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NCT05335096 Clinical Trial

An AI-based mHealth Intervention to Improve HIV Testing

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05335096
Other study ID # 2000032663
Secondary ID 1R21TW011663-014
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 15, 2024
Est. completion date May 15, 2025

Study information
Verified date April 2024
Source Yale University
Contact Zhao Ni, PhD
Phone 203-737-3039
Email zhao.ni@yale.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 296
Est. completion date May 15, 2025
Est. primary completion date May 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• An AI-chatbot-based mHealth intervention
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.
• An attention-chatbot-based mHealth intervention
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.
• Educational materials
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).

Locations
Country Name City State
Malaysia University of Malaysia Kuala Lumpur

Sponsors (3)
Lead Sponsor Collaborator
Yale University Fogarty International Center of the National Institute of Health, University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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