NCT04979728 · University of Colorado, Denver
HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots
(HOME-1)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.)
Where
- Aurora, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2026 · Source of record for eligibility and locations