Home self-collection of blood samples for HIV monitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using B-OK Bottles to boost HIV and ART literacy in South Africa

  This study tests whether low-cost B-OK bottles help adults in Gauteng understand HIV, ART, and U=U better, compared with standard information or a short video.

  Recruiting University of Pennsylvania · Johannesburg, Gauteng · NCT07703891

• Pharmacist-guided PEP/PrEP Access Using PEPPI Software

  This trial tests whether the PEPPI software helps pharmacists provide PEP/PrEP and helps patients access these HIV prevention options.

  Recruiting Empowerx INC · Del Mar, California · NCT07683117

• Feasibility of Online HIV Prevention Research for People Who Inject Drugs

  This study tests whether online recruitment and at-home HIV testing can be done reliably by and for people who inject drugs.

  Recruiting Montefiore Medical Center · The Bronx, New York · NCT07625917

• Host-led harm reduction for men who have sex with men who engage in chemsex in Bangkok

  This project will try a host-led harm reduction approach to reduce substance-related, sexual, mental health, and legal harms among men who have sex with men who engage in chemsex in Bangkok.

  Recruiting Institute of HIV Research and Innovation Foundation, Thailand · Pathum Wan, Bangkok · NCT07512869

• Transgender-tailored harm reduction and PrEP service for people who engage in chemsex in Bangkok

  This project will try a comprehensive harm-reduction service tailored for transgender and non-binary adults in Bangkok who engage in chemsex or substance use to increase PrEP use, reduce HIV/STIs, and address mental health and socio-legal needs.

  Recruiting Institute of HIV Research and Innovation Foundation, Thailand · Pathum Wan, Bangkok · NCT07512856

• See if PrEP Choice helps young people start and stick with HIV prevention methods

  This trial tests whether the PrEP Choice package helps 13-24 year-olds in the U.S. begin and continue using PrEP or DoxyPEP for HIV prevention.

  Recruiting at 6 sites Westat · San Francisco, California and 5 other locations · NCT07510048

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.