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Project Yes+ for Young MSM Living With HIV in Vietnam

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07514221
Acronym
To-Hieu
Enrollment
80
Registered
2026-04-07
Start date
2026-06-01
Completion date
2028-02-28
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Stigma, Mental Disorder

Keywords

MSM, youth, Project Yes, Self-Help+, Project Yes+, internalized stigma, mental disorders, Vietnam

Brief summary

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.

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.

Interventions

BEHAVIORALTo-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.

Sponsors

Hanoi Medical University
Lead SponsorOTHER
Fogarty International Center of the National Institute of Health
CollaboratorNIH
Johns Hopkins University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
16 Years to 24 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability: Client satisfactionAt 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.
Feasibility: intervention attendanceFrom enrollment to the end of the intervention at 4 monthsPercentage of participants who complete at least 80% of the required sessions of To-Hieu
Acceptability: perception of implementationAt the end of the intervention at 4 months.Acceptability will be assessed qualitatively with exit interviews with AYMSMLH and youth peer mentors
Feasibility: Perception of implementationAt the end of the intervention at 4 monthsFeasibility will be assessed qualitatively in exit interviews with AYMSMLH and youth peer mentors.

Secondary

MeasureTime frameDescription
Preliminary effectiveness: changes in mental health symptom severityBaseline and at the end of the intervention at 4 monthsDepression 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.
Preliminary effectiveness: Change in percentage of ART adherenceBaseline and at the end of the intervention at 4 monthsART 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.
Preliminary effectiveness: HIV viral loadBaseline and at the end of the intervention at 4 monthsHIV viral load will be assessed with a test provided by the study or through participants' medical records (if available)
Preliminary effectiveness: changes in internalized HIV stigma scoresBaseline and at the end of the intervention at 4 monthsChanges 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.
Preliminary effectiveness: changes in sexual minority stigmaBaseline and at the end of the intervention at 4 monthsChanges 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.

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026