Background: Youth living with HIV (YLWH) are confronted with many self-care challenges that can be experienced as overwhelming in the context of normal developmental processes that characterize adolescence and young adulthood. A sizable minority of YLWH have unsuppressed viral loads in the United States attributable to antiretroviral therapy (ART) nonadherence. Interventions to promote sustained viral suppression in YLWH are needed. Objective: The aim of this study is to evaluate the efficacy of the Triggered Escalating Real-Time Adherence (TERA) intervention in comparison with standard of care (SOC) in YLWH (aged 13-24 years) failing ART on (1) primary outcome measures-HIV viral suppression (VLS), defined as both <200 copies/ml and <50 copies/ml at 12 weeks, and (2) secondary outcome measures-VLS rates and rates of ART adherence at 24, 36, and 48 weeks as well as patterns of adherence over time as measured by an electronic dose monitoring (EDM) device. Methods: The TERA study is a phase 2, multisite clinical trial conducted with 120 YLWH failing ART (randomized 1:1 to TERA or SOC) at participating clinical sites within the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Participants are followed for a total of 48 weeks. For TERA arm participants, the first 12 weeks involve delivery of the intervention. For all participants, clinical outcomes are collected throughout follow-up, and adherence is assessed using EDM over the full 48 weeks. During the 12-week intervention period, TERA arm participants receive 3 remote coaching sessions delivered in clinic via videoconferencing timed to coincide with baseline and follow-up clinical visits, text message reminders when the EDM hasnot been opened at dose time (which escalate to 2-way theory-informed short message service coaching interactions in response to real-time nonadherence), and review of dosing graphs produced by EDM at follow-up visits. Results: Launch dates for enrollment varied by site. Enrollment began in April 2018 and is expected to be completed by August 2019, with results presented by the second quarter of 2021. Conclusions: Effective, generalizable, and scalable approaches to rapidly assist YLWH failing to achieve and sustain VLS may have a substantial impact on individual health and efforts to curb transmission. Coaching for a brief but intensive period from remote coaches and using communication channels common to youth may offer multiple unique advantages in promoting self-care.
Bibliographical noteFunding Information:
This study is supported by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) from the National Institutes of Health (5U24HD089880-02) through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD; B Kapogiannis and S Lee), National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Mental Health (NIMH), and National Institute on Drug Abuse (NIDA). Network operations are supported through the ATN Coordinating Center (University of North Carolina at Chapel Hill), and data management support is provided by Frontier Science and Technology Research Foundation (FSTRF: Marlene Cooper), and support for statistical analyses is provided by the Clinical Trials Statistical Data Analyses Center (SDAC: David Shapiro). The authors acknowledge the contribution of the investigators and staff at all participating research sites and the virtual youth advisory board. The content in this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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- Medication adherence