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HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea (HMP Korea)

2026年7月28日 更新者:Seul Ki Choi

Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea

This study tests a mobile application (app) designed to support sexual health and prevent human immunodeficiency virus (HIV) among young men in South Korea. Researchers are interested to learn if the app is acceptable, easy to use, and helpful for young men who have sex with men (MSM).

Participants will complete a 15-minute online survey at the start of the study and another 15-minute survey 3 months later. Participants will be randomly assigned to 1 of 2 study groups for 3 months:

  1. Intervention Group: Participants receive access to the full mobile app, called Bandi. The app includes health articles, quizzes, community discussion forums, a personal sexual health log, and a clinic finder.
  2. Control Group: Participants receive access to a basic version of the app that includes informational articles and the clinic finder only.

Researchers will compare both groups over 3 months to see if using the full app leads to higher rates of HIV testing and lower sexual risk behaviors.

研究概览

详细说明

This pilot study evaluates Bandi, a culturally adapted digital HIV prevention intervention for young Korean men who have sex with men (MSM). Bandi is adapted from HealthMpowerment (HMP 2.0), an evidence-informed, status-neutral digital health platform designated by the U.S. Centers for Disease Control and Prevention (CDC) for HIV risk reduction. Guided by Barrera and Castro's heuristic model for cultural adaptation, the trial represents Phase 3 (preliminary adaptation testing) following preliminary information gathering and beta testing (N=10).

Participants randomized to the full intervention arm receive 3-month access to the complete Bandi platform, consisting of five core integrated components:

  1. Resource Center (Activities & Articles): Culturally tailored educational materials, pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) adherence strategies, interactive quizzes, and skill-building activities.
  2. Forums: Moderated online discussion forums and structured polls facilitating peer-to-peer support on topics including relationships, stigma, and sexual health.
  3. Love Log: An interactive self-monitoring tool allowing users to log past sexual encounters, plan future encounters, track behavioral patterns, and evaluate risk.
  4. Care Locator: A map database identifying local, culturally sensitive HIV and STI testing facilities.
  5. Gamification: Engagement features including customizable avatars and accomplishment badges.

The control arm receives access restricted to static health articles and the Care Locator component.

The study is conducted remotely in South Korea through a partnership between the University of Pennsylvania and Ewha Womans University. Local recruitment and participant communication are managed by trained staff at Ewha Womans University in collaboration with community stakeholder collectives.

In addition to self-reported web-based survey data (Qualtrics) collected at baseline and 3 months, application engagement will be continuously monitored via passively recorded paradata (e.g., module usage, login frequency, feature interactions). Statistical analyses will follow an intent-to-treat (ITT) approach. Chi-square/Fisher's Exact tests and Wilcoxon Two-Sample tests will evaluate preliminary differences between study arms regarding primary outcomes (routine HIV testing rates, reduction in condomless anal intercourse) and secondary outcomes (PrEP awareness/uptake, everyday discrimination, social support, depression, anxiety, and resilience).

研究类型

介入性

注册 (估计的)

50

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

      • Seoul、韩国
        • Ewha Womans University
        • 接触:
        • 首席研究员:
          • Sook Jung Kang, PhD, FNP-C

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

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Male sex assigned at birth and current male gender identity
  • Aged 18 to 35 years
  • Current residence in the Seoul Metropolitan area
  • Korean nationality
  • Self-identify as a sexual minority (e.g., gay, bisexual, queer, or other non-heterosexual identity)
  • HIV-negative or HIV-unaware serostatus
  • Report at least 1 episode of condomless anal intercourse with a male partner in the prior 6 months

Exclusion Criteria:

  • Assigned female at birth or do not currently identify as male
  • Younger than 18 or older than 35 years of age
  • Non-residence in the Seoul Metropolitan area
  • Do not hold Korean nationality
  • Do not identify as a sexual minority
  • Known HIV-positive status
  • No reported episodes of condomless anal intercourse with a male partner in the prior 6 months

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:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Bandi App (Full Access)
Participants in this arm receive full 3-month access to the complete Bandi mobile application. Key features include interactive health articles and quizzes, moderated peer community forums and polls, the Love Log (a sexual health self-monitoring tool), a HIV/STI care locator, and gamification elements (custom avatars and accomplishment badges).
A culturally adapted digital HIV prevention mobile application designed for young men who have sex with men (MSM) in South Korea. Participants receive 3-month access to five core integrated features: interactive health articles and quizzes (covering PrEP, adherence, and sexual health); moderated peer community discussion forums and polls; Love Log (a sexual health tracking and planning tool); Care Locator (a directory of local HIV/STI testing centers); and gamification elements (customizable avatars and badges).
有源比较器:Information-Only App (Limited Access)
Participants in this arm receive 3-month access to a limited version of the mobile application. Features are restricted to static educational articles and a care locator.
A limited version of the mobile application provided to the control group over a 3-month period. Access is restricted to static online educational articles/resources and the Care Locator feature for finding local HIV/STI testing centers.

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
Proportion of Participants Who Reported Receiving an HIV Test
大体时间:3 months post-randomization
Self-reported status of receiving an HIV test (Yes/No) as assessed via a web-based survey.
3 months post-randomization
Change in Frequency of Condomless Anal Intercourse (CAI)
大体时间:Baseline and 3 months post-randomization
Self-reported number of condomless anal intercourse episodes with male partners in the prior 3 months, assessed via web-based survey.
Baseline and 3 months post-randomization

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。

赞助

调查人员

  • 首席研究员:Seul Ki Choi, MPH, PhD、University of Pennsylvania

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。

一般刊物

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)

2026年9月1日

初级完成 (估计的)

2027年3月31日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2026年7月28日

首先提交符合 QC 标准的

2026年7月28日

首次发布 (实际的)

2026年8月3日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月28日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

To protect participant privacy under local and international regulations-including South Korea's Personal Information Protection Act (PIPA) and IRB protocols-individual participant data will not be publicly shared. The study involves sensitive sexual health data among a vulnerable population, and local regulatory restrictions prohibit the open release or cross-border sharing of raw individual participant records.

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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