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TERA (Triggered Escalating Real-time Adherence) Summary

Status:

Open

Sites Participating:

  • Bronx-Lebanon Hospital Center
  • Johns Hopkins University
  • Broward Health Children's Diagnostic and Treatment Center
  • St. Jude Children’s Research Hospital
  • University of Colorado Denver, Children’s Hospital Colorado
  • University of Florida Center for HIV/AIDS, Research, Education & Service
  • Wayne State University School of Medicine
  • Emory University

Staff:

  • K. Rivet Amico, PhD, University of Michigan
    Principal Investigator
  • Amanda Dunlap, University of Michigan
    Project Manager

ClinicalTrials.gov Number: NCT03292432

Protocol team organizations:

  • University of Michigan School of Public Health 
  • Frontier Science & Technology Research Foundation 
  • Harvard University T. H. Chan School of Public Health 
  • University of Minnesota School of Public Health 

The TERA project 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 will also have a prescribed once-daily (one or more pills once a day) ART regimen with at least two active agents.  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. Institutional balancing will ensure roughly equal numbers of participants in each study arm at each site. 

After being randomized to study arm, a second procedure will randomly select a subset of participants to engage in the qualitative interviews. To promote ART adherence, participants in the TERA intervention arm will receive intensive, time-limited (12-weeks) adherence coaching, where trained counselors work with participants through video enabled conferencing at three care visits and interact with text, phone, and video as-needed in real-time for any missed doses signaled by the participant’s electronic dose monitoring (EDM) device.  This intensive “boot camp” strategy is used to unsettle or disrupt established non-adherence behaviors and factors promoting ongoing non-adherence but for a time-limited period.

Counselors are remotely located and interact with the local study team on a case by case basis. All participants use EDM throughout their 48 weeks of participation as a method to track adherence. The main goal of the TERA intervention is to promote viral suppression by the 3-month mark, with additional objectives including sustained viral suppression throughout the 48-weeks of participation.

Schema

A) Randomization

Randomization chart for TERA summary

 

B) Intervention and Data Collection Overview

TERA Participant View

Duration

The study will last approximately 96 weeks total. Participants will be followed for 48 weeks.

Sample Size

120 youth living with HIV (YLWH)

Inclusion Criteria

- Potential participants must meet all of the following criteria in order to be included in this study:

- Age 13 through 24 years (inclusive)

- 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 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 IRB policy, and detailed in each site's protocol implementation plan [PIP]) to be screened for and to enroll in this study

Exclusion Criteria

To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.

- 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

Outcome Measures

Primary Outcome Measure:

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

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

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 Measure:

3.  Proportion of participants with HIV-1 RNA < 50 copies/ml at weeks 24, 36 and 48

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.

4. Proportion of participants with HIV-1 RNA < 200 copies/ml at weeks 24, 36 and 48

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.

5. Proportion of participants with HIV-1 RNA < 200 copies/ml at 12 weeks and maintained through 48 weeks

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.

6. Percent of days with all doses taken per week from weeks 0-12, 12-24, 24-36 and 36-48

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).

7. 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

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).

8. 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

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.

 

Learn more about this study at the ClinicalTrials.gov website.