Home self-collection of blood samples for HIV monitoring
HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots (HOME-1)
University of Colorado, Denver · NCT04979728
This study is testing if people with HIV can successfully collect their own blood samples at home to check how well their treatment is working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04979728 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a framework for patients to self-collect blood samples at home to measure antiviral drug concentrations for HIV treatment and prevention. Participants will continue their prescribed antiviral therapy and will be followed for up to one year. The study will compare drug concentrations from clinic-collected and self-collected samples, with participants receiving training on how to properly collect and handle their samples. Data on demographics, clinical history, and adherence will also be collected to assess the feasibility and effectiveness of this self-collection method.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are currently receiving antiviral treatment for HIV at the UCH-IDGP clinic.
Not a fit: Patients who are unable or unwilling to comply with self-collection procedures or who have uncontrolled medical or mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient convenience and adherence to HIV treatment by allowing for home monitoring.
How similar studies have performed: Other studies have explored self-collection methods for various health monitoring purposes, showing promising results, but this specific approach for HIV monitoring is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Aurora, Colorado
- University of Colorado Hospital (UCHealth) — Aurora, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Peter Anderson, PharmD — University of Colorado, Denver
- Study coordinator: Ryan Coyle, MPH
- Email: ryan.coyle@cuanschutz.edu
- Phone: 720-695-8020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV Treatment, HIV Prevention, antivirals, ART, PrEP, long-acting, cabotegravir, rilpivirine