HIV Self-testing With Online Supervision for Vietnamese MSM

NCT05797961 | Completed Results DMC

• 1 other identifier: R34MH123337
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Assessed at 12 months

Secondary Outcomes (6)

• Prevalence of HIV Positive Among YMSM at Baseline

  Assessed at baseline

• Prevalence of HIV Positive Among YMSM at 6 Months

  Assessed at 6 months

• Prevalence of HIV Positive Among YMSM at 12 Months

  Assessed at 12 months

• HIV Incidence/Seroconversion at Baseline

  Assessed at baseline

• HIV Incidence/Seroconversion at 6 Months

  Assessed at 6 months

Study Arms (2)

HIV self-testing with online supervision

EXPERIMENTAL

HIV self-testing with online supervision

Behavioral: HIV self-testing with online supervision

Control

OTHER

venue-based HIV testing

Other: Control

Interventions

HIV self-testing with online supervision BEHAVIORAL

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

HIV self-testing with online supervision

Control OTHER

venue-based HIV testing

Control

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead
• University of Puerto Rico: collaborator
• US Military HIV Research Program: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for Applied Research on Men and Health (CARMAH)

Ho Chi Minh City, 700000, Vietnam

Location

Results Point of Contact

• Title: Chair of the Institutional Review Board
• Organization: Mahidol University Faculty of Social Sciences and Humanities

mussirb310@gmail.com

+662-441-9180

Study Officials

• Thomas E Guadamuz, PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

• Giang M Le, MD

  Hanoi Medical University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: May 1, 2023
• Primary Completion: December 25, 2024
• Study Completion: May 21, 2025
• Last Updated: January 29, 2026
• Results First Posted: December 17, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)