HIVNCT03134833
Engaging Seronegative Youth to Optimize HIV Prevention Continuum
A study testing Automated Messaging & Monitoring, Peer Support and Coaching in people with HIV and Mental Health, run by University of California, Los Angeles at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Mental Health, Substance Use
- What is being tested?
- Automated Messaging & Monitoring, Peer Support and Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,478 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 May 2017to 30 Nov 2022
- 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 12 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Los Angeles
Los Angeles, California, 90024
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
About this study
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).
Read the detailed description
Despite dramatic improvements in the biomedical treatments for both preventing and treating HIV infection, American adolescents are increasingly likely to become infected, are not using ARV for prevention or treatment, and are not learning they are HIV seropositive when they have become infected. America's HIV epidemic among youth has more than doubled in the last 15 years and now represents 26% of the epidemic. These youth are not found in every community - geography is destiny in HIV prevention (www.AIDSVu.com). YLH are concentrated along I-95 on the East Coast, in Southern cities, and West Coast. Given the distribution of emerging infections, we have chosen two HIV epicenters, Los Angeles (LA) and New Orleans, to test a strategy to identify, link to care, and intervene to prevent HIV. Even in those two areas, adolescent HIV will not be found in every neighborhood. In LA, six neighborhoods account for 80% of HIV cases in the County - reflecting the concentration of HIV within neighborhoods and settings. In each epicenter, the youth at highest risk of infection will be gay, bisexual, and transgendered youth (GBTY), especially those who are Black and Latino. Homeless youth will also be at highest risk: the last HIV seroprevalence study showed a 5.3% rate among homeless youth. Youth who are incarcerated are at higher risk of being in risk setting and will be targeted for recruitment to this study. Having a sexual orientation as GBTY is highly stigmatizing and youth are developmentally challenged about who, when, how, and what to disclose their sexual orientation of HIV status to their families and their peers. Unfortunately 42% of GBTY's parents eject their children when children disclose being GBTY resulting in 40% of homeless youth being GBTY. Homeless GBTY had a seroprevalence of 24.8% in 1989.
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
- HIV, Mental Health, Substance Use, STI
- Being tested
- Automated Messaging & Monitoring, Peer Support, Coaching
- Keywords
- HIV, STI, Mental Health, Substance Use, Peer Support
- Medical subject headings
- Psychological Well-Being, Substance-Related Disorders, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Messaging & MonitoringBehavioural
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 SupportBehavioural
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.
CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Automated Messaging & Monitoring; Behavioral: Peer Support; Behavioral: Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Testing
Self-reported # of times - lifetime, past 4 months (reported at four-month assessment points)
Measured: 24 months
STI Testing
Self-reported # of times - lifetime, past 4 months (reported at four-month assessment points)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 24 months
Secondary outcomes (3)
Mental Health Symptoms
Self-reported symptoms of anxiety and depression (reported on weekly surveys, at four-month assessment points)
Measured: 24 months
Substance Use
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)
Measured: 24 months
Housing Insecurity
Self-reported housing insecurity (reported on weekly surveys, at four-month assessment points)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start6 May 2017
- Primary completion31 Oct 2021
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,478 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- 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.
- Responsible party
- Principal investigator, Dallas Swendeman, University of California, Los Angeles
- Investigators
- Dallas Swendeman, PhD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134833
- Sponsor's protocol ID
- U19HD089886 - Study 3
- Other IDs
- U19HD089886
- Status last verified
- Dec 2022
- First submitted
- 4 Apr 2017
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
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.
PubMed 2014885Swendeman 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.
PubMed 16846325Adolescent sexual orientation. Paediatr Child Health. 2008 Sep;13(7):619-30. doi: 10.1093/pch/13.7.619. No abstract available.
PubMed 19436504Rotheram-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.
PubMed 8553426D'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.
PubMed 11530306D'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.
PubMed 9686289Durso 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.
PubMed 24926026International 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.
PubMed 26527218Milburn 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.
PubMed 21494426Ringwalt 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.
PubMed 9657892Rosario 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.
PubMed 21656284Dowshen 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.
PubMed 22481246Rice 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.
PubMed 21094441
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Seronegative Youth to Optimize HIV Prevention Continuum
- ClinicalTrials.gov ID
- NCT03134833
- Acronym / sponsor ID
- U19HD089886 - Study 3
- Conditions
- HIV, Mental Health, Substance Use, STI
- Keywords
- HIV, STI, Mental Health, Substance Use, Peer Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,478 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- 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.
- Study start
- 6 May 2017 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 1 May 2017 (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.
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).
Detailed description
Despite dramatic improvements in the biomedical treatments for both preventing and treating HIV infection, American adolescents are increasingly likely to become infected, are not using ARV for prevention or treatment, and are not learning they are HIV seropositive when they have become infected. America's HIV epidemic among youth has more than doubled in the last 15 years and now represents 26% of the epidemic. These youth are not found in every community - geography is destiny in HIV prevention (www.AIDSVu.com). YLH are concentrated along I-95 on the East Coast, in Southern cities, and West Coast. Given the distribution of emerging infections, we have chosen two HIV epicenters, Los Angeles (LA) and New Orleans, to test a strategy to identify, link to care, and intervene to prevent HIV. Even in those two areas, adolescent HIV will not be found in every neighborhood. In LA, six neighborhoods account for 80% of HIV cases in the County - reflecting the concentration of HIV within neighborhoods and settings. In each epicenter, the youth at highest risk of infection will be gay, bisexual, and transgendered youth (GBTY), especially those who are Black and Latino. Homeless youth will also be at highest risk: the last HIV seroprevalence study showed a 5.3% rate among homeless youth. Youth who are incarcerated are at higher risk of being in risk setting and will be targeted for recruitment to this study. Having a sexual orientation as GBTY is highly stigmatizing and youth are developmentally challenged about who, when, how, and what to disclose their sexual orientation of HIV status to their families and their peers. Unfortunately 42% of GBTY's parents eject their children when children disclose being GBTY resulting in 40% of homeless youth being GBTY. Homeless GBTY had a seroprevalence of 24.8% in 1989.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Automated Messaging & Monitoring | Experimental | Behavioral: Automated Messaging & MonitoringYouth 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. |
| Peer Support | Experimental | Behavioral: Automated Messaging & Monitoring, Behavioral: Peer SupportYouth 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. |
| Coaching | Experimental | Behavioral: Automated Messaging & Monitoring, Behavioral: CoachingYouth 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. |
| Coaching + Peer Support | Experimental | Behavioral: Automated Messaging & Monitoring, Behavioral: Peer Support, Behavioral: CoachingYouth 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. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Youth aged 12-24
- HIV-negative status
- Able to provide informed consent
- At high-risk* of HIV
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Automated Messaging & MonitoringYouth 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. | Behavioural | Automated Messaging & Monitoring, Coaching, Coaching + Peer Support, Peer Support |
| Peer SupportYouth 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. | Behavioural | Coaching + Peer Support, Peer Support |
| CoachingYouth 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. | Behavioural | Coaching, Coaching + Peer Support |
Primary outcome
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)
3 secondary outcomes
Mental Health Symptoms
Time frame: 24 months
Substance Use
Time frame: 24 months
Housing Insecurity
Time frame: 24 months
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 5 Dec 2022.
- BackgroundLightfoot 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: PubMed 2014885Stricof 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.
- Background: PubMed 16846325Swendeman 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.
- Background: PubMed 19436504Adolescent sexual orientation. Paediatr Child Health. 2008 Sep;13(7):619-30. doi: 10.1093/pch/13.7.619. No abstract available.
- Background: PubMed 8553426Rotheram-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.
- Background: PubMed 11530306D'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.
- Background: PubMed 9686289D'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.
- BackgroundDurso 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: PubMed 24926026McNairy 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.
- Background: PubMed 26527218International 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.
- Background: PubMed 21494426Milburn 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.
- Background: PubMed 9657892Ringwalt 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.
- Annual HIV surveillance report. (2013). LADPH.Link provided by the sponsor.
- NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding 2015.Link provided by the sponsor.
- Teens, Social Media \& Technology Overview. (2015). Lenhart, A.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Dallas Swendeman, PhD, MPH principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Messaging & Monitoring, Peer Support and Coaching in people with HIV and Mental Health, run by University of California, Los Angeles at 2 sites 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 5 inclusion and 5 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 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
HIV Testing (time frame: 24 months). The study lists 6 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 NCT03134833, which also lists 27 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 5 Dec 2022.