hiv outpatient monitoring evaluation through self-collection of dried blood spots

Conditions: HIV Treatment; HIV Prevention

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.

up to 150 people receiving care at the uch-idgp will be enrolled in the study at a routine clinic visit where a standard of care (soc) blood collection and/or soc dose of la antivirals (e.g., la im cab±rpv) is planned. once consented, demographic and clinical data will be obtained. clinical data that will be collected from participant and medical records may include: age, sex at birth and gender identity, race, ethnicity, medication history, duration of current antiviral therapy, hematocrit, cd4+ t-cell count, hiv vl, and self-reported adherence. the investigators will collect an extra \~5 ml of blood in edta by venipuncture for dbs, plasma, whole blood, and blood cells at each clinic-collection visit. at the first clinic-collection visit, participants will be given home self-collection kits and instructed to self-collect samples at various timepoints prior to their next injection (if on la antivirals), monitored by live video-streaming or time-stamped video. the investigators will go through how to self-collect, handle, and mail the blood samples by self-collecting together in the clinic (in-person training), and participants will be asked about their medical history and medications. participants on po antivirals (e.g., tfv/ftc) may only complete one clinic-collection visit (and one at-home self-collection). at home self-collections and clinic-collections may continue for participants on la antivirals (e.g., la im cab±rpv) for up to approximately 1 year. all study visits will be linked to soc visits; there will be no additional visits to the clinic beyond what is already required for soc: * if continuing prescribed q8w injections, up to 7 soc clinic visits at (approximately) weeks 0, 8, 16, 24, 32, 40, and 48 * if initiating prescribed q8w injections, up to 7 soc clinic visits at (approximately) weeks 0, 4, 12, 20, 28, 36, and 44 * if continuing or initiating prescribed q4w injections, up to 13 soc clinic visits at (approximately) weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 * if continuing or initiating prescribed q26w injections, up to 3 soc clinic visits at (approximately) weeks 0, 26, and 52 participants will be asked to self-collect samples at home by two or more methods (self-collection kits): fingerstick and spotting onto whatman 903 protein saver card, and/or use of one or more self-collection devices (e.g., tasso-m20/tasso+, mitra, others). after sample collection, samples/devices will be shipped back to our laboratory in their provided box(es). all samples obtained by self-collection methods/devices are approved for shipping via mail or other carriers in the us. participants may complete up to 25 at home self-collections (approximately once biweekly for the participants followed longitudinally).

Eligibility 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.)

Keywords: antivirals art prep long-acting cabotegravir rilpivirine tenofovir lenacapavir self-collections self-collected blood samples drug concentrations