Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Triggered Escalating Real-time Adherence (TERA) Intervention (TERA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03292432
Recruitment Status : Completed
First Posted : September 25, 2017
Results First Posted : January 8, 2021
Last Update Posted : March 11, 2021
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
National Institute on Drug Abuse (NIDA)
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: TERA Intervention (TERA) Behavioral: Standard of Care (SOC) Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Phase II, two-arm, randomized, open-label study.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Triggered Escalating Real-time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: The TERA Study
Actual Study Start Date : April 12, 2018
Actual Primary Completion Date : January 6, 2020
Actual Study Completion Date : October 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Standard of Care (SOC)
Standard of Care for adherence support at Site
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.

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




Primary Outcome Measures :
  1. Percentage of Participants With Plasma Human Immunodeficiency Virus - Type I Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/mL at Week 12 [ Time Frame: 12 weeks post enrollment ]
    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.

  2. Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 12 [ Time Frame: 12 weeks post enrollment ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24, 36 and 48 [ Time Frame: 24, 36 and 48 weeks post enrollment ]
    Participants with HIV-1 RNA < 50 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA >= 50 copies/mL or who had the opportunity to reach the study visit week and with no HIV-1 RNA measurement within the week window are classified as failures.

  2. Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Weeks 24, 36 and 48 [ Time Frame: 24, 36 and 48 weeks post enrollment ]
    Participants with HIV-1 RNA < 200 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA >= 200 copies/mL or who had the opportunity to reach the study visit week and with no HIV-1 RNA measurement within the week window are classified as failures.

  3. Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks [ Time Frame: 48 weeks post enrollment ]
    Participants are classified as successes if both the week 12 (+/- 14 days) and week 48 (+/- 28 days) HIV-1 RNA measurements are < 200 copies/mL and at least one of the week 24 (+/- 28 days) or week 36 (+/- 28 days) HIV-1 RNA measurements is < 200 copies/mL. Otherwise, the participant is classified as a failure.

  4. Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48 [ Time Frame: Enrollment through 48 weeks ]
    For each participant and each 12-week period, the percentage is calculated as the number of days with dose taken divided by the number of days with data reported in the Electronic Monitoring Device (EDM).

  5. Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48 [ Time Frame: Enrollment through 48 weeks ]
    For each participant and each 12-week period, the percentage is calculated as the number of days with dose taken within acceptable window divided by the number of days with data reported in the EDM.

  6. Incidence Rate of 7-day Gaps Between Dosing for Weeks 0-12, >12-24, >24-36 and >36-48 [ Time Frame: Enrollment through 48 weeks ]
    For each participant, the incidence rate during each 12 week interval is calculated as the ratio of the number of 7-day gaps between doses relative to the number of weeks with data reported, times 12. Consecutive gaps of more than 7 days increase the gap count by one, e.g., missing 20 days counts as 2 gaps.


Other Outcome Measures:
  1. Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48 [ Time Frame: 48 weeks post enrollment ]
    Participants with HIV-1 RNA < 200 copies/mL at Week 48 are classified as successes. Participants with HIV-1 RNA >= 200 copies/mL or with no HIV-1 RNA measurement after 44 weeks follow-up are classified as failures.

  2. Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks [ Time Frame: 12, 24, 36, and 48 weeks post enrollment ]
    Participants are classified as successes if both the week 12 (+/- 14 days) and week 48 (+/- 28 days) HIV-1 RNA measurements are < 200 copies/mL and at least one of the week 24 (+/- 28 days) or week 36 (+/- 28 days) HIV-1 RNA measurements is < 200 copies/mL. Otherwise, the participant is classified as a failure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Participant aware of his or her HIV infection, as determined by site staff
  3. Documented plasma HIV-1 RNA plasma ≥200 copies/mL within 45 days of the date of the enrollment visit
  4. Prescribed antiretroviral therapy for at least 24 weeks or more prior to documented plasma HIV-1 RNA plasma ≥200 copies/mL.
  5. 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
  6. Able to communicate in spoken and written English
  7. Currently has a cellular phone that is also able to send and receive text messages
  8. Willing and able to provide at least one additional contact phone number (preferably two) to contact participant
  9. 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

Exclusion Criteria:

  1. 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
  2. Concurrent participation in interventional studies addressing adherence unless approved in advance by study team
  3. Positive pregnancy test at the time of enrollment. If participant becomes pregnant while on study, they may continue on study
  4. Currently using or planning to use an electronic dose monitoring and reminder device outside of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292432


Locations
Layout table for location information
United States, Colorado
University of Colorado Denver Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Broward Health Childrens Diagnostic and Treatment Center (CDTC)
Fort Lauderdale, Florida, United States, 33316
University of Florida Center for HIV/AIDS, Research, Education & Service
Jacksonville, Florida, United States, 32209
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Michigan
Wayne State University School of Medicine
Detroit, Michigan, United States, 48201
United States, New York
Bronx-Lebanon Hospital Center
Bronx, New York, United States, 10457
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
National Institute on Drug Abuse (NIDA)
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Layout table for investigator information
Principal Investigator: K. Rivet Amico, PhD University of Michigan School of Public Health
Study Director: Michael Hudgens, PhD University of North Carolina, Chapel Hill
Principal Investigator: Aditya H Gaur, MD St. Jude Children's Research Hospital
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
Statistical Analysis Plan  [PDF] June 24, 2020
Study Protocol: Protocol Version 3.1  [PDF] January 21, 2020

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03292432    
Other Study ID Numbers: ATN 152
5U24HD089880-02 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2017    Key Record Dates
Results First Posted: January 8, 2021
Last Update Posted: March 11, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of North Carolina, Chapel Hill:
Adherence, Medication
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases