[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619583":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":18,"responsibleParty":34,"collaborators":18,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":18,"enrollmentInfo":45,"targetDuration":18,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":56,"whyStopped":18,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":18},{"fullName":5,"class":6},"KC Care Health Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SPEED Intervention Group","EXPERIMENTAL","Participants receiving care at LPHDs randomized to the SPEED intervention:",[13],"Other: nurse-driven protocol for delivering Long-acting Injectable Cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual PrEP care at Health Departments","NO_INTERVENTION","Participants receiving care at LPHDs randomized to current practice. The study team will not influence or standardize protocols for care delivery at these LPHDs. Providers will continue to operate based solely on the clinic's usual protocols and provider decisions, without enhancements or additional resources introduced by the study.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"nurse-driven protocol for delivering Long-acting Injectable Cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP)","Nurse-led PrEP Delivery:\n\nNurses assess PrEP eligibility, administer injections, and provide tailored support under established protocols and collaborative practice agreements with medical providers.\n\nSpecialized Training for Nurses:\n\nTraining on sexual health assessments, HIV-risk reduction counseling, PrEP options, injection administration, and identification\u002Freporting of side effects.\n\nRapid PrEP Initiation:\n\nParticipants are evaluated for eligibility and receive LAI-CAB within 7 days of enrollment, following CDC guidelines and US prescribing information.\n\nComprehensive Care:\n\nServices include sexual health assessments, rapid HIV testing, STI screening, vaccinations (e.g., HPV, Hepatitis B, MPOX), and HIV\u002FSTI risk counseling.\n\nMedication Procurement and Administration:\n\nCollaboration with specialty pharmacies for benefits verification, medication procurement, and timely delivery of LAI-CAB to LPHDs for administration.\n\nFollow-up and Adherence Support:",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Blair Thedinger, MD","CONTACT","8162259489","Blairt@kccare.org",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Dima Dandachi, MD, MPH","3128236118","dima.dandachi@como.gov",{"type":35,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100619583","project-speed---streamlined-protocol-for-early-engagement-and-delivery-of-hiv-prevention-with-long-acting-injectable-cabotegravir-a-nurse-driven-protocol-100619583",false,"NCT07346508","Project SPEED - Streamlined Protocol for Early Engagement and Delivery of HIV Prevention With Long-acting Injectable Cabotegravir: A Nurse-driven Protocol","Project SPEED","Inclusion Criteria:\n\n1. Participant seeking medical care at participating LPHDs for family planning, women's wellness exam, STI evaluation, screening, and treatment, and\u002For any other medical care services.\n2. ≥ 18 years of age. The study's focus is on adults. Adolescents may have unique healthcare access challenges, behavioral factors, and parental consent requirements that could complicate study participation.\n3. Has an indication for PrEP per guidelines.\n4. Understand the commitment to the study and be willing to participate.\n\nExclusion Criteria:\n\n1. Recent high-risk HIV exposure in the last month and\u002For has signs\u002Fsymptoms consistent with acute HIV infection (such as fever, weight loss, skin rash).\n2. Unknown, positive, or indeterminate HIV-1 test result by a test approved by the FDA for the diagnosis of acute HIV-1 infection.\n3. Any other contraindications based on the most current US Prescribing information.\n4. Currently on LAI-CAB, prior use of oral PrEP is not an exclusion criterion.\n5. Patients with mental health conditions that are severe enough to interfere with understanding of PrEP requirements (adherence, follow-up visits). The exclusion does not prevent these patients from receiving standard care at the LPHDs; it only excludes them from research-related activities.\n6. Inability to provide informed consent, such as due to cognitive or language barriers that prevent understanding of the study requirements.\n7. Institutionalized in prison, jail, or healthcare facility. Participants who are institutionalized are excluded because their autonomy may be restricted. Institutional settings also pose logistical challenges for ensuring follow-up and consistent participation in study-related activities.\n8. Patients who do not have a confirmed means of contact. Participants must have a reliable means of contact (e.g., phone) to receive laboratory test results, follow-up reminders, and study-related communications.\n9. Planning to move out of the area for the follow-up duration of the study. Justification: participants planning to move out of the area cannot reliably complete the study's follow-up visits, which could result in incomplete data.\n10. Concurrent participation in another clinical trial. Participants enrolled in other clinical trials may face conflicting protocols, treatment regimens, or follow-up schedules, which could confound study results, introducing biases or safety concerns.","ALL","18 Years",{"count":46,"type":47},250,"ESTIMATED","INTERVENTIONAL",[50],"NA","Project SPEED (Streamlined Protocol for Early Engagement and Delivery of HIV Prevention) is a pragmatic, cluster randomized implementation study evaluating a nurse-driven model for delivering long-acting injectable cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP) within local public health departments (LPHDs) in Missouri. Although LAI-CAB is a highly effective HIV prevention strategy, access remains limited in many rural and resource-constrained settings due to workforce shortages and barriers to specialty care.\n\nIn this study, LPHDs are randomized to either implement a structured nurse-led PrEP delivery protocol (SPEED intervention) or continue current standard practices. At intervention sites, trained registered nurses assess PrEP eligibility, provide HIV and sexually transmitted infection testing, administer LAI-CAB injections under standing orders, and support ongoing follow-up as part of routine public health services. Control sites continue their usual workflows without additional training or standardized PrEP delivery processes introduced by the study.\n\nThe study uses an effectiveness-implementation hybrid type III design and is guided by established implementation science frameworks to evaluate reach, adoption, implementation, and sustainability of the nurse-driven model. Participants receiving care at participating LPHDs are followed for up to 48 weeks.\n\nProject SPEED aims to generate real-world evidence on whether a nurse-driven approach can expand access to long-acting HIV prevention in public health settings, particularly in rural and underserved communities, and to inform scalable strategies for broader implementation of LAI-CAB PrEP.",[53],"HIV (Human Immunodeficiency Virus)",[55],"HIV","NOT_YET_RECRUITING","2026-01-15",{"date":59,"type":60},"2026-01-16","ACTUAL",{"date":62,"type":47},"2026-04-01",{"date":64,"type":47},"2028-12-31",{"name":5,"class":6}]