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

RecruitingN/A

Sponsor: University of Colorado, Denver

Conditions: HIV Treatment, HIV Prevention

Interventions: At Home Self-Collections

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.)

Locations (1)

Aurora, Colorado, United States