Triggered Escalating Real-time Adherence (TERA) Intervention

NACompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

April 12, 2018

Primary Completion Date

January 6, 2020

Study Completion Date

October 12, 2020

Conditions
HIV Infections
Interventions
BEHAVIORAL

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)."

BEHAVIORAL

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.

Trial Locations (8)

10457

Bronx-Lebanon Hospital Center, The Bronx

21287

Johns Hopkins University, Baltimore

30322

Emory University School of Medicine, Atlanta

32209

University of Florida Center for HIV/AIDS, Research, Education & Service, Jacksonville

33316

Broward Health Childrens Diagnostic and Treatment Center (CDTC), Fort Lauderdale

38105

St. Jude Children's Research Hospital, Memphis

48201

Wayne State University School of Medicine, Detroit

80045

University of Colorado Denver Children's Hospital Colorado, Aurora

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

lead

University of North Carolina, Chapel Hill

OTHER

NCT03292432 - Triggered Escalating Real-time Adherence (TERA) Intervention | Biotech Hunter | Biotech Hunter