NCT04710901

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
388

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

November 24, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

3.5 years

First QC Date

November 9, 2020

Last Update Submit

November 21, 2024

Conditions

Sexually Transmitted DiseasesHIV InfectionsImplementation ScienceSubstance UseMSM

Keywords

MSMSexual and gender minoritiesSubstance useSocial mediaHIV prevention

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

uTECH + Young Men's Health Project (YMHP)

ACTIVE COMPARATOR

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

Young Men's Health Project (YMHP)

ACTIVE COMPARATOR

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

uTECH

ACTIVE COMPARATOR

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

Behavioral: uTECH

Interventions

uTECH + YMHPBEHAVIORAL

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.

uTECH + Young Men's Health Project (YMHP)
YMHPBEHAVIORAL

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.

Young Men's Health Project (YMHP)
uTECHBEHAVIORAL

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.

uTECH

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSexual and/or gender minorities who have sex with men
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (2)

  • Boka C, Yonko EA, Beikzadeh M, Karkkainen K, Hong C, Sarrafzadeh M, Holloway IW. Utilizing Machine Learning for Predicting PrEP Use Status Among Sexual and Gender Minority Young Adults. Prev Sci. 2026 Jan 10. doi: 10.1007/s11121-025-01872-1. Online ahead of print.

    PMID: 41519977DERIVED

  • 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.

    PMID: 39163591DERIVED

MeSH Terms

Conditions

Sexually Transmitted DiseasesHIV InfectionsSubstance-Related DisordersCoitus

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced DisordersMental DisordersSexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 9, 2020

First Posted

January 15, 2021

Study Start

November 24, 2020

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)