Project Yes+ for Young MSM Living With HIV in Vietnam (To Hieu)

April 6, 2026 updated by: Hanoi Medical University

Adaptation of Project Yes+ to Improve Mental Health and Reduce HIV-related Stigma Among Adolescent and Young Men Who Have Sex With Men Living With HIV in Vietnam

In Vietnam, adolescent and young men who have sex with men (AYMSM) are among those most affected by HIV, and they also experience significant HIV-related mental health and stigma challenges. The study team proposes to adapt Project YES+ to address both mental health and internalized HIV stigma among AYMSM living with HIV in Vietnam. This research will build local capacity and develop networks for collaborative research on mental health and stigma in this population between Vietnam, Zambia and the United States.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The specific aims of this proposal are to (1) adapt Project YES+ to create To Hieu (I understand) to improve mental health and internalized HIV stigma for AYMSM living with HIV in Vietnam and (2) examine acceptability and feasibility of To Hieu among AYMSM living with HIV in Vietnam through a pilot randomized controlled trial.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 16-24 years old Vietnamese;
  • assigned male sex at birth and identifying as male;
  • anal intercourse with another man in the last 12 months;
  • HIV positive status and currently receiving ART at the study sites;
  • currently living in Hanoi and not moving in the next 12 months;
  • at least a score of 5 on either the Patient Health Questionnaire (PHQ-9) or Generalized Anxiety Disorder - 7 (GAD-7)

Exclusion Criteria:

  • Being currently enrolled in another HIV intervention;
  • Severe psychotic disorders or other interfering problems that require specialty care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: To Hieu
The participants will receive the To Hieu intervention for 4 months
Behavioral: To Hieu (I understand)
Project YES+ was developed from two evidence-based interventions - Project Yes! and Self-Help Plus, based on Social Cognitive Theory (Project Yes!) and Acceptance and Commitment Therapy (Self-Help Plus). The youth-focused intervention component comprises 6 individual sessions with a youth peer mentor, 3 youth group sessions facilitated by a youth peer mentor and 5 group sessions to learn stress management skills. The original intervention was designed for 4 months and involves caregivers. The adaptation of Project YES+ for adolescents and young men who have sex with men living with HIV in Vietnam will make revisions on the content, frequency and delivery format of the intervention.
Other Names:
  • Project YES+
No Intervention: Standard of care
The participants will receive standard of care at their clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability: Client satisfaction
Time Frame: At the end of the intervention at 4 months.
Ratings on the Client Satisfaction Questionnaire.
At the end of the intervention at 4 months.
Feasibility: intervention attendance
Time Frame: From enrollment to the end of the intervention at 4 months
Percentage of participants who complete at least 80% of the required sessions of To Hieu
From enrollment to the end of the intervention at 4 months
Acceptability: perception of implementation
Time Frame: At the end of the intervention at 4 months.
Acceptability will be assessed qualitatively with exit interviews with AYMSMLH and youth peer mentors
At the end of the intervention at 4 months.
Feasibility: Perception of implementation
Time Frame: At the end of the intervention at 4 months
Feasibility will be assessed qualitatively in exit interviews with AYMSMLH and youth peer mentors.
At the end of the intervention at 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary effectiveness: mental health symptoms and stigma
Time Frame: Baseline and at the end of the intervention at 4 months
Depression, anxiety symptoms, internalized HIV and sexual minority stigma will be assessed using questionnaires.
Baseline and at the end of the intervention at 4 months
Preliminary effectiveness: ART adherence
Time Frame: Baseline and at the end of the intervention at 4 months
ART adherence will be assessed using existing medical records.
Baseline and at the end of the intervention at 4 months
Preliminary effectiveness: HIV viral load
Time Frame: Baseline and at the end of the intervention at 4 months
HIV viral load will be assessed with a test provided by the study or through participants' medical records (if available)
Baseline and at the end of the intervention at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanoi Medical University

Collaborators

Johns Hopkins University
Fogarty International Center of the National Institute of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21TW013174 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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