Behaviors, HealthNCT05796622
Evaluating an Innovative HIV Self-testing Service With Counseling Provided by a Chatbot
A study testing HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot) and HIVST-OIC (HIV self-testing services with counseling provided by administrators) in people with Behaviors, Health, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
A parallel-group non-inferiority randomized controlled trial will then be conducted to evaluate the performance of HIVST-Chatbot. A total of 528 Hong Kong Chinese speaking men who have sex with men (MSM) aged ≥18 years who have access to live-chat applications are recruited from multiple sources. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Behaviors, Health
- What is being tested?
- HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot) and HIVST-OIC (HIV self-testing services with counseling provided by administrators)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 1 siteHong Kong
- Study dates
- 16 Apr 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hong Kong Chinese-speaking men aged at least 18 years old
- Having had anal intercourse with at least one man in the past six months
- Willing to leave contact information and be followed up at Month 6
- Having access to the online live-chat application (WhatsApp)
- Not intending to leave Hong Kong for one month consecutively within the next six months
Who cannot join
- Self-reported as HIV positive
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Centre for Health Behaviours Research, the Chinese University of Hong Kong
Hong Kong, 666888
About this study
Official title: A Randomized Controlled Trial Evaluating an Innovative HIV Self-testing Service With Online Real-time Instruction, Pre-test and Post-test Counselling Provided by a Fully-automated Artificial Intelligence Chatbot (HIVST-Chatbot)
A parallel-group non-inferiority randomized controlled trial will then be conducted to evaluate the performance of HIVST-Chatbot. A total of 528 Hong Kong Chinese speaking men who have sex with men (MSM) aged ≥18 years who have access to live-chat applications are recruited from multiple sources. Those who are diagnosed as HIV positive are excluded. Participants are 1:1 randomized into the intervention group (n=264) or the control group (n=264). The research team will implement the HIVST-Chatbot (HIVST services with real-time counselling provided by a fully-automated artificial intelligence Chatbot) in the intervention group and HIVST-OIC (HIVST with real-time counselling provided by trained administrators) in the control group. Participants completed two telephone surveys at baseline and six months afterwards.
- Conditions
- Behaviors, Health
- Being tested
- HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot), HIVST-OIC (HIV self-testing services with counseling provided by administrators)
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot)Behavioural
Promote and implement HIVST-Chatbot
HIVST-OIC (HIV self-testing services with counseling provided by administrators)Behavioural
Promote and implement HIVST-OIC
| Study group | Role | What they receive |
|---|---|---|
| HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot) | Experimental | Promote and implement HIV self-testing (HIVST) services with real-time counselling provided by a fully-automated artificial intelligence Chatbot (HIVST-Chatbot) Receives: Behavioral: HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot) |
| HIVST-OIC (HIV self-testing services with counseling provided by administrators) | Active comparator | Promote and implement HIV self-testing (HIVST) services with real-time counselling provided by trained administrators) Receives: Behavioral: HIVST-OIC (HIV self-testing services with counseling provided by administrators) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of HIV self-testing
Proportion of participants who use HIV self-testing during the 6-month follow-up period
Measured: 6 months
Proportion of HIV self-testing users receiving counselling along with testing
Proportion of HIV self-testing users receiving counselling along with testing during the 6-month follow-up period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start16 Apr 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Behaviors, HealthStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zixin Wang, Chinese University of Hong Kong
- Investigators
- Zixin Wang, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796622
- Sponsor's protocol ID
- MSS349R
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen S, Yu FY, Fang Y, Yau J, Ng N, Zhang Q, Ni Z, Duong MC, Sun F, Mo PKH, Wang Z. Chatbot-Delivered Real-Time Support to Improve HIV Self-Testing Rates: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2544821. doi: 10.1001/jamanetworkopen.2025.44821.
PubMed 41284298Chen S, Zhang Q, Chan CK, Yu FY, Chidgey A, Fang Y, Mo PKH, Wang Z. Evaluating an Innovative HIV Self-Testing Service With Web-Based, Real-Time Counseling Provided by an Artificial Intelligence Chatbot (HIVST-Chatbot) in Increasing HIV Self-Testing Use Among Chinese Men Who Have Sex With Men: Protocol for a Noninferiority Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 30;12:e48447. doi: 10.2196/48447.
PubMed 37389935
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating an Innovative HIV Self-testing Service With Online Real-time Instruction, Pre-test and Post-test Counselling Provided by a Fully-automated Artificial Intelligence Chatbot (HIVST-Chatbot)
- ClinicalTrials.gov ID
- NCT05796622
- Acronym / sponsor ID
- MSS349R
- Conditions
- Behaviors, Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 16 Apr 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A parallel-group non-inferiority randomized controlled trial will then be conducted to evaluate the performance of HIVST-Chatbot. A total of 528 Hong Kong Chinese speaking men who have sex with men (MSM) aged ≥18 years who have access to live-chat applications are recruited from multiple sources. Those who are diagnosed as HIV positive are excluded. Participants are 1:1 randomized into the intervention group (n=264) or the control group (n=264). The research team will implement the HIVST-Chatbot (HIVST services with real-time counselling provided by a fully-automated artificial intelligence Chatbot) in the intervention group and HIVST-OIC (HIVST with real-time counselling provided by trained administrators) in the control group. Participants completed two telephone surveys at baseline and six months afterwards.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot) | Experimental | Behavioral: HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot)Promote and implement HIV self-testing (HIVST) services with real-time counselling provided by a fully-automated artificial intelligence Chatbot (HIVST-Chatbot) |
| HIVST-OIC (HIV self-testing services with counseling provided by administrators) | Active comparator | Behavioral: HIVST-OIC (HIV self-testing services with counseling provided by administrators)Promote and implement HIV self-testing (HIVST) services with real-time counselling provided by trained administrators) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hong Kong Chinese-speaking men aged at least 18 years old
- Having had anal intercourse with at least one man in the past six months
- Willing to leave contact information and be followed up at Month 6
- Having access to the online live-chat application (WhatsApp)
- Not intending to leave Hong Kong for one month consecutively within the next six months
Key exclusion criteria (1 listed)
- Self-reported as HIV positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot)Promote and implement HIVST-Chatbot | Behavioural | HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot) |
| HIVST-OIC (HIV self-testing services with counseling provided by administrators)Promote and implement HIVST-OIC | Behavioural | HIVST-OIC (HIV self-testing services with counseling provided by administrators) |
Primary outcome
Uptake of HIV self-testing
Time frame: 6 months
Proportion of participants who use HIV self-testing during the 6-month follow-up period
Proportion of HIV self-testing users receiving counselling along with testing
Time frame: 6 months
Proportion of HIV self-testing users receiving counselling along with testing during the 6-month follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Derived from this study: PubMed 41284298Chen S, Yu FY, Fang Y, Yau J, Ng N, Zhang Q, Ni Z, Duong MC, Sun F, Mo PKH, Wang Z. Chatbot-Delivered Real-Time Support to Improve HIV Self-Testing Rates: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2544821. doi: 10.1001/jamanetworkopen.2025.44821.
- Derived from this study: PubMed 37389935Chen S, Zhang Q, Chan CK, Yu FY, Chidgey A, Fang Y, Mo PKH, Wang Z. Evaluating an Innovative HIV Self-Testing Service With Web-Based, Real-Time Counseling Provided by an Artificial Intelligence Chatbot (HIVST-Chatbot) in Increasing HIV Self-Testing Use Among Chinese Men Who Have Sex With Men: Protocol for a Noninferiority Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 30;12:e48447. doi: 10.2196/48447.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zixin Wang, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot) and HIVST-OIC (HIV self-testing services with counseling provided by administrators) in people with Behaviors, Health, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Apr 2023. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zixin Wang, PhD (+852 22528740, wangzx@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of HIV self-testing (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05796622, which also lists 2 linked publications.
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 3 Apr 2023.