NCT04979728 HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots
| NCT ID | NCT04979728 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | HIV Treatment |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-05-27 |
| Primary Completion | 2027-06-30 |
Trial Parameters
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Brief Summary
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.
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 incarcer
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