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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05796622
Collaborator
(none)
564
Enrollment
1
Location
2
Arms
10.4
Anticipated Duration (Months)
54
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot)
  • Behavioral: HIVST-OIC (HIV self-testing services with counseling provided by administrators)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
564 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
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)
Anticipated Study Start Date :
Apr 16, 2023
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

Behavioral: HIVST-Chatbot (HIV self-testing services with counseling provided by a Chatbot)
Promote and implement HIVST-Chatbot
Active Comparator: 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)

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

Outcome Measures

Primary Outcome Measures

  1. Uptake of HIV self-testing [6 months]

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

  2. Proportion of HIV self-testing users receiving counselling along with testing [6 months]

    Proportion of HIV self-testing users receiving counselling along with testing during the 6-month follow-up period

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Health Behaviours Research, the Chinese University of Hong Kong Hong Kong Hong Kong 666888

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

  • Principal Investigator: Zixin Wang, PhD, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zixin Wang, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05796622
Other Study ID Numbers:
  • MSS349R
First Posted:
Apr 3, 2023
Last Update Posted:
Apr 3, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 3, 2023