Engaging Seronegative Youth to Optimize HIV Prevention Continuum

HIV Clinical Trial

Official title:

Engaging Seronegative Youth to Optimize HIV Prevention Continuum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134833
• Other study ID #: U19HD089886 - Study 3
• Secondary ID: U19HD089886
• Status: Completed
• Phase: N/A
• Start date: May 6, 2017
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1478
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Mental Health
• STI
• Substance Use
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California
United States	Tulane University Health Sciences Center	New Orleans	Louisiana

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

References & Publications (21)

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

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Testing	Self-reported # of times - lifetime, past 4 months (reported at four-month assessment points)	24 months
Primary	STI Testing	Self-reported # of times - lifetime, past 4 months (reported at four-month assessment points)	24 months
Primary	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
Primary	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
Primary	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
Primary	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	Mental Health Symptoms	Self-reported symptoms of anxiety and depression (reported on weekly surveys, at four-month assessment points)	24 months
Secondary	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)	24 months
Secondary	Housing Insecurity	Self-reported housing insecurity (reported on weekly surveys, at four-month assessment points)	24 months

External Links

•   Annual HIV surveillance report. (2013). LADPH.
•   HIV/AIDS among youth. (2011). CDC.
•   NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding 2015.
•   Teens, Social Media & Technology Overview. (2015). Lenhart, A.
•   The Status of HIV Prevention in the United States. (2015). CDC.