HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots
- Conditions
- HIV PreventionHIV Treatment
- Interventions
- Other: At Home Self-Collections
- Registration Number
- NCT04979728
- Lead Sponsor
- University of Colorado, Denver
- Brief 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Q4W CAB±RPV Continuation/Initiation At Home Self-Collections Arm 4: People continuing or initiating Q4W injections of CAB±RPV for HIV treatment or prevention Oral Antivirals At Home Self-Collections Arm 1: People continuing oral (PO) antivirals for HIV treatment or prevention Q8W CAB±RPV Continuation At Home Self-Collections Arm 2: People continuing Q8W injections of CAB±RPV for HIV treatment or prevention Q8W CAB±RPV Initiation At Home Self-Collections Arm 3: People initiating Q8W injections of CAB±RPV for HIV treatment or prevention Q26W LEN Continuation/Initiation At Home Self-Collections Arm 5: People continuing or initiating Q26W injections of LEN for HIV treatment or prevention
- Primary Outcome Measures
Name Time Method Agreement of drug concentrations of antivirals and relevant metabolites/anabolites in blood samples Up to approximately 1 year Drug concentrations will be quantified and compared between clinic-collected and at home self-collected samples.
- Secondary Outcome Measures
Name Time Method Acceptability of at home self-collection of blood samples One-time, approximately 1-2 weeks after first clinic-collection visit Acceptability will be assessed using the Acceptability of Intervention Measure (AIM). The AIM consists of four questions. For each question, responses range from 1-5, with 1 = completely disagree and 5 = completely agree. The responses to the four questions are then averaged to get an overall acceptability score.
Feasibility of at home self-collection of blood samples One-time, approximately 1-2 weeks after first clinic-collection visit Feasibility will be assessed using the Feasibility of Intervention Measure (FIM). The FIM consists of four questions. For each question, responses range from 1-5, with 1 = completely disagree and 5 = completely agree. The responses to the four questions are then averaged to get an overall feasibility score.
Trial Locations
- Locations (1)
University of Colorado Hospital (UCHealth)
🇺🇸Aurora, Colorado, United States