NCT07559266

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Dec 2027

Study Start

First participant enrolled

March 10, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

April 20, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

HIVYMSMAntiretroviral Therapy AdherenceViral SuppressionHIV Care ContinuumRetention in CareMental HealthPerson-Centered CareOne-Stop-Shop ServicesIntegrated HIV CareHo Chi Minh City

Outcome Measures

Primary Outcomes (2)

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

    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

    6 months after enrollment

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

    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.

    12 months after enrollment

Secondary Outcomes (6)

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

    6 months and 12 months after enrollment

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

    Baseline, 6 months, and 12 months

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

    At a single time point during the 12 month follow up

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

    Baseline, 6 months, and 12 months

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

    Baseline, 6 months, and 12 months

  • +1 more secondary outcomes

Study Arms (1)

Young MSM Living With HIV

Young men who have sex with men (YMSM) living with HIV enrolled from public, private, and community-based clinics in Ho Chi Minh City, Vietnam. Participants are followed prospectively for 12 months with assessments at baseline, 6 months, and 12 months to evaluate HIV treatment outcomes, including viral suppression, antiretroviral therapy adherence, retention in care, mental health, and quality of life.

Other: NO interventions listed

Interventions

NO interventions listed

Young MSM Living With HIV

Eligibility Criteria

Age18 Years - 24 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young men who have sex with men (YMSM) aged 18-24 years living with HIV in Ho Chi Minh City, Vietnam, recruited from public, private, and community based clinics providing HIV care and related services.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GoVap, MaiKhoi, Galant, Xomchieu

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

HIV InfectionsPsychological Well-BeingMedication Adherence

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPersonal SatisfactionBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Central Study Contacts

An Bao, Master of Public Health

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 30, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations