CClinicalTrials.gg
CompletedNCT05732675VINA STEAMUpdated Aug 6, 2026Results posted

Skills to Empower Affirmative Men

An interventional study of "VINA STEAM" (Skills to Empower Affirmative Men) in Bisexuality, Homosexuality and HIV Infections, sponsored by Florida State University. Completed at 1 site in Vietnam. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Florida State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Sep 2021, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The mixed-method study will involve: (1) preparation stage; (2) formative stage, where qualitative data from Vietnamese GBM and key informants will inform the adaptation of the ESTEEM package; (3) feasibility test, where the adapted intervention will be piloted-test in a small sample (4 small group, N = 24) of GBM and further adjusted on the pilot-test results; and (4) small-scale efficacy test of the adjusted intervention using a randomized waitlist controlled design in a cohort of 120 GBM, where they will be randomly assigned to either the immediate intervention (6 groups) or a waitlist arm (6 groups) with 10 men per groups. During the preparation stage, the investigators will obtain ethical approval from the Florida State University's Institutional Review Board. The investigators will identify and hire staff knowledgeable about the local socio-cultural context pertaining to GBM, fluent in Vietnamese, and familiar with research-oriented studies. All personnel and individual contacting with the study on human participants will be trained on human subject protection. During the qualitative formative stage, the investigators will conduct individual interviews (N = 15) of GBM community representatives, focus group (4 group, N = 25) with GBN community representative and individual interviews (N = 10) of key informants. Key informants (e.g., outreach workers, counselors, consultant, psychologists, program managers) will consist of adults with experience working with GBM in the areas of mental or sexual health, stigma, and/or legal protection. Interviews and focus groups will be audio-recorded. The investigators will intersperse key informant interviews, individual interviews, and focus groups with GBM and the process of ESTEEM adaptation in an iterative manner. For the feasibility test stage, the investigators will recruit 24 GBM to pilot test the adapted intervention in small groups (N = 6 per group) setting to meet once weekly for a period of 8 week. During the intervention, qualitative data will be collected via baseline and endline surveys. Qualitative data will be collected from individual interviews after each individual session in addition to ta final individual and 4 focus groups after completion of all sessions in the intervention. These data will be used to revise the intervention as needed for the small-scale efficacy stage. Audio-recordings of interviews and focus groups from the formative and feasibility test stages will be transcribed verbatim and analyzed in MaxQDA software using thematic analysis. Data from interviews and focus groups will be complemented by information from peer facilitators' oral feedback and participants' open-ended questionnaires.

Qualitative data analysis will be guided by the intervention feasibility domains --acceptability, demand, implementation, practicality, adaptation, integration, and expansion. Due to the small sample size (N = 24) in the feasibility test no inferential statistical analysis of quantitative data will be performed. The investigators will only determine the direction of changes in the primary outcomes and assess effect sizes. For the small-scale efficacy stage, the investigators will enroll and assign 120 consented participants to 12 small groups and with 10 individuals in each group. Then the investigators will randomize the small groups into the immediate intervention and waitlist arms (6 groups in each arm). All participants will complete 3 waves of data collection: baseline, 3-month follow-up, and 6-month follow-up. Power calculations (using PROC POWRR in SAS 9.4 and assuming an intra-cluster correlation of 10%) demonstrates that a sample size of 120 is sufficiently large to detect medium effect size of d = 0.477 via a one-sided independent t-test. The investigators will include all randomized participants into the analysis using an intent-to-treat approach. The investigators will use mixed models with appropriate distribution and link functions based on endpoint variable properties along with repeated measures approach to account for within individual and group correction.

02

Conditions studied

  • Bisexuality
  • Homosexuality
  • HIV Infections
03

In context

Homosexuality

28 studies on the registry are indexed under Homosexuality; 6 are open to participants now.

This study's enrollment of 167 is below the median of 288 across 25 interventional studies indexed under Homosexuality.

Browse Homosexuality studies →

Lead sponsor

Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Has a known psychiatric disorder
  • is under influence of alcohol and/or drugs
  • ages 17 and below.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
167 participants (actual)

Study arms

  • Other
    Immediate Intervention

    Participants immediately enter the intervention upon enrollment

    Behavioral: "VINA STEAM" (Skills to Empower Affirmative Men)

  • Other
    Waitlist

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

    Behavioral: "VINA STEAM" (Skills to Empower Affirmative Men)

Interventions

  • Behavioral"VINA STEAM" (Skills to Empower Affirmative Men)

    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.

06

What researchers measure

Primary outcomes

  1. Audit-C

    Alcohol Use Disorders Identification Test Min Score: 0 Max Score: 12 Higher score correlates with worse outcome

    Time frame: T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 mo. (SD 0.20). T2Intervention: Mean timing 1.73 months (SD 0.87), T2Waitlist: 2.02 mo. (SD 1.04). T3Intervention: Mean timing 5.51 mo. (SD 0.57), T3Waitlist 3.41 mo. (SD 0.95)

  2. Illicit Drug Use

    Any illicit drug use and count of illicit drug use by intervention arm and time

    Time frame: T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 mo. (SD 0.20). T2Intervention: Mean timing 1.73 months (SD 0.87), T2Waitlist: 2.02 mo. (SD 1.04). T3Intervention: Mean timing 5.51 mo. (SD 0.57), T3Waitlist 3.41 mo. (SD 0.95)

  3. Condom Use

    Condom use episodes with main partner in last 3 months

    Time frame: T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 mo. (SD 0.20). T2Intervention: Mean timing 1.73 months (SD 0.87), T2Waitlist: 2.02 mo. (SD 1.04). T3Intervention: Mean timing 5.51 mo. (SD 0.57), T3Waitlist 3.41 mo. (SD 0.95)

  4. HIV Testing

    HIV testing results (ever) Measures number of participants who have ever been tested for HIV, at least once Administered at T2 timepoint Participants must be HIV-negative to enroll and maintain enrollment in study

    Time frame: Over course of participant's lifetime

  5. CES-D

    Center for Epidemiological Studies Depression Scale Min Score: 0 Max Score: 60 Higher score correlates with worse outcome

    Time frame: T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 mo. (SD 0.20). T2Intervention: Mean timing 1.73 months (SD 0.87), T2Waitlist: 2.02 mo. (SD 1.04). T3Intervention: Mean timing 5.51 mo. (SD 0.57), T3Waitlist 3.41 mo. (SD 0.95)

  6. ODSIS

    Overall Depression Severity and Impairment Scale Min Score: 0 Max Score: 20 Higher score correlates with worse outcome

    Time frame: T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 mo. (SD 0.20). T2Intervention: Mean timing 1.73 months (SD 0.87), T2Waitlist: 2.02 mo. (SD 1.04). T3Intervention: Mean timing 5.51 mo. (SD 0.57), T3Waitlist 3.41 mo. (SD 0.95)

  7. OASIS

    Overall Anxiety Severity and Impairment Scale Min Score: 0 Max Score: 20 Higher score correlates with worse outcome

    Time frame: T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 mo. (SD 0.20). T2Intervention: Mean timing 1.73 months (SD 0.87), T2Waitlist: 2.02 mo. (SD 1.04). T3Intervention: Mean timing 5.51 mo. (SD 0.57), T3Waitlist 3.41 mo. (SD 0.95)

07

Results

Posted Aug 6, 2026

Participant flow

194 people assessed for eligibility. 20 did not meet inclusion criteria for attendance. 7 could not be reached despite repeated contact attempts. 167 people were thus enrolled in the study.

Participant flow — Overall Study
MilestoneImmediate InterventionWaitlist
Started8384
Completed6977
Not completed147
Withdrew: Lost to follow-up147

Outcome measures

PrimaryAudit-C

Alcohol Use Disorders Identification Test Min Score: 0 Max Score: 12 Higher score correlates with worse outcome

Time frame:
T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 mo. (SD 0.20). T2Intervention: Mean timing 1.73 months (SD 0.87), T2Waitlist: 2.02 mo. (SD 1.04). T3Intervention: Mean timing 5.51 mo. (SD 0.57), T3Waitlist 3.41 mo. (SD 0.95)
Reported as:
Mean · score on a scale
Audit-C
score on a scaleT1 Immediate InterventionT2 Immediate InterventionT3 Immediate InterventionT1 WaitlistT2 WaitlistT3 Waitlist
Audit-C1.75 ± 21.78 ± 2.781.78 ± 1.932.74 ± 2.593.06 ± 2.583.25 ± 2.64
Statistical analysis
  • T1 Immediate Intervention vs T2 Immediate Intervention vs T3 Immediate Intervention vs T1 Waitlist vs T2 Waitlist vs T3 Waitlist · Mixed Models Analysis · p = 0.588 · Mean difference (net): -0.12 · 95% CI -0.552 to 0.312
  • T1 Immediate Intervention vs T3 Immediate Intervention · Mixed Models Analysis · p = 0.426 · Mean difference (net): 0.26 · 95% CI -0.383 to 0.909
  • T1 Waitlist vs T3 Waitlist · Mixed Models Analysis · p = 0.091 · Mean difference (net): 0.50 · 95% CI -0.077 to 1.074
  • T1 Immediate Intervention vs T1 Waitlist · Mixed Models Analysis · p = 0.008 · Mean difference (net): -1.09 · 95% CI -1.881 to -0.293
PrimaryIllicit Drug Use

Any illicit drug use and count of illicit drug use by intervention arm and time

Time frame:
T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 mo. (SD 0.20). T2Intervention: Mean timing 1.73 months (SD 0.87), T2Waitlist: 2.02 mo. (SD 1.04). T3Intervention: Mean timing 5.51 mo. (SD 0.57), T3Waitlist 3.41 mo. (SD 0.95)
Reported as:
Count of participants · Participants
Illicit Drug Use
ParticipantsT1 Immediate InterventionT2 Immediate InterventionT3 Immediate InterventionT1 WaitlistT2 WaitlistT3 Waitlist
Illicit Drug Use14107322223
Statistical analysis
  • T1 Immediate Intervention vs T2 Immediate Intervention vs T3 Immediate Intervention vs T1 Waitlist vs T2 Waitlist vs T3 Waitlist · Regression, Logistic · p = 0.0304 · Odds ratio (or): 0.444 · 95% CI 0.213 to 0.926
  • T1 Waitlist vs T3 Waitlist · Regression, Logistic · p = 0.030 · Odds ratio (or): 0.44 · 95% CI 0.21 to 0.93
  • T1 Immediate Intervention vs T1 Waitlist · Regression, Logistic · p = 0.183 · Odds ratio (or): .71 · 95% CI .21 to .93
PrimaryCondom Use

Condom use episodes with main partner in last 3 months

Time frame:
T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 mo. (SD 0.20). T2Intervention: Mean timing 1.73 months (SD 0.87), T2Waitlist: 2.02 mo. (SD 1.04). T3Intervention: Mean timing 5.51 mo. (SD 0.57), T3Waitlist 3.41 mo. (SD 0.95)
Reported as:
Count of participants · Participants
Condom Use
ParticipantsT1 Immediate InterventionT2 Immediate InterventionT3 Immediate InterventionT1 WaitlistT2 WaitlistT3 Waitlist
Never191814181616
<50%1186141614
>50%74310107
Always111311231414
No anal sex with main partner89111073
Statistical analysis
  • T2 Immediate Intervention vs T2 Waitlist · Chi-squared · p = 0.3271
  • T2 Immediate Intervention vs T2 Waitlist · Chi-squared · p = 0.33
PrimaryHIV Testing

HIV testing results (ever) Measures number of participants who have ever been tested for HIV, at least once Administered at T2 timepoint Participants must be HIV-negative to enroll and maintain enrollment in study

Time frame:
Over course of participant's lifetime
Reported as:
Count of participants · Participants
HIV Testing
ParticipantsT2 Immediate InterventionT2 Waitlist
HIV Testing5255
Statistical analysis
  • T2 Immediate Intervention vs T2 Waitlist · Fisher's Exact Test · p = .0008 · Risk difference (rd): 0.127 · 95% CI 0.027 to 0.227
PrimaryCES-D

Center for Epidemiological Studies Depression Scale Min Score: 0 Max Score: 60 Higher score correlates with worse outcome

Time frame:
T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 mo. (SD 0.20). T2Intervention: Mean timing 1.73 months (SD 0.87), T2Waitlist: 2.02 mo. (SD 1.04). T3Intervention: Mean timing 5.51 mo. (SD 0.57), T3Waitlist 3.41 mo. (SD 0.95)
Reported as:
Mean · score on a scale
CES-D
score on a scaleT1 Immediate InterventionT2 Immediate InterventionT3 Immediate InterventionT1 WaitlistT2 WaitlistT3 Waitlist
CES-D19.5 ± 16.216.3 ± 16.014.8 ± 15.813.4 ± 12.611.1 ± 12.77.5 ± 11.2
Statistical analysis
  • T1 Immediate Intervention vs T2 Immediate Intervention vs T3 Immediate Intervention vs T1 Waitlist vs T2 Waitlist vs T3 Waitlist · Mixed Effects Model · p = 0.20 · Mean difference (final values): 3.25 · 95% CI -1.79 to 8.30
PrimaryODSIS

Overall Depression Severity and Impairment Scale Min Score: 0 Max Score: 20 Higher score correlates with worse outcome

Time frame:
T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 mo. (SD 0.20). T2Intervention: Mean timing 1.73 months (SD 0.87), T2Waitlist: 2.02 mo. (SD 1.04). T3Intervention: Mean timing 5.51 mo. (SD 0.57), T3Waitlist 3.41 mo. (SD 0.95)
Reported as:
Mean · score on a scale
ODSIS
score on a scaleT1 Immediate InterventionT2 Immediate InterventionT3 Immediate InterventionT1 WaitlistT2 WaitlistT3 Waitlist
ODSIS4.5 ± 4.24.0 ± 4.33.8 ± 4.13.8 ± 3.52.4 ± 3.23.5 ± 3.9
Statistical analysis
  • T1 Immediate Intervention vs T2 Immediate Intervention vs T3 Immediate Intervention vs T1 Waitlist vs T2 Waitlist vs T3 Waitlist · Mixed Effects Model · p = 0.14 · Mean difference (final values): -1.10 · 95% CI -2.57 to 0.37
PrimaryOASIS

Overall Anxiety Severity and Impairment Scale Min Score: 0 Max Score: 20 Higher score correlates with worse outcome

Time frame:
T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 mo. (SD 0.20). T2Intervention: Mean timing 1.73 months (SD 0.87), T2Waitlist: 2.02 mo. (SD 1.04). T3Intervention: Mean timing 5.51 mo. (SD 0.57), T3Waitlist 3.41 mo. (SD 0.95)
Reported as:
Mean · score on a scale
OASIS
score on a scaleT1 Immediate InterventionT2 Immediate InterventionT3 Immediate InterventionT1 WaitlistT2 WaitlistT3 Waitlist
OASIS4.8 ± 4.54.5 ± 4.44.1 ± 4.34.1 ± 3.93.2 ± 3.51.8 ± 2.8
Statistical analysis
  • T1 Immediate Intervention vs T2 Immediate Intervention vs T3 Immediate Intervention vs T1 Waitlist vs T2 Waitlist vs T3 Waitlist · Mixed Effects Model · p = 0.08 · Mean difference (final values): -1.50 · 95% CI -3.20 to 0.20

Adverse events

Collected over T1Intervention: Mean time from baseline 0.09 months (SD 0.28), T1Waitlist: 0.03 months (SD 0.20). T2Intervention: Mean timing from T1 1.73 months (SD 0.87), T2Waitlist: 2.02 months. (SD 1.04). T3Intervention: Mean timing from T2 5.51 months (SD 0.57), T3Waitlist 3.41 months (SD 0.95).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Immediate Intervention0/83 (0%)0/83 (0%)0/83 (0%)
Waitlist0/84 (0%)0/84 (0%)0/84 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Immediate InterventionWaitlistTotal
Mean25 ± 5.326.4 ± 5.325.9 ± 5.3
Sex: Female, Male
Sex: Female, Male(Participants)Immediate InterventionWaitlistTotal
Female000
Male6977146
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Immediate InterventionWaitlistTotal
Ethnicity — Kinh (Viet)6471135
Ethnicity — Other5611
Region of Enrollment
Region of Enrollment(participants)Immediate InterventionWaitlistTotal
Vietnam6977146
Sexual Orientation
Sexual Orientation(Participants)Immediate InterventionWaitlistTotal
Homosexual6075135
Bisexual202
Heterosexual000
Other729
Marital Status
Marital Status(Participants)Immediate InterventionWaitlistTotal
Single4756103
Married123
Relationship201838
Declined to Answer112
Education
Education(Participants)Immediate InterventionWaitlistTotal
No school000
Elementary000
Junior HS112
High School212647
Vocational156
Bachelor444387
Masters/PhD213
Don't Know000
Refused011
Number of Children
Number of Children(Number of children)Immediate InterventionWaitlistTotal
Mean0.1 ± 1.00.1 ± 0.60.1 ± 0.8

6 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Center for Research for Men and Gender Health
    Ho Chi Minh City, Vietnam
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 5, 2021
  • Informed consent form · Oct 5, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05732675
Lead sponsor
Florida State University
Collaborators
Fogarty International Center of the National Institute of Health
Responsible party
Frankie Wong (McKenzie Endowed Professor, Florida State University) — Principal investigator
First posted
Feb 17, 2023
Start date
Sep 1, 2021
Primary completion
Mar 1, 2025
Completion
Mar 1, 2025
Results posted
Aug 6, 2026
Last update
Aug 6, 2026

Study contacts

Frankie Wong
principal investigator · Florida State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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