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HIV Self-testing With Online Supervision for Vietnamese MSM

HIV Self-testing With Online Supervision for Vietnamese MSM

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05797961
Enrollment
100
Registered
2023-04-04
Start date
2023-05-01
Completion date
2025-05-21
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Brief 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 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.

Interventions

BEHAVIORALHIV self-testing with online supervision

A pilot study to assess the feasibility of HIV self-testing with online supervision

OTHERControl

venue-based HIV testing

Sponsors

Mahidol University
Lead SponsorOTHER
University of Puerto Rico
CollaboratorOTHER
US Military HIV Research Program
CollaboratorNETWORK
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

1:1 randomization to either HIV testing with online supervision or venue testing as usual

Eligibility

Sex/Gender
MALE
Age
16 Years to 29 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Do not consent to HIV self-testing with online supervision * Not willing to give contact information for follow-up assessments

Design outcomes

Primary

MeasureTime frameDescription
HIV Self-testing With Online Supervision Past 6 Months at BaselineAssessed at baselineNumber 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 MonthsAssessed at 6 monthsNumber 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 MonthsAssessed at 12 monthsNumber 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.

Secondary

MeasureTime frameDescription
Prevalence of HIV Positive Among YMSM at BaselineAssessed at baselineNumber 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.
Prevalence of HIV Positive Among YMSM at 6 MonthsAssessed at 6 monthsNumber 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.
Prevalence of HIV Positive Among YMSM at 12 MonthsAssessed at 12 monthsNumber 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.
HIV Incidence/Seroconversion at BaselineAssessed at baselineNumber 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.
HIV Incidence/Seroconversion at 6 MonthsAssessed at 6 monthsNumber 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.
HIV Incidence/Seroconversion at 12 MonthsAssessed at 12 monthsNumber 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.

Countries

Vietnam

Contacts

PRINCIPAL_INVESTIGATORThomas E Guadamuz, PhD

Mahidol University

STUDY_CHAIRGiang M Le, MD

Hanoi Medical University

Participant flow

Recruitment details

Participants will be recruited over one year using online and offline outreach to reach YMSM in Ho Chi Minh City. Online recruitment will use social media, NGO networks, and youth networks. All survey respondents will receive a mobile top-up worth approximately 2 USD. Interested individuals will complete online eligibility screening and provide electronic informed consent (e-consent). Those testing HIV-positive will not join the pilot. The pilot will recruit 100 YMSM, randomized into a 50-person

Participants by arm

ArmCount
HIV Self-testing With Online Supervision
Participants receive an HIV self-testing kit delivered to their home and complete the test with real-time online counselling and supervision by a nurse via Zalo. The nurse provides pre-test counselling, guides proper use of the kit, assists with result interpretation, and ensures confidentiality throughout the process.
50
Control
Venue-based HIV testing
50
Total100

Baseline characteristics

CharacteristicTotalControlHIV Self-testing With Online Supervision
Age, Continuous24.2 years
STANDARD_DEVIATION 3.3
24.3 years
STANDARD_DEVIATION 3.2
24.0 years
STANDARD_DEVIATION 3.4
Condom use at last anal intercourse49 Participants21 Participants28 Participants
Depression (CES-D-10)54 Participants27 Participants27 Participants
Participant has given or received items or opportunities in exchange for sex
No
84 Participants40 Participants44 Participants
Participant has given or received items or opportunities in exchange for sex
Yes, I have both given and received money, things, opportunities and so on
8 Participants6 Participants2 Participants
Participant has given or received items or opportunities in exchange for sex
Yes, I was the one giving money, things, opportunities and so on
2 Participants0 Participants2 Participants
Participant has given or received items or opportunities in exchange for sex
Yes, I was the one receiving money, things, opportunities and so on
6 Participants4 Participants2 Participants
Participation in group sex activities (ever)36 Participants17 Participants19 Participants
Race/Ethnicity, Customized
Vietnamese
100 Participants50 Participants50 Participants
Region of Enrollment
Vietnam
100 Participants50 Participants50 Participants
Risk of Suicide (SBQ-R)35 Participants21 Participants14 Participants
Self-Reporteed Last HIV Testing Data
≤ 6 months ago
77 Participants44 Participants33 Participants
Self-Reporteed Last HIV Testing Data
7-12 months ago
7 Participants1 Participants6 Participants
Self-Reporteed Last HIV Testing Data
More than 12 months ago
12 Participants3 Participants9 Participants
Self-Reporteed Last HIV Testing Data
Never tested
4 Participants2 Participants2 Participants
Sex/Gender, Customized
Bisexual Males
6 Participants3 Participants3 Participants
Sex/Gender, Customized
Males who have sex with Men
94 Participants47 Participants47 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 500 / 50
other
Total, other adverse events
0 / 500 / 50
serious
Total, serious adverse events
0 / 500 / 50

Outcome results

Primary

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.

Time frame: Assessed at 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HIV Self-testing With Online SupervisionHIV Self-testing With Online Supervision Past 6 Months at 12 Months45 Participants
ControlHIV Self-testing With Online Supervision Past 6 Months at 12 Months35 Participants
Primary

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.

Time frame: Assessed at 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HIV Self-testing With Online SupervisionHIV Self-testing With Online Supervision Past 6 Months at 6 Months46 Participants
ControlHIV Self-testing With Online Supervision Past 6 Months at 6 Months38 Participants
Primary

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.

Time frame: Assessed at baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HIV Self-testing With Online SupervisionHIV Self-testing With Online Supervision Past 6 Months at Baseline50 Participants
ControlHIV Self-testing With Online Supervision Past 6 Months at Baseline44 Participants
Secondary

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.

Time frame: Assessed at 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HIV Self-testing With Online SupervisionHIV Incidence/Seroconversion at 12 Months0 Participants
ControlHIV Incidence/Seroconversion at 12 Months1 Participants
Secondary

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.

Time frame: Assessed at 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HIV Self-testing With Online SupervisionHIV Incidence/Seroconversion at 6 Months0 Participants
ControlHIV Incidence/Seroconversion at 6 Months1 Participants
Secondary

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.

Time frame: Assessed at baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HIV Self-testing With Online SupervisionHIV Incidence/Seroconversion at Baseline2 Participants
ControlHIV Incidence/Seroconversion at Baseline0 Participants
Secondary

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.

Time frame: Assessed at 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HIV Self-testing With Online SupervisionPrevalence of HIV Positive Among YMSM at 12 Months0 Participants
ControlPrevalence of HIV Positive Among YMSM at 12 Months2 Participants
Secondary

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.

Time frame: Assessed at 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HIV Self-testing With Online SupervisionPrevalence of HIV Positive Among YMSM at 6 Months0 Participants
ControlPrevalence of HIV Positive Among YMSM at 6 Months1 Participants
Secondary

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.

Time frame: Assessed at baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HIV Self-testing With Online SupervisionPrevalence of HIV Positive Among YMSM at Baseline2 Participants
ControlPrevalence of HIV Positive Among YMSM at Baseline0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026