Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 27, 2018
Open Peer Review Period: Jun 30, 2018 - Jul 14, 2018
Date Accepted: Jan 23, 2019
(closed for review but you can still tweet)
Triggered Escalating Real-time Adherence Intervention to Promote Rapid HIV Viral Suppression among Youth Living with HIV Failing Antiretroviral Therapy: The TERA Study
ABSTRACT
Background:
Youth living with HIV (YLWH) are confronted with a number of self-care challenges that can be experienced as overwhelming in the context of the normal developmental processes that characterize adolescence and young adulthood. Challenges to antiretroviral therapy (ART) adherence create a sizable minority of YLWH with unsuppressed viral load in the United States (US). Interventions to promote sustained viral suppression in YLWH are needed.
Objective:
To evaluate the efficacy of a tailored, remote coaching intervention utilizing electronic dose monitoring for unsuppressed YLWH.
Methods:
The Triggered Escalating Real-Time Adherence (TERA) support project is a phase 2, multi-site clinical trial of an intensive 12-week remote coaching intervention conducted with 120 viremic youth (randomized 1:1 to intervention or standard of care) receiving care at a participating clinical care site within the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). All participants are followed for a total of 48 weeks, divided for those in the intervention condition into active intervention (first 12-weeks) and observation (remaining 36-weeks). Clinical outcomes are collected throughout the project, and adherence is assessed using Electronic Dose Monitoring (EDM) for all participants over the full 48-weeks. During the 12-week intervention period, intervention arm participants will receive: 3 remote coaching sessions delivered in-clinic via video-counseling and theory-informed coaching outreach through short message service (SMS) text messages or phone tailored to dosing and non-dosing as indicated by the EDM device. The primary outcome is viral suppression at 12-weeks, with secondary outcomes focused on more distal time points and more liberal cut-off for suppression. Other outcomes include patterns of adherence, psychosocial factors and extracted themes from interviews with participants, as well as costing data for implementation.
Results:
Enrollment is expected to be completed by April 2019 and results presented by last quarter of 2020.
Conclusions:
Effective, generalizable, scalable approaches to rapidly assist YLWH failing treatment to reach viral suppression can have a substantial impact on individual health and efforts to curb transmission. Coaching for a brief but intensive period from remote counselors trained and experienced in working with youth using communication channels common to youth may offer multiple unique advantages in promoting self-care. Clinical Trial: NCT03292432 Clinicaltrials.gov
Citation
Per the author's request the PDF is not available.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.