Evaluating an Innovative HIV Self-testing Service With Counseling Provided by a Chatbot

Behaviors, Health Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05796622
• Other study ID #: MSS349R
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 16, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2023
• Source: Chinese University of Hong Kong
• Contact: Zixin Wang, PhD
• Phone: +852 22528740
• Email: wangzx[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 564
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Self-reported as HIV positive

Related Conditions & MeSH terms

• Behaviors, Health

Intervention

Behavioral:
• HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot)
Promote and implement HIVST-Chatbot
• HIVST-OIC (HIV self-testing services with counseling provided by administrators)
Promote and implement HIVST-OIC

Locations

Country	Name	City	State
Hong Kong	Centre for Health Behaviours Research, the Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of HIV self-testing	Proportion of participants who use HIV self-testing during the 6-month follow-up period	6 months
Primary	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