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HIV Prevention ProgramCINTAINCT06373952

Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Men Who Have Sex With Men

A study testing Online to offline counseling in people with HIV Prevention Program, run by University of Connecticut at 1 site in Malaysia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs… Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV Prevention Program
What is being tested?
Online to offline counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteMalaysia
Study dates
2 May 2024to 18 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • • Age ≥18 years;
  • Cisgender male;
  • HIV-negative or HIV status unknown;
  • Own or have access to a computer, tablet, or internet-enabled smartphone

Who cannot join

  • • Unable to provide informed consent
  • Unable to read and understand English or Bahasa Malaysia

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • Centre of Excellence For Research in AIDS (CERiA)

    Kuala Lumpur

Other trials in Malaysia

About this study

The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for men who have sex with men (MSM) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like MSM, and allows immediate engagement in the post-test linkage process to prevention or treatment services.

Read the detailed description

Malaysia's HIV epidemic is rapidly expanding, with recent evidence suggesting increasing sexual transmission, especially in MSM. HIV prevalence among MSM is now at an all-time high of 21.6% and is concentrated in the country's capital, Kuala Lumpur, where prevalence among MSM is 43% in 2020, up from 22% just four years before. Insights into Malaysia's expanding HIV epidemic are multi-factorial: Both homosexuality and substance use are criminalized in Malaysia. MSM are, therefore, often hesitant to disclose their sexuality or risk behaviors, primarily due to fear of stigma, discrimination, or criminalization. Further, evidence suggests the widespread use (24%) of psychoactive substances (e.g., amphetamine-type stimulants) before or during a sexual encounter, also known as sexualized drug use (chemsex) among Malaysian MSM, which leads to high-risk sexual practices (e.g., condomless sex). Stigma and discrimination are also enacted on MSM by healthcare providers, which foster a hostile environment toward MSM, complicating efforts to scale-up of HIV testing and subsequent linkage to HIV prevention (pre-exposure prophylaxis) and treatment (antiretroviral therapy) services. HIV testing jumpstarts entry into the HIV prevention and treatment cascades. New HIV testing guidelines recommend MSM test every 3 to 6 months, as early HIV testing is a cost-effective strategy for stemming the HIV epidemic. Yet, HIV testing rates remain low among Malaysian MSM: ever tested (70.3%) and last year tested (30.9%). HIV selftesting (HIVST) may be particularly impactful among MSM in Malaysia. Although willingness to use HIVST is high in this group, its use is still minimal due to lack of access to HIVST kits, concerns related to misinterpreting results, and missed opportunities for counseling and linkage to care. In this context, eHealth represents an innovative platform to transform the face of HIV service delivery (i.e., testing and linkage to care). Leveraging eHealth platforms for HIV services delivery in Malaysia is ideal given that nearly all (>99%) MSM use some form of communication technology (e.g., smartphone, laptop) and has a strong preference for web-based platforms for HIVST. Therefore, a web-based HIVST platform, called Jom-Test®, was developed to promote HIV testing by providing free anonymous HIVST. The results demonstrated high feasibility and acceptability for the platform but low post-test linkage to treatment and prevention services. The findings further indicated the need for real-time (online) access to counselors for pre- and post-test counseling and support for linkage to HIV and chemsex-related harm reduction services (offline). To address this evidence gap, this application proposes to jump-start the broader HIV care continuum by adapting, expanding, and refining an existing Jom-Test® platform. The enhanced version, to be called Jom-TestPlus, will include real-time e-counseling (eHIVST) with integrated O2O linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for Malaysian MSM. This model represents a potentially impactful strategy for reaching marginalized populations, like MSM, and allows immediate engagement in the post-test linkage process to prevention or treatment services.

Being tested
Online to offline counseling
Keywords
HIV, men who have sex with men, website
Medical subject headings
Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online to offline counselingBehavioural

    • Online registration and risk assessment: Users complete an onboarding process comprised of creating an account, entering demographic data, customizing settings, and completing the baseline risk assessment.
    • HIVST kit order, management, and monitoring: The platform will allow users to request HIVST kits via standard mail or self-pickup at user-preferred sites (e.g., LGBT-friendly clinics). After completing the mandatory section of the questionnaire and selecting a delivery option, a random personal identification number will be assigned by the system, which will be used to track future HIVST requests, collect HIVST results, and monitor subsequent linkage to further testing and HIV care.
    • eHIVST and O2O linkage to HIV clinical services: After unsealing the test kit, participants will find a reminder card to schedule their O2O pre- and post-test e-counseling appointment.
Study groups in NCT06373952
Study groupRoleWhat they receive
CINTAIExperimentalParticipants randomized to the Jom-TestPlus group will have access to all Jom-TestPlus features, including: assessment center; online registration; risk calculator; HIVST kit order, management, and monitoring; automated reminders; real-time e-counseling (eHIVST, active referral services); chemsex-related harm reduction services (screening, chemsex e-counseling, PartyPack ordering), chat function (ability to chat with counselors and research staff); and knowledge center (multimedia library on information and resources on HIV testing, PrEP, treatment, risks, and chemsex). Participants will follow a defined pathway to accessing HIVST kit ordering, e-counseling, and subsequent O2O linkage to clinical services.
Receives: Behavioral: Online to offline counseling
ControlActive comparatorbeing deactivated. The TAU group will have access to the assessment center (risk assessment, follow-up surveys), knowledge center (multimedia library on information and resources on HIV testing, PrEP, treatment, risks, and chemsex), and a voucher for no-cost community-based HIV testing (sent via secure, encrypted email or can be downloaded on the Jom-TestPlus).
Receives: Behavioral: Online to offline counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIVST uptake

    Uptake of HIV self-testing (yes/no) will be assessed at each follow-up time point (3 and 6 months) using self-reported measure.

    Measured: Time Frame: 3 and 6 months post-randomization

  2. Linkage to PrEP

    Linked to PrEP services (yes/no) will be assessed at each follow-up time point (3 and 6 months) using self-reported measure.

    Measured: Time Frame: 3 and 6 months post-randomization

  3. Linkage to HIV treatment services

    Linked to ART services (yes/no) will be assessed at each follow-up time point (3 and 6 months) using self-reported measure.

    Measured: Time Frame: 3 and 6 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start2 May 2024
  3. Primary completion10 Dec 2025
  4. Study completion18 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06373952
Sponsor's protocol ID
23-08-658-910
Acronym
CINTAI
Status last verified
Oct 2026
First submitted
15 Apr 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Online to offline counseling in people with HIV Prevention Program, run by University of Connecticut at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIVST uptake (time frame: Time Frame: 3 and 6 months post-randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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