Engaging Seronegative Youth to Optimize HIV Prevention Continuum
NCT ID: NCT03134833
Last Updated: 2022-12-05
Study Results
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Basic Information
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COMPLETED
NA
1478 participants
INTERVENTIONAL
2017-05-06
2022-11-30
Brief Summary
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Detailed Description
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The sites that typically serve GBTY and High Risk Youth (HRY) (gay-identified CBO and homeless shelters) in HIV epicenters only provide HIV testing to about 10% of youth currently. To effectively stop HIV among youth, a more integrated strategy that tests for HIV and STIs repeatedly, links youth to care, and helps youth access all HIV prevention strategies, including Pre Exposure Prophylaxis (PrEP) and Post Exposure Prophylaxis (PEP), is needed. The proposed research will test such a strategy.
To eliminate HIV among youth, scalable, efficacious, and cost-effective strategies are needed to optimize the HIV Prevention Continuum of repeat testing, linkage to biomedical and behavioral prevention, and retention and adherence over time to PrEP, PEP, condom use and reduced number of partners. The HIV Prevention Continuum is a framework for guiding prevention efforts.
Advances in mobile and social media technologies have created opportunities to engage and intervene with large numbers of youth at relatively low costs, technologies that permeate their daily routines. This study will use two primary technology platforms: text-messaging and social media. Text-messaging, email, internet and social media use are nearly universal among youth, including homeless youth. Rates of mobile phone, smartphone, and internet usage increase with age, and nearly 90% of young adolescents (age 13-17) having a mobile phone. Texting is particularly important for adolescents; 90% of those with phones text, typically receiving and sending 30 texts each day. Similarly, over 90% of adolescents under age 18 go online daily, more than half several times a day, which is facilitated the three quarters with smartphones that are crossing the digital divide. African-American and Latino youth have higher rates of smartphone and internet use than White. All of these rates increase for adolescents 18 and over. Ownership, access, and use rates are similar for homeless youth, although with less frequency and some inconsistency. Much of this online activity is driven by social media, particularly via smartphones, with over 70% of adolescents under 18, for example, using Facebook and other applications (about half also use Instagram and Snapchat).
The interventions proposed in this study will use text-messaging and social media to engage "youth where they're at" in the digital environment as preferences and functions change. Importantly, mobile phones continue to receive text-messages even when data plans run out of credit to use apps' and mobile-web browsers or send text-messages. Therefore, the core component our technology strategy will be text-messaging in the Automated Messaging and Monitoring Intervention (AMMI) for all youth in the cohort. Social media will be used by Peer Supporters to engage and support their peers through online discussion boards while Coaches will engage through social media, text-messaging, and voice and video-chats (however most acceptable to individual youth), as well as in person contacts. Mobile and social media technology-based engagement, retention, prevention, and mobilization strategies are likely to be scalable. This study will test whether they are also efficacious and cost-effective.
Upon study launch in April 2017, decisions were made with the funder to provide three-site STI testing at baseline and every follow-up assessment. In December 2018, the funder changed priorities and reduced support for STI testing to rectal testing only at baseline, 12- and 24-month follow-up, unless the participant displays STI symptoms or requests testing at other follow-up assessments. The funder has also decided to terminate the intervention and follow-up assessments at 12 months, rather than 24 months, for youth who are at lower behavioral risk for HIV acquisition.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
24 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Tulane University Health Sciences Center
OTHER
University of California, San Francisco
OTHER
Friends Research Institute, Inc.
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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Dallas Swendeman
Associate Professor
Principal Investigators
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Dallas Swendeman, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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University of California, Los Angeles
Los Angeles, California, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Countries
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References
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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.
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.
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.
Adolescent sexual orientation. Paediatr Child Health. 2008 Sep;13(7):619-30. doi: 10.1093/pch/13.7.619. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
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.
Other Identifiers
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U19HD089886 - Study 3
Identifier Type: -
Identifier Source: org_study_id
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