Triggered Escalating Real-time Adherence (TERA) Intervention (TERA)
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|ClinicalTrials.gov Identifier: NCT03292432|
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: TERA Intervention Behavioral: Standard of Care||Not Applicable|
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|
|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 :||December 7, 2019|
|Estimated Study Completion Date :||August 31, 2020|
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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
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
|Contact: K. Rivet Amico, PhDemail@example.com|
|Contact: Aditya H Gaur, MDfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham||Withdrawn|
|Birmingham, Alabama, United States, 35233|
|United States, California|
|David Geffen School of Medicine at UCLA||Withdrawn|
|Los Angeles, California, United States, 90095|
|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)||Recruiting|
|Fort Lauderdale, Florida, United States, 33316|
|Contact: Lisa-Gaye Robinson, MD 954-728-1136 email@example.com|
|University of Florida Center for HIV/AIDS, Research, Education & Service||Recruiting|
|Jacksonville, Florida, United States, 32209|
|Contact: Mobeen Rathore, MD 904-798-4179 Mobeen.firstname.lastname@example.org|
|United States, Georgia|
|Emory University School of Medicine||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Andres Camacho-Gonzalez, MD 404-727-5642 email@example.com|
|Contact: LaTeshia Seaton, MS, APRN 404-616-5936 firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Allison Agwu, MD 410-614-0732 email@example.com|
|United States, Michigan|
|Wayne State University School of Medicine||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Elizabeth Secord, MD 313-745-4450 firstname.lastname@example.org|
|United States, New York|
|Bronx-Lebanon Hospital Center||Recruiting|
|Bronx, New York, United States, 10457|
|Contact: Murli Purswani, MD 718-590-1800 email@example.com|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Aditya Gaur, MD 901-595-5067 firstname.lastname@example.org|
|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|