Developing a Chatbot to Promote HIV Testing

HIV Infections Clinical Trial

Official title:

Developing an Artificial Intelligence Chatbot to Promote HIV Testing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04910984
• Other study ID #: 2000027864
• Secondary ID: 1R21AI152927-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 20, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Chatbot messages
Automated personalized messages containing HIV testing-related information, motivation and skills
• 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.

Locations

Country	Name	City	State
Malaysia	University of Malaya	Kuala Lumpur	Jalan Pantai Baharu

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute of Allergy and Infectious Diseases (NIAID), University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recruitment rate	The number of participants contacted divided by the number of participants who signed the consent form	180 days
Secondary	Completion rate	The number of participants who signed the consent form divided by the number of participants who completed the study	180 days
Secondary	Interaction time	The time of the interaction between participants and Chatbot	180 days
Secondary	Interaction frequency	The frequency of the interaction between participants and Chatbot	180 days