Feasibility of a novel self-collection method for blood samples and its acceptability for future home-based PrEP monitoring

Chase A Cannon, Meena S Ramchandani, Matthew R Golden, Chase A Cannon, Meena S Ramchandani, Matthew R Golden

Abstract

Background: Most non-clinic based HIV pre-exposure prophylaxis (PrEP) programs require fingersticks to self-collect blood specimens for laboratory monitoring, a technique that often results in inadequate blood volume for quantitative syphilis and HIV serological testing. We evaluated the acceptability and feasibility of using the Tasso OnDemand™ device as a self-sampling method for PrEP monitoring tests and compared results from samples obtained using the Tasso device to clinician-collected blood samples.

Methods: We enrolled study subjects online and in a sexual health clinic and HIV clinic in Seattle, WA, USA to assess the acceptability of blood self-sampling and preferences for home-based PrEP monitoring. We compared HIV antigen/antibody, quantitative rapid plasma reagin and creatinine results in paired self-collected and clinical specimens collected from a subset of participants.

Results: Of 141 participants, 124 (88%) were interested in collecting samples for PrEP monitoring at home. Among 48 who completed blood collections, 94% found the Tasso device easy to use and 95% felt they could perform self-sampling at home. Of 27 participants who used two devices, 100% collected sufficient blood to perform up to two tests while 33% collected sufficient serum for three tests. Agreement in test results between paired samples was high.

Conclusions: These pilot data suggest that using the Tasso self-collection device is acceptable and could feasibly be used to obtain serum specimens sufficient for guideline-recommended PrEP monitoring, though use of a larger volume device may be preferable.

Keywords: Blood self-collection; Home sampling; PrEP; Syphilis.

Conflict of interest statement

Tasso, Inc. donated blood collection devices for this study. All authors have no competing financial or non-financial interests to disclose.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Comparison of qualitative RPR values from self-collected Tasso vs. clinical venipuncture specimens
Fig. 2
Fig. 2
Comparison of creatinine values from self-collected Tasso vs. clinical venipuncture specimens

References

    1. Serota DP, Rosenberg ES, Sullivan PS, Thorne AL, Rolle C-PM, Del Rio C, et al. Pre-exposure prophylaxis uptake and discontinuation among young black men who have sex with men in Atlanta, Georgia: a prospective cohort study. Clin Infect Dis. 2020;71(3):574–582. doi: 10.1093/cid/ciz894.
    1. Rusie LK, Orengo C, Burrell D, Ramachandran A, Houlberg M, Keglovitz K, et al. Preexposure prophylaxis initiation and retention in care over 5 years, 2012–2017: are quarterly visits too much? Clin Infect Dis. 2018;67(2):283–287. doi: 10.1093/cid/ciy160.
    1. Krakower D, Maloney KM, Powell VE, Levine K, Grasso C, Melbourne K, et al. Patterns and clinical consequences of discontinuing HIV preexposure prophylaxis during primary care. J Int AIDS Soc. 2019;22(2):e25250. doi: 10.1002/jia2.25250.
    1. John SA, Rendina HJ, Grov C, Parsons JT. Home-based pre-exposure prophylaxis (PrEP) services for gay and bisexual men: an opportunity to address barriers to PrEP uptake and persistence. PLoS ONE. 2017;12(12):e0189794. doi: 10.1371/journal.pone.0189794.
    1. Refugio ON, Kimble MM, Silva CL, Lykens JE, Bannister C, Klausner JD. PrEPTECH: a telehealth-based initiation program for HIV pre-exposure prophylaxis in young men of color who have sex with men. A pilot study of feasibility. J Acquir Immune Defic Syndr. 2019;80(1):6. doi: 10.1097/QAI.0000000000001873.
    1. Centers for Disease Control and Prevention: US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States—2017 Update: a clinical practice guideline [Internet]. 2018 Mar [cited 2019 Dec 6]. Available from: .
    1. Siegler AJ, Mayer KH, Liu AY, Patel RR, Ahlschlager LM, Kraft CS, et al. Developing and assessing the feasibility of a home-based preexposure prophylaxis monitoring and support program. Clin Infect Dis. 2019;68(3):501–504. doi: 10.1093/cid/ciy529.
    1. Chasco EE, Hoth AB, Cho H, Shafer C, Siegler AJ, Ohl ME. Mixed-methods evaluation of the incorporation of home specimen self-collection kits for laboratory testing in a telehealth program for HIV pre-exposure prophylaxis. AIDS Behav. 2021;25(8):2463–2482. doi: 10.1007/s10461-021-03209-9.
    1. TASSO-SST [Internet]. Tasso Inc. [cited 2020 Aug 22]. Available from: .
    1. Fedoruk MN. Virtual drug testing: redefining sample collection in a global pandemic. Bioanalysis. 2020;12(11):715–718. doi: 10.4155/bio-2020-0119.
    1. Williams KJ, Lutman J, McCaughey C, Fischer SK. Assessment of low volume sampling technologies: utility in nonclinical and clinical studies. Bioanalysis. 2021;13(9):679–691. doi: 10.4155/bio-2021-0027.
    1. Hendelman T, Chaudhary A, LeClair AC, van Leuven K, Chee J, Fink SL, et al. Self-collection of capillary blood using Tasso-SST devices for Anti-SARS-CoV-2 IgG antibody testing. PLoS ONE. 2021;16(9):e0255841. doi: 10.1371/journal.pone.0255841.
    1. Dombrowski JC, Ramchandani M, Dhanireddy S, Harrington RD, Moore A, Golden MR. The max clinic: medical care designed to engage the hardest-to-reach persons living with HIV in Seattle and King County, Washington. AIDS Patient Care STDS. 2018;32(4):149–156. doi: 10.1089/apc.2017.0313.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Tasso-SST Instructional Video [Internet]. [cited 2020 Feb 2]. Available from: .
    1. Centers for Disease Control and Prevention 2015 STD treatment guidelines. Morb Mortal Wkly Rep. 2015;64(3):140.
    1. Haneder S. Evaluation of a handheld creatinine measurement device for real-time determination of serum creatinine in radiology departments. WJR. 2012;4(7):328. doi: 10.4329/wjr.v4.i7.328.
    1. Fauci AS, Redfield RR, Sigounas G, Weahkee MD, Giroir BP. Ending the HIV epidemic: a plan for the United States. JAMA. 2019;321(9):844–845. doi: 10.1001/jama.2019.1343.
    1. Vanhamel J, Rotsaert A, Reyniers T, Nöstlinger C, Laga M, Landeghem EV, et al. The current landscape of pre-exposure prophylaxis service delivery models for HIV prevention: a scoping review. BMC Health Serv Res. 2020;20(1):1–18. doi: 10.1186/s12913-020-05568-w.
    1. Dubé K, Eskaf S, Hastie E, Agarwal H, Henley L, Roebuck C, et al. Preliminary acceptability of a home-based peripheral blood collection device for viral load testing in the context of analytical treatment interruptions in HIV cure trials: results from a Nationwide Survey in the United States. JPM. 2022;12(2):231. doi: 10.3390/jpm12020231.

Source: PubMed

3
購読する