HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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.)
Trial population
Study subjects will be invited to participate in the HOME-1 study by enrolling a convenience sample of people receiving TFV (as TDF or TAF) and FTC (or 3TC)-based, LA (e.g., LA IM CAB±RPV Q4W or Q8W), or other antivirals for HIV treatment or prevention at the UCH-IDGP. Study visits will only be conducted when blood is to be collected for routine SOC clinical laboratory tests and/or a SOC dose of LA antivirals is to be given.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
At Home Self-Collections
Other interventionDirectly observed at home self-collection of blood samples
Treatment groups
150 Participants
are divided into 5 treatment groupsGroup A: Oral Antivirals1 intervention
Group B: Q8W CAB±RPV Continuation1 intervention
Group C: Q8W CAB±RPV Initiation1 intervention
Group D: Q4W CAB±RPV Continuation/Initiation1 intervention
Group E: Q26W LEN Continuation/Initiation1 intervention
Trial outcomes
Primary outcomes
1
Agreement of drug concentrations of antivirals and relevant metabolites/anabolites in blood samples
Drug concentrations will be quantified and compared between clinic-collected and at home self-collected samples.
Time frame
Up to approximately 1 yearSecondary outcomes
1
Acceptability of at home self-collection of blood samples
Acceptability will be assessed using the Acceptability of Intervention Measure (AIM). The AIM consists of four questions. For each question, responses range from 1-5, with 1 = completely disagree and 5 = completely agree. The responses to the four questions are then averaged to get an overall acceptability score.
Time frame
One-time, approximately 1-2 weeks after first clinic-collection visit2
Feasibility of at home self-collection of blood samples
Feasibility will be assessed using the Feasibility of Intervention Measure (FIM). The FIM consists of four questions. For each question, responses range from 1-5, with 1 = completely disagree and 5 = completely agree. The responses to the four questions are then averaged to get an overall feasibility score.
Time frame
One-time, approximately 1-2 weeks after first clinic-collection visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov