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CompletedNCT05335096Updated Jul 2, 2026

An AI-based mHealth Intervention to Improve HIV Testing

An interventional study of An AI-chatbot-based mHealth intervention and An attention-chatbot-based mHealth intervention in HIV Infections, sponsored by Yale University. Completed at 1 site in Malaysia. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Yale University · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
307
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 307 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Does not have a smartphone
  • HIV status previously tested positive
  • cannot speak Bahasa Malaysia or English
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
307 participants (actual)

Study arms

  • Experimental
    Intervention group

    Behavioral: An AI-chatbot-based mHealth intervention · Behavioral: Educational materials

  • Active comparator
    TAU group

    Behavioral: An attention-chatbot-based mHealth intervention · Behavioral: Educational materials

Interventions

  • BehavioralAn 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.

  • BehavioralAn 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.

  • BehavioralEducational 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 180 days

07

Study locations

1 site
  • University of Malaysia
    Kuala Lumpur, 50603, Malaysia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05335096
Lead sponsor
Yale University
Collaborators
University of Malaya, Fogarty International Center of the National Institute of Health
Responsible party
Sponsor
First posted
Apr 19, 2022
Start date
Nov 26, 2024
Primary completion
May 29, 2026
Completion
Jun 5, 2026
Last update
Jul 2, 2026

Study contacts

Zhao Ni, PhD
principal investigator · Yale University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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