An AI-based mHealth Intervention to Improve HIV Testing

Not Applicable

Recruiting

• Conditions: HIV Infections
• Interventions: Behavioral: An AI-chatbot-based mHealth intervention; Behavioral: An attention-chatbot-based mHealth intervention; Behavioral: Educational materials

• Registration Number: NCT05335096
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-19
• Study Start: 2024-11-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 296

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Educational materials	-
TAU group	Educational materials	-
Intervention group	An AI-chatbot-based mHealth intervention	-
TAU group	An attention-chatbot-based mHealth intervention	-

Primary Outcome Measures

Name	Time	Method
Number of participants that get tested for HIV within 180 days	up to 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.

Trial Locations

Locations (1)

University of Malaysia; 🇲🇾 Kuala Lumpur, Malaysia