HIV Infections, Medication Adherence, Mental Health
Conditions
Keywords
HIV, YMSM, Antiretroviral Therapy Adherence, Viral Suppression, HIV Care Continuum, Retention in Care, Mental Health, Person-Centered Care, One-Stop-Shop Services, Integrated HIV Care, Ho Chi Minh City
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.
Interventions
NO interventions listed
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression Rate at 6 Months (HIV RNA <200 copies/mL) | 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 |
| Viral Suppression Rate at 12 Months (HIV RNA <200 copies/mL) | 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
| Measure | Time frame | Description |
|---|---|---|
| ART Adherence (≥95% of Prescribed Doses, 30-Day Recall) | 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. |
| Depressive Symptoms (Center for Epidemiologic Studies Depression Scale-Revised [CESD-R] Total Score) | 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. |
| Experience of Person-Centered HIV Care (Qualitative Assessment via In-Depth Interviews) | 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. |
| Overall Depression Severity and Impairment (Overall Depression Severity and Impairment Scale [ODSIS] Total Score) | 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 |
| Anxiety Severity and Impairment (Overall Anxiety Severity and Impairment Scale [OASIS] Total Score) | 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. |
| Perceived Social Support (Multidimensional Scale of Perceived Social Support [MSPSS] Mean Score) | 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. |
Countries
Vietnam