89
Participants
Start Date
April 12, 2018
Primary Completion Date
January 6, 2020
Study Completion Date
October 12, 2020
TERA Intervention (TERA)
"A sequence of adherence support strategies implemented at care visits and as needed on the basis of EDM data. Components include: (1) remote education/preparation with an adherence coach conducted with VSee software (video conferencing) at site at baseline, week 4 and week 12; (2) one-way text alert at dose time when bottle has not yet been opened for that dosing window (users can disable this on request); (3) missed dose two-way outreach text asking What's the plan? which gets sent to both the participant's phone and a study phone; and (4) implementation of the coach-outreach (phone, text, remote counseling) triggered by missed doses or as a check-in to inquire about the well-being of the youth (once per week when no other contact with coach occurred the week prior)."
Standard of Care (SOC)
Cell-phone reminders, patient-education, adherence planning (medication management), and checking-in on adherence at clinical care visits, as well as Viral load (VL) monitoring with patient feedback on VL, are used at sites. Less common, but available as a general service at some sites, on several websites, and at many pharmacies, youth may also receive text messages at dose times, for appointment reminders, and for refill reminders.
Bronx-Lebanon Hospital Center, The Bronx
Johns Hopkins University, Baltimore
Emory University School of Medicine, Atlanta
University of Florida Center for HIV/AIDS, Research, Education & Service, Jacksonville
Broward Health Childrens Diagnostic and Treatment Center (CDTC), Fort Lauderdale
St. Jude Children's Research Hospital, Memphis
Wayne State University School of Medicine, Detroit
University of Colorado Denver Children's Hospital Colorado, Aurora
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Mental Health (NIMH)
NIH
National Institute on Drug Abuse (NIDA)
NIH
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of North Carolina, Chapel Hill
OTHER