RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots (HOME-1)

Quick Facts

Study Start:2021-05-27

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04979728

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.)

Inclusion Criteria

Exclusion 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

* 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.)

Contacts and Locations

Study Contact

Ryan Coyle, MPH

CONTACT

720-695-8020

ryan.coyle@cuanschutz.edu

Principal Investigator

Peter Anderson, PharmD

PRINCIPAL_INVESTIGATOR

University of Colorado - Anschutz Medical Campus

Study Locations (Sites)

University of Colorado Hospital (UCHealth)

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Peter Anderson, PharmD, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-27

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-05-27

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

HIV Treatment
HIV Prevention