NCT05796622

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
564

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

April 16, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 20, 2023

Last Update Submit

March 31, 2023

Conditions

Behaviors, Health

Outcome Measures

Primary Outcomes (2)

  • Uptake of HIV self-testing

    Proportion of participants who use HIV self-testing during the 6-month follow-up period

    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

    6 months

Study Arms (2)

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)

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)

Behavioral: HIVST-OIC (HIV self-testing services with counseling provided by administrators)

Interventions

HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot)BEHAVIORAL

Promote and implement HIVST-Chatbot

HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot)
HIVST-OIC (HIV self-testing services with counseling provided by administrators)BEHAVIORAL

Promote and implement HIVST-OIC

HIVST-OIC (HIV self-testing services with counseling provided by administrators)

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale at birth
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Self-reported as HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Health Behaviours Research, the Chinese University of Hong Kong

Hong Kong, 666888, Hong Kong

Location

Related Publications (2)

  • 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.

    PMID: 41284298DERIVED

  • Chen 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.

    PMID: 37389935DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Zixin Wang, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zixin Wang, PhD

CONTACT

+852 22528740wangzx@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 3, 2023

Study Start

April 16, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)