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uTECH: Machine Learning for HIV Prevention Among Substance Using GBMSM (uTECH)

Primary Purpose

Sexually Transmitted Diseases, HIV Infections, Implementation Science

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
uTECH + YMHP
YMHP
uTECH
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring MSM, Sexual and gender minorities, Substance use, Social media, HIV prevention

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older
  • Current sexual identity as a sexual minority
  • Current gender identity as a gender minority
  • Have had anal and/or oral sex with a man in the past 3 months
  • Use an illicit substance (such as methamphetamine, cocaine, ecstasy) OR a legal substance (such as alcohol or marijuana) in the past 3 months
  • Have had sex while using any substance in the past 3 months
  • Use a gay-specific social media/networking/dating app in the past 3 months to seek sexual and drug use partners
  • Willing to participate in audio-recorded interviews over Zoom
  • Comfortable answering questions in English
  • Use an Android or iOS smartphone
  • Negative or Unsure about HIV status
  • Comfortable with downloading an app that captures a variety of text-based information from their phone over the course of 12-months
  • Currently living and/or sleeping in Los Angeles County
  • Willing to participate in this study.

Exclusion Criteria:

  • Under 18 years of age
  • Does not currently identify as a gender or sexual minority
  • Have not had anal and/or oral sex with a man in the past 3 months
  • Have not used an illicit substance (such as methamphetamine, cocaine, ecstasy) or legal substance (such as alcohol or marijuana) in the past 3 months
  • Have not had sex while using any substance in the past 3 months
  • Have not used a gay-specific social media/networking/dating app in the past 3 months to seek sexual and drug use partners
  • Are not willing to participate in audio-recorded interviews over Zoom
  • Do not feel comfortable answering questions in English
  • Do not use an Android or iOS smartphone
  • HIV status is positive
  • Do not feel comfortable with downloading an app that captures a variety of text-based information from their phone over the course of 12-months
  • Are not currently living and/or sleeping in Los Angeles County
  • Am not willing to participate in this study.

Sites / Locations

  • UCLA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

uTECH + Young Men's Health Project (YMHP)

Young Men's Health Project (YMHP)

uTECH

Arm Description

Approximately 165 participants will be randomly assigned to this arm and will receive the uTECH intervention over the course of 12 months and YMHP intervention over the course of 3 months.

Approximately 165 participants will be randomly assigned to this arm and will receive the YMHP intervention over the course of the first 3 months. Months 3-12 will be inactive, and they will be followed for a total of 12 months.

Approximately 60 participants will be randomly assigned to this arm and will receive the uTECH intervention over the course of 12 months.

Outcomes

Primary Outcome Measures

Perception of Intervention Acceptability [4-item scale, 5-point ordinal response]
Drawing from work of Weiner et al (2017), we will rely on a psychometrically validated implementation science measure called "Acceptability of Intervention Measure (AIM)" that will measure the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. This measure is a 5-item scale with 5-point ordinal response that ranges from "completely disagree" to "completely agree."
Perception of Intervention Appropriateness [4-item scale, 5-point ordinal response]
Drawing from work of Weiner et al (2017), we will rely on a psychometrically validated implementation science measure called "Intervention Appropriateness Measure (IAM)" that will measure the perceived fit, relevance, or compatibility of the innovation for a given consumer. This measure is a 4-item scale with 5-point ordinal response that ranges from "completely disagree" to "completely agree."
Perception of Intervention Feasibility [4-item scale, 5-point ordinal response]
Drawing from work of Weiner et al (2017), we will rely on a psychometrically validated implementation science measure called "Feasibility of Intervention Measure (FIM)" that will measure the extent to which the intervention or innovation can be successfully used or carried out within this setting. This measure is a 4-item scale with 5-point ordinal response that ranges from "completely disagree" to "completely agree."

Secondary Outcome Measures

Full Information

First Posted
November 9, 2020
Last Updated
August 15, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04710901
Brief Title
uTECH: Machine Learning for HIV Prevention Among Substance Using GBMSM
Acronym
uTECH
Official Title
uTECH: Machine Learning for HIV Prevention Among Substance Using GBMSM
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)

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
This project seeks to develop and test the acceptability, appropriateness and feasibility of uTECH, a novel social media "big data" machine learning intervention for HIV-negative substance-using sexual and gender minority people who have sex with men that aims to reduce HIV transmission risk by integrating biomedical and behavioral risk reduction strategies, including pre-exposure prophylaxis (PrEP) for HIV prevention and medication assisted treatment (MAT) for substance use harm reduction
Detailed Description
The project will occur in two phases. In Phase 1, we will conduct qualitative interviews with gay and bisexual men who have sex with men (GBMSM) using an iterative user-centered design process, which will result in a refined version of the uTECH intervention. In Phase 2, we will conduct a comparative acceptability, appropriateness and feasibility trial with 330 individuals, who will be randomized to (1) receive the uTECH intervention and an existing, evidence-based motivational enhancement intervention for HIV risk and substance use prevention (YMHP) or (2) receive YMHP alone. uTECH is innovative in that it includes both core intervention modules and highly personalized intervention content based on participants' social media use. The tailored intervention content can be delivered via text message or Facebook messenger. This content relies on our previously developed machine learning algorithm, which helps participants understand their technology-use behavior in relation to HIV-risk and substance use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases, HIV Infections, Implementation Science, Substance Use, MSM
Keywords
MSM, Sexual and gender minorities, Substance use, Social media, HIV prevention

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
uTECH + Young Men's Health Project (YMHP)
Arm Type
Active Comparator
Arm Description
Approximately 165 participants will be randomly assigned to this arm and will receive the uTECH intervention over the course of 12 months and YMHP intervention over the course of 3 months.
Arm Title
Young Men's Health Project (YMHP)
Arm Type
Active Comparator
Arm Description
Approximately 165 participants will be randomly assigned to this arm and will receive the YMHP intervention over the course of the first 3 months. Months 3-12 will be inactive, and they will be followed for a total of 12 months.
Arm Title
uTECH
Arm Type
Active Comparator
Arm Description
Approximately 60 participants will be randomly assigned to this arm and will receive the uTECH intervention over the course of 12 months.
Intervention Type
Behavioral
Intervention Name(s)
uTECH + YMHP
Intervention Description
uTECH intervention utilizes a machine learning algorithm that leverages baseline data, individual social media use patterns, and strategic opportunistic learning questions to "push" messages to participants that offer strategic content about biomedical and behavioral HIV prevention. In addition, participants in this arm will also receive the YMHP intervention, which provides a four-session, evidence-based Motivational Enhancement intervention developed as part of the Young Men's Health Project (YMHP) and delivered via Zoom. Participants complete the four-session intervention during the first three months of their enrollment in the study.
Intervention Type
Behavioral
Intervention Name(s)
YMHP
Intervention Description
YMHP intervention provides a four-session evidence-based Motivational Enhancement intervention developed as part of the Young Men's Health Project (YMHP) and delivered via Zoom. Participants complete the four-session intervention during the first three months of their enrollment in this study. Months 3-12 are inactive.
Intervention Type
Behavioral
Intervention Name(s)
uTECH
Intervention Description
uTECH intervention utilizes a machine learning algorithm that leverages baseline data, individual social media use patterns, and strategic opportunistic learning questions to "push" messages to participants that offer strategic content about biomedical and behavioral HIV prevention.
Primary Outcome Measure Information:
Title
Perception of Intervention Acceptability [4-item scale, 5-point ordinal response]
Description
Drawing from work of Weiner et al (2017), we will rely on a psychometrically validated implementation science measure called "Acceptability of Intervention Measure (AIM)" that will measure the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. This measure is a 5-item scale with 5-point ordinal response that ranges from "completely disagree" to "completely agree."
Time Frame
12 months
Title
Perception of Intervention Appropriateness [4-item scale, 5-point ordinal response]
Description
Drawing from work of Weiner et al (2017), we will rely on a psychometrically validated implementation science measure called "Intervention Appropriateness Measure (IAM)" that will measure the perceived fit, relevance, or compatibility of the innovation for a given consumer. This measure is a 4-item scale with 5-point ordinal response that ranges from "completely disagree" to "completely agree."
Time Frame
12 months
Title
Perception of Intervention Feasibility [4-item scale, 5-point ordinal response]
Description
Drawing from work of Weiner et al (2017), we will rely on a psychometrically validated implementation science measure called "Feasibility of Intervention Measure (FIM)" that will measure the extent to which the intervention or innovation can be successfully used or carried out within this setting. This measure is a 4-item scale with 5-point ordinal response that ranges from "completely disagree" to "completely agree."
Time Frame
12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Sexual and/or gender minorities who have sex with men
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Current sexual identity as a sexual minority Current gender identity as a gender minority Have had anal and/or oral sex with a man in the past 3 months Use an illicit substance (such as methamphetamine, cocaine, ecstasy) OR a legal substance (such as alcohol or marijuana) in the past 3 months Have had sex while using any substance in the past 3 months Use a gay-specific social media/networking/dating app in the past 3 months to seek sexual and drug use partners Willing to participate in audio-recorded interviews over Zoom Comfortable answering questions in English Use an Android or iOS smartphone Negative or Unsure about HIV status Comfortable with downloading an app that captures a variety of text-based information from their phone over the course of 12-months Currently living and/or sleeping in Los Angeles County Willing to participate in this study. Exclusion Criteria: Under 18 years of age Does not currently identify as a gender or sexual minority Have not had anal and/or oral sex with a man in the past 3 months Have not used an illicit substance (such as methamphetamine, cocaine, ecstasy) or legal substance (such as alcohol or marijuana) in the past 3 months Have not had sex while using any substance in the past 3 months Have not used a gay-specific social media/networking/dating app in the past 3 months to seek sexual and drug use partners Are not willing to participate in audio-recorded interviews over Zoom Do not feel comfortable answering questions in English Do not use an Android or iOS smartphone HIV status is positive Do not feel comfortable with downloading an app that captures a variety of text-based information from their phone over the course of 12-months Are not currently living and/or sleeping in Los Angeles County Am not willing to participate in this study.
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

uTECH: Machine Learning for HIV Prevention Among Substance Using GBMSM

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