A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
NCT ID: NCT05514509
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
370 participants
INTERVENTIONAL
2022-10-28
2025-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Implementation (SI)
PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as oral lead in (OLI). The SI arm receives the standard toolkits that are anticipated to be available for APRETUDE that includes information resource for PSPs and SSPs.
APRETUDE
Available as intramuscular injection.
Cabotegravir tablet
Available as marketed orally administered tablets.
Enhanced Implementation (EI)
PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The EI arm will receive all components of SI arm and additional provider-focused implementation strategies. Provider-focused strategies will include a patient-provider communication tool, Provider Education, and enhanced tool kit materials.
APRETUDE
Available as intramuscular injection.
Cabotegravir tablet
Available as marketed orally administered tablets.
Enhanced Collaborative Implementation (ECI)
PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The ECI arm will involve implementation strategies to support patient activation and provider awareness. Clinics randomized to ECI will receive all components of SI and additional implementation strategies to support patient activation and ensure provider awareness. ECI strategies will include a patient information and product resources and peer support.
APRETUDE
Available as intramuscular injection.
Cabotegravir tablet
Available as marketed orally administered tablets.
Interventions
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APRETUDE
Available as intramuscular injection.
Cabotegravir tablet
Available as marketed orally administered tablets.
Eligibility Criteria
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Inclusion Criteria
* HIV negative at screening. Type of HIV-1 test is per standard of care.
* No prior history of receiving oral CAB or CAB LA injections.
* PrEP provider deems CAB PrEP use to be appropriate per the applicable CAB PrEP prescribing information prior to enrollment in the study.
* Female at birth or self-identified Transgender Female.
* Self-identified as African American/Black
* Capable of giving signed informed consent
Exclusion Criteria
* A participant of concurrent interventional clinical or implementation science study at any time during the study.
* Cis-gender or Transgender male
18 Years
FEMALE
Yes
Sponsors
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ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
ViiV Healthcare
Locations
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GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Bridgeport, Kansas, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Brooklyn, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Memphis, Tennessee, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Norfolk, Virginia, United States
Countries
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References
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Nelson KL, Evans Cooper T, Lawson Y, Baker D, Mocherla S, Dieterich M, Hodge T, Dyson A, Sutherland-Philips D, Swygard H, Petty L, Jeffery P, Sutton K, Bonner CP, Andrews SM, Chang S, Budnik P, Smith K, de Ruiter A, Czarnogorski M, Pilgrim N. Strategies for implementing long-acting cabotegravir for PrEP in US clinics serving Black women: interim healthcare provider findings from the EBONI study. J Int AIDS Soc. 2025 Jul;28 Suppl 2(Suppl 2):e26497. doi: 10.1002/jia2.26497.
Other Identifiers
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217711
Identifier Type: -
Identifier Source: org_study_id
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