Clinical trial NCT05797961: HIV Self-testing With Online Supervision for Vietnamese MSM
Official title: HIV Self-testing With Online Supervision for Vietnamese MSM
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: University of Puerto Rico
name: US Military HIV Research Program
First posted: 2023-04-04
Enrollment: 100
Sex: MALE
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization to either HIV testing with online supervision or venue testing as usual
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: HIV self-testing with online supervision past 6 months
timeFrame: Past 6 months
Secondary outcomes:
measure: HIV prevalence
timeFrame: baseline
measure: HIV incidence/seroconversion
timeFrame: 6 months
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Center for Applied Research on Men and Health (CARMAH)
Study officials:
affiliation: Mahidol University
name: Thomas E Guadamuz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanoi Medical University
name: Giang M Le, MD
role: STUDY_CHAIR
References: