HIV (Human Immunodeficiency Virus)Project SPEEDNCT07346508
Project SPEED - Streamlined Protocol for Early Engagement and Delivery of HIV Prevention With Long-acting Injectable Cabotegravir: A Nurse-driven Protocol
A study testing nurse-driven protocol for delivering Long-acting Injectable Cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP) in people with HIV (Human Immunodeficiency Virus), run by KC Care Health Center.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV (Human Immunodeficiency Virus)
- What is being tested?
- nurse-driven protocol for delivering Long-acting Injectable Cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
- Inability to provide informed consent, such as due to cognitive or language barriers that prevent understanding of the study requirements.
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- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
Project SPEED (Streamlined Protocol for Early Engagement and Delivery of HIV Prevention) is a pragmatic, hybrid type III effectiveness-implementation study designed to evaluate the adoption, implementation, and sustainability of a nurse-driven model for the delivery of long-acting injectable cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP) within local public health departments (LPHDs) in Missouri. Although LAI-CAB is highly efficacious for HIV prevention, uptake remains limited in the United States, particularly in rural and resource-limited settings where access to licensed prescribers is constrained. This study addresses a critical implementation gap by testing whether trained registered nurses (RNs), operating under protocol-driven supervision and standing orders, can safely and effectively initiate and manage LAI-CAB PrEP services in real-world public health settings.
The study uses a parallel, two-arm, single-blind, cluster randomized controlled design in which LPHDs are the unit of randomization. Participating LPHDs are stratified by geographic and population characteristics (urban, metropolitan, micropolitan, and rural) and randomized in a 1:1 ratio to either the SPEED intervention or current practice. Eight LPHDs are expected to participate, with four assigned to implement the nurse-driven protocol and four continuing usual care. Participants receiving care at these LPHDs are followed for up to 48 weeks.
The SPEED intervention consists of a structured, nurse-led PrEP delivery model that integrates HIV risk assessment, counseling, laboratory testing, vaccination, rapid initiation of PrEP, and ongoing follow-up within routine public health services. RNs at intervention sites are trained to assess PrEP eligibility, conduct HIV and sexually transmitted infection (STI) testing, review laboratory results under standing orders, administer LAI-CAB injections, and provide adherence and risk-reduction counseling. Nurses operate within a collaborative practice framework that includes access to an experienced PrEP provider for consultation when clinically indicated. Rapid PrEP initiation strategies, including short-term oral cabotegravir bridging while insurance approval is pending, are used to minimize delays in starting prevention.
LPHDs assigned to the control arm continue their existing clinical workflows without additional training, protocol changes, or standardized PrEP delivery processes introduced by the study. At these sites, PrEP services, if offered, occur according to local practice, and individuals interested in PrEP may be referred to external providers. Data collection at control sites focuses on documenting current PrEP-related practices and outcomes to allow comparison with intervention sites.
The study is guided by established implementation science frameworks. The Promoting Action on Research Implementation in Health Services (PARIHS) framework informs the implementation strategy, emphasizing the interaction of evidence, context, and facilitation in achieving successful implementation. Evaluation of implementation outcomes is structured using the RE-AIM framework, assessing reach, effectiveness, adoption, implementation, and maintenance at both the participant and organizational levels. Quantitative data from clinical records and surveys are complemented by qualitative interviews with participants and staff to identify barriers, facilitators, and contextual factors influencing implementation.
Project SPEED is designed to generate actionable, real-world evidence on the feasibility, acceptability, and sustainability of nurse-driven LAI-CAB PrEP delivery in public health settings that serve populations disproportionately affected by HIV. Findings will inform the development of a scalable implementation blueprint to support broader adoption of long-acting PrEP within local public health infrastructures, particularly in rural and underserved communities.
- Conditions
- HIV (Human Immunodeficiency Virus)
- Being tested
- nurse-driven protocol for delivering Long-acting Injectable Cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP)
- Keywords
- HIV
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse-driven protocol for delivering Long-acting Injectable Cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP)Other
Nurse-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:
| Study group | Role | What they receive |
|---|---|---|
| SPEED Intervention Group | Experimental | Participants receiving care at LPHDs randomized to the SPEED intervention: Receives: Other: nurse-driven protocol for delivering Long-acting Injectable Cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a pragmatic implementation science study. Using a parallel 2-arm, single-blind, hybrid type III, cluster randomized controlled design, we will prospectively evaluate the implementation of a nurse-driven LAI-CAB program at the level of LPHDs in MO, USA.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KC Care Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346508
- Sponsor's protocol ID
- Pro00089751
- Acronym
- Project SPEED
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project SPEED - Streamlined Protocol for Early Engagement and Delivery of HIV Prevention With Long-acting Injectable Cabotegravir: A Nurse-driven Protocol
- ClinicalTrials.gov ID
- NCT07346508
- Acronym / sponsor ID
- Project SPEED / Pro00089751
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- HIV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- KC Care Health CenterUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Project SPEED (Streamlined Protocol for Early Engagement and Delivery of HIV Prevention) is a pragmatic, hybrid type III effectiveness-implementation study designed to evaluate the adoption, implementation, and sustainability of a nurse-driven model for the delivery of long-acting injectable cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP) within local public health departments (LPHDs) in Missouri. Although LAI-CAB is highly efficacious for HIV prevention, uptake remains limited in the United States, particularly in rural and resource-limited settings where access to licensed prescribers is constrained. This study addresses a critical implementation gap by testing whether trained registered nurses (RNs), operating under protocol-driven supervision and standing orders, can safely and effectively initiate and manage LAI-CAB PrEP services in real-world public health settings.
The study uses a parallel, two-arm, single-blind, cluster randomized controlled design in which LPHDs are the unit of randomization. Participating LPHDs are stratified by geographic and population characteristics (urban, metropolitan, micropolitan, and rural) and randomized in a 1:1 ratio to either the SPEED intervention or current practice. Eight LPHDs are expected to participate, with four assigned to implement the nurse-driven protocol and four continuing usual care. Participants receiving care at these LPHDs are followed for up to 48 weeks.
The SPEED intervention consists of a structured, nurse-led PrEP delivery model that integrates HIV risk assessment, counseling, laboratory testing, vaccination, rapid initiation of PrEP, and ongoing follow-up within routine public health services. RNs at intervention sites are trained to assess PrEP eligibility, conduct HIV and sexually transmitted infection (STI) testing, review laboratory results under standing orders, administer LAI-CAB injections, and provide adherence and risk-reduction counseling. Nurses operate within a collaborative practice framework that includes access to an experienced PrEP provider for consultation when clinically indicated. Rapid PrEP initiation strategies, including short-term oral cabotegravir bridging while insurance approval is pending, are used to minimize delays in starting prevention.
LPHDs assigned to the control arm continue their existing clinical workflows without additional training, protocol changes, or standardized PrEP delivery processes introduced by the study. At these sites, PrEP services, if offered, occur according to local practice, and individuals interested in PrEP may be referred to external providers. Data collection at control sites focuses on documenting current PrEP-related practices and outcomes to allow comparison with intervention sites.
The study is guided by established implementation science frameworks. The Promoting Action on Research Implementation in Health Services (PARIHS) framework informs the implementation strategy, emphasizing the interaction of evidence, context, and facilitation in achieving successful implementation. Evaluation of implementation outcomes is structured using the RE-AIM framework, assessing reach, effectiveness, adoption, implementation, and maintenance at both the participant and organizational levels. Quantitative data from clinical records and surveys are complemented by qualitative interviews with participants and staff to identify barriers, facilitators, and contextual factors influencing implementation.
Project SPEED is designed to generate actionable, real-world evidence on the feasibility, acceptability, and sustainability of nurse-driven LAI-CAB PrEP delivery in public health settings that serve populations disproportionately affected by HIV. Findings will inform the development of a scalable implementation blueprint to support broader adoption of long-acting PrEP within local public health infrastructures, particularly in rural and underserved communities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a pragmatic implementation science study. Using a parallel 2-arm, single-blind, hybrid type III, cluster randomized controlled design, we will prospectively evaluate the implementation of a nurse-driven LAI-CAB program at the level of LPHDs in MO, USA.
| Arm | Type | Receives |
|---|---|---|
| SPEED Intervention Group | Experimental | Other: nurse-driven protocol for delivering Long-acting Injectable Cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP)Participants receiving care at LPHDs randomized to the SPEED intervention: |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse-driven protocol for delivering Long-acting Injectable Cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP)Nurse-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: | Other | SPEED Intervention Group |
Primary outcome
Reach: Did the target population participate in the intervention?
Time frame: 2 years
Compare the proportion of participants who started on LAI-CAB during the study period per study arm.
1 secondary outcome
Effectiveness: How effective was the intervention in reducing HIV-1 incidence rates?
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing nurse-driven protocol for delivering Long-acting Injectable Cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP) in people with HIV (Human Immunodeficiency Virus), run by KC Care Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Blair Thedinger, MD (8162259489, Blairt@kccare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach: Did the target population participate in the intervention? (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.