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

July 28, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • South Korea
      • Seoul, South Korea
        • Ewha Womans University
        • Contact:
        • Principal Investigator:
          • Sook Jung Kang, PhD, FNP-C

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Behavioral: 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).
Active Comparator: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants Who Reported Receiving an HIV Test
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seul Ki Choi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ewha Womans University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seul Ki Choi, MPH, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26-7236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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