NCT04910984

Brief Summary

In this study, the feasibility of a Chatbot in promoting HIV testing in a pilot RCT with 80 men who have sex with men in Kuala Lumpur, Malaysia will be studied. Participants will be randomized to Chatbot or treatment as usual (TAU) groups. Participants in the intervention group will receive automated personalized messages containing HIV testing-related information, motivation and skills.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
13mo left

Started Jul 2026

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
5.1 years until next milestone

Study Start

First participant enrolled

July 20, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

May 27, 2021

Last Update Submit

January 27, 2026

Conditions

Keywords

HIV testingPrEpHIV careChatbotMSM

Outcome Measures

Primary Outcomes (1)

  • Change in HIV testing

    The efficacy of the Chatbot versus TAU with HIV testing as the primary outcome will be measured. The primacy efficacy outcome is the proportion of MSM who get tested within 180 days. This will be measured every 30 days by asking if MSM tested for HIV in the past 30 days.

    30 days, 60 days, 90 days, 120 days, 150 days, and 180 days

Secondary Outcomes (4)

  • Recruitment rate

    180 days

  • Completion rate

    180 days

  • Interaction time

    180 days

  • Interaction frequency

    180 days

Study Arms (2)

Chatbot group

EXPERIMENTAL
Behavioral: Chatbot messages

TAU group

PLACEBO COMPARATOR
Behavioral: Attention-matched educational materials

Interventions

Automated personalized messages containing HIV testing-related information, motivation and skills

Chatbot group

Attention-matched educational materials manually sent by our research assistant. These educational materials will be retrieved from CDC and WHO websites and curated into short articles (\<200 words) and pictures. All educational materials will be screened by HIV experts from University of Malaya to ensure accuracy before being sent to participants.

TAU group

Eligibility Criteria

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

You may qualify if:

  • cis-gender male
  • + years;
  • had condomless sex with men in the past 6 months
  • has a smartphone
  • speaks Bahasa Malay or English.

You may not qualify if:

  • Not able to read Malay or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya

Kuala Lumpur, Jalan Pantai Baharu, 59990, Malaysia

Location

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

  • Jeffrey A. Wickersham, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 2, 2021

Study Start (Estimated)

July 20, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations