Summary

for people ages 13-24 (full criteria)
healthy people welcome
at UCLA
study started
estimated completion:

Description

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.

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

Details

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.

Keywords

HIV Infections Adherence, Medication TERA Intervention Standard of Care

Eligibility

You can join if…

Open to people ages 13-24

  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:
  3. 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);
  4. Plasma HIV-1 quantitative ribonucleic acid (RNA) assay >1,000 copies/mL;
  5. Positive HIV-1 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay;or
  6. Positive plasma HIV-1 RNA qualitative assay
  7. Participant aware of his or her HIV infection, as determined by site staff
  8. Documented plasma HIV-1 RNA plasma ≥200 copies/mL within 45 days of the date of the enrollment visit
  9. Prescribed antiretroviral therapy for at least 24 weeks or more prior to documented plasma HIV-1 RNA plasma ≥200 copies/mL.
  10. 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
  11. Able to communicate in spoken and written English
  12. Currently has a cellular phone that is also able to send and receive text messages
  13. Willing and able to provide at least one additional contact phone number (preferably two) to contact participant
  14. . 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

You CAN'T join if...

  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

Locations

  • David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles California 90095 United States
  • University of Colorado Denver Children's Hospital Colorado accepting new patients
    Aurora Colorado 80045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of North Carolina, Chapel Hill
ID
NCT03292432
Study Type
Interventional
Last Updated