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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
This research aims to evaluate an Interactive Digital PrEP Toolkit designed to help cisgender women in Alabama and Mississippi learn about and access pre-exposure prophylaxis PrEP, a medication that prevents HIV infection. The study focuses on addressing barriers such as limited PrEP awareness, low HIV risk perception, and challenges in client-provider communication, especially in rural southeastern U.S. regions where PrEP use among women remains low. Participants will use the Digital PrEP Toolkit on a tablet during a clinic visit, which includes educational content tailored to women and information about various PrEP options, such as daily pills and injections. After using the Toolkit, participants receive a Personalized HIV Prevention Summary and discuss PrEP options with healthcare staff. Those interested can schedule a PrEP clinic appointment. Follow-up includes phone interviews at 3 months and medical record reviews at 3 and 6 months to assess PrEP uptake and persistence. Participants will be involved in a 30-minute enrollment visit including consent and baseline assessments, use of the Digital PrEP Toolkit, and follow-up interviews. Researchers will evaluate feasibility by measuring Toolkit completion rates and time, acceptability through satisfaction surveys, and preliminary efficacy by tracking PrEP initiation and knowledge changes. Medical records will be reviewed up to 6 months post-enrollment to monitor ongoing PrEP use, with total study participation lasting up to 18 months.
Actively Recruiting
Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.