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HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots
HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots (HOME-1)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion criteria: * ≥18 years old * Receiving one or more antivirals for HIV treatment or prevention. This may include TFV (as TDF or TAF) and FTC (or 3TC)-based, LA (e.g., LA IM CAB±RPV Q4W or Q8W), or other antivirals (those who are transitioning to LA antivirals \[e.g., LA IM CAB±RPV Q4W or Q8W\] will also be eligible) * Current patient at the UCH-IDGP clinic * Able to comply with study procedures, including directly observed self-collection of DBS by fingerstick, Tasso-M20/Tasso+, Mitra, and/or other self-collection methods/devices, and completion of survey Exclusion criteria: * Inability to provide informed consent * Unable or unwilling to comply with directly observed self-collection of DBS (e.g., unavailable or unable to use live video-streaming or time-stamped video recording technology) * Any uncontrolled medical, social, or mental health issue(s) that, in the opinion of the investigators, could interfere with the study participation or study outcomes (e.g., current incarceration) * Any medical condition that, in the opinion of the study team, acutely and/or transiently influences the PK of CAB±RPV, including acute kidney injury, hepatic insufficiency, significant drug-drug interactions, active hemolysis or symptomatic hemoglobinopathies, etc. (Note: Given the need for PK data in pregnancy, women who become pregnant while on LA IM CAB±RPV Q4W or Q8W will be allowed to participate in this study, if their clinical provider decides to continue this regimen.)
About the study
The goal of this observational study is to establish an operational framework for home self-collections of blood samples to be used for antiviral drug concentration measurements.
Participants will continue on their prescribed antiviral(s) for HIV treatment or prevention and followed for up to approximately 1 year. The investigators will compare drug concentrations of antivirals and relevant metabolites/anabolites in clinic-collected and self-collected blood samples.
What is being tested
- At Home Self-Collections (other)
Sponsor: University of Colorado, Denver · Participants: 150 · Started: May 27, 2021
Contact the study team
- Ryan Coyle, MPH · Phone: 720-695-8020
Official record on ClinicalTrials.gov — NCT04979728
Locations in the U.S.
| Colorado | University of Colorado Hospital (UCHealth), Aurora |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.