Trial Outcomes & Findings for HIV Self-testing With Online Supervision for Vietnamese MSM (NCT NCT05797961)
NCT ID: NCT05797961
Last Updated: 2025-12-17
Results Overview
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.
COMPLETED
NA
100 participants
Assessed at baseline
2025-12-17
Participant Flow
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
Participant milestones
| Measure |
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.
|
Control
Venue-based HIV testing
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
Completed 6 Months Follow-up
|
46
|
48
|
|
Overall Study
Completed 12 Months Follow-up
|
45
|
49
|
|
Overall Study
COMPLETED
|
45
|
49
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HIV Self-testing With Online Supervision for Vietnamese MSM
Baseline characteristics by cohort
| Measure |
HIV Self-testing With Online Supervision
n=50 Participants
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.
|
Control
n=50 Participants
Venue-based HIV testing
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.0 years
STANDARD_DEVIATION 3.4 • n=6 Participants
|
24.3 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
24.2 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Sex/Gender, Customized
Males who have sex with Men
|
47 Participants
n=6 Participants
|
47 Participants
n=5 Participants
|
94 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Bisexual Males
|
3 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Vietnamese
|
50 Participants
n=6 Participants
|
50 Participants
n=5 Participants
|
100 Participants
n=5 Participants
|
|
Region of Enrollment
Vietnam
|
50 Participants
n=6 Participants
|
50 Participants
n=5 Participants
|
100 Participants
n=5 Participants
|
|
Self-Reporteed Last HIV Testing Data
Never tested
|
2 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
|
Self-Reporteed Last HIV Testing Data
More than 12 months ago
|
9 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=5 Participants
|
|
Self-Reporteed Last HIV Testing Data
7-12 months ago
|
6 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=5 Participants
|
|
Self-Reporteed Last HIV Testing Data
≤ 6 months ago
|
33 Participants
n=6 Participants
|
44 Participants
n=5 Participants
|
77 Participants
n=5 Participants
|
|
Condom use at last anal intercourse
|
28 Participants
n=6 Participants
|
21 Participants
n=5 Participants
|
49 Participants
n=5 Participants
|
|
Participation in group sex activities (ever)
|
19 Participants
n=6 Participants
|
17 Participants
n=5 Participants
|
36 Participants
n=5 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
|
2 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=5 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 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=5 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
|
2 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
|
Participant has given or received items or opportunities in exchange for sex
No
|
44 Participants
n=6 Participants
|
40 Participants
n=5 Participants
|
84 Participants
n=5 Participants
|
|
Depression (CES-D-10)
|
27 Participants
n=6 Participants
|
27 Participants
n=5 Participants
|
54 Participants
n=5 Participants
|
|
Risk of Suicide (SBQ-R)
|
14 Participants
n=6 Participants
|
21 Participants
n=5 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed 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.
Outcome measures
| Measure |
HIV Self-testing With Online Supervision
n=50 Participants
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.
|
Control
n=50 Participants
Venue-based HIV testing
|
|---|---|---|
|
HIV Self-testing With Online Supervision Past 6 Months at Baseline
|
50 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: Assessed 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.
Outcome measures
| Measure |
HIV Self-testing With Online Supervision
n=46 Participants
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.
|
Control
n=48 Participants
Venue-based HIV testing
|
|---|---|---|
|
HIV Self-testing With Online Supervision Past 6 Months at 6 Months
|
46 Participants
|
38 Participants
|
PRIMARY outcome
Timeframe: Assessed 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.
Outcome measures
| Measure |
HIV Self-testing With Online Supervision
n=45 Participants
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.
|
Control
n=49 Participants
Venue-based HIV testing
|
|---|---|---|
|
HIV Self-testing With Online Supervision Past 6 Months at 12 Months
|
45 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Assessed 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.
Outcome measures
| Measure |
HIV Self-testing With Online Supervision
n=50 Participants
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.
|
Control
n=50 Participants
Venue-based HIV testing
|
|---|---|---|
|
Prevalence of HIV Positive Among YMSM at Baseline
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed 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.
Outcome measures
| Measure |
HIV Self-testing With Online Supervision
n=46 Participants
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.
|
Control
n=48 Participants
Venue-based HIV testing
|
|---|---|---|
|
Prevalence of HIV Positive Among YMSM at 6 Months
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed 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.
Outcome measures
| Measure |
HIV Self-testing With Online Supervision
n=45 Participants
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.
|
Control
n=49 Participants
Venue-based HIV testing
|
|---|---|---|
|
Prevalence of HIV Positive Among YMSM at 12 Months
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessed 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.
Outcome measures
| Measure |
HIV Self-testing With Online Supervision
n=50 Participants
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.
|
Control
n=50 Participants
Venue-based HIV testing
|
|---|---|---|
|
HIV Incidence/Seroconversion at Baseline
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed 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.
Outcome measures
| Measure |
HIV Self-testing With Online Supervision
n=46 Participants
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.
|
Control
n=48 Participants
Venue-based HIV testing
|
|---|---|---|
|
HIV Incidence/Seroconversion at 6 Months
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed 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.
Outcome measures
| Measure |
HIV Self-testing With Online Supervision
n=45 Participants
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.
|
Control
n=49 Participants
Venue-based HIV testing
|
|---|---|---|
|
HIV Incidence/Seroconversion at 12 Months
|
0 Participants
|
1 Participants
|
Adverse Events
HIV Self-testing With Online Supervision
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chair of the Institutional Review Board
Mahidol University Faculty of Social Sciences and Humanities
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place