UTECH: Machine Learning for HIV Prevention Among Substance Using GBMSM

NCT ID: NCT04710901

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-24
• Study Completion Date: 2024-05-31

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.

Conditions

Sexually Transmitted Diseases; HIV Infections; Implementation Science; Substance Use; MSM

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

uTECH + Young Men's Health Project (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.

Group Type: ACTIVE_COMPARATOR

uTECH + YMHP

Intervention Type: 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.

Young Men's Health Project (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.

Group Type: ACTIVE_COMPARATOR

YMHP

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

uTECH

Intervention Type: 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.

Interventions

uTECH + YMHP

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

YMHP

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

uTECH

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Ian Holloway

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCLA

Los Angeles, California, United States

Countries

United States

References

Holloway IW, Wu ESC, Boka C, Young N, Hong C, Fuentes K, Karkkainen K, Beikzadeh M, Avendano A, Jauregui JC, Zhang A, Sevillano L, Fyfe C, Brisbin CD, Beltran RM, Cordero L, Parsons JT, Sarrafzadeh M. Novel Machine Learning HIV Intervention for Sexual and Gender Minority Young People Who Have Sex With Men (uTECH): Protocol for a Randomized Comparison Trial. JMIR Res Protoc. 2024 Aug 20;13:e58448. doi: 10.2196/58448.

Reference Type: DERIVED

PMID: 39163591 (View on PubMed)

Other Identifiers

DP2DA049296-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-000805

Identifier Type: -

Identifier Source: org_study_id