Triggered Escalating Real-time Adherence (TERA) Intervention

NCT03292432 | Completed Results DMC

• 2 other identifiers: ATN 1525U24HD089880-02
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 8

Brief Summary

Youth Living with HIV (YLWH) often face unique challenges achieving high and sustained rates of adherence to their antiretroviral therapy (ART). Poor adherence can lead to unsuppressed virus, more advanced HIV disease and poorer health outcomes, eventually exhausting treatment options. To date however, there are few demonstrated interventions for youth failing first line therapy. This study evaluated a novel intervention that used remote coaching through video enabled counseling sessions, an Electronic Dose Monitoring (EDM) pill bottle that notified an adherence coach when youth failed to open/close the device around dose time, and problem solving outreach by the coach in response to not dosing from the EDM. This intensive 'boot camp' strategy was implemented for 12 weeks followed by observation through 48 weeks.

Conditions

HIV Infections

Keywords

Adherence, Medication

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Plasma Human Immunodeficiency Virus - Type I Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/mL at Week 12

  Participants with HIV-1 RNA \< 50 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA \>= 50 copies/mL or with no HIV-1 RNA measurement within the week 12 window are classified as failures.

  12 weeks post enrollment

• Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 12

  Participants with HIV-1 RNA \< 200 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA \>= 200 copies/mL or with no HIV-1 RNA measurement within the week 12 window are classified as failures.

  12 weeks post enrollment

Secondary Outcomes (6)

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24, 36 and 48

  24, 36 and 48 weeks post enrollment

• Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Weeks 24, 36 and 48

  24, 36 and 48 weeks post enrollment

• Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks

  48 weeks post enrollment

• Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48

  Enrollment through 48 weeks

• Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48

  Enrollment through 48 weeks

Other Outcomes (2)

• Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48

  48 weeks post enrollment

• Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks

  12, 24, 36, and 48 weeks post enrollment

Study Arms (2)

Standard of Care (SOC)

ACTIVE COMPARATOR

Standard of Care for adherence support at Site

Behavioral: Standard of Care (SOC)

TERA Intervention (TERA)

EXPERIMENTAL

Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks.

Behavioral: TERA Intervention (TERA)

Interventions

TERA Intervention (TERA) BEHAVIORAL

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).

TERA Intervention (TERA)

Standard of Care (SOC) BEHAVIORAL

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.

Standard of Care (SOC)

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Confirmation of HIV-1 Infection as documented in the participant's medical record by at least two of the following criteria:
• Reactive HIV screening test result with an HIV antibody or HIV antibody/antigen-based, Food and Drug Administration (FDA)-licensed assay followed by a positive supplemental assay (e.g., HIV-1 Western Blot, HIV-1 indirect immunofluorescence, HIV-1/HIV-2 discriminatory immunoassay);
• Plasma HIV-1 quantitative ribonucleic acid (RNA) assay \>1,000 copies/mL;
• Positive HIV-1 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay; or
• Positive plasma HIV-1 RNA qualitative assay
• Participant aware of his or her HIV infection, as determined by site staff
• Documented plasma HIV-1 RNA plasma ≥200 copies/mL within 45 days of the date of the enrollment visit
• Prescribed antiretroviral therapy for at least 24 weeks or more prior to documented plasma HIV-1 RNA plasma ≥200 copies/mL.
• Prescribed a once-daily (one or more pills once a day) ART regimen with at least two active agents (per clinician judgment or genotype evidence) at enrollment
• Able to communicate in spoken and written English
• Currently has a cellular phone that is also able to send and receive text messages
• Willing and able to provide at least one additional contact phone number (preferably two) to contact participant
• Able and willing to provide written informed assent/consent and able to obtain written parental or guardian permission (if required as specified by the site, by state law, and/or Institutional Review Board policy, and detailed in each site's Protocol Implementation Plans) to be screened for and to enroll in this study

You may not qualify if:

• Gross cognitive limitations, acute emotional instability, or medical or mental health illness that in the opinion of site personnel would impair the individual's ability to provide informed consent and/or interfere with the protocol's objectives
• Concurrent participation in interventional studies addressing adherence unless approved in advance by study team
• Positive pregnancy test at the time of enrollment. If participant becomes pregnant while on study, they may continue on study
• Currently using or planning to use an electronic dose monitoring and reminder device outside of the study

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Mental Health (NIMH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (8)

University of Colorado Denver Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Broward Health Childrens Diagnostic and Treatment Center (CDTC)

Fort Lauderdale, Florida, 33316, United States

Location

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

Jacksonville, Florida, 32209, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Wayne State University School of Medicine

Detroit, Michigan, 48201, United States

Location

Bronx-Lebanon Hospital Center

The Bronx, New York, 10457, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (3)

• Amico KR, Dunlap A, Dallas R, Lindsey J, Heckman B, Flynn P, Lee S, Horvath K, West Goolsby R, Hudgens M, Filipowicz T, Polier M, Hill E, Mueller Johnson M, Miller J, Neilan A, Ciaranello A, Gaur A. 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. JMIR Res Protoc. 2019 Mar 18;8(3):e11416. doi: 10.2196/11416.

  PMID: 30882360 BACKGROUND

• Lindsey JC, Hudgens M, Gaur AH, Horvath KJ, Dallas R, Heckman B, Mueller Johnson M, Amico KR. Electronic Dose Monitoring Device Patterns in Youth Living With HIV Enrolled in an Adherence Intervention Clinical Trial. J Acquir Immune Defic Syndr. 2023 Mar 1;92(3):231-241. doi: 10.1097/QAI.0000000000003126.

  PMID: 36730762 DERIVED

• Amico KR, Crawford J, Ubong I, Lindsey JC, Gaur AH, Horvath K, Goolsby R, Mueller Johnson M, Dallas R, Heckman B, Filipowicz T, Polier M, Rupp BM, Hudgens M. Correlates of High HIV Viral Load and Antiretroviral Therapy Adherence Among Viremic Youth in the United States Enrolled in an Adherence Improvement Intervention. AIDS Patient Care STDS. 2021 May;35(5):145-157. doi: 10.1089/apc.2021.0005.

  PMID: 33960843 DERIVED

MeSH Terms

Conditions

HIV Infections; Medication Adherence

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Accrual was closed before reaching the targeted enrollment of 120 participants. Study visits were paused on March 20, 2020 due to the outbreak of COVID-19, interrupting systematic collection of secondary outcome measures. Statistical comparisons between arms therefore had lower than anticipated power to detect differences. For EDM data, the time the device was opened can only be assumed to correspond with when the participant took their antiretroviral dose.

Results Point of Contact

• Title: Rachel Goolsby - Research Manager
• Organization: University of North Carolina at Chapel Hill

rwgoolsby@unc.edu

9198430685

Study Officials

• K. Rivet Amico, PhD

  University of Michigan School of Public Health

  PRINCIPAL INVESTIGATOR

• Michael Hudgens, PhD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

• Aditya H Gaur, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Phase II, two-arm, randomized, open-label study.

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: April 12, 2018
• Primary Completion: January 6, 2020
• Study Completion: October 12, 2020
• Last Updated: March 11, 2021
• Results First Posted: January 8, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)