Engaging Seronegative Youth to Optimize HIV Prevention Continuum
Status: | Recruiting |
---|---|
Conditions: | HIV / AIDS, Psychiatric, Psychiatric |
Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 12 - 24 |
Updated: | 2/14/2019 |
Start Date: | May 6, 2017 |
End Date: | September 2021 |
Contact: | Dallas Swendeman, PhD, MPH |
Email: | dswendeman@mednet.ucla.edu |
Phone: | (310) 794-8128 |
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).
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).
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.
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.
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
We found this trial at
2
sites
Los Angeles, California 90095
310-825-4321
Phone: 310-794-0357
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 588-5912
Phone: 504-988-5348
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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