An AI-based mHealth Intervention to Improve HIV Testing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop an artificial intelligence (AI)-chatbot-based mobile health (mHealth) intervention to promote HIV testing in Malaysia.

Detailed Description
-----------------
A randomized controlled trial (RCT) will be conducted in Malaysia to assess the efficacy of an AI-chatbot-based mHealth intervention versus treatment as usual (TAU) with HIV testing as the primary outcome. The primary outcome will be the proportion of participants who get tested within 180 days. Participants will be randomized to the chatbot group and TAU group. Participants in the intervention group will get access to an AI-chatbot and can interact with the AI-chatbot at any time. In each round of the interactive communication, the chatbot will provide automated personalized messages containing pre-exposure prophylaxis (PrEP), mental health, or HIV testing-related information, motivation and skills based on the participants' answers and will continuously update over time. The participants assigned to the TAU group will get access to an attention-chatbot and can interact with the attention-chatbot at any time. In each round of the interaction, the chatbot will provide pre-scripted time-attention health education messages to the participants. In addition to the above interventions, the research assistant will manually sent to the participants' phone a piece of educational material and an online survey link every 30 days (at days 30, 60, 90, 120, 150 and 180). The primary outcome of HIV testing will be collected through the survey.

Official Title
-----------------
Developing an Artificial Intelligence (AI)-Based mHealth Intervention to Improve HIV Testing in Malaysia

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: An AI-chatbot-based mHealth intervention
* Behavioral: An attention-chatbot-based mHealth intervention
* Behavioral: Educational materials


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cis-gender male condomless sex with men in the past 6 months HIV status unknown or previously tested negative speaks Bahasa Malaysia or English. Exclusion Criteria: Does not have a smartphone HIV status previously tested positive cannot speak Bahasa Malaysia or English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Behavioral: An AI-chatbot-based mHealth intervention<br>* The participants assigned to the intervention group will get access to an AI-chatbot and can interact with the AI-chatbot at any time. In each round of the interactive communication, the chatbot will provide automated personalized messages containing PrEP, mental health, or HIV testing-related information, motivation and skills based on the participants' answers and will continuously update over time.<br>Behavioral: Educational materials<br>* the research assistant will manually sent to the participants' phone a piece of educational material and an online survey link every 30 days (at days 30, 60, 90, 120, 150 and 180).<br>|
| Active Comparator: TAU group<br> | Behavioral: An attention-chatbot-based mHealth intervention<br>* The participants assigned to the control group will get access to an attention-chatbot and can interact with the attention-chatbot at any time. In each round of the interaction, the chatbot will provide pre-scripted time-attention health education messages to the participants.<br>Behavioral: Educational materials<br>* the research assistant will manually sent to the participants' phone a piece of educational material and an online survey link every 30 days (at days 30, 60, 90, 120, 150 and 180).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that get tested for HIV within 180 days | The number of participants who get tested for HIV within 180 days assessed by an online survey link that will be manually sent by the research assistant to the participant's phone every 30 days, up to 180 days. The survey consists of a question asking if the participant has been tested for HIV in the last 30 days with an answer of yes or no. | up to 180 days |