Skills to Empower Affirmative Men

NCT05732675 | Completed Results

• 2 other identifiers: REL000000855R21TW011759-02
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Bisexuality; Homosexuality; HIV Infections

Outcome Measures

Primary Outcomes (7)

• Audit-C

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

  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

  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

  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

  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

  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

  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

  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)

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

"VINA STEAM" (Skills to Empower Affirmative Men) BEHAVIORAL

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 Intervention; Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

Sponsors & Collaborators

• Florida State University: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Center for Research for Men and Gender Health

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Bisexuality; Homosexuality; HIV Infections

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Frank Y. Wong
• Organization: Center of Population Sciences for Health Empowerment, Florida State University

fwong@fsu.edu

2025386653

Study Officials

• Frankie Wong

  Florida State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: McKenzie Endowed Professor

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.

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: September 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 6, 2026
• Results First Posted: August 6, 2026

Record last verified: 2023-03

Locations

VN (1)