uTECH: Machine Learning for HIV Prevention Among Substance Using GBMSM

Study Overview
=================
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.

Official Title
-----------------
uTECH: Machine Learning for HIV Prevention Among Substance Using GBMSM

Conditions
-----------------
Sexually Transmitted Diseases, HIV Infections, Implementation Science, Substance Use, MSM

Intervention / Treatment
-----------------
* Behavioral: uTECH + YMHP
* Behavioral: YMHP
* Behavioral: uTECH


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: uTECH + Young Men's Health Project (YMHP)<br>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. | Behavioral: uTECH + YMHP<br>* 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.<br>|
| Active Comparator: Young Men's Health Project (YMHP)<br>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. | Behavioral: YMHP<br>* 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.<br>|
| Active Comparator: uTECH<br>Approximately 60 participants will be randomly assigned to this arm and will receive the uTECH intervention over the course of 12 months. | Behavioral: uTECH<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| 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. | 12 months | 
| 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. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MSM, Sexual and gender minorities, Substance use, Social media, HIV prevention