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NCT Number: NCT07514221

Project Yes+ for Young MSM 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.

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Key information

Conditions

Mental Disorder HIV Stigma Mental Disorders

Age range

16 year–24 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hanoi Medical University

Hanoi, 100000, Vietnam

Location contact

Thuy T. T. Dinh, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

To-Hieu (I understand)

Behavioral

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+

Primary outcomes

  1. Acceptability: Client satisfaction

    Time frame: At the end of the intervention at 4 months.

    Scores on the Client Satisfaction Questionnaire (CSQ-8). Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

  2. 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

  3. 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

  4. 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.

Secondary outcomes

  1. Preliminary effectiveness: changes in mental health symptom severity

    Time frame: Baseline and at the end of the intervention at 4 months

    Depression and anxiety symptoms over the past two weeks will be assessed using the 9-item Patient Health Questionnaire (PHQ-9) and the 7-item Generalized Anxiety Disorder (GAD-7) questionnaire. PHQ-9 scores range from 0 to 27 and GAD-7 scores range from 0 to 21, with higher scores indicate greater symptom severity.

  2. Preliminary effectiveness: Change in percentage of ART adherence

    Time frame: Baseline and at the end of the intervention at 4 months

    ART adherence will be assessed as the percentage of prescribed doses taken over the past 4 days, calculated using the self-reported number of missed doses and the total number of prescribed doses during that period.

  3. 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)

  4. Preliminary effectiveness: changes in internalized HIV stigma scores

    Time frame: Baseline and at the end of the intervention at 4 months

    Changes in internalized HIV stigma scores will be measured using the 6-item Internalized AIDS-Related Stigma Scale. Scores range from 6 to 24, with higher scores indicate greater internalized stigma.

  5. Preliminary effectiveness: changes in sexual minority stigma

    Time frame: Baseline and at the end of the intervention at 4 months

    Changes in sexual minority stigma will be assessed using the 7-item, 3-factor Reactions to Homosexuality Scale. Total scores range from 7 to 49, with higher scores indicate lower levels of internalized stigma.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Denison, PhD, MHS

CONTACT

[email protected]

Trang T. Nguyen, PhD

CONTACT

[email protected]

+84988424871

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: To-Hieu

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 7, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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