- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07741123
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea (HMP Korea)
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:
- 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.
- 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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:
- Resource Center (Activities & Articles): Culturally tailored educational materials, pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) adherence strategies, interactive quizzes, and skill-building activities.
- Forums: Moderated online discussion forums and structured polls facilitating peer-to-peer support on topics including relationships, stigma, and sexual health.
- Love Log: An interactive self-monitoring tool allowing users to log past sexual encounters, plan future encounters, track behavioral patterns, and evaluate risk.
- Care Locator: A map database identifying local, culturally sensitive HIV and STI testing facilities.
- 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).
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Willey Lin, MBIOT, PMP, ACRP-CP
- Numéro de téléphone: 669-333-9925
- E-mail: willey@nursing.upenn.edu
Sauvegarde des contacts de l'étude
- Nom: Seul Ki Choi, MPH, PhD
- Numéro de téléphone: 215-573-4734
- E-mail: skchoi@nursing.upenn.edu
Lieux d'étude
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Seoul, Corée du Sud
- Ewha Womans University
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Contact:
- Sook Jung Kang, PhD, FNP-C
- Numéro de téléphone: 82-2-3277-2882
- E-mail: sookjungkang@ewha.ac.kr
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Chercheur principal:
- Sook Jung Kang, PhD, FNP-C
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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).
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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).
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Comparateur actif: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of Participants Who Reported Receiving an HIV Test
Délai: 3 months post-randomization
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Self-reported status of receiving an HIV test (Yes/No) as assessed via a web-based survey.
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3 months post-randomization
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Change in Frequency of Condomless Anal Intercourse (CAI)
Délai: Baseline and 3 months post-randomization
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Self-reported number of condomless anal intercourse episodes with male partners in the prior 3 months, assessed via web-based survey.
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Baseline and 3 months post-randomization
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Seul Ki Choi, MPH, PhD, University of Pennsylvania
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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 Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 16;9(12):e24043. doi: 10.2196/24043.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections transmissibles par le sang
- Maladies urogénitales
- Maladies génitales
- Maladies du système immunitaire
- Infections
- Infections par virus à ARN
- Maladies virales
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Comportement
- Comportement social
- Infections à VIH
- Stigmatisation sociale
- Comportement de réduction des risques
Autres numéros d'identification d'étude
- 26-7236
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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