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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Behaviors, Health

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention 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)<br>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)<br>* Promote and implement HIVST-Chatbot<br>|
| Active Comparator: HIVST-OIC (HIV self-testing services with counseling provided by administrators)<br>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)<br>* Promote and implement HIVST-OIC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |