BEYOND Study: Improving HIV Treatment and Well-Being Among Young MSM in Vietnam
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-24
SponsorCenter for Applied Research on Men and Community Health, Vietnam
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
NO interventions listed
Other interventionNO interventions listed
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Young MSM Living With HIV1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
6 months after enrollment2
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.
Time frame
12 months after enrollmentSecondary outcomes
1
ART Adherence (≥95% of Prescribed Doses, 30-Day Recall)
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.
Time frame
6 months and 12 months after enrollment2
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale-Revised [CESD-R] Total Score)
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.
Time frame
Baseline, 6 months, and 12 months3
Experience of Person-Centered HIV Care (Qualitative Assessment via In-Depth Interviews)
Participant reported experience and perceived quality of person-centered HIV care and integrated service delivery assessed through in depth interviews.
Time frame
At a single time point during the 12 month follow up4
Overall Depression Severity and Impairment (Overall Depression Severity and Impairment Scale [ODSIS] Total Score)
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
Time frame
Baseline, 6 months, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov