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Background: We compared women's acceptability of urine and cervico-vaginal sample self-collection for high-risk (oncogenic) human papillomavirus (hrHPV) testing and assessed whether acceptability v...

Medicaid programs are increasingly adopting incentive programs to improve health behaviors among beneficiaries. There is limited evidence on what incentives are being offered to Medicaid beneficiaries, how programs are engaging beneficiaries, and how programs are evaluated. In 2017-18 we synthesized available information on these programs and interviewed eighty policy stakeholders to identify the rationale behind key program design decisions and stakeholders' recommendations for beneficiary engagement and program evaluation. Key underlying program rationales included improving the use of preventive services and promoting personal responsibility. Beneficiary engagement strategies emphasized meeting members where they are and offering prizes or services customized for certain groups. Stakeholders recommended collaborating with external evaluators to design and conduct robust evaluations of incentive programs. Finally, stakeholders recommended aligning beneficiary incentives with provider incentives and other payment reforms through the use of common meaningful measures to streamline program evaluation.

Background: Good clinical practice (GCP) training is the industry standard for ensuring the quality conduct of registrational clinical trials. However, concerns have been raised about whether the current structure and delivery of GCP training sufficiently prepares clinical investigators and their delegates to conduct clinical trials. Methods: We conducted qualitative semi-structured interviews with 13 clinical investigators and 10 research sponsors to 1) examine characteristics of the quality conduct of sponsored clinical trials, including critical tasks and concerns perceived as essential for trial quality, 2) identify key knowledge and skills required to perform critical tasks, and 3) identify gaps and redundancies in GCP training and areas of improvement to ensure the quality conduct of clinical trials. We used applied thematic analysis to analyze the data. Results: The top three tasks identified as critical for the quality conduct of clinical trials were obtaining informed consent, ensuring protocol compliance, and protecting participants’ health and safety. Respondents acknowledged that GCP principles address each of these critical tasks; however, they described many challenges and burdens of GCP training, including high training frequency and repetitive content. Respondents suggested moving beyond GCP training as a mere check-box activity by making it more effective, engaging, and interactive. They also emphasized that applying GCP principles in a real-world, skills-based environment would increase the relevance of GCP training to investigators and their delegates. Conclusion: Our findings indicate that although investigators and sponsors recognize that GCP training addresses critical tasks necessary to the quality conduct of clinical trials, they articulated the need for significant improvement in the design, content, and presentation of GCP training.

The use of mobile technologies to collect participant data in clinical trials offers a number of scientific and logistical advantages. However, little is known about potential research participant preferences about how to incorporate mobile technologies into the design and conduct of a trial. Using a web-based survey which described hypothetical mobile clinical trial and traditional clinical trial scenarios, we explored patients’ perceptions of and willingness to participate in mobile and traditional clinical trials, their preferred trial procedures related to the use of mobile technologies, and the preferred attributes of mobile technologies. The majority of survey respondents reported that they would prefer participating in a clinical trial that used mobile technology than a traditional trial that relied on standard in-clinic assessments. They expressed that mobile clinical trials offered greater convenience, a reduction of in-person clinic visits, and greater data collection accuracy. Respondents also reported preferences for the frequency of in-clinic visits during mobile clinical trials, device training and troubleshooting, data privacy and confidentiality, the location of data storage, and user access to data collected by the trial device. As research participants become more involved in capturing their own data to inform trial endpoints, their user-preferences of mobile technology, such as those described here, should be considered in the design and conduct of mobile clinical trials. Keywords: Mobile clinical trials, Mobile technology, Wearable, Patient preferences, Patient-centered