NCT05732675

Brief Summary

Participants are Vietnamese national. Over the course of the study activities, approximately 184 self-identified Vietnamese national gay and bisexual men ages 18 and above living in HCMC, Viet Nam, as well as 10 key informants (about 5 females) ages 18 and above will participate in the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 10, 2025

Status Verified

March 1, 2023

Enrollment Period

3.2 years

First QC Date

February 8, 2023

Last Update Submit

April 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Increase in HIV testing.

    Increase in HIV testing

    24 months

Study Arms (2)

Immediate Intervention

OTHER

Participants immediately enter the intervention upon enrollment

Behavioral: "Vina-STEAM" (Skills to Empower Affirmative Men)

Waitlist

OTHER

Participants enter a waitlist for 4-weeks prior to participating in the intervention

Behavioral: "Vina-STEAM" (Skills to Empower Affirmative Men)

Interventions

The investigators propose and pilot test a community-based, peer-driven minority stress as well as HIV-stigma reduction program in small group of GBM in Ho Chi Minh City, Viet Nam.

Immediate InterventionWaitlist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • born as a biological male and self-identifying as a man
  • ages 18 and above,
  • self-reported as gay or bisexual
  • a verifiable HIV-negative status
  • reporting at least one episode of unprotected anal sex with a casual male partner or male partner with positive or unknown HIV-status in the past 30 days
  • able and willing to provide verbal and written informed consent in Vietnamese
  • intending to Stay in Ho Chi Minh City, Viet Nam, not to leave the city for more than one week in the next two months.

You may not qualify if:

  • Has a known psychiatric disorder
  • is under influence of alcohol and/or drugs
  • ages 17 and below.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Research for Men and Gender Health

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

BisexualityHomosexualityHIV Infections

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehaviorBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Frankie Wong

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study does not involve masking of participants, care providers, or investigators.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study follows a parallel design, where participants are randomized into two arms-immediate intervention and waitlist control. The study aims to test the feasibility and efficacy of the ESTEEM intervention in small groups, with ongoing assessment over a 6-month period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
McKenzie Endowed Professor of Health Equity Research

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

September 1, 2021

Primary Completion

November 1, 2024

Study Completion

January 1, 2025

Last Updated

April 10, 2025

Record last verified: 2023-03

Locations