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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT04979728
Status
Recruiting
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Conditions

  • HIV Prevention
  • HIV Treatment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • At Home Self-Collections — OTHER
    Directly observed at home self-collection of blood samples

Study Details

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.

Key Dates

Start date
May 27, 2021
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Oral Antivirals
    Arm 1: People continuing oral (PO) antivirals for HIV treatment or prevention
  • Arm: Q8W CAB±RPV Continuation
    Arm 2: People continuing Q8W injections of CAB±RPV for HIV treatment or prevention
  • Arm: Q8W CAB±RPV Initiation
    Arm 3: People initiating Q8W injections of CAB±RPV for HIV treatment or prevention
  • Arm: Q4W CAB±RPV Continuation/Initiation
    Arm 4: People continuing or initiating Q4W injections of CAB±RPV for HIV treatment or prevention
  • Arm: Q26W LEN Continuation/Initiation
    Arm 5: People continuing or initiating Q26W injections of LEN for HIV treatment or prevention

Primary Outcome Measure

Agreement of drug concentrations of antivirals and relevant metabolites/anabolites in blood samples [ Time Frame: Up to approximately 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Hospital (UCHealth)AuroraColorado80045
Ryan Coyle, MPH
[email protected]
720-695-8020

Find similar trials in Aurora, CO

By research site
University of Colorado Hospital (UCHealth)· Aurora, CO

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