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.
In 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.
The 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.
Project 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.
Participant seeking medical care at participating LPHDs for family planning, women's wellness exam, STI evaluation, screening, and treatment, and/or any other medical care services.
≥ 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.
Has an indication for PrEP per guidelines.
Understand the commitment to the study and be willing to participate.
Recent high-risk HIV exposure in the last month and/or has signs/symptoms consistent with acute HIV infection (such as fever, weight loss, skin rash).
Unknown, positive, or indeterminate HIV-1 test result by a test approved by the FDA for the diagnosis of acute HIV-1 infection.
Any other contraindications based on the most current US Prescribing information.
Currently on LAI-CAB, prior use of oral PrEP is not an exclusion criterion.
Parallel
nurse-driven protocol for delivering Long-acting Injectable Cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP)
Other interventionNurse-led PrEP Delivery: Nurses assess PrEP eligibility, administer injections, and provide tailored support under established protocols and collaborative practice agreements with medical providers. Specialized Training for Nurses: Training on sexual health assessments, HIV-risk reduction counseling, PrEP options, injection administration, and identification/reporting of side effects. Rapid PrEP Initiation: Participants are evaluated for eligibility and receive LAI-CAB within 7 days of enrollment, following CDC guidelines and US prescribing information. Comprehensive Care: Services include sexual health assessments, rapid HIV testing, STI screening, vaccinations (e.g., HPV, Hepatitis B, MPOX), and HIV/STI risk counseling. Medication Procurement and Administration: Collaboration with specialty pharmacies for benefits verification, medication procurement, and timely delivery of LAI-CAB to LPHDs for administration. Follow-up and Adherence Support:
Reach: Did the target population participate in the intervention?
Compare the proportion of participants who started on LAI-CAB during the study period per study arm.
Effectiveness: How effective was the intervention in reducing HIV-1 incidence rates?
HIV-1 incidence rates per 100 person-years adjusted for sexual risk behavior in intervention group versus standard care
▪ Adoption: How much did the target population accept the intervention and use it?
o To evaluate the acceptability of clinical care associated with the SPEED intervention as reported by participants using the Acceptability Intervention Measure (AIM) at Week 24 and to assess changes in AIM from Week 24 to end of study
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This trial is not recruiting at the moment. You can still explore other options:
