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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)

28. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Sør -Korea
      • Seoul, Sør -Korea
        • Ewha Womans University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sook Jung Kang, PhD, FNP-C

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Atferdsmessig: 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 avatars and badges).
Aktiv komparator: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants Who Reported Receiving an HIV Test
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Seul Ki Choi

Samarbeidspartnere

Ewha Womans University

Etterforskere

  • Hovedetterforsker: Seul Ki Choi, MPH, PhD, University of Pennsylvania

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

31. mars 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

28. juli 2026

Først innsendt som oppfylte QC-kriteriene

28. juli 2026

Først lagt ut (Faktiske)

3. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 26-7236

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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