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Completed

NCT Number: NCT04710901

UTECH: Machine Learning for HIV Prevention Among Substance Using GBMSM

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

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Key information

Conditions

Sexually Transmitted Diseases Behavior Blood-Borne Infections Chemically-Induced Disorders Coitus Communicable Diseases Disease Attributes Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Implementation Science Infections Lentivirus Infections MSM Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexual Behavior Sexually Transmitted Diseases, Viral Substance Use Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCLA

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

uTECH + YMHP

Behavioral

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.

YMHP

Behavioral

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.

uTECH

Behavioral

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 outcomes

  1. Perception of Intervention Acceptability [4-item scale, 5-point ordinal response]

    Time frame: 12 months

    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."

  2. Perception of Intervention Appropriateness [4-item scale, 5-point ordinal response]

    Time frame: 12 months

    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."

  3. Perception of Intervention Feasibility [4-item scale, 5-point ordinal response]

    Time frame: 12 months

    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."

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Acronym: uTECH

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 15, 2021
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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