TY - JOUR
T1 - The stepped care intervention to suppress viral load in youth living with HIV
T2 - Protocol for a randomized controlled trial
AU - Adolescent Medicine Trials Network CARES Team
AU - Arnold, Elizabeth Mayfield
AU - Swendeman, Dallas
AU - Harris, Danielle
AU - Fournier, Jasmine
AU - Kozina, Leslie
AU - Abdalian, Susan
AU - Rotheram, Mary Jane
N1 - Funding Information:
The Comprehensive Adolescent Research and Engagement Studies (CARES) is a program project grant funded by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) at the National Institutes of Health (U19HD089886). The Eunice Kennedy National Institute of Child Health and Human Development (NICHD) is the primary funder of this network, with support of the National Institute of Mental Health (NIMH), National Institute of Drug Abuse (NIDA), and National Institute on Minority Health and Health Disparities (NIMHD).
Publisher Copyright:
© Elizabeth Mayfield Arnold, Dallas Swendeman, Danielle Harris, Jasmine Fournier, Leslie Kozina, Susan Abdalian, Mary Jane Rotheram, Adolescent Medicine Trials Network CARES Team.
PY - 2019/2
Y1 - 2019/2
N2 - Background: Among youth living with HIV (YLH) aged 12-24 years who have health care in the United States, only 30% to 40% are virally suppressed. YLH must achieve viral suppression in order to reduce the probability of infecting others as well as increasing the length and quality of their own life. Objective: This randomized controlled trial aimed to evaluate the efficacy of an Enhanced Standard Care condition (n=110) compared to an Enhanced Stepped Care intervention condition (n=110) to increase viral suppression among YLH aged 12-24 years with established infection (not acutely infected). Methods: YLH (N=220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community-based organizations in Los Angeles, CA, and New Orleans, LA. Informed consent will be obtained from all participants. YLH will be randomly assigned to one of two study conditions: Enhanced Standard Care, which includes standard clinical care plus an automated messaging and monitoring intervention (AMMI), or an Enhanced Stepped Care, which includes three levels of intervention (AMMI, Peer Support via social media plus AMMI, or Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at 4-month intervals for 24 months. For the Enhanced Stepped Care intervention group, those who do not achieve viral suppression (via blood draw, viral load<200 copies/mL) at any 4-month assessment will “step up” to the next level of intervention. Secondary outcomes will be retention in care, antiretroviral therapy adherence, alcohol use, substance use, sexual behavior, and mental health symptoms. Results: Recruitment for this study began in June 2017 and is ongoing. We estimate data collection to be completed by the end of 2020. Conclusions: This is the first known application of an Enhanced Stepped Care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost-effective method of helping YLH achieve viral suppression and improve their quality of life.
AB - Background: Among youth living with HIV (YLH) aged 12-24 years who have health care in the United States, only 30% to 40% are virally suppressed. YLH must achieve viral suppression in order to reduce the probability of infecting others as well as increasing the length and quality of their own life. Objective: This randomized controlled trial aimed to evaluate the efficacy of an Enhanced Standard Care condition (n=110) compared to an Enhanced Stepped Care intervention condition (n=110) to increase viral suppression among YLH aged 12-24 years with established infection (not acutely infected). Methods: YLH (N=220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community-based organizations in Los Angeles, CA, and New Orleans, LA. Informed consent will be obtained from all participants. YLH will be randomly assigned to one of two study conditions: Enhanced Standard Care, which includes standard clinical care plus an automated messaging and monitoring intervention (AMMI), or an Enhanced Stepped Care, which includes three levels of intervention (AMMI, Peer Support via social media plus AMMI, or Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at 4-month intervals for 24 months. For the Enhanced Stepped Care intervention group, those who do not achieve viral suppression (via blood draw, viral load<200 copies/mL) at any 4-month assessment will “step up” to the next level of intervention. Secondary outcomes will be retention in care, antiretroviral therapy adherence, alcohol use, substance use, sexual behavior, and mental health symptoms. Results: Recruitment for this study began in June 2017 and is ongoing. We estimate data collection to be completed by the end of 2020. Conclusions: This is the first known application of an Enhanced Stepped Care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost-effective method of helping YLH achieve viral suppression and improve their quality of life.
KW - Adolescent
KW - HIV seroposivity
KW - Sustained virologic responses
KW - Young adult
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UR - http://www.scopus.com/inward/citedby.url?scp=85066839600&partnerID=8YFLogxK
U2 - 10.2196/10791
DO - 10.2196/10791
M3 - Article
C2 - 30810536
AN - SCOPUS:85066839600
SN - 1929-0748
VL - 8
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 2
M1 - e10791
ER -