A Narrative Review of Remote Biospecimen Collection Product and Implementation Considerations for Sexual Health Clinical Research
Bibliographic Data
Remote biospecimen collection (RBSC), such as home-based HIV testing and self-collection of dried blood spots (DBS) to assess adherence to antiretroviral drug regimens, has become an important tool to support clinical research because it can facilitate participant reach, lower participant burden, and reduce discomfort with attending research visits in clinic spaces. RBSC is common in sexual health clinical intervention trials to assess the impact of an intervention or program on primary and secondary outcomes. However, the products and strategies employed to successfully implement RBSC can vary widely across studies. The purpose of this narrative review is twofold. First, to provide an overview of currently available RBSC products, their attributes, and their suitability for various clinical research applications. Considerations for blood-based and volumetric absorptive microsampling collection products, as well as self-administered sexually transmitted infection testing and other specimen types, are described. Second, RBSC implementation considerations at each stage of the collection process are discussed primarily from the perspective of the authors' collective expertise and experience with RBSC in HIV prevention and treatment clinical research. Successful RBSC product selection and implementation require a multidisciplinary team approach that is participant-centered to achieve high return rates, and ample time should be allotted to address the complexities of the procedures and processes. This review of RBSC product and implementation considerations offers an actionable framework and roadmap when considering incorporation of RBSC into clinical trials research. TRIAL REGISTRATION: N/A
Clinical trial · Data collection · Multidisciplinary approach · Outreach · Biosimilars and Bioanalytical Methods · Ethics in Clinical Research · HIV/AIDS Research and Interventions
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