Engaging Seronegative Youth to Optimize HIV Prevention Continuum

NCT03134833 | Completed DMC

• 2 other identifiers: U19HD089886 - Study 3U19HD089886
• Study Type: interventional
• Target: 1,478
• Locations: 1 country
• Sites: 2

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).

Conditions

HIV; Mental Health; Substance Use; STI

Keywords

HIV; STI; Mental Health; Substance Use; Peer Support

Outcome Measures

Primary Outcomes (6)

• HIV Testing

  Self-reported # of times - lifetime, past 4 months (reported at four-month assessment points)

  24 months

• STI Testing

  Self-reported # of times - lifetime, past 4 months (reported at four-month assessment points)

  24 months

• Condom Use Frequency

  Self-reported condomless sex - lifetime, past four months - using Likert-type scale (reported on weekly surveys, at four-month assessment points)

  24 months

• PEP Use / Adherence

  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)

  24 months

• PrEP Use / Adherence

  Self-reported current use, lifetime use, adherence; using Likert-type scale (all reported at four-month assessment points, adherence also reported on weekly surveys)

  24 months

• Sexual Partners

  Self-reported # of sexual partners, # of female/male/transgender sexual partners - lifetime, past 4 months (reported at four-month assessment points)

  24 months

Secondary Outcomes (3)

• Mental Health Symptoms

  24 months

• Substance Use

  24 months

• Housing Insecurity

  24 months

Study Arms (4)

Automated Messaging & Monitoring

EXPERIMENTAL

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

Peer Support

EXPERIMENTAL

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; Behavioral: Peer Support

Coaching

EXPERIMENTAL

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; Behavioral: Coaching

Coaching + Peer Support

EXPERIMENTAL

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; Behavioral: Peer Support; Behavioral: Coaching

Interventions

Automated Messaging & Monitoring BEHAVIORAL

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.

Automated Messaging & Monitoring; Coaching; Coaching + Peer Support; Peer Support

Peer Support BEHAVIORAL

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.

Coaching + Peer Support; Peer Support

Coaching BEHAVIORAL

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.

Coaching; Coaching + Peer Support

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Tulane University Health Sciences Center: collaborator
• University of California, San Francisco: collaborator
• Friends Research Institute, Inc.: collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (26)

• 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.

  BACKGROUND

• Stricof RL, Kennedy JT, Nattell TC, Weisfuse IB, Novick LF. HIV seroprevalence in a facility for runaway and homeless adolescents. Am J Public Health. 1991 May;81 Suppl(Suppl):50-3. doi: 10.2105/ajph.81.suppl.50.

  PMID: 2014885 BACKGROUND

• Swendeman D, Rotheram-Borus MJ, Comulada S, Weiss R, Ramos ME. Predictors of HIV-related stigma among young people living with HIV. Health Psychol. 2006 Jul;25(4):501-9. doi: 10.1037/0278-6133.25.4.501.

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• Adolescent sexual orientation. Paediatr Child Health. 2008 Sep;13(7):619-30. doi: 10.1093/pch/13.7.619. No abstract available.

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• Rotheram-Borus MJ, Fernandez MI. Sexual orientation and developmental challenges experienced by gay and lesbian youths. Suicide Life Threat Behav. 1995;25 Suppl:26-34; discussion 35-9.

  PMID: 8553426 BACKGROUND

• D'Angelo LJ, Abdalian SE, Sarr M, Hoffman N, Belzer M; Adolescent Medicine HIV/AIDS Research Network. Disclosure of serostatus by HIV infected youth: the experience of the REACH study. Reaching for Excellence in Adolescent Care and Health. J Adolesc Health. 2001 Sep;29(3 Suppl):72-9. doi: 10.1016/s1054-139x(01)00285-3.

  PMID: 11530306 BACKGROUND

• D'Augelli AR, Hershberger SL, Pilkington NW. Lesbian, gay, and bisexual youth and their families: disclosure of sexual orientation and its consequences. Am J Orthopsychiatry. 1998 Jul;68(3):361-71; discussion 372-5. doi: 10.1037/h0080345.

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• 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.

  BACKGROUND

• McNairy ML, El-Sadr WM. A paradigm shift: focus on the HIV prevention continuum. Clin Infect Dis. 2014 Jul;59 Suppl 1(Suppl 1):S12-5. doi: 10.1093/cid/ciu251.

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• International Advisory Panel on HIV Care Continuum Optimization. IAPAC Guidelines for Optimizing the HIV Care Continuum for Adults and Adolescents. J Int Assoc Provid AIDS Care. 2015 Nov-Dec;14 Suppl 1:S3-S34. doi: 10.1177/2325957415613442. Epub 2015 Nov 2.

  PMID: 26527218 BACKGROUND

• Milburn NG, Liang LJ, Lee SJ, Rotheram-Borus MJ. Trajectories of risk behaviors and exiting homelessness among newly homeless adolescents. Vulnerable Child Youth Stud. 2009 Jan 1;4(4):346-352. doi: 10.1080/17450120902884068.

  PMID: 21494426 BACKGROUND

• Ringwalt CL, Greene JM, Robertson MJ. Familial backgrounds and risk behaviors of youth with thrownaway experiences. J Adolesc. 1998 Jun;21(3):241-52. doi: 10.1006/jado.1998.0150.

  PMID: 9657892 BACKGROUND

• Rosario M, Schrimshaw EW, Hunter J. Homelessness among lesbian, gay, and bisexual youth: implications for subsequent internalizing and externalizing symptoms. J Youth Adolesc. 2012 May;41(5):544-60. doi: 10.1007/s10964-011-9681-3. Epub 2011 Jun 7.

  PMID: 21656284 BACKGROUND

• Dowshen N, Kuhns LM, Johnson A, Holoyda BJ, Garofalo R. Improving adherence to antiretroviral therapy for youth living with HIV/AIDS: a pilot study using personalized, interactive, daily text message reminders. J Med Internet Res. 2012 Apr 5;14(2):e51. doi: 10.2196/jmir.2015.

  PMID: 22481246 BACKGROUND

• Rice E, Monro W, Barman-Adhikari A, Young SD. Internet use, social networking, and HIV/AIDS risk for homeless adolescents. J Adolesc Health. 2010 Dec;47(6):610-3. doi: 10.1016/j.jadohealth.2010.04.016. Epub 2010 Jun 23.

  PMID: 21094441 BACKGROUND

• Rice E, Barman-Adhikari A. Internet and Social Media Use as a Resource Among Homeless Youth. J Comput Mediat Commun. 2014 Jan 1;19(2):232-247. doi: 10.1111/jcc4.12038.

  PMID: 25328374 BACKGROUND

• Rotheram-Borus MJ, Tomlinson M, Gwegwe M, Comulada WS, Kaufman N, Keim M. Diabetes buddies: peer support through a mobile phone buddy system. Diabetes Educ. 2012 May-Jun;38(3):357-65. doi: 10.1177/0145721712444617. Epub 2012 Apr 30.

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• Swendeman D, Ramanathan N, Baetscher L, Medich M, Scheffler A, Comulada WS, Estrin D. Smartphone self-monitoring to support self-management among people living with HIV: perceived benefits and theory of change from a mixed-methods randomized pilot study. J Acquir Immune Defic Syndr. 2015 May 1;69 Suppl 1(0 1):S80-91. doi: 10.1097/QAI.0000000000000570.

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• 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.

  BACKGROUND

• Swendeman D, Rotheram-Borus MJ. Innovation in sexually transmitted disease and HIV prevention: internet and mobile phone delivery vehicles for global diffusion. Curr Opin Psychiatry. 2010 Mar;23(2):139-44. doi: 10.1097/YCO.0b013e328336656a.

  PMID: 20087189 BACKGROUND

• Tomlinson M, Rotheram-Borus MJ, Doherty T, Swendeman D, Tsai AC, Ijumba P, le Roux I, Jackson D, Stewart J, Friedman A, Colvin M, Chopra M. Value of a mobile information system to improve quality of care by community health workers. S Afr J Inf Manag. 2013;15(1):10.4102/sajim.v15i1.528. doi: 10.4102/sajim.v15i1.528.

  PMID: 25147730 BACKGROUND

• Ma AM, Lewis KA, Wani M, Liu C, Ghalambor S, Yuva Raju R, Wong C, Swendeman D; ATN CARES Study Team; Abdalian SE, Arnold E, Bolan R, Bryson Y, Chaplin A, Comulada WS, Cortado R, Donahue C, Fernandez MI, Flynn R, Fournier J, Gertsch W, Ishimoto K, Jimenez S, Kerin T, Klausner J, Kussin J, Lee SJ, Lightfoot M, Milburn N, Mosafer J, Moses A, Murphy DA, Nielsen K, Ocasio MA, Polanco D, Ramos W, Reback CJ, Rezvan PH, Rotheram-Borus MJ, Tang W, Tapia Y, Thomas D, Urauchi S. Online Peer Support for Youth at Higher Risk of or Living with HIV: A Qualitative Content Analysis. AIDS Behav. 2025 Jul;29(7):2135-2143. doi: 10.1007/s10461-025-04677-z. Epub 2025 Mar 16.

  PMID: 40089955 DERIVED

• Swendeman D, Rotheram-Borus MJ, Arnold EM, Fernandez MI, Comulada WS, Lee SJ, Ocasio MA, Ishimoto K, Gertsch W, Duan N, Reback CJ, Murphy DA, Lewis KA; Adolescent HIV Medicine Trials Network (ATN) CARES Study Team. Optimal strategies to improve uptake of and adherence to HIV prevention among young people at risk for HIV acquisition in the USA (ATN 149): a randomised, controlled, factorial trial. Lancet Digit Health. 2024 Mar;6(3):e187-e200. doi: 10.1016/S2589-7500(23)00252-2.

  PMID: 38395539 DERIVED

• Man OM, Ramos WE, Vavala G, Goldbeck C, Ocasio MA, Fournier J, Romero-Espinoza A, Fernandez MI, Swendeman D, Lee SJ, Comulada S, Rotheram-Borus MJ, Klausner JD. Optimizing Screening for Anorectal, Pharyngeal, and Urogenital Chlamydia trachomatis and Neisseria gonorrhoeae Infections in At-Risk Adolescents and Young Adults in New Orleans, Louisiana and Los Angeles, California, United States. Clin Infect Dis. 2021 Nov 2;73(9):e3201-e3209. doi: 10.1093/cid/ciaa1838.

  PMID: 33300564 DERIVED

• Swendeman D, Arnold EM, Harris D, Fournier J, Comulada WS, Reback C, Koussa M, Ocasio M, Lee SJ, Kozina L, Fernandez MI, Rotheram MJ; Adolescent Medicine Trials Network (ATN) CARES Team. Text-Messaging, Online Peer Support Group, and Coaching Strategies to Optimize the HIV Prevention Continuum for Youth: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Aug 9;8(8):e11165. doi: 10.2196/11165.

  PMID: 31400109 DERIVED

• Shannon CL, Koussa M, Lee SJ, Fournier J, Abdalian SE, Rotheram MJ, Klausner JD; Adolescent Medicine Trials Network CARES Team. Community-Based, Point-of-Care Sexually Transmitted Infection Screening Among High-Risk Adolescents in Los Angeles and New Orleans: Protocol for a Mixed-Methods Study. JMIR Res Protoc. 2019 Mar 22;8(3):e10795. doi: 10.2196/10795.

  PMID: 30900994 DERIVED

Related Links

• Annual HIV surveillance report. (2013). LADPH.
• NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding 2015.
• Teens, Social Media \& Technology Overview. (2015). Lenhart, A.

MeSH Terms

Conditions

Psychological Well-Being; Substance-Related Disorders; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Chemically-Induced Disorders; Mental Disorders; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dallas Swendeman, PhD, MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: May 1, 2017
• Study Start: May 6, 2017
• Primary Completion: October 31, 2021
• Study Completion: November 30, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)