BisexualityVINA STEAMNCT05732675
Skills to Empower Affirmative Men
A study testing "VINA STEAM" (Skills to Empower Affirmative Men) in people with Bisexuality and Homosexuality, run by Florida State University at 1 site in Vietnam.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bisexuality, Homosexuality, HIV Infections
- What is being tested?
- "VINA STEAM" (Skills to Empower Affirmative Men)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Sep 2021to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Has a known psychiatric disorder
- is under influence of alcohol and/or drugs
- ages 17 and below.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress and HIV-related Stigma Among Men in Viet Nam
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.
- Conditions
- Bisexuality, Homosexuality, HIV Infections
- Being tested
- "VINA STEAM" (Skills to Empower Affirmative Men)
- Medical subject headings
- Bisexuality, Homosexuality, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"VINA STEAM" (Skills to Empower Affirmative Men)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Other | Participants immediately enter the intervention upon enrollment Receives: Behavioral: "VINA STEAM" (Skills to Empower Affirmative Men) |
| Waitlist | Other | Participants enter a waitlist for 4-weeks prior to participating in the intervention Receives: Behavioral: "VINA STEAM" (Skills to Empower Affirmative Men) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audit-C
Alcohol Use Disorders Identification Test Min Score: 0 Max Score: 12 Higher score correlates with worse outcome
Measured: 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)
Illicit Drug Use
Any illicit drug use and count of illicit drug use by intervention arm and time
Measured: 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)
Condom Use
Condom use episodes with main partner in last 3 months
Measured: 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)
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
Measured: Over course of participant's lifetime
CES-D
Center for Epidemiological Studies Depression Scale Min Score: 0 Max Score: 60 Higher score correlates with worse outcome
Measured: 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)
ODSIS
Overall Depression Severity and Impairment Scale Min Score: 0 Max Score: 20 Higher score correlates with worse outcome
Measured: 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)
OASIS
Overall Anxiety Severity and Impairment Scale Min Score: 0 Max Score: 20 Higher score correlates with worse outcome
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Sep 2021
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BisexualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Frankie Wong, Florida State University
- Investigators
- Frankie Wong, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732675
- Sponsor's protocol ID
- REL00000085
- Other IDs
- 5R21TW011759-02
- Acronym
- VINA STEAM
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2023
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and HIV-related Stigma Among Men in Viet Nam
- ClinicalTrials.gov ID
- NCT05732675
- Acronym / sponsor ID
- VINA STEAM / REL00000085
- Conditions
- Bisexuality, Homosexuality, HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 17 Feb 2023 (actual)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Other | Behavioral: "VINA STEAM" (Skills to Empower Affirmative Men)Participants immediately enter the intervention upon enrollment |
| Waitlist | Other | Behavioral: "VINA STEAM" (Skills to Empower Affirmative Men)Participants enter a waitlist for 4-weeks prior to participating in the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Has a known psychiatric disorder
- is under influence of alcohol and/or drugs
- ages 17 and below.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Behavioural | Immediate Intervention, Waitlist |
Primary outcome
Audit-C
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)
Alcohol Use Disorders Identification Test Min Score: 0 Max Score: 12 Higher score correlates with worse outcome
Illicit Drug Use
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)
Any illicit drug use and count of illicit drug use by intervention arm and time
Condom Use
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)
Condom use episodes with main partner in last 3 months
HIV Testing
Time frame: Over course of participant's lifetime
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
CES-D
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)
Center for Epidemiological Studies Depression Scale Min Score: 0 Max Score: 60 Higher score correlates with worse outcome
ODSIS
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)
Overall Depression Severity and Impairment Scale Min Score: 0 Max Score: 20 Higher score correlates with worse outcome
OASIS
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)
Overall Anxiety Severity and Impairment Scale Min Score: 0 Max Score: 20 Higher score correlates with worse outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frankie Wong principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "VINA STEAM" (Skills to Empower Affirmative Men) in people with Bisexuality and Homosexuality, run by Florida State University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Audit-C (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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.