Dataset Information

Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention.

ABSTRACT: 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 has not 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. TRIAL REGISTRATION:ClinicalTrials.gov NCT03292432; https://clinicaltrials.gov/ct2/show/NCT03292432 (Archived by WebCite at http://www.webcitation.org/768J8ijjp). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11416.

SUBMITTER: Amico KR

PROVIDER: S-EPMC6441855 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention.

Amico K Rivet KR Dunlap Amanda A Dallas Ronald R Lindsey Jane J Heckman Barbara B Flynn Patricia P Lee Sonia S Horvath Keith K West Goolsby Rachel R Hudgens Michael M Filipowicz Teresa T Polier Melissa M Hill Emily E Mueller Johnson Megan M Miller Jessica J Neilan Anne A Ciaranello Andrea A Gaur Aditya A

JMIR research protocols 20190318 3

<h4>Background</h4>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.<h4>Objective</h4>The aim of this study is to evaluate th ...[more]

PMID: 30882360

Similar Datasets

Project description:BACKGROUND:HIV infection among youth in the United States is on the rise. A high level of antiretroviral therapy (ART) adherence is crucial to treatment success and can minimize the population burden of the disease. However, the overall rate of ART adherence among youth is generally suboptimal and no published efficacious interventions exist to address the specific needs of this population. This paper describes the design of a stepped-care, "adaptive" ART adherence intervention protocol for HIV-infected adolescents and young adults. METHODS:This is a randomized controlled trial (RCT) to establish the efficacy of "Positive STEPS," a behavioral and technology-based intervention to optimize ART adherence and viral suppression among HIV-infected youth, ages 16 to 29. Participants are equally randomized to 1) the Positive STEPS intervention, which begins with two-way daily text messaging as a reminder system to take their medications; participants progress to a more intensive in-person counseling intervention if text messaging is not sufficient to overcome barriers; or 2) or standard of care (SOC). At randomization, all participants receive standardized ART adherence education. During the 4 major study assessment visits (baseline, 4-, 8-, and 12-months), participants have their blood drawn to measure HIV viral load and complete a mix of computer-based self-administered and interviewer-administered behavioral and psychosocial measures. The primary outcomes are improvements in viral load and ART adherence measured via a medication-tracking device (i.e., Wisepill) and self-report. DISCUSSION:Behavioral interventions are greatly needed to improve ART adherence among HIV-infected adolescents and young adults and prevent onward transmission. If effective, the intervention tested here will be one of the first rigorously-designed efficacy trials to promote ART adherence in this population, using an approach that holds promise for being readily integrated into real-world clinical settings. TRIAL REGISTRATION:ClinicalTrials.gov number NCT03092531 , registered March 28, 2017.

Project description:IntroductionRecent changes in antiretroviral therapies (ARTs) may have affected medication adherence of people living with human immunodeficiency virus-1 (HIV-1). In this study adherence to ART regimens among patients with HIV-1 (PWH) across the US during a recent time period was examined and study findings were stratified by US region and state.MethodsA retrospective observational study using the Symphony Health Solution Integrated Dataverse database was conducted. Patients ≥ 18 years of age who had a diagnosis of HIV-1 (without an HIV-2 diagnosis) and who were treated with ART between July 2017 and September 2018 (first pharmacy record: index date) were selected from the data source. Both patients who had not been previously treated with ART and those who were treatment experienced were included. Patients were required to have ≥ 1 medical/pharmacy record ≥ 12 months after their index date (follow-up period). Patient characteristics were examined during a 12-month pre-index period. During the follow-up, medication adherence, measured as the proportion of days covered (PDC), was examined for all patients and stratified by US region and state.ResultsAmong 206,474 adult PWH treated with ART, mean age was 47.9 years, 73.4% were male, and 30.0% were Caucasian. The most prevalent comorbid conditions were hyperlipidemia (25.1%), depressive disorders (14.8%), and type 2 diabetes (12.1%). During the follow-up period, mean (standard deviation) PDC was 74.1% (25.9%) among PWH across the US [Midwest: 74.4% (25.5%); Northeast: 74.3% (26.1%); South: 73.2% (26.3%); West: 76.4% (24.8%)]. Across all US regions, > 60% of PWH had adherence < 90% and > 40% had adherence < 80%; the West had the highest adherent population.ConclusionsAmong PWH treated with ART across the US, a majority had suboptimal adherence. Implementation of strategies to improve ART adherence, including clinical consideration of ARTs with high genetic barriers to resistance, is needed in the US.

Dataset Information

Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention.

Publications

Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets