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

First listed
Jul 28, 2021
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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