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Mental DisorderTo-HieuNCT07514221

Project Yes+ for Young MSM Living With HIV in Vietnam

A study testing To-Hieu (I understand) in people with Mental Disorder and HIV Stigma, run by Hanoi Medical University at 1 site in Vietnam.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 24 years, men only
Conditions the study is for
Mental Disorder, HIV Stigma
What is being tested?
To-Hieu (I understand)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteVietnam
Study dates
1 Jun 2026to 28 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 24 years
  • Men only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Hanoi Medical University

    Hanoi, Hanoi, 100000

Other trials in Vietnam

About this study

Official 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

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.

Read the 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.

Being tested
To-Hieu (I understand)
Keywords
MSM, youth, Project Yes, Self-Help+, Project Yes+, internalized stigma, mental disorders, Vietnam
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • To-Hieu (I understand)Behavioural

    Also called Project YES+

    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.

Study groups in NCT07514221
Study groupRoleWhat they receive
To-HieuExperimentalThe participants will receive the To Hieu intervention for 4 months
Receives: Behavioral: To-Hieu (I understand)
Standard of careNo interventionThe participants will receive standard of care at their clinics.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability: Client satisfaction

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

    Measured: At the end of the intervention at 4 months.

  2. Feasibility: intervention attendance

    Percentage of participants who complete at least 80% of the required sessions of To-Hieu

    Measured: From enrollment to the end of the intervention at 4 months

  3. Acceptability: perception of implementation

    Acceptability will be assessed qualitatively with exit interviews with AYMSMLH and youth peer mentors

    Measured: At the end of the intervention at 4 months.

  4. Feasibility: Perception of implementation

    Feasibility will be assessed qualitatively in exit interviews with AYMSMLH and youth peer mentors.

    Measured: At the end of the intervention at 4 months

Secondary outcomes (5)

  1. Preliminary effectiveness: changes in mental health symptom severity

    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.

    Measured: Baseline and at the end of the intervention at 4 months

  2. Preliminary effectiveness: Change in percentage of ART adherence

    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.

    Measured: Baseline and at the end of the intervention at 4 months

  3. Preliminary effectiveness: HIV viral load

    HIV viral load will be assessed with a test provided by the study or through participants' medical records (if available)

    Measured: Baseline and at the end of the intervention at 4 months

  4. Preliminary effectiveness: changes in internalized HIV stigma scores

    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.

    Measured: Baseline and at the end of the intervention at 4 months

  5. Preliminary effectiveness: changes in sexual minority stigma

    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.

    Measured: Baseline and at the end of the intervention at 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study start1 Jun 2026
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07514221
Sponsor's protocol ID
R21TW013174
Other IDs
R21TW013174
Acronym
To-Hieu
Status last verified
Mar 2026
First submitted
30 Mar 2026
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the primary and secondary outcomes reported in publications will be shared, including baseline characteristics, intervention allocation, and follow-up outcome measures. Identifiable information and sensitive qualitative data will not be shared.

Publications

  • Li Z, Shang W, Wang C, Yang K, Guo J. Characteristics and trends in acceptance and commitment therapy research: A bibliometric analysis. Front Psychol. 2022 Nov 14;13:980848. doi: 10.3389/fpsyg.2022.980848. eCollection 2022.

    PubMed 36452380

  • Nguyen MX, Dowdy D, Latkin CA, Hutton HE, Chander G, Frangakis C, Lancaster KE, Sripaipan T, Bui QX, Tran HV, Go VF. Social support modifies the association between hazardous drinking and depression symptoms among ART clients in Vietnam. Drug Alcohol Depend. 2020 Oct 1;215:108249. doi: 10.1016/j.drugalcdep.2020.108249. Epub 2020 Aug 25.

    PubMed 32871505

  • World Health Organization. SELF-HELP PLUS (SH+): A group-based stress management course for adults. 2023.

  • Fowler JA, Viskovich S, Buckley L, Dean JA. A call for ACTion: A systematic review of empirical evidence for the use of Acceptance and Commitment Therapy (ACT) with LGBTQI+ individuals. Journal of Contextual Behavioral Science. 2022;25:78-89

  • Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 2001;52:1-26. doi: 10.1146/annurev.psych.52.1.1.

    PubMed 11148297

  • Lerner JV, Bowers EP, Minor K, et al. Positive youth development: Processes, philosophies, and programs. In: Handbook of psychology: Developmental psychology, Vol. 6, 2nd ed. Hoboken, NJ, US: John Wiley & Sons, Inc.; 2013:365-392.

  • Beres LK, Simbeza S, Holmes CB, Mwamba C, Mukamba N, Sharma A, Munamunungu V, Mwachande M, Sikombe K, Bolton Moore C, Mody A, Koyuncu A, Christopoulos K, Jere L, Pry J, Ehrenkranz PD, Budden A, Geng E, Sikazwe I. Human-Centered Design Lessons for Implementation Science: Improving the Implementation of a Patient-Centered Care Intervention. J Acquir Immune Defic Syndr. 2019 Dec;82 Suppl 3(3):S230-S243. doi: 10.1097/QAI.0000000000002216.

    PubMed 31764259

  • Meyer IH. Prejudice, social stress, and mental health in lesbian, gay, and bisexual populations: conceptual issues and research evidence. Psychol Bull. 2003 Sep;129(5):674-697. doi: 10.1037/0033-2909.129.5.674.

    PubMed 12956539

  • Fox AB, Earnshaw VA, Taverna EC, Vogt D. Conceptualizing and Measuring Mental Illness Stigma: The Mental Illness Stigma Framework and Critical Review of Measures. Stigma Health. 2018 Nov;3(4):348-376. doi: 10.1037/sah0000104. Epub 2017 Sep 21.

    PubMed 30505939

  • Safarnejad A, Nga NT, Son VH. Population Size Estimation of Men Who Have Sex with Men in Ho Chi Minh City and Nghe An Using Social App Multiplier Method. J Urban Health. 2017 Jun;94(3):339-349. doi: 10.1007/s11524-016-0123-0.

    PubMed 28138799

  • PEPFAR. Country Operational Plan of Vietnam: Strategic Direction Summary. 2019.

  • Hamilton AB, Finley EP. Qualitative methods in implementation research: An introduction. Psychiatry Res. 2019 Oct;280:112516. doi: 10.1016/j.psychres.2019.112516. Epub 2019 Aug 10.

    PubMed 31437661

  • Schexnayder J, Perry KR, Sheahan K, Majette Elliott N, Subramaniam S, Strawbridge E, Webel AR, Bosworth HB, Gierisch JM. Team-Based Qualitative Rapid Analysis: Approach and Considerations for Conducting Developmental Formative Evaluation for Intervention Design. Qual Health Res. 2023 Jul;33(8-9):778-789. doi: 10.1177/10497323231167348. Epub 2023 Jun 6.

    PubMed 37278662

  • Muessig KE, Knudtson KA, Soni K, Larsen MA, Traum D, Dong W, Conserve DF, Leuski A, Artstein R, Hightow-Weidman LB. "I DIDN'T TELL YOU SOONER BECAUSE I DIDN'T KNOW HOW TO HANDLE IT MYSELF." DEVELOPING A VIRTUAL REALITY PROGRAM TO SUPPORT HIV-STATUS DISCLOSURE DECISIONS. Digit Cult Educ. 2018;10:22-48. Epub 2018 Jul 13.

    PubMed 30123342

  • Broglio K. Randomization in Clinical Trials: Permuted Blocks and Stratification. JAMA. 2018 Jun 5;319(21):2223-2224. doi: 10.1001/jama.2018.6360. No abstract available.

    PubMed 29872845

Questions about this trial

What is this clinical trial studying?

A study testing To-Hieu (I understand) in people with Mental Disorder and HIV Stigma, run by Hanoi Medical University at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability: Client satisfaction (time frame: At the end of the intervention at 4 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07514221, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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