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Recruiting NCT04979728

NCT04979728 HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots

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Clinical Trial Summary
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

Condition HIV Treatment
Sponsor University of Colorado, Denver
Study Type OBSERVATIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-05-27
Completion 2027-06-30
Interventions
At Home Self-Collections

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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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