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Engaging Seronegative Youth to Optimize HIV Prevention Continuum

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ClinicalTrials.gov Identifier: NCT03134833
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : June 24, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Tulane University Health Sciences Center
University of California, San Francisco
Friends Research Institute, Inc.
Information provided by (Responsible Party):
Dallas Swendeman, University of California, Los Angeles

Brief Summary:
The focus of this study (Engaging Seronegative Youth to Optimize HIV Prevention Continuum) - will be to stop HIV-related risk acts and to encourage youth at high risk for HIV to adopt antiretroviral medications as treatment and prevention (either pre exposure prophylaxis (PrEP) or post exposure prophylaxis) among gay, bisexual and transgender and/or homeless youth with contact with the criminal justice system in the HIV epicenters of Los Angeles and New Orleans. A cohort of 1500 youth at the highest risk of seroconverting over 24 months will be identified. The goal will be to optimize the HIV Prevention Continuum over 24 months. The proposed randomized controlled trial (RCT) aims to compare youth outcomes when randomized to one of four automated and person-mediated social media delivered intervention conditions: 1) Automated Messaging and Monitoring Intervention (AMMI) only (n=900) consisting of daily motivational, instructional, and referral text-messaging (SMS), and brief, weekly SMS monitoring surveys of outcomes; 2) Peer Support through social media plus AMMI (n=200) via private online discussion boards; 3) Coaching plus AMMI (n=200) to provide service linkages, eligibility support, appointment coordination and follow-up, communication with healthcare providers, and brief motivational and strengths-based counseling for linkage and retention to prevention, mental health, and substance abuse services; and, 4) Coaching plus Peer Support and AMMI (n=200).

Condition or disease Intervention/treatment Phase
HIV Mental Health Substance Use STI Behavioral: Automated Messaging & Monitoring Behavioral: Peer Support Behavioral: Coaching Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 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
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
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.
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.




Primary Outcome Measures :
  1. HIV Testing [ Time Frame: 24 months ]
    Self-reported # of times - lifetime, past 4 months (reported at four-month assessment points)

  2. STI Testing [ Time Frame: 24 months ]
    Self-reported # of times - lifetime, past 4 months (reported at four-month assessment points)

  3. 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)

  4. 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)

  5. 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)

  6. 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)


Secondary Outcome Measures :
  1. Mental Health Symptoms [ Time Frame: 24 months ]
    Self-reported symptoms of anxiety and depression (reported on weekly surveys, at four-month assessment points)

  2. 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)

  3. Housing Insecurity [ Time Frame: 24 months ]
    Self-reported housing insecurity (reported on weekly surveys, at four-month assessment points)



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Youth aged 12-24
  • HIV-negative status
  • Able to provide informed consent
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Dallas Swendeman, PhD, MPH (310) 794-8128 dswendeman@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Sung-Jae Lee, PhD    310-794-0357    sjlee@mednet.ucla.edu   
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Leslie Kozina, RN, CCRC    504-988-5348    lkozina@tulane.edu   
Sponsors and Collaborators
University of California, Los Angeles
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Tulane University Health Sciences Center
University of California, San Francisco
Friends Research Institute, Inc.
Investigators
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Principal Investigator: Dallas Swendeman, PhD, MPH University of California, Los Angeles

Additional Information:
Publications:
Lightfoot M, Rotheram-Borus MJ. Interventions for high-risk youth. In: Peterson JL, DiClemente RJ, editors. Handbook of HIV prevention AIDS prevention and mental health. Dordrecht, Netherlands: Kluwer Academic Publishers; 2000. p. 129-45.
Durso LE, Gates GJ. Serving our youth: Finding from a national survey of service providers working with lesbian, gay, bisexual and transgender youth who are homeless or at risk of becoming homeless. Los Angeles: The Williams Institute with True Colors Fund and The Palette Fund; 2012.
Swendeman D, Ramanathan N, Comulada WS, Rotheram-Borus MJ, Estrin D. Efficacy of Daily Self- Monitoring of Health Behaviors and Quality of Life by Mobile Phone: Mixed-Methods Results from Two Studies with Diverse Populations. Annals of Behavioral Medicine. 2014;47:S263-S.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dallas Swendeman, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03134833     History of Changes
Other Study ID Numbers: U19HD089886 - Study 3
U19HD089886 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dallas Swendeman, University of California, Los Angeles:
HIV
STI
Mental Health
Substance Use
Peer Support