HIV InfectionsBEYONDNCT07559266
BEYOND Study: Improving HIV Treatment and Well-Being Among Young MSM in Vietnam
An observational study of HIV Infections and Mental Health, run by Center for Applied Research on Men and Community Health, Vietnam at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 years, men only
- Conditions the study is for
- HIV Infections, Mental Health, Medication Adherence
- How many people
- 300 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Mar 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Men only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
GoVap, MaiKhoi, Galant, Xomchieu
Ho Chi Minh City
Vu Hoang Thai, Bachelor of Psychology, +84932725600, thaihoangvu.thv@gmail.com
About this study
Official 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
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.
- Conditions
- HIV Infections, Mental Health, Medication Adherence
- Being tested
- NO interventions listed
- 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
- Medical subject headings
- HIV Infections, Psychological Well-Being, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO interventions listedOther
NO interventions listed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NO interventions listed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 months after enrollment
Secondary outcomes (6)
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.
Measured: 6 months and 12 months after enrollment
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.
Measured: Baseline, 6 months, and 12 months
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.
Measured: 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)
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
Measured: Baseline, 6 months, and 12 months
Anxiety Severity and Impairment (Overall Anxiety Severity and Impairment Scale [OASIS] Total Score)
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.
Measured: Baseline, 6 months, and 12 months
Perceived Social Support (Multidimensional Scale of Perceived Social Support [MSPSS] Mean Score)
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.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start10 Mar 2026
- Primary completion30 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Applied Research on Men and Community Health, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559266
- Sponsor's protocol ID
- CARMAH
- Other IDs
- IN-US-380-7737
- Acronym
- BEYOND
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07559266
- Acronym / sponsor ID
- BEYOND / CARMAH
- Conditions
- HIV Infections, Mental Health, Medication Adherence
- Keywords
- HIV, YMSM, Antiretroviral Therapy Adherence, Viral Suppression, HIV Care Continuum, Retention in Care, Mental Health, Person-Centered Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Center for Applied Research on Men and Community Health, VietnamUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young MSM Living With HIV | – | Other: NO interventions listedYoung 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO interventions listedNO interventions listed | Other | Young MSM Living With HIV |
Primary outcome
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
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.
6 secondary outcomes
ART Adherence (≥95% of Prescribed Doses, 30-Day Recall)
Time frame: 6 months and 12 months after enrollment
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale-Revised [CESD-R] Total Score)
Time frame: Baseline, 6 months, and 12 months
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
Overall Depression Severity and Impairment (Overall Depression Severity and Impairment Scale [ODSIS] Total Score)
Time frame: Baseline, 6 months, and 12 months
Anxiety Severity and Impairment (Overall Anxiety Severity and Impairment Scale [OASIS] Total Score)
Time frame: Baseline, 6 months, and 12 months
Perceived Social Support (Multidimensional Scale of Perceived Social Support [MSPSS] Mean Score)
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Mental Health, run by Center for Applied Research on Men and Community Health, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact An Bao, Master of Public Health (0084913650536, baoan.lab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Suppression Rate at 6 Months (HIV RNA <200 copies/mL) (time frame: 6 months after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.