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

Elizabeth Mayfield Arnold, Dallas Swendeman, Danielle Harris, Jasmine Fournier, Leslie Kozina, Susan Abdalian, Mary Jane Rotheram, Adolescent Medicine Trials Network CARES Team, M Isabel Fernandez, Jeffrey D Klausner, Sung-Jae Lee, Maryann Koussa, Manuel Ocasio, W Scott Comulada, Robert Weiss, Ronald Brookmeyer, Wenze Tang, Karin Nielsen-Saines, Yvonne Bryson, Tara Kerin, Chelsea Shannon, Ruth Cortado, Kate Mitchell, Norweeta Milburn, Cathy Reback, Marguerita Lightfoot, Elizabeth Mayfield Arnold, Dallas Swendeman, Danielle Harris, Jasmine Fournier, Leslie Kozina, Susan Abdalian, Mary Jane Rotheram, Adolescent Medicine Trials Network CARES Team, M Isabel Fernandez, Jeffrey D Klausner, Sung-Jae Lee, Maryann Koussa, Manuel Ocasio, W Scott Comulada, Robert Weiss, Ronald Brookmeyer, Wenze Tang, Karin Nielsen-Saines, Yvonne Bryson, Tara Kerin, Chelsea Shannon, Ruth Cortado, Kate Mitchell, Norweeta Milburn, Cathy Reback, Marguerita Lightfoot

Abstract

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.

Trial registration: ClinicalTrials.gov NCT03109431; https://ichgcp.net/clinical-trials-registry/NCT03109431.

International registered report identifier (irrid): DERR1-10.2196/10791.

Keywords: HIV seroposivity; adolescent; sustained virologic responses; young adult.

Conflict of interest statement

Conflicts of Interest: None declared.

©Elizabeth Mayfield Arnold, Dallas Swendeman, Danielle Harris, Jasmine Fournier, Leslie Kozina, Susan Abdalian, Mary Jane Rotheram, Adolescent Medicine Trials Network CARES Team. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 27.02.2019.

Figures

Figure 1
Figure 1
Design of ATN Protocol 148—randomized controlled trial for youth living with HIV (YLH). AMMI: automated messaging and monitoring intervention.

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