An AI-based mHealth Intervention to Improve HIV Testing

• Sponsor: Yale University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05335096
• Collaborator: University of Malaya (Other), Fogarty International Center of the National Institute of Health (NIH)
• Enrollment: 296
• Arms: 2
• Anticipated Duration (Months): 24.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: An AI-chatbot-based mHealth intervention; Behavioral: An attention-chatbot-based mHealth intervention; Behavioral: Educational materials	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 296 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Screening
• Official Title: Developing an Artificial Intelligence (AI)-Based mHealth Intervention to Improve HIV Testing in Malaysia
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Jul 15, 2024
• Anticipated Study Completion Date: Dec 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group	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.; Behavioral: 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).
Active Comparator: TAU group	Behavioral: 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.; Behavioral: 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).

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yale University
• University of Malaya
• Fogarty International Center of the National Institute of Health

Investigators

• Principal Investigator: Zhao Ni, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT05335096
• Other Study ID Numbers: 2000032663; 1R21TW011663-01
• First Posted: Apr 19, 2022
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Aug 15, 2022