with relevant intervention content. Message timing and content may be adapted based on participant engagement.

实验性的:Factorial Condition 6

Participants receive HC-HMP with the Low-Touch (Video Introduction) and High-Touch (Asynchronous Support) implementation strategies and without the Medium-Touch implementation strategy.

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy receive a brief, personalized video introduction to an HC peer counselor designed to foster early trust and empathy and support participant autonomy.

Participants randomized to this strategy have access for three months to individualized asynchronous messaging with an HC counselor through the HMP platform. The support is designed to address barriers to participation and support engagement with HC and HMP resources.

实验性的:Factorial Condition 7

Participants receive HC-HMP with the Medium-Touch (Tailored Digital Messaging) and High-Touch (Asynchronous Support) implementation strategies and without the Low-Touch implementation strategy.

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy receive tailored motivational and self-management messages designed to support participation in Healthy Choices and engagement with relevant intervention content. Message timing and content may be adapted based on participant engagement.

Participants randomized to this strategy have access for three months to individualized asynchronous messaging with an HC counselor through the HMP platform. The support is designed to address barriers to participation and support engagement with HC and HMP resources.

实验性的:Factorial Condition 8

Participants receive HC-HMP with all three implementation strategies: Low-Touch (Video Introduction), Medium-Touch (Tailored Digital Messaging), and High-Touch (Asynchronous Support).

Healthy Choices is an evidence-based behavioral intervention consisting of four individual counseling sessions grounded in Motivational Interviewing. Sessions are delivered remotely by trained interventionists using secure videoconferencing and address alcohol use, HIV prevention and treatment behaviors, stress management, and other HIV-related health behaviors.

HealthMpowerment is a mobile digital health platform providing digital health education and behavioral resources, peer and community features, self-monitoring tools, scheduling and reminders, and other intervention resources.

Participants randomized to this strategy receive a brief, personalized video introduction to an HC peer counselor designed to foster early trust and empathy and support participant autonomy.

Participants randomized to this strategy receive tailored motivational and self-management messages designed to support participation in Healthy Choices and engagement with relevant intervention content. Message timing and content may be adapted based on participant engagement.

Participants randomized to this strategy have access for three months to individualized asynchronous messaging with an HC counselor through the HMP platform. The support is designed to address barriers to participation and support engagement with HC and HMP resources.

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
Healthy Choices Direct-to-Consumer Fidelity
大体时间:Baseline through 3 months

Number of Healthy Choices counseling sessions completed by each participant during the 3-month intervention period. Participants may complete 0 to 4 sessions. A session is considered completed when the participant attends at least 15 minutes of the 30-minute virtual session.

Baseline through 3 months

次要结果测量

结果测量
措施说明
大体时间
HealthMpowerment Fidelity
大体时间:Baseline through 6 months

Engagement with the HealthMpowerment platform assessed using platform-generated usage paradata, including frequency of logins, time spent on the platform, and use of individual HMP features.

Baseline through 6 months
Maximum Alcohol Consumption Over a 3-Day Period
大体时间:Baseline, 3 months, and 6 months

Alcohol use assessed using the Timeline Followback (TLFB), which assesses daily alcohol consumption during the prior 14 days. The outcome is the maximum number of drinks consumed during a 3-day period.

Baseline, 3 months, and 6 months
HIV Transmission Risk
大体时间:Baseline, 3 months, and 6 months

Dichotomous status-neutral HIV transmission risk measure based on participant self-report. Participants reporting no condomless anal or vaginal intercourse, PrEP adherence of more than four doses per week, or self-reported viral suppression are classified as low risk (0); participants not meeting any of these criteria are classified as higher risk (1).

Baseline, 3 months, and 6 months

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。

调查人员

  • 首席研究员:Sylvie Naar, PhD、Florida State University
  • 首席研究员:Lisa Hightow-Weidman, MD, MPH、Florida State University College of Nursing
  • 研究主任:Sara Green, MSW、Florida State University College of Medicine, Center for Translational Behavioral Science

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 (估计的)

2027年6月1日

初级完成 (估计的)

2030年8月31日

研究完成 (估计的)

2030年11月30日

研究注册日期

首次提交

2026年10月28日

首先提交符合 QC 标准的

2026年10月28日

首次发布 (实际的)

2026年11月3日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月28日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

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

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.

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