PMID- 30882360 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20201001 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 8 IP - 3 DP - 2019 Mar 18 TI - 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. PG - e11416 LID - 10.2196/11416 [doi] LID - e11416 AB - 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. CI - (c)K Rivet Amico, Amanda Dunlap, Ronald Dallas, Jane Lindsey, Barbara Heckman, Patricia Flynn, Sonia Lee, Keith Horvath, Rachel West Goolsby, Michael Hudgens, Teresa Filipowicz, Melissa Polier, Emily Hill, Megan Mueller Johnson, Jessica Miller, Anne Neilan, Andrea Ciaranello, Aditya Gaur. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.03.2019. FAU - Amico, K Rivet AU - Amico KR AUID- ORCID: 0000-0002-4458-6934 AD - School of Public Health, Department of Health Behavior and Health Education, University of Michigan, Ann Arbor, MI, United States. FAU - Dunlap, Amanda AU - Dunlap A AUID- ORCID: 0000-0002-0887-2423 AD - School of Public Health, Department of Health Behavior and Health Education, University of Michigan, Ann Arbor, MI, United States. FAU - Dallas, Ronald AU - Dallas R AUID- ORCID: 0000-0002-3259-6801 AD - St. Jude Children's Research Hospital, Department of Infectious Diseases, Memphis, TN, United States. FAU - Lindsey, Jane AU - Lindsey J AUID- ORCID: 0000-0002-5939-3924 AD - Chan School of Public Health, Department of Biostatistics, Harvard University, Boston, MA, United States. FAU - Heckman, Barbara AU - Heckman B AUID- ORCID: 0000-0002-2289-7387 AD - Frontier Science and Technology Research Foundation, Amherst, NY, United States. FAU - Flynn, Patricia AU - Flynn P AUID- ORCID: 0000-0003-4918-6881 AD - St. Jude Children's Research Hospital, Department of Infectious Diseases, Memphis, TN, United States. FAU - Lee, Sonia AU - Lee S AUID- ORCID: 0000-0003-1024-3834 AD - National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States. FAU - Horvath, Keith AU - Horvath K AUID- ORCID: 0000-0003-1372-7244 AD - School of Public Health, Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, United States. FAU - West Goolsby, Rachel AU - West Goolsby R AUID- ORCID: 0000-0001-9744-967X AD - Gillings School of Public Health, Department of Biostatistics, Collaborative Studies Coordinating Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States. FAU - Hudgens, Michael AU - Hudgens M AUID- ORCID: 0000-0002-9106-4194 AD - Gillings School of Public Health, Department of Biostatistics, Collaborative Studies Coordinating Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States. FAU - Filipowicz, Teresa AU - Filipowicz T AUID- ORCID: 0000-0001-5934-3217 AD - Gillings School of Public Health, Department of Biostatistics, Collaborative Studies Coordinating Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States. FAU - Polier, Melissa AU - Polier M AUID- ORCID: 0000-0001-8975-1123 AD - Gillings School of Public Health, Department of Biostatistics, Collaborative Studies Coordinating Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States. FAU - Hill, Emily AU - Hill E AUID- ORCID: 0000-0002-3555-9213 AD - School of Public Health, Department of Health Behavior and Health Education, University of Michigan, Ann Arbor, MI, United States. FAU - Mueller Johnson, Megan AU - Mueller Johnson M AUID- ORCID: 0000-0003-4943-1015 AD - School of Public Health, Department of Health Behavior and Health Education, University of Michigan, Ann Arbor, MI, United States. FAU - Miller, Jessica AU - Miller J AUID- ORCID: 0000-0002-5113-9227 AD - School of Public Health, Department of Health Behavior and Health Education, University of Michigan, Ann Arbor, MI, United States. FAU - Neilan, Anne AU - Neilan A AUID- ORCID: 0000-0001-7915-4974 AD - Massachusetts General Hospital, Division of Infectious Diseases, Boston, MA, United States. FAU - Ciaranello, Andrea AU - Ciaranello A AUID- ORCID: 0000-0002-4268-3263 AD - Massachusetts General Hospital, Division of Infectious Diseases, Boston, MA, United States. FAU - Gaur, Aditya AU - Gaur A AUID- ORCID: 0000-0002-6639-5231 AD - St. Jude Children's Research Hospital, Department of Infectious Diseases, Memphis, TN, United States. LA - eng SI - ClinicalTrials.gov/NCT03292432 GR - P30 AI050410/AI/NIAID NIH HHS/United States GR - U24 HD089880/HD/NICHD NIH HHS/United States GR - UM1 AI069536/AI/NIAID NIH HHS/United States PT - Journal Article DEP - 20190318 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC6441855 OTO - NOTNLM OT - HIV OT - adolescents OT - medication adherence OT - telemedicine COIS- Conflicts of Interest: None declared. EDAT- 2019/03/19 06:00 MHDA- 2019/03/19 06:01 PMCR- 2019/03/18 CRDT- 2019/03/19 06:00 PHST- 2018/06/27 00:00 [received] PHST- 2019/01/23 00:00 [accepted] PHST- 2018/11/05 00:00 [revised] PHST- 2019/03/19 06:00 [entrez] PHST- 2019/03/19 06:00 [pubmed] PHST- 2019/03/19 06:01 [medline] PHST- 2019/03/18 00:00 [pmc-release] AID - v8i3e11416 [pii] AID - 10.2196/11416 [doi] PST - epublish SO - JMIR Res Protoc. 2019 Mar 18;8(3):e11416. doi: 10.2196/11416.