Sexually Transmitted DiseasesuTECHNCT04710901
UTECH: Machine Learning for HIV Prevention Among Substance Using GBMSM
A study testing uTECH + YMHP, YMHP and uTECH in people with Sexually Transmitted Diseases and HIV Infections, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, HIV Infections, Implementation Science
- What is being tested?
- uTECH + YMHP, YMHP and uTECH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2020to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Being tested
- uTECH + YMHP, YMHP, uTECH
- Keywords
- MSM, Sexual and gender minorities, Substance use, Social media, HIV prevention
- Medical subject headings
- Sexually Transmitted Diseases, HIV Infections, Substance-Related Disorders, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uTECH + YMHPBehavioural
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.
YMHPBehavioural
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.
uTECHBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: uTECH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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."
Measured: 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."
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start24 Nov 2020
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Ian Holloway, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710901
- Sponsor's protocol ID
- 19-000805
- Other IDs
- DP2DA049296-01
- Acronym
- uTECH
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2020
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41519977Holloway 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.
PubMed 39163591
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UTECH: Machine Learning for HIV Prevention Among Substance Using GBMSM
- ClinicalTrials.gov ID
- NCT04710901
- Acronym / sponsor ID
- uTECH / 19-000805
- Keywords
- MSM, Sexual and gender minorities, Substance use, Social media, HIV prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| uTECH + Young Men's Health Project (YMHP) | Active comparator | Behavioral: uTECH + YMHPApproximately 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. |
| Young Men's Health Project (YMHP) | Active comparator | Behavioral: YMHPApproximately 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. |
| uTECH | Active comparator | Behavioral: uTECHApproximately 60 participants will be randomly assigned to this arm and will receive the uTECH intervention over the course of 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uTECH + YMHPuTECH 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. | Behavioural | uTECH + Young Men's Health Project (YMHP) |
| YMHPYMHP 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. | Behavioural | Young Men's Health Project (YMHP) |
| uTECHuTECH 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. | Behavioural | uTECH |
Primary outcome
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."
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."
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."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 41519977Boka 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.
- Derived from this study: PubMed 39163591Holloway 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.
- Individual participant dataSharing planned: No
Related trials for Sexually Transmitted Diseases
Recruiting
Using Mobile Health (mHealth) to Improve STI Treatment Adherence Among Adolescents
Sexually Transmitted Diseases
Active, not recruiting
CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama
Hiv, Sexually Transmitted Diseases
Not yet recruitingPhase 3
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
Sexually Transmitted Infection (STI), Gonorrhea
Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
RecruitingPhase 4
Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
Gonorrhea, Chlamydia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uTECH + YMHP, YMHP and uTECH in people with Sexually Transmitted Diseases and HIV Infections, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of Intervention Acceptability [4-item scale, 5-point ordinal response] (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04710901, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.