Actively Recruiting
HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots HOME-1
Led by University of Colorado, Denver · Updated on 2026-03-03
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a home-based blood sample self-collection method to measure antiviral drug concentrations for people receiving HIV treatment or prevention. This observational study aims to compare drug levels in blood samples collected in the clinic versus those collected by participants at home. The study involves adults who are already prescribed antivirals, including long-acting injections, and follows them for up to about one year. Participants will continue their usual antiviral medications and attend routine clinic visits aligned with their standard care schedule. They will collect extra blood samples during clinic visits and learn how to self-collect blood samples at home using fingerstick methods and special devices. Self-collection will be monitored by video and participants will mail samples back to the laboratory. Those on oral antivirals may only have one clinic and one home visit, while those on long-acting injections may continue for up to a year with multiple visits. Throughout the study, demographic and clinical data will be gathered, including medication history and adherence. Participants will complete up to 25 home blood collections approximately every two weeks. Researchers will assess how well the home self-collection method works by comparing drug concentrations in self-collected and clinic-collected samples. The study also evaluates the acceptability and feasibility of self-collection shortly after the first clinic visit, with safety and outcome monitoring continuing through the study duration.
CONDITIONS
Brief Title
HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Receiving one or more antivirals for HIV treatment or prevention, including oral antivirals, long-acting injections, or transitioning to long-acting antivirals
- Current patient at the University of Colorado Health Infectious Diseases Group Practice clinic
- Able to comply with study procedures, including observed self-collection of blood samples and completion of surveys
You will not qualify if you...
- Unable to provide informed consent
- Unable or unwilling to comply with observed self-collection of blood samples or use of video technology
- Any uncontrolled medical, social, or mental health issue that could interfere with study participation or outcomes (e.g., current incarceration)
- Any medical condition that acutely or transiently affects the pharmacokinetics of study drugs, such as acute kidney injury, liver insufficiency, significant drug interactions, active hemolysis, or symptomatic hemoglobinopathies
- Pregnant women may participate only if their provider continues the long-acting injection regimen
Research Team
R
Ryan Coyle, MPH
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