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Набор скоро начнётся NCT07741123

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

Без фазы С лечением HIV Infections HIV Prevention and Care Risk Reduction Behavior Digital Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Bandi Mobile Application (Full Access), Information-Only Mobile Application (Limited Access).
Кому может быть актуально
Состояния в реестре: HIV Infections, HIV Prevention and Care, Risk Reduction Behavior, Digital Health. Базовые параметры: 18 лет — 35 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

  • Поведенческое Bandi Mobile Application (Full Access)
    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 ava
  • Поведенческое Information-Only Mobile Application (Limited Access)
    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.

Первичные конечные точки

  • Proportion of Participants Who Reported Receiving an HIV Test [Срок оценки: 3 months post-randomization]
  • Change in Frequency of Condomless Anal Intercourse (CAI) [Срок оценки: Baseline and 3 months post-randomization]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

South Korea · 1 центр
  • Ewha Womans University — Seoul

Публикации

  • Bauermeister JA, Muessig KE, Flores DD, LeGrand S, Choi S, Dong W, Harper GW, Hightow-Weidman LB. Stigma Diminishes the Protective Effect of Social Support on Psychological Distress Among Young Black Men Who Have Sex With Men. AIDS Educ Prev. 2018 Oct;30(5):406-418. doi: 10.1521/aeap.2018.30.5.406. PMID 30332312
  • Yang HJ, Bang JH, Kim J, Lee YH, Park Y, Huh IS, Shin SM, Kang CR, Seong MH, Kim GD, Hong HS, Cho SI, Oh MD, Hwang ES, Lee JK. Factors associated with intention to be tested for HIV among men who have sex with men in a country with a very low HIV prevalence. AIDS Care. 2018 Mar;30(3):289-295. doi: 10.1080/09540121.2017.1371666. Epub 2017 Aug 31. PMID 28859484
  • Sohn A, Cho B. Knowledge, Attitudes, and Sexual Behaviors in HIV/AIDS and Predictors Affecting Condom Use among Men Who Have Sex with Men in South Korea. Osong Public Health Res Perspect. 2012 Sep;3(3):156-64. doi: 10.1016/j.phrp.2012.07.001. PMID 24159508
  • Muessig KE, Golinkoff JM, Hightow-Weidman LB, Rochelle AE, Mulawa MI, Hirshfield S, Rosengren AL, Aryal S, Buckner N, Wilson MS, Watson DL, Houang S, Bauermeister JA. Increasing HIV Testing and Viral Suppression via Stigma Reduction in a Social Networking Mobile Health Intervention Among Black and Latinx Young Men and Transgender Women Who Have Sex With Men (HealthMpowerment): Protocol for a Rando PMID 33325838
  • Lee H, Park J, Choi B, Yi H, Kim SS. Association between Discrimination and Depressive Symptoms Among 2,162 Lesbian, Gay, and Bisexual Adults in South Korea: Does Community Connectedness Modify the Association? J Homosex. 2021 Jan 2;68(1):70-87. doi: 10.1080/00918369.2019.1624456. Epub 2019 Jun 13. PMID 31194923
  • Baek YJ, Sung K, Park S, Lee EJ, Youm Y, Choi JY. Closing the Gap in Pre-Exposure Prophylaxis Access for Sexual and Gender Minorities in South Korea: Implications for HIV Prevention Policy. AIDS Patient Care STDS. 2026 Jul;40(6-7):231-239. doi: 10.1177/10872914261450671. Epub 2026 May 18. PMID 42145104
  • Choi SK, Golinkoff J, Lin WY, Hightow-Weidman L, Muessig K, Bauermeister J. Current and Future Perspectives of HIV Prevention Research Among Young Sexual Minority Men in South Korea. Arch Sex Behav. 2023 Feb;52(2):721-732. doi: 10.1007/s10508-022-02403-7. Epub 2022 Sep 12. PMID 36097068

Идентификаторы

NCT: NCT07741123 · 26-7236

Первоисточники (государственные реестры)

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