Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05797961 |
| Other study ID # |
R34MH123337 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Mahidol University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
