Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT04979728

Conditions

HIV Treatment

HIV Prevention

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

At Home Self-Collections

Study Details

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.

Conditions

HIV Treatment

HIV Prevention

Study ID

NCT04979728

Start date

May 27, 2021

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Oral Antivirals

Arm 1: People continuing oral (PO) antivirals for HIV treatment or prevention

Q8W CAB±RPV Continuation

Arm 2: People continuing Q8W injections of CAB±RPV for HIV treatment or prevention

Q8W CAB±RPV Initiation

Arm 3: People initiating Q8W injections of CAB±RPV for HIV treatment or prevention

Q4W CAB±RPV Continuation/Initiation

Arm 4: People continuing or initiating Q4W injections of CAB±RPV for HIV treatment or prevention

Q26W LEN Continuation/Initiation

Arm 5: People continuing or initiating Q26W injections of LEN for HIV treatment or prevention

Interventions

At Home Self-Collections

Directly observed at home self-collection of blood samples

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 and Locations

Central contacts

Ryan Coyle, MPH

720-695-8020ryan.coyle@cuanschutz.edu

Locations

University of Colorado Hospital (UCHealth)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Ryan Coyle, MPH

720-695-8020ryan.coyle@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Keywords

  • antivirals
  • ART
  • PrEP
  • long-acting
  • cabotegravir
  • rilpivirine
  • tenofovir
  • lenacapavir
  • self-collections
  • self-collected blood samples
  • drug concentrations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-03-03.