Engaging Seronegative Youth to Optimize HIV Prevention Continuum
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03134833 |
Recruitment Status :
Completed
First Posted : May 1, 2017
Last Update Posted : December 5, 2022
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Condition or disease | Intervention/treatment | Phase |
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HIV Mental Health Substance Use STI | Behavioral: Automated Messaging & Monitoring Behavioral: Peer Support Behavioral: Coaching | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1478 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Engaging Seronegative Youth to Optimize HIV Prevention Continuum |
Actual Study Start Date : | May 6, 2017 |
Actual Primary Completion Date : | October 31, 2021 |
Actual Study Completion Date : | November 30, 2022 |

Arm | Intervention/treatment |
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Experimental: Automated Messaging & Monitoring
Youth randomized to the Automated Messaging and Monitoring Intervention (AMMI) arm will receive daily texts to motivate, inform, and refer youth to health care and HIV services. Message banks will focus on the HIV Prevention Continuum, with libraries of text messages dedicated to healthcare, wellness, sexual health, drug use and medication reminders (e.g., for PrEP) for young men-who-have-sex-with-men (MSM) and non-MSM. Youth will also receive a weekly monitoring survey that covers seven domains, including: use of PrEP/PEP, condomless sex, potential symptoms of acute HIV infection, potential symptoms of STI, excessive use of alcohol and/or drugs, feelings of sadness or depression, and housing or food insecurity. |
Behavioral: Automated Messaging & Monitoring
Youth will receive messages 1-5 messages per day for 24 months. Message banks of about 750 text messages (70-120/domain) will focus on the HIV Prevention Continuum, with messages dedicated to healthcare, wellness, sexual health, drug use and medication reminders (e.g., for PrEP) for MSM and non-MSM. Youth will be able to choose the time that they receive daily texts. Text timing and the frequency of texts (e.g., if the youth "comes out") will be updated at 4-month intervals. Youth will complete weekly monitoring surveys by text message. The survey will cover seven domains related to the HIV Prevention Continuum. In case of non-response, reminder messages will be sent to the youth. After three days of non-response, a follow-telephone call will occur. |
Experimental: Peer Support
Youth randomized to the Peer Support arm will be enrolled in private, online peer support groups, where they can post information and have discussions with other participants, guided broadly by topics relevant to the HIV Prevention Continuum. Peer Supporters will post to encourage and broadly guide discussion, while Coaches and Project Coordinators will be available to provide factual information (as needed), and remove inappropriate content. All youth will also receive AMMI messages.
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Behavioral: Automated Messaging & Monitoring
Youth will receive messages 1-5 messages per day for 24 months. Message banks of about 750 text messages (70-120/domain) will focus on the HIV Prevention Continuum, with messages dedicated to healthcare, wellness, sexual health, drug use and medication reminders (e.g., for PrEP) for MSM and non-MSM. Youth will be able to choose the time that they receive daily texts. Text timing and the frequency of texts (e.g., if the youth "comes out") will be updated at 4-month intervals. Youth will complete weekly monitoring surveys by text message. The survey will cover seven domains related to the HIV Prevention Continuum. In case of non-response, reminder messages will be sent to the youth. After three days of non-response, a follow-telephone call will occur. Behavioral: Peer Support Youth will be enrolled in online, private discussion groups. Peer Support will be offered by fellow participants and/or Youth Advisory Board members that have been trained in basic information on HIV, STI, drug use, mental health, homelessness, and stigma; using social media to create wall posts and use chat functions; and, how to initiate conversations on sensitive topics. By posting and responding to messages, Peer Supporters will encourage and broadly guide conversation related to the HIV Prevention Continuum, and other relevant topics. Coaches and Project Coordinators will be available to provide factual information (as needed), and remove inappropriate content. |
Experimental: Coaching
Youth randomized to the Coaching arm will have access to a dedicated Coach for crisis management, problem-solving, linkage to HIV and related services, and care coordination. The Coach's primary means of contact with youth will be electronic - using e-mail, social media, text messages - and phone calls. In person contacts may also occur. AMMI is also provided to all youth.
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Behavioral: Automated Messaging & Monitoring
Youth will receive messages 1-5 messages per day for 24 months. Message banks of about 750 text messages (70-120/domain) will focus on the HIV Prevention Continuum, with messages dedicated to healthcare, wellness, sexual health, drug use and medication reminders (e.g., for PrEP) for MSM and non-MSM. Youth will be able to choose the time that they receive daily texts. Text timing and the frequency of texts (e.g., if the youth "comes out") will be updated at 4-month intervals. Youth will complete weekly monitoring surveys by text message. The survey will cover seven domains related to the HIV Prevention Continuum. In case of non-response, reminder messages will be sent to the youth. After three days of non-response, a follow-telephone call will occur. Behavioral: Coaching Youth will have access to a dedicated Coach to assist with crisis support and problem-solving, linkage to HIV and related services (e.g., for substance use, mental health), and care coordination. Coaches will be accessible electronically (using social media, e-mail, text messaging) and by phone. In cases where virtual support has failed, Coaches will be available in-person (e.g., to accompany a participant to a doctor's appointment). We anticipate that Coaches will provide each youth with 10 hours of support, on average, per year. |
Experimental: Coaching + Peer Support
Youth randomized to the Coach + Peer Support arm will be enrolled in online, private peer support groups and have access to a Coach. As well as AMMI messages.
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Behavioral: Automated Messaging & Monitoring
Youth will receive messages 1-5 messages per day for 24 months. Message banks of about 750 text messages (70-120/domain) will focus on the HIV Prevention Continuum, with messages dedicated to healthcare, wellness, sexual health, drug use and medication reminders (e.g., for PrEP) for MSM and non-MSM. Youth will be able to choose the time that they receive daily texts. Text timing and the frequency of texts (e.g., if the youth "comes out") will be updated at 4-month intervals. Youth will complete weekly monitoring surveys by text message. The survey will cover seven domains related to the HIV Prevention Continuum. In case of non-response, reminder messages will be sent to the youth. After three days of non-response, a follow-telephone call will occur. Behavioral: Peer Support Youth will be enrolled in online, private discussion groups. Peer Support will be offered by fellow participants and/or Youth Advisory Board members that have been trained in basic information on HIV, STI, drug use, mental health, homelessness, and stigma; using social media to create wall posts and use chat functions; and, how to initiate conversations on sensitive topics. By posting and responding to messages, Peer Supporters will encourage and broadly guide conversation related to the HIV Prevention Continuum, and other relevant topics. Coaches and Project Coordinators will be available to provide factual information (as needed), and remove inappropriate content. Behavioral: Coaching Youth will have access to a dedicated Coach to assist with crisis support and problem-solving, linkage to HIV and related services (e.g., for substance use, mental health), and care coordination. Coaches will be accessible electronically (using social media, e-mail, text messaging) and by phone. In cases where virtual support has failed, Coaches will be available in-person (e.g., to accompany a participant to a doctor's appointment). We anticipate that Coaches will provide each youth with 10 hours of support, on average, per year. |
- HIV Testing [ Time Frame: 24 months ]Self-reported # of times - lifetime, past 4 months (reported at four-month assessment points)
- STI Testing [ Time Frame: 24 months ]Self-reported # of times - lifetime, past 4 months (reported at four-month assessment points)
- Condom Use Frequency [ Time Frame: 24 months ]Self-reported condomless sex - lifetime, past four months - using Likert-type scale (reported on weekly surveys, at four-month assessment points)
- PEP Use / Adherence [ Time Frame: 24 months ]Self-reported current use, lifetime use, adherence, willingness to use - using Likert-type scale (all reported at four-month assessment points, adherence also reported on weekly surveys)
- PrEP Use / Adherence [ Time Frame: 24 months ]Self-reported current use, lifetime use, adherence; using Likert-type scale (all reported at four-month assessment points, adherence also reported on weekly surveys)
- Sexual Partners [ Time Frame: 24 months ]Self-reported # of sexual partners, # of female/male/transgender sexual partners - lifetime, past 4 months (reported at four-month assessment points)
- Mental Health Symptoms [ Time Frame: 24 months ]Self-reported symptoms of anxiety and depression (reported on weekly surveys, at four-month assessment points)
- Substance Use [ Time Frame: 24 months ]Rapid Diagnostic Tests (RDTs) for alcohol, marijuana, methamphetamines, opiates, cocaine (at four-month assessment points); self-reported AUDIT-C measure (at four-month assessment points); self-reported excessive substance use (reported on weekly surveys)
- Housing Insecurity [ Time Frame: 24 months ]Self-reported housing insecurity (reported on weekly surveys, at four-month assessment points)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Youth aged 12-24
- HIV-negative status
- Able to provide informed consent
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At high-risk* of HIV
- Youth will be considered at high-risk of HIV based on their responses to a screening questionnaire, which assesses - HIV status; PrEP / PEP use; gender; race/ethnicity; sexual orientation; homelessness; history of probation/incarceration; history of hospitalization for mental health issues; history of substance abuse use and treatment; and, history of STI.
Exclusion Criteria:
- Youth under 12 years of age or above 24 years of age
- HIV-positive (if you become HIV-positive, they will be invited to participate in another, related ATN study)
- Unable to understand the study procedures due to intoxication or cognitive difficulties (any youth who appear to be under the influence of alcohol or drugs will be unable to enroll in the study but invited to return at a later date)
- Unable to provide voluntary written informed consent
- Do not meet aforementioned criteria for being at high-risk of HIV

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134833
United States, California | |
University of California, Los Angeles | |
Los Angeles, California, United States, 90024 | |
United States, Louisiana | |
Tulane University Health Sciences Center | |
New Orleans, Louisiana, United States, 70112 |
Principal Investigator: | Dallas Swendeman, PhD, MPH | University of California, Los Angeles |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dallas Swendeman, Associate Professor, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT03134833 |
Other Study ID Numbers: |
U19HD089886 - Study 3 U19HD089886 ( U.S. NIH Grant/Contract ) |
First Posted: | May 1, 2017 Key Record Dates |
Last Update Posted: | December 5, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HIV STI Mental Health Substance Use Peer Support |
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |