Triggered Escalating Real-time Adherence (TERA) Intervention

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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 evaluated a novel intervention that used remote coaching through video enabled counseling sessions, an Electronic Dose Monitoring (EDM) pill bottle that notified an adherence coach when youth failed to open/close the device around dose time, and problem solving outreach by the coach in response to not dosing from the EDM. This intensive 'boot camp' strategy was implemented for 12 weeks followed by observation through 48 weeks.

Key facts

Study ID

NCT03292432

Run by

University of North Carolina, Chapel Hill

People needed

89

Starts

2018-04-12

Expected to finish

2020-10-12

Last updated by the study team

2021-03-11

Who can join

Age: 13 and older, up to 24. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Denver Children's Hospital Colorado — Aurora, Colorado, United States
• Broward Health Childrens Diagnostic and Treatment Center (CDTC) — Fort Lauderdale, Florida, United States
• University of Florida Center for HIV/AIDS, Research, Education & Service — Jacksonville, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Wayne State University School of Medicine — Detroit, Michigan, United States
• Bronx-Lebanon Hospital Center — The Bronx, New York, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.