HIVNCT05797961
HIV Self-testing With Online Supervision for Vietnamese MSM
A study testing HIV self-testing with online supervision in people with HIV, run by Mahidol University at 1 site in Vietnam.
Trial summary
Although global rates of HIV infection have decreased overall, rates among men who have sex with men (MSM) in Southeast Asia are increasing. A recent review of available global data and the molecular epidemiology of HIV among MSM in Southeast Asia suggests that targeted interventions for MSM populations are necessary… Read more about this study
- Who is it for?
- Ages 16 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- HIV self-testing with online supervision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteVietnam
- Study dates
- 1 May 2023to 21 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 29 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16-29 years at cohort baseline
- Self-reported male gender
- Self-reported having had anal sex with another man in the past 12 months
- Speak, read and write Vietnamese
- Vietnamese citizenship
- Resident of the assessment city (Ho Chi Minh City) for at least 6 months
Who cannot join
- Do not consent to HIV self-testing with online supervision
- Not willing to give contact information for follow-up assessments
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Center for Applied Research on Men and Health (CARMAH)
Ho Chi Minh City, 700000
About this study
Although global rates of HIV infection have decreased overall, rates among men who have sex with men (MSM) in Southeast Asia are increasing. A recent review of available global data and the molecular epidemiology of HIV among MSM in Southeast Asia suggests that targeted interventions for MSM populations are necessary to reduce HIV incidence in the region. For example, in Vietnam's urban centers, the HIV epidemic among MSM is growing rapidly, with an estimated prevalence of 17% in Ho Chi Minh City and an estimated incidence of 5.8% among young men who have sex with men in Hanoi. Behavioral epidemiology has also been well-described, with high rates of unprotected sex, multiple concurrent partners, untreated STIs, and poor engagement in the HIV care continuum, including low rates of HIV testing, all contributing to high levels of circulating virus among MSM risk networks.
Read the detailed description
HIV rates among MSM in Vietnam have increased sharply since 2006. By 2011, rates had reached 19%, with HCMC accounting for the largest number of infections. MSM, particularly YMSM, continue to have low rates of HIV testing and poor engagement in HIV care. Studies have identified various risk factors, including low knowledge and perceived risk, sexual risk and STIs/HIV, complexity in identity and meaning, substance use and mental health, limited HIV interventions, and poor engagement in health services. Increasing HIV testing among MSM, particularly YMSM, is crucial for early detection and enrolment in ART. However, individual and institutional-level barriers hinder testing, such as poor knowledge, stigma, and poor repeat testing. Using the internet as an intervention platform can reach and engage MSM who cannot be reached using conventional health-engagement approaches.
The proposed study aims to adapt and pilot test an online HIV testing intervention (OHT) targeted at young men who have sex with men (MSM) in Ho Chi Minh City, Vietnam. The OHT intervention was developed and successfully implemented among MSM in Thailand, showing significant impacts on testing rates and linkage to HIV care. The proposed study builds on longstanding collaborations between HIV researchers from Mahidol University in Thailand and a local community-based organization that serves YMSM in Vietnam. The findings from the proposed study will have important implications for assessing the potential for OHT intervention to overcome profound and longstanding barriers to HIV testing among YMSM in Vietnam, an outcome that if brought to scale could significantly improve enrolment in ART and reduce HIV incidence. Innovative strategies to increase testing and improve continuum will be needed to reduce HIV transmission in Vietnam, where little data is available on uptake of HIV testing among Vietnamese MSM, and a high proportion of men who have sex with men surveyed have never been voluntarily tested for HIV. HIV self-testing with online supervision represents an important strategy to improve scale-up of HIV testing among Vietnamese MSM. The proposed OHT can overcome the barrier of face-to-face testing and counseling, while ensuring that Vietnamese YMSM receive real-time guidance and support for self-testing and linkage to care and treatment, if positive.
The project's aims are: (1) to conduct a qualitative study with Focus Group Discussions (FGDs) to identify potential barriers and facilitators to the uptake of OHT among YMSM in HCMC; (2) to conduct a quantitative study with online survey questionnaires to adapt the existing Thai OHT intervention for use among YMSM in Vietnam, including translation and socio-cultural refinement of testing kits, clip video content, online pre-and post-test counseling, and broader socio-cultural contexts. Data from Aim 1 will be analyzed and used to design the test kit, the clip video content, and when and how the HIV counselor will conduct pre-and post-test counseling. Moreover, willingness to engage in OHT as well as factors related to sustained testing will be collected through an online survey, and (3) to conduct a pilot study with Randomized Control Trial to demonstrate the feasibility and acceptability of the adapted OHT intervention, including the use of an HIV rapid diagnostic antibody/antigen-based self-testing with an HIV counselor through video conferencing. YMSM recruited through the online survey who indicated an interest in OHT will be randomly selected to the OHT group or the venue-based testing group (standard of care), using repeated measures at 6 and 12 months to compare HIV testing rates and behavioral outcomes because of retention and we need to understand how the socio-cultural factors affecting to OHT retention.
- Conditions
- HIV
- Being tested
- HIV self-testing with online supervision, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV self-testing with online supervisionBehavioural
A pilot study to assess the feasibility of HIV self-testing with online supervision
ControlOther
venue-based HIV testing
| Study group | Role | What they receive |
|---|---|---|
| HIV self-testing with online supervision | Experimental | HIV self-testing with online supervision Receives: Behavioral: HIV self-testing with online supervision |
| Control | Other | venue-based HIV testing Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Self-testing With Online Supervision Past 6 Months at Baseline
Number of participants who have gone through the intervention (self-tested for HIV with online supervision past 6 months). For the control group, participants will answer a yes/no question if they have tested for HIV in the past 6 months.
Measured: Assessed at baseline
HIV Self-testing With Online Supervision Past 6 Months at 6 Months
Number of participants who have gone through the intervention (self-tested for HIV with online supervision past 6 months). For the control group, participants will answer a yes/no question if they have tested for HIV in the past 6 months.
Measured: Assessed at 6 months
HIV Self-testing With Online Supervision Past 6 Months at 12 Months
Number of participants who have gone through the intervention (self-tested for HIV with online supervision past 6 months). For the control group, participants will answer a yes/no question if they have tested for HIV in the past 6 months.
Measured: Assessed at 12 months
Secondary outcomes (6)
Prevalence of HIV Positive Among YMSM at Baseline
Number of participants who are HIV-positive. For the intervention group (participants who performed HIV self-testing with online supervision in the past 6 months), HIV status is obtained from the supervised self-test results. For the control group, participants report their HIV status through the survey, based on whether they had an HIV test in the past 6 months.
Measured: Assessed at baseline
Prevalence of HIV Positive Among YMSM at 6 Months
Number of participants who are HIV-positive. For the intervention group (participants who performed HIV self-testing with online supervision in the past 6 months), HIV status is obtained from the supervised self-test results. For the control group, participants report their HIV status through the survey, based on whether they had an HIV test in the past 6 months.
Measured: Assessed at 6 months
Prevalence of HIV Positive Among YMSM at 12 Months
Number of participants who are HIV-positive. For the intervention group (participants who performed HIV self-testing with online supervision in the past 6 months), HIV status is obtained from the supervised self-test results. For the control group, participants report their HIV status through the survey, based on whether they had an HIV test in the past 6 months.
Measured: Assessed at 12 months
HIV Incidence/Seroconversion at Baseline
Number of participants with new HIV infections (seroconversion) during each follow-up period, reported as the number of cases. HIV status in the intervention group is obtained from supervised HIV self-testing, while in the control group it is self-reported through the survey.
Measured: Assessed at baseline
HIV Incidence/Seroconversion at 6 Months
Number of participants with new HIV infections (seroconversion) during each follow-up period, reported as the number of cases. HIV status in the intervention group is obtained from supervised HIV self-testing, while in the control group it is self-reported through the survey.
Measured: Assessed at 6 months
HIV Incidence/Seroconversion at 12 Months
Number of participants with new HIV infections (seroconversion) during each follow-up period, reported as the number of cases. HIV status in the intervention group is obtained from supervised HIV self-testing, while in the control group it is self-reported through the survey.
Measured: Assessed at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 May 2023
- Primary completion25 Dec 2024
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization to either HIV testing with online supervision or venue testing as usual
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Puerto Rico, US Military HIV Research Program, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Thomas E Guadamuz, PhD, Principal investigator, Mahidol UniversityGiang M Le, MD, Study chair, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797961
- Sponsor's protocol ID
- R34MH123337
- Other IDs
- R34MH123337
- Status last verified
- Jan 2026
- First submitted
- 22 Mar 2023
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Self-testing With Online Supervision for Vietnamese MSM
- ClinicalTrials.gov ID
- NCT05797961
- Acronym / sponsor ID
- R34MH123337
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- University of Puerto Rico, US Military HIV Research Program, National Institute of Mental Health (NIMH)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Posted 17 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although global rates of HIV infection have decreased overall, rates among men who have sex with men (MSM) in Southeast Asia are increasing. A recent review of available global data and the molecular epidemiology of HIV among MSM in Southeast Asia suggests that targeted interventions for MSM populations are necessary to reduce HIV incidence in the region. For example, in Vietnam's urban centers, the HIV epidemic among MSM is growing rapidly, with an estimated prevalence of 17% in Ho Chi Minh City and an estimated incidence of 5.8% among young men who have sex with men in Hanoi. Behavioral epidemiology has also been well-described, with high rates of unprotected sex, multiple concurrent partners, untreated STIs, and poor engagement in the HIV care continuum, including low rates of HIV testing, all contributing to high levels of circulating virus among MSM risk networks.
Detailed description
HIV rates among MSM in Vietnam have increased sharply since 2006. By 2011, rates had reached 19%, with HCMC accounting for the largest number of infections. MSM, particularly YMSM, continue to have low rates of HIV testing and poor engagement in HIV care. Studies have identified various risk factors, including low knowledge and perceived risk, sexual risk and STIs/HIV, complexity in identity and meaning, substance use and mental health, limited HIV interventions, and poor engagement in health services. Increasing HIV testing among MSM, particularly YMSM, is crucial for early detection and enrolment in ART. However, individual and institutional-level barriers hinder testing, such as poor knowledge, stigma, and poor repeat testing. Using the internet as an intervention platform can reach and engage MSM who cannot be reached using conventional health-engagement approaches.
The proposed study aims to adapt and pilot test an online HIV testing intervention (OHT) targeted at young men who have sex with men (MSM) in Ho Chi Minh City, Vietnam. The OHT intervention was developed and successfully implemented among MSM in Thailand, showing significant impacts on testing rates and linkage to HIV care. The proposed study builds on longstanding collaborations between HIV researchers from Mahidol University in Thailand and a local community-based organization that serves YMSM in Vietnam. The findings from the proposed study will have important implications for assessing the potential for OHT intervention to overcome profound and longstanding barriers to HIV testing among YMSM in Vietnam, an outcome that if brought to scale could significantly improve enrolment in ART and reduce HIV incidence. Innovative strategies to increase testing and improve continuum will be needed to reduce HIV transmission in Vietnam, where little data is available on uptake of HIV testing among Vietnamese MSM, and a high proportion of men who have sex with men surveyed have never been voluntarily tested for HIV. HIV self-testing with online supervision represents an important strategy to improve scale-up of HIV testing among Vietnamese MSM. The proposed OHT can overcome the barrier of face-to-face testing and counseling, while ensuring that Vietnamese YMSM receive real-time guidance and support for self-testing and linkage to care and treatment, if positive.
The project's aims are: (1) to conduct a qualitative study with Focus Group Discussions (FGDs) to identify potential barriers and facilitators to the uptake of OHT among YMSM in HCMC; (2) to conduct a quantitative study with online survey questionnaires to adapt the existing Thai OHT intervention for use among YMSM in Vietnam, including translation and socio-cultural refinement of testing kits, clip video content, online pre-and post-test counseling, and broader socio-cultural contexts. Data from Aim 1 will be analyzed and used to design the test kit, the clip video content, and when and how the HIV counselor will conduct pre-and post-test counseling. Moreover, willingness to engage in OHT as well as factors related to sustained testing will be collected through an online survey, and (3) to conduct a pilot study with Randomized Control Trial to demonstrate the feasibility and acceptability of the adapted OHT intervention, including the use of an HIV rapid diagnostic antibody/antigen-based self-testing with an HIV counselor through video conferencing. YMSM recruited through the online survey who indicated an interest in OHT will be randomly selected to the OHT group or the venue-based testing group (standard of care), using repeated measures at 6 and 12 months to compare HIV testing rates and behavioral outcomes because of retention and we need to understand how the socio-cultural factors affecting to OHT retention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization to either HIV testing with online supervision or venue testing as usual
| Arm | Type | Receives |
|---|---|---|
| HIV self-testing with online supervision | Experimental | Behavioral: HIV self-testing with online supervisionHIV self-testing with online supervision |
| Control | Other | Other: Controlvenue-based HIV testing |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 16-29 years at cohort baseline
- Self-reported male gender
- Self-reported having had anal sex with another man in the past 12 months
- Speak, read and write Vietnamese
- Vietnamese citizenship
Key exclusion criteria (2 listed)
- Do not consent to HIV self-testing with online supervision
- Not willing to give contact information for follow-up assessments
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 |
|---|---|---|
| HIV self-testing with online supervisionA pilot study to assess the feasibility of HIV self-testing with online supervision | Behavioural | HIV self-testing with online supervision |
| Controlvenue-based HIV testing | Other | Control |
Primary outcome
HIV Self-testing With Online Supervision Past 6 Months at Baseline
Time frame: Assessed at baseline
Number of participants who have gone through the intervention (self-tested for HIV with online supervision past 6 months). For the control group, participants will answer a yes/no question if they have tested for HIV in the past 6 months.
HIV Self-testing With Online Supervision Past 6 Months at 6 Months
Time frame: Assessed at 6 months
Number of participants who have gone through the intervention (self-tested for HIV with online supervision past 6 months). For the control group, participants will answer a yes/no question if they have tested for HIV in the past 6 months.
HIV Self-testing With Online Supervision Past 6 Months at 12 Months
Time frame: Assessed at 12 months
Number of participants who have gone through the intervention (self-tested for HIV with online supervision past 6 months). For the control group, participants will answer a yes/no question if they have tested for HIV in the past 6 months.
6 secondary outcomes
Prevalence of HIV Positive Among YMSM at Baseline
Time frame: Assessed at baseline
Prevalence of HIV Positive Among YMSM at 6 Months
Time frame: Assessed at 6 months
Prevalence of HIV Positive Among YMSM at 12 Months
Time frame: Assessed at 12 months
HIV Incidence/Seroconversion at Baseline
Time frame: Assessed at baseline
HIV Incidence/Seroconversion at 6 Months
Time frame: Assessed at 6 months
HIV Incidence/Seroconversion at 12 Months
Time frame: Assessed at 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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. This study is not recruiting at the moment.
Thomas E Guadamuz, PhD principal investigator
Mahidol University
Giang M Le, MD study chair
Hanoi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV self-testing with online supervision in people with HIV, run by Mahidol University 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 29 Jan 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?
Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Self-testing With Online Supervision Past 6 Months at Baseline (time frame: Assessed at baseline). The study lists 3 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 29 Jan 2026.