NCT05335096

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
296

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
2.6 years until next milestone

Study Start

First participant enrolled

November 26, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

April 12, 2022

Last Update Submit

January 26, 2026

Conditions

Outcome Measures

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.

    up to 180 days

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: An AI-chatbot-based mHealth interventionBehavioral: Educational materials

TAU group

ACTIVE COMPARATOR
Behavioral: An attention-chatbot-based mHealth interventionBehavioral: Educational materials

Interventions

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.

TAU group

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).

Intervention groupTAU group

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cis-gender male
  • condomless sex with men in the past 6 months
  • HIV status unknown or previously tested negative
  • speaks Bahasa Malaysia or English.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaysia

Kuala Lumpur, 50603, Malaysia

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Zhao Ni, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Ni, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 19, 2022

Study Start

November 26, 2024

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations