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Stress and HIV-related Stigma Among Men in Viet Nam

Primary Purpose

Bisexuality, Homosexuality, HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
"Vina-STEAM" (Skills to Empower Affirmative Men)
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bisexuality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Research for Men and Gender HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Immediate Intervention

Waitlist

Arm Description

Participants immediately enter the intervention upon enrollment

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

Outcomes

Primary Outcome Measures

Increase in HIV testing.
Increase in HIV testing

Secondary Outcome Measures

Full Information

First Posted
February 8, 2023
Last Updated
March 20, 2023
Sponsor
Florida State University
Collaborators
The Center for Applied Research for Men and Community Health
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1. Study Identification

Unique Protocol Identification Number
NCT05732675
Brief Title
Stress and HIV-related Stigma Among Men in Viet Nam
Official Title
Building Resilience to Minority Stress and HIV-related Stigma for Promoting Positive Sexual Health Among Vietnamese High-risk Men
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
The Center for Applied Research for Men and Community Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bisexuality, Homosexuality, HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention
Arm Type
Other
Arm Description
Participants immediately enter the intervention upon enrollment
Arm Title
Waitlist
Arm Type
Other
Arm Description
Participants enter a waitlist for 4-weeks prior to participating in the intervention
Intervention Type
Behavioral
Intervention Name(s)
"Vina-STEAM" (Skills to Empower Affirmative Men)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increase in HIV testing.
Description
Increase in HIV testing
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Has a known psychiatric disorder is under influence of alcohol and/or drugs ages 17 and below.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Liebrich
Phone
850-645-6887
Email
sliebrich@fsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frankie Wong
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Research for Men and Gender Health
City
Ho Chi Minh City
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
An Bao
Phone
84913650536
Email
baoan.lab@gmail.com
First Name & Middle Initial & Last Name & Degree
Donn Colby

12. IPD Sharing Statement

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Stress and HIV-related Stigma Among Men in Viet Nam

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