UTECH: Machine Learning for HIV Prevention Among Substance Using GBMSM

Not Applicable

Completed

• Conditions: Sexually Transmitted Diseases; HIV Infections; Substance Use; Implementation Science; MSM
• Interventions: Behavioral: uTECH + YMHP; Behavioral: uTECH; Behavioral: YMHP

• Registration Number: NCT04710901
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2020-11-09
• Study Start: 2020-11-24
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-15
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 388

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
uTECH + Young Men's Health Project (YMHP)	uTECH + YMHP	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.
uTECH	uTECH	Approximately 60 participants will be randomly assigned to this arm and will receive the uTECH intervention over the course of 12 months.
Young Men's Health Project (YMHP)	YMHP	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.

Primary Outcome Measures

Name	Time	Method
Perception of Intervention Appropriateness [4-item scale, 5-point ordinal response]	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."
Perception of Intervention Acceptability [4-item scale, 5-point ordinal response]	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."
Perception of Intervention Feasibility [4-item scale, 5-point ordinal response]	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."

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States