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NCT Number: NCT07559266

BEYOND Study: Improving HIV Treatment and Well-Being Among Young MSM in Vietnam

The BEYOND Study aims to evaluate HIV treatment outcomes and well-being among young men who have sex with men (YMSM) living with HIV in Ho Chi Minh City, Vietnam. Despite progress in HIV services, YMSM continue to experience disparities in engagement in care, antiretroviral therapy (ART) adherence, and viral suppression, influenced by individual, social, and structural factors including stigma and limited access to person-centered care.

This prospective cohort study will enroll 300 YMSM living with HIV from four clinical sites, including public, private, and community-based clinics. Participants will be followed for 12 months, with data collection at baseline, 6 months, and 12 months. The study will assess key outcomes including viral suppression, ART adherence, retention in care, mental health, and quality of life. In addition, in-depth interviews will be conducted with a subset of 20-30 participants to explore experiences with HIV care and barriers and facilitators to engagement.

The study will also examine the implementation and perceived impact of person-centered care and one-stop-shop service models across different healthcare settings. Findings from this study will inform strategies to improve HIV treatment outcomes and support the development of integrated, patient-centered approaches to care for YMSM living with HIV in Vietnam and similar settings.

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Key information

Conditions

HIV Infections Behavior Blood-Borne Infections Communicable Diseases Genital Diseases Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Mental Health Patient Acceptance of Health Care Patient Compliance Personal Satisfaction Psychological Well-Being RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year–24 year

Sex eligibility

Male

Study type

Observational

Primary location

GoVap, MaiKhoi, Galant, Xomchieu

Ho Chi Minh City, Vietnam

Location status: Recruiting

Location contact

Vu Hoang Thai, Bachelor of Psychology

CONTACT

[email protected]

+84932725600

Who can participate

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

Inclusion criteria

  • Aged 18 to 24 years
  • Self-identified as male and reporting sex with men in the past 12 months
  • Confirmed HIV diagnosis according to Vietnam Ministry of Health (MOH) national HIV testing guidelines
  • Currently receiving antiretroviral therapy (ART) at one of the participating study clinics
  • Residing in Ho Chi Minh City or nearby areas and able to attend study visits at participating clinics
  • Able to understand and communicate in Vietnamese
  • Willing and able to provide informed consent and participate in study procedures

Exclusion criteria

  • Younger than 18 years or older than 24 years
  • Not currently receiving ART or receiving ART from a non-participating clinic
  • Severe cognitive impairment or mental health condition that, in the judgment of the research team, would interfere with the ability to provide informed consent or participation
  • Currently enrolled in another clinical or behavioral study that may interfere with this study
  • Unwilling or unable to provide informed consent or comply with study procedures

Treatment and study plan

NO interventions listed

Other

NO interventions listed

Primary outcomes

  1. Viral Suppression Rate at 6 Months (HIV RNA <200 copies/mL)

    Time frame: 6 months after enrollment

    Proportion of participants achieving viral suppression, defined as HIV RNA <200 copies/mL, based on clinical records. Participants lost to follow-up or with missing viral load data will be classified as not virally suppressed in the primary analysis

  2. Viral Suppression Rate at 12 Months (HIV RNA <200 copies/mL)

    Time frame: 12 months after enrollment

    Proportion of participants achieving viral suppression, defined as HIV RNA <200 copies/mL, based on clinical records. Participants lost to follow up or with missing viral load data will be considered not virally suppressed in the primary analysis.

Secondary outcomes

  1. ART Adherence (≥95% of Prescribed Doses, 30-Day Recall)

    Time frame: 6 months and 12 months after enrollment

    Proportion of participants achieving optimal adherence to antiretroviral therapy, defined as ≥95% of prescribed doses taken over the past 30 days, assessed using clinical records.

  2. Depressive Symptoms (Center for Epidemiologic Studies Depression Scale-Revised [CESD-R] Total Score)

    Time frame: Baseline, 6 months, and 12 months

    Depressive symptoms assessed using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R). Items are scored on a scale of 0 to 4, with higher scores indicating greater severity of depressive symptoms.

  3. Experience of Person-Centered HIV Care (Qualitative Assessment via In-Depth Interviews)

    Time frame: At a single time point during the 12 month follow up

    Participant reported experience and perceived quality of person-centered HIV care and integrated service delivery assessed through in depth interviews.

  4. Overall Depression Severity and Impairment (Overall Depression Severity and Impairment Scale [ODSIS] Total Score)

    Time frame: Baseline, 6 months, and 12 months

    Depression severity and functional impairment assessed using the Overall Depression Severity and Impairment Scale (ODSIS). Total scores range from 0 to 20 (5 items scored 0-4), with higher scores indicating greater depression severity and impairment

  5. Anxiety Severity and Impairment (Overall Anxiety Severity and Impairment Scale [OASIS] Total Score)

    Time frame: Baseline, 6 months, and 12 months

    Anxiety severity and functional impairment assessed using the Overall Anxiety Severity and Impairment Scale (OASIS). Total scores range from 0 to 20 (5 items scored 0-4), with higher scores indicating greater anxiety severity and impairment.

  6. Perceived Social Support (Multidimensional Scale of Perceived Social Support [MSPSS] Mean Score)

    Time frame: Baseline, 6 months, and 12 months

    Perceived social support assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). Items are scored on a scale from 1 to 7, with higher scores indicating greater perceived social support.

Study contacts

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

An Bao, Master of Public Health

CONTACT

[email protected]

0084913650536

Sponsors and collaborators

Lead sponsor

Center for Applied Research on Men and Community Health, Vietnam

Other

Registry information

Official study title

BEYOND Study: Bridging Equity, Youth, And Optimal Nurture for HIV Dynamics - Enhancing Treatment and Well-Being Among Young MSM Living With HIV in Vietnam

Acronym: BEYOND

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Apr 30, 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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