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

NCT04979728 | Recruiting

• 2 other identifiers: 20-0382R01AI170298
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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.

  Up to approximately 1 year

Secondary Outcomes (2)

• Acceptability of at home self-collection of blood samples

  One-time, approximately 1-2 weeks after first clinic-collection visit

• Feasibility of at home self-collection of blood samples

  One-time, approximately 1-2 weeks after first clinic-collection visit

Study Arms (5)

Oral Antivirals

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

Other: At Home Self-Collections

Q8W CAB±RPV Continuation

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

Other: At Home Self-Collections

Q8W CAB±RPV Initiation

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

Other: At Home Self-Collections

Q4W CAB±RPV Continuation/Initiation

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

Other: At Home Self-Collections

Q26W LEN Continuation/Initiation

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

Other: At Home Self-Collections

Interventions

At Home Self-Collections OTHER

Directly observed at home self-collection of blood samples

Also known as: Tasso-M20, Tasso+, Mitra, DBS by fingerstick

Oral Antivirals; Q26W LEN Continuation/Initiation; Q4W CAB±RPV Continuation/Initiation; Q8W CAB±RPV Continuation; Q8W CAB±RPV Initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• ≥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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Colorado Hospital (UCHealth)

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, dried blood samples, capillary blood, plasma, blood cells

Study Officials

• Peter Anderson, PharmD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Coyle, MPH

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 28, 2021
• Study Start: May 27, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)