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.
Who can participate
Age range13 Years – 24 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Confirmation of HIV-1 Infection as documented in the participant's medical record by at least two of the following criteria:
✓. 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
Exclusion criteria
✕
What they're measuring
1
Percentage of Participants With Plasma Human Immunodeficiency Virus - Type I Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/mL at Week 12
Timeframe: 12 weeks post enrollment
2
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 12
. 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