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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03292432
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : July 31, 2018
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 will evaluate a novel intervention that uses remote coaching through video enabled counseling sessions, a 'smart' pill bottle that notifies an adherence coach when youth fail to open/close the device around dose time, and problem solving outreach by the coach when and as needed. This intensive 'boot camp' strategy is implemented for 12 weeks followed by observation through 48 weeks.

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

Detailed Description:

This is a phase II, two-arm, randomized, open-label study. Eligible participants will have failed ART therapy, defined as having detectable HIV virus (HIV-1 RNA ≥200 copies/ml) within 45 days of enrollment despite having been on ART for at least 24 weeks. They may be continuing the same ART regimen or starting a new once daily regimen. Participants will be stratified by age (<18 vs. ≥18 years of age) and randomized in equal proportions to receive the study intervention (TERA) or standard of care (SOC), with no enrollment limits in each stratum.

TERA is a time-limited (12 weeks) intervention approach that (a) uses wireless electronic dose monitoring (EDM) to identify dose-times passing with no bottle opening, (b) sends a text asking about the delay, (c) evaluates response to text and (d) initiates follow-up by an adherence coach depending on response and if the bottle remains unopened for a designated period post dosing. Phone based outreach will use problem solving discussion with an adherence coach, who can use an agreed-upon contact tree to reach the youth through other individuals. This "boot camp" strategy is used to unsettle or disrupt established non-adherence behaviors and factors promoting ongoing non-adherence. The TERA intervention will be compared with standard of care (SOC).

Participants will be followed for 48 weeks, with clinic visits at entry and weeks 4, 12, 24, 36 and 48. Audio computer assisted self-interviews (ACASI) are conducted every 12 weeks to collect information on adherence, motivation and skills, social support, mental and physical health functioning. Viral loads, medication and medical histories are also collected at each study visit.

The primary objective of the study is to compare HIV-virologic suppression (VLS) rates at 12 weeks. Secondary objectives include comparing VLS rates and EDM rates of ART adherence at 24, 36, and 48 weeks as well as patterns of adherence over time.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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 : February 1, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Standard of Care
Standard of Care for adherence support at Site
Behavioral: Standard of Care
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
Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks.
Behavioral: TERA Intervention
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. Proportion 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. Proportion 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. Proportion 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 with no HIV-1 RNA measurement within the week window are classified as failures.

  2. Proportion 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 with no HIV-1 RNA measurement within the week window are classified as failures.

  3. Proportion of participants with HIV-1 RNA < 200 copies/mL at 12 weeks and maintained through 48 weeks [ Time Frame: 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.

  4. Percent of days with all doses taken per week from weeks 0-12, 12-24, 24-36 and 36-48 [ Time Frame: Enrollment through 48 weeks ]
    For each participant, the percentage of days in each 7-day period in which all doses were taken is calculated, and then averaged across the 12 week interval (or number of weeks with available data).

  5. Percent of days with all doses taken within defined acceptable windows (within 4 hours for once/day ART and within 2 hours for twice/day ART) per week from weeks 0-12, 12-24, 24-36 and 36-48 [ Time Frame: Enrollment through 48 weeks ]
    For each participant, the percentage of days in each 7-day period in which all doses were taken within the defined acceptable windows (within 4 hours for once/day ART and within 2 hours for twice/day ART) is calculated, and then averaged across the 12 week interval (or number of weeks with available data).

  6. Incidence rate (per 100 days) of gaps between dosing of at least 7 consecutive days between 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 gaps between doses of >7 consecutive days relative to the number of days with data reported, times 100. Consecutive gaps of more than 7 days increase the gap count by one, e.g. missing 20 days counts as 2 gaps.



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.


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

Inclusion Criteria:

  1. Age 13 through 24 years (inclusive)
  2. 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
  3. Participant aware of his or her HIV infection, as determined by site staff
  4. Documented plasma HIV-1 RNA plasma ≥200 copies/mL within 45 days of the date of the enrollment visit
  5. Prescribed antiretroviral therapy for at least 24 weeks or more prior to documented plasma HIV-1 RNA plasma ≥200 copies/mL.
  6. 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
  7. Able to communicate in spoken and written English
  8. Currently has a cellular phone that is also able to send and receive text messages
  9. Willing and able to provide at least one additional contact phone number (preferably two) to contact participant
  10. 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 [IRB] policy, and detailed in each site's protocol implementation plans [PIPs]) 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


Contacts
Contact: K. Rivet Amico, PhD 734-763-0051 ramico@umich.edu
Contact: Aditya H Gaur, MD 901-595-5067 aditya.gaur@stjude.org

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Henna Budhwanni, PhD    205-975-7613    budhwani@uab.edu   
United States, California
David Geffen School of Medicine at UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Jaime Deville, MD    310-825-5226    jdeville@mednet.ucla.edu   
United States, Colorado
University of Colorado Denver Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Daniel Reirden, MD    720-777-1234    Daniel.Reirden@childrenscolorado.org   
United States, Florida
Broward Health Childrens Diagnostic and Treatment Center (CDTC) Not yet recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Lisa-Gaye Robinson, MD    954-728-1136    lerobinson@browardhealth.org   
University of Florida Center for HIV/AIDS, Research, Education & Service Recruiting
Jacksonville, Florida, United States, 32209
Contact: Mobeen Rathore, MD    904-798-4179    Mobeen.rathore@jax.ufl.edu   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Allison Agwu, MD    410-614-0732    ageorg10@jhmi.edu   
United States, Michigan
Wayne State University School of Medicine Recruiting
Detroit, Michigan, United States, 48201
Contact: Elizabeth Secord, MD    313-745-4450    esecord@med.wayne.edu   
United States, New York
Bronx-Lebanon Hospital Center Recruiting
Bronx, New York, United States, 10457
Contact: Murli Purswani, MD    718-590-1800    mpurswan@bronxleb.org   
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Aditya Gaur, MD    901-595-5067    aditya.gaur@stjude.org   
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
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

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03292432     History of Changes
Other Study ID Numbers: 17-1458
5U24HD089880-02 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases