An AI-based mHealth Intervention to Improve HIV Testing
Primary Purpose
HIV Infections
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
An AI-chatbot-based mHealth intervention
An attention-chatbot-based mHealth intervention
Educational materials
Sponsored by
About this trial
This is an interventional screening trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- Cis-gender male
- condomless sex with men in the past 6 months
- HIV status unknown or previously tested negative
- speaks Bahasa Malaysia or English.
Exclusion Criteria:
- Does not have a smartphone
- HIV status previously tested positive
- cannot speak Bahasa Malaysia or English
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
TAU group
Arm Description
Outcomes
Primary Outcome Measures
Number of participants that get tested for HIV within 180 days
The number of participants who get tested for HIV within 180 days assessed by an online survey link that will be manually sent by the research assistant to the participant's phone every 30 days, up to 180 days. The survey consists of a question asking if the participant has been tested for HIV in the last 30 days with an answer of yes or no.
Secondary Outcome Measures
Full Information
NCT ID
NCT05335096
First Posted
April 12, 2022
Last Updated
July 12, 2023
Sponsor
Yale University
Collaborators
University of Malaya, Fogarty International Center of the National Institute of Health
1. Study Identification
Unique Protocol Identification Number
NCT05335096
Brief Title
An AI-based mHealth Intervention to Improve HIV Testing
Official Title
Developing an Artificial Intelligence (AI)-Based mHealth Intervention to Improve HIV Testing in Malaysia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
University of Malaya, Fogarty International Center of the National Institute of Health
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
The purpose of this study is to develop an artificial intelligence (AI)-chatbot-based mobile health (mHealth) intervention to promote HIV testing in Malaysia.
Detailed Description
A randomized controlled trial (RCT) will be conducted in Malaysia to assess the efficacy of an AI-chatbot-based mHealth intervention versus treatment as usual (TAU) with HIV testing as the primary outcome. The primary outcome will be the proportion of participants who get tested within 180 days.
Participants will be randomized to the chatbot group and TAU group. Participants in the intervention group will get access to an AI-chatbot and can interact with the AI-chatbot at any time. In each round of the interactive communication, the chatbot will provide automated personalized messages containing pre-exposure prophylaxis (PrEP), mental health, or HIV testing-related information, motivation and skills based on the participants' answers and will continuously update over time. The participants assigned to the TAU group will get access to an attention-chatbot and can interact with the attention-chatbot at any time. In each round of the interaction, the chatbot will provide pre-scripted time-attention health education messages to the participants.
In addition to the above interventions, the research assistant will manually sent to the participants' phone a piece of educational material and an online survey link every 30 days (at days 30, 60, 90, 120, 150 and 180). The primary outcome of HIV testing will be collected through the survey.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
296 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
TAU group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
An AI-chatbot-based mHealth intervention
Intervention Description
The participants assigned to the intervention group will get access to an AI-chatbot and can interact with the AI-chatbot at any time. In each round of the interactive communication, the chatbot will provide automated personalized messages containing PrEP, mental health, or HIV testing-related information, motivation and skills based on the participants' answers and will continuously update over time.
Intervention Type
Behavioral
Intervention Name(s)
An attention-chatbot-based mHealth intervention
Intervention Description
The participants assigned to the control group will get access to an attention-chatbot and can interact with the attention-chatbot at any time. In each round of the interaction, the chatbot will provide pre-scripted time-attention health education messages to the participants.
Intervention Type
Behavioral
Intervention Name(s)
Educational materials
Intervention Description
the research assistant will manually sent to the participants' phone a piece of educational material and an online survey link every 30 days (at days 30, 60, 90, 120, 150 and 180).
Primary Outcome Measure Information:
Title
Number of participants that get tested for HIV within 180 days
Description
The number of participants who get tested for HIV within 180 days assessed by an online survey link that will be manually sent by the research assistant to the participant's phone every 30 days, up to 180 days. The survey consists of a question asking if the participant has been tested for HIV in the last 30 days with an answer of yes or no.
Time Frame
up to 180 days
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Cis-gender male
condomless sex with men in the past 6 months
HIV status unknown or previously tested negative
speaks Bahasa Malaysia or English.
Exclusion Criteria:
Does not have a smartphone
HIV status previously tested positive
cannot speak Bahasa Malaysia or English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Ni, PhD
Phone
203-737-3039
Email
zhao.ni@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Ni, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An AI-based mHealth Intervention to Improve HIV Testing
We'll reach out to this number within 24 hrs