Project Yes+ for Young MSM Living With HIV in Vietnam

NCT07514221 | Not Yet Recruiting

• 1 other identifier: R21TW013174
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder; HIV Stigma

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  At the end of the intervention at 4 months.

• Feasibility: intervention attendance

  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

  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

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

  At the end of the intervention at 4 months

Secondary Outcomes (5)

• Preliminary effectiveness: changes in mental health symptom severity

  Baseline and at the end of the intervention at 4 months

• Preliminary effectiveness: Change in percentage of ART adherence

  Baseline and at the end of the intervention at 4 months

• Preliminary effectiveness: HIV viral load

  Baseline and at the end of the intervention at 4 months

• Preliminary effectiveness: changes in internalized HIV stigma scores

  Baseline and at the end of the intervention at 4 months

• Preliminary effectiveness: changes in sexual minority stigma

  Baseline and at the end of the intervention at 4 months

Study Arms (2)

To-Hieu

EXPERIMENTAL

The participants will receive the To Hieu intervention for 4 months

Behavioral: To-Hieu (I understand)

Standard of care

NO INTERVENTION

The participants will receive standard of care at their clinics.

Interventions

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.

Also known as: Project YES+

To-Hieu

Eligibility Criteria

• Age: 16 Years - 24 Years
• Gender Eligibility Details: This study focuses on adolescent and young men who have sex with men.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hanoi Medical University: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Hanoi Medical University

Hanoi, Hanoi, 100000, Vietnam

Location

Related Publications (36)

• 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.

  PMID: 36452380 BACKGROUND

• 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.

  PMID: 32871505 BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

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

  PMID: 11148297 BACKGROUND

• 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.

  BACKGROUND

• 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:S230-S243. doi: 10.1097/QAI.0000000000002216.

  PMID: 31764259 BACKGROUND

• 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.

  PMID: 12956539 BACKGROUND

• 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.

  PMID: 30505939 BACKGROUND

• 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.

  PMID: 28138799 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 31437661 BACKGROUND

• 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.

  PMID: 37278662 BACKGROUND

• 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.

  PMID: 30123342 BACKGROUND

• 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.

  PMID: 29872845 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Kalichman SC, Simbayi LC, Cloete A, Mthembu PP, Mkhonta RN, Ginindza T. Measuring AIDS stigmas in people living with HIV/AIDS: the Internalized AIDS-Related Stigma Scale. AIDS Care. 2009 Jan;21(1):87-93. doi: 10.1080/09540120802032627.

  PMID: 19085224 BACKGROUND

• Ross MW, Rosser BR. Measurement and correlates of internalized homophobia: a factor analytic study. J Clin Psychol. 1996 Jan;52(1):15-21. doi: 10.1002/(SICI)1097-4679(199601)52:13.0.CO;2-V.

  PMID: 8682906 BACKGROUND

• Vietnam Ministry of Health. Decision 5968/QD-BYT 2021: Guidelines on treatment of HIV/AIDS. In:2021

  BACKGROUND

• Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.

  PMID: 24049221 BACKGROUND

• World Health Organization. Doing What Matters in Times of Stress. An illustrated guide. 2020; https://www.who.int/publications/i/item/9789240003927. Accessed December 4th, 2024

  BACKGROUND

• Knettel BA, Fernandez KM, Wanda L, Amiri I, Cassiello-Robbins C, Watt MH, Mmbaga BT, Relf MV. The Role of Community Health Workers in HIV Care Engagement: A Qualitative Study of Stakeholder Perspectives in Tanzania. J Assoc Nurses AIDS Care. 2021 Nov-Dec 01;32(6):682-692. doi: 10.1097/JNC.0000000000000267.

  PMID: 33908407 BACKGROUND

• Bateganya MH, Amanyeiwe U, Roxo U, Dong M. Impact of support groups for people living with HIV on clinical outcomes: a systematic review of the literature. J Acquir Immune Defic Syndr. 2015 Apr 15;68 Suppl 3(0 3):S368-74. doi: 10.1097/QAI.0000000000000519.

  PMID: 25768876 BACKGROUND

• Ogard-Repal A, Berg RC, Fossum M. Peer Support for People Living With HIV: A Scoping Review. Health Promot Pract. 2023 Jan;24(1):172-190. doi: 10.1177/15248399211049824. Epub 2021 Oct 23.

  PMID: 34693785 BACKGROUND

• Nguyen MX, Li C, Muessig K, Gaynes BN, Go VF. A Systematic Review of Interventions for Young Men Who Have Sex With Men and Young Transgender Women Living with HIV. AIDS Behav. 2024 May;28(5):1485-1511. doi: 10.1007/s10461-023-04166-1. Epub 2023 Sep 28.

  PMID: 37768429 BACKGROUND

• Boyes ME, Cluver LD, Meinck F, Casale M, Newnham E. Mental health in South African adolescents living with HIV: correlates of internalising and externalising symptoms. AIDS Care. 2019 Jan;31(1):95-104. doi: 10.1080/09540121.2018.1524121. Epub 2018 Sep 21.

  PMID: 30241443 BACKGROUND

• Zhan S, Ouyang F, Zhai W, Yang H. Prevalence of mental disorders among young people living with HIV: a systematic review and meta-analysis. Front Public Health. 2024 Aug 21;12:1392872. doi: 10.3389/fpubh.2024.1392872. eCollection 2024.

  PMID: 39234077 BACKGROUND

• Mhlongo S, Mason-Jones AJ, Ford K. Sexual, reproductive and mental health among young men (10-24) in low-and-middle income countries: a scoping review. Front Reprod Health. 2023 Dec 4;5:1119407. doi: 10.3389/frph.2023.1119407. eCollection 2023.

  PMID: 38111839 BACKGROUND

• Tao J, Wang L, Kipp AM, Qian HZ, Yin L, Ruan Y, Shao Y, Lu H, Vermund SH. Relationship of Stigma and Depression Among Newly HIV-Diagnosed Chinese Men Who Have Sex with Men. AIDS Behav. 2017 Jan;21(1):292-299. doi: 10.1007/s10461-016-1477-8.

  PMID: 27376900 BACKGROUND

• Vreeman RC, McCoy BM, Lee S. Mental health challenges among adolescents living with HIV. J Int AIDS Soc. 2017 May 16;20(Suppl 3):21497. doi: 10.7448/IAS.20.4.21497.

  PMID: 28530045 BACKGROUND

• Zhang R, Qiao S, Aggarwal A, Yuan G, Muttau N, Sharma A, Lwatula C, Ngosa L, Kabwe M, Manasyan A, Menon A, Ostermann J, Weissman S, Li X, Harper GW. Impact of enacted stigma on mental health, substance use, and HIV-related behaviors among sexual minority men in Zambia. Arch Psychiatr Nurs. 2024 Feb;48:51-58. doi: 10.1016/j.apnu.2024.01.004. Epub 2024 Jan 9.

  PMID: 38453282 BACKGROUND

• Haas AD, Lienhard R, Didden C, Cornell M, Folb N, Boshomane TMG, Salazar-Vizcaya L, Ruffieux Y, Nyakato P, Wettstein AE, Tlali M, Davies MA, von Groote P, Wainberg M, Egger M, Maartens G, Joska JA. Mental Health, ART Adherence, and Viral Suppression Among Adolescents and Adults Living with HIV in South Africa: A Cohort Study. AIDS Behav. 2023 Jun;27(6):1849-1861. doi: 10.1007/s10461-022-03916-x. Epub 2023 Jan 2.

  PMID: 36592251 BACKGROUND

• Dada D, Abu-Ba'are GR, Turner D, Mashoud IW, Owusu-Dampare F, Apreku A, Ni Z, Djiadeu P, Aidoo-Frimpong G, Zigah EY, Nyhan K, Nyblade L, Nelson LE. Scoping review of HIV-related intersectional stigma among sexual and gender minorities in sub-Saharan Africa. BMJ Open. 2024 Feb 12;14(2):e078794. doi: 10.1136/bmjopen-2023-078794.

  PMID: 38346887 BACKGROUND

• Trang K, Jovanovic T, Hinton DE, Sullivan P, Worthman CM, Lam LX, Chi NK, Thanh NC, Ha TV, Go V, Hoffman I, Giang LM. Elevated trauma exposure and mental health burden among men who have sex with men in Vietnam. Transcult Psychiatry. 2022 Jun;59(3):362-379. doi: 10.1177/13634615211058348. Epub 2022 Jan 24.

  PMID: 35072562 BACKGROUND

• Nyblade L, Mingkwan P, Stockton MA. Stigma reduction: an essential ingredient to ending AIDS by 2030. Lancet HIV. 2021 Feb;8(2):e106-e113. doi: 10.1016/S2352-3018(20)30309-X.

  PMID: 33539757 BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Trang T. Nguyen, PhD

CONTACT

+84988424871; trangthu@hmu.edu.vn

Julie Denison, PhD, MHS

CONTACT

jdenison@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 7, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: De-identified IPD and supporting information will be available beginning 12 months after publication of the main trial results and ending 5 years after publication.
• Access Criteria: De-identified IPD and supporting information will be made available upon reasonable request to qualified researchers with a methodologically sound proposal. Requests will be reviewed by the study investigators, and approved researchers may be required to sign a data use agreement. Data and supporting documents will be shared through a secure data-sharing platform or another secure transfer method.

Locations

VN (1)