The Stepped Care Intervention to Suppress Viral Load in Youth Living With HIV: Protocol for a Randomized Controlled Trial

Pediatric Research Initiative Comparative Effectiveness Research Pediatric AIDS Social Determinants of Health Clinical Trials and Supportive Activities Clinical Sciences 03 medical and health sciences 0302 clinical medicine Clinical Research Health Services and Systems Health Sciences Behavioral and Social Science sustained virologic responses Health services and systems Protocol Minority Health 360 Pediatric Adolescent Medicine Trials Network CARES Team Public health Prevention 3. Good health Health Disparities Mental Health Infectious Diseases Good Health and Well Being adolescent Public Health and Health Services Sexually Transmitted Infections HIV/AIDS Women's Health young adult Infection HIV seroposivity Adolescent Sexual Activity
DOI: 10.2196/10791 Publication Date: 2018-12-13T15:48:36Z
ABSTRACT
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 order reduce probability of infecting others as well increasing length and quality their own life.This randomized controlled trial aimed evaluate efficacy an Enhanced Standard Care condition (n=110) compared Stepped intervention increase among established infection (not acutely infected).YLH (N=220) not suppressed will be identified at homeless shelters, clinics, gay-identified community-based organizations Los Angeles, CA, New Orleans, LA. Informed consent obtained from all participants. randomly assigned one two study conditions: Care, which includes standard clinical plus automated messaging monitoring (AMMI), or three levels (AMMI, Peer Support via social media AMMI, Coaching AMMI). The primary outcome is HIV, assessed 4-month intervals for 24 months. For group, those do (via blood draw, load<200 copies/mL) any assessment "step up" next level intervention. Secondary outcomes retention care, antiretroviral therapy adherence, alcohol use, substance sexual behavior, mental symptoms.Recruitment this began June 2017 ongoing. We estimate data collection completed by end 2020.This first known application model YLH. By providing lowest needed suppression, has potential a cost-effective method helping improve life.ClinicalTrials.gov NCT03109431; https://clinicaltrials.gov/ct2/show/NCT03109431.DERR1-10.2196/10791.
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