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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
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV Infections

Eligibility Criteria

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

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

    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
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    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

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