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Developing a Chatbot to Promote HIV Testing

Primary Purpose

HIV Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Chatbot messages
Attention-matched educational materials
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV testing, PrEp, HIV care, Chatbot, MSM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Malaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chatbot group

TAU group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Recruitment rate
The number of participants contacted divided by the number of participants who signed the consent form
Completion rate
The number of participants who signed the consent form divided by the number of participants who completed the study
Interaction time
The time of the interaction between participants and Chatbot
Interaction frequency
The frequency of the interaction between participants and Chatbot

Full Information

First Posted
May 27, 2021
Last Updated
July 12, 2023
Sponsor
Yale University
Collaborators
University of Malaya, National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT04910984
Brief Title
Developing a Chatbot to Promote HIV Testing
Official Title
Developing an Artificial Intelligence Chatbot to Promote HIV Testing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 20, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
University of Malaya, National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV testing, PrEp, HIV care, Chatbot, MSM

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chatbot group
Arm Type
Experimental
Arm Title
TAU group
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Chatbot messages
Intervention Description
Automated personalized messages containing HIV testing-related information, motivation and skills
Intervention Type
Behavioral
Intervention Name(s)
Attention-matched educational materials
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in HIV testing
Description
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.
Time Frame
30 days, 60 days, 90 days, 120 days, 150 days, and 180 days
Secondary Outcome Measure Information:
Title
Recruitment rate
Description
The number of participants contacted divided by the number of participants who signed the consent form
Time Frame
180 days
Title
Completion rate
Description
The number of participants who signed the consent form divided by the number of participants who completed the study
Time Frame
180 days
Title
Interaction time
Description
The time of the interaction between participants and Chatbot
Time Frame
180 days
Title
Interaction frequency
Description
The frequency of the interaction between participants and Chatbot
Time Frame
180 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Wickersham, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya
City
Kuala Lumpur
State/Province
Jalan Pantai Baharu
ZIP/Postal Code
59990
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rumana Akhter Saifi, PhD
Phone
22463383
Ext
603
Email
rumanasaifi@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Developing a Chatbot to Promote HIV Testing

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