Developing a Chatbot to Promote HIV Testing

April 17, 2024 updated by: Yale University

Developing an Artificial Intelligence Chatbot to Promote HIV Testing

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

After informed consent, participants will be randomly assigned to Chatbot or TAU groups using stratified randomization by age. Participants in TAU will receive attention-matched educational materials manually sent by the research assistant. Participants in the intervention group will receive an automated personalized question message (root-node message) from the Chabot. In each round of the interactive communication, the Chatbot will provide automated personalized messages containing HIV testing-related information, motivation and skills based on participants' answers and will continuously update over time. Participants will be observed over 180 days with responses and interactions stored on a HIPAA-compliant and protected cloud. An independent assessment of recent testing and reasons why will be sent by link to both TAU and intervention groups using a link to a Qualtrics survey housed on REDCap at baseline and after 90 and 180 days. After 180 days, the RA will send an additional REDCap survey to intervention participants to assess the feasibility of the Chabot to measure 4 key elements: acceptability, practicality, demand, and adaptation.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Jalan Pantai Baharu
      • Kuala Lumpur, Jalan Pantai Baharu, Malaysia, 59990
        • University of Malaya
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not able to read Malay or English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chatbot group
Behavioral: Chatbot messages
Automated personalized messages containing HIV testing-related information, motivation and skills
Placebo Comparator: TAU group
Behavioral: Attention-matched educational materials
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HIV testing
Time Frame: 30 days, 60 days, 90 days, 120 days, 150 days, and 180 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 180 days
The number of participants contacted divided by the number of participants who signed the consent form
180 days
Completion rate
Time Frame: 180 days
The number of participants who signed the consent form divided by the number of participants who completed the study
180 days
Interaction time
Time Frame: 180 days
The time of the interaction between participants and Chatbot
180 days
Interaction frequency
Time Frame: 180 days
The frequency of the interaction between participants and Chatbot
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
University of Malaya

Investigators

  • Principal Investigator: Jeffrey A. Wickersham, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

May 27, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000027864
  • 1R21AI152927-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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