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

Abstract

Frequent viral load testing is necessary during analytical treatment interruptions (ATIs) in HIV cure-directed clinical trials, though such may be burdensome and inconvenient to trial participants. We implemented a national, cross-sectional survey in the United States to examine the acceptability of a novel home-based peripheral blood collection device for HIV viral load testing. Between June and August 2021, we distributed an online survey to people with HIV (PWH) and community members, biomedical HIV cure researchers and HIV care providers. We performed descriptive analyses to summarize the results. We received 73 survey responses, with 51 from community members, 12 from biomedical HIV cure researchers and 10 from HIV care providers. Of those, 51 (70%) were cisgender men and 50 (68%) reported living with HIV. Most (>80% overall) indicated that the device would be helpful during ATI trials and they would feel comfortable using it themselves or recommending it to their patients/participants. Of the 50 PWH, 42 (84%) indicated they would use the device if they were participating in an ATI trial and 27 (54%) also expressed a willingness to use the device outside of HIV cure studies. Increasing sensitivity of viral load tests and pluri-potency of the device (CD4 count, chemistries) would augment acceptability. Survey findings provide evidence that viral load home testing would be an important adjunct to ongoing HIV cure-directed trials involving ATIs. Survey findings may help inform successful implementation and uptake of the device in the context of personalized HIV care.

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

“…It may also be possible to increase sample collection by improving local blood flow with the use of heating packs. Our finding that most participants preferred homebased sampling over coming into clinic is consistent with conclusions from three other studies, [5,7,20] but whether these reported preferences will translate to consistent use of kits for HB-PrEP is uncertain. Chasco, et al found that the majority of individuals who were offered a home monitoring option did not prefer self-collection of blood and that use of home kits was associated with Fig.…”

“…The pilot study was approved by the University of Washington's Human Subjects Division and institutional review board (STUDY00009004) and Public Health-Seattle & King County's Research Administrative Review Committee [20]. All participants completed written or electronic informed consent to participate in all aspects of the study.…”

Leveraging patient‐centric sampling for clinical drug development and decentralized clinical trials: Promise to reality

“… 10 Although not all PCS approaches are less painful than traditional venous blood collection, many PCS devices are less painful due to the size of the microneedles used and location of the sample collection. Surveys of patients have shown that patients prefer at‐home sampling over in‐clinic venous blood collections 3 , 11 and patients report less pain with upper arm capillary blood sampling devices compared to venous blood collection. 12 , 13 Diminished collection volumes result in significant reduction in the total amount of blood drawn per participant.…”

“…This novel approach has been strongly recommended by patient advocacy groups and encouraged as well by health regulatory authorities. 1 , 2 , 3 …”

HIV cure: an acceptability scientific agenda

“…Already, there are at least two reported cases of sexual transmission during ATI for vaccine studies [ 39 , 40 ]. Implementation of ATI during HIV cure-related clinical trials is a necessity, yet the modalities are complex and the outcomes unpredictable [ 41 , 42 ]. There are currently no biomarkers to predict viral rebound, despite ongoing research [ 38 , 43 , 44 ]; therefore, frequent viral load measurements, often once week, must be done to inform when ART should be resumed [ 45 ].…”