NCT04979728

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• HIV Treatment
• HIV Prevention

Interventions

Type	Name	Description
OTHER	At Home Self-Collections	Directly observed at home self-collection of blood samples

Timeline

• Start date: 2021-05-27
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2021-07-28
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States