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

March 31, 2023 updated by: Zixin Wang, Chinese University of Hong Kong

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

564

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 666888
        • Centre for Health Behaviours Research, the Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of HIV self-testing
Time Frame: 6 months
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
Time Frame: 6 months
Proportion of HIV self-testing users receiving counselling along with testing during the 6-month follow-up period
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 16, 2023

Primary Completion (Anticipated)

February 28, 2024

Study Completion (Anticipated)

February 28, 2024

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • MSS349R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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