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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Vietnam

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 groups in NCT05797961
Study groupRoleWhat they receive
HIV self-testing with online supervisionExperimentalHIV self-testing with online supervision
Receives: Behavioral: HIV self-testing with online supervision
ControlOthervenue-based HIV testing
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted4 Apr 2023
  2. Study start1 May 2023
  3. Primary completion25 Dec 2024
  4. Study completion21 May 2025

Resources

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)
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
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

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