Project Yes+ for Young MSM Living With HIV in Vietnam

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

Overview

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

• 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 ad

Primary outcome measures

• Acceptability: Client satisfaction [Time frame: 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]
• Acceptability: perception of implementation [Time frame: At the end of the intervention at 4 months.]
• Feasibility: Perception of implementation [Time frame: At the end of the intervention at 4 months]

Secondary outcome measures (5)

• Preliminary effectiveness: changes in mental health symptom severity [Time frame: Baseline and at the end of the intervention at 4 months]
• Preliminary effectiveness: Change in percentage of ART adherence [Time frame: 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]
• Preliminary effectiveness: changes in internalized HIV stigma scores [Time frame: Baseline and at the end of the intervention at 4 months]
• Preliminary effectiveness: changes in sexual minority stigma [Time frame: Baseline and at the end of the intervention at 4 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Vietnam · 1 center

• Hanoi Medical University — Hanoi

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. PMID 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. PMID 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. PMID 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:S230-S243. PMID 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. PMID 12956539

Identifiers

NCT: NCT07514221 · R21TW013174 · R21TW013174

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗