Status:
COMPLETED
Triggered Escalating Real-time Adherence (TERA) Intervention
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
Conditions:
HIV Infections
Eligibility:
All Genders
13-24 years
Phase:
NA
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 adv...
Detailed Description
This was a Phase II, two-arm, randomized, open-label study. Eligible participants had failed ART therapy, defined as having a detectable plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (...
Eligibility Criteria
Inclusion
- 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 plasma 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 Institutional Review Board policy, and detailed in each site's Protocol Implementation Plans) to be screened for and to enroll in this study
Exclusion
- 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
Key Trial Info
Start Date :
April 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2020
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT03292432
Start Date
April 12 2018
End Date
October 12 2020
Last Update
March 11 2021
Active Locations (8)
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1
University of Colorado Denver Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Broward Health Childrens Diagnostic and Treatment Center (CDTC)
Fort Lauderdale, Florida, United States, 33316
3
University of Florida Center for HIV/AIDS, Research, Education & Service
Jacksonville, Florida, United States, 32209
4
Emory University School of Medicine
Atlanta, Georgia, United States, 30322