Developing a Chatbot to Promote HIV Testing

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04910984
Collaborator
University of Malaya (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
80
1
2
14.9
5.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Chatbot messages
  • Behavioral: Attention-matched educational materials
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Developing an Artificial Intelligence Chatbot to Promote HIV Testing
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in HIV testing [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.

Secondary Outcome Measures

  1. Recruitment rate [180 days]

    The number of participants contacted divided by the number of participants who signed the consent form

  2. Completion rate [180 days]

    The number of participants who signed the consent form divided by the number of participants who completed the study

  3. Interaction time [180 days]

    The time of the interaction between participants and Chatbot

  4. Interaction frequency [180 days]

    The frequency of the interaction between participants and Chatbot

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Malaya Kuala Lumpur Jalan Pantai Baharu Malaysia 59990

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT04910984
Other Study ID Numbers:
  • 2000027864
  • 1R21AI152927-01A1
First Posted:
Jun 2, 2021
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yale University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2022