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A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
Sponsor: ViiV Healthcare
Summary
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.
Official title: A Phase 4, Randomized, Open-label, Three-arm Study to Evaluate Implementation Strategies for the Delivery of CAB for HIV Pre-exposure Prophylaxis (PrEP) Across Clinical Settings for Adult (≥18 Years) Black cis-and Transgender Women Without HIV Infection Living in the United States Ending the Epidemic (EHE) Territories
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
295
Start Date
2022-10-28
Completion Date
2025-09-02
Last Updated
2026-10-01
Healthy Volunteers
Yes
Conditions
Interventions
APRETUDE
Available as intramuscular injection.
Cabotegravir tablet
Available as marketed orally administered tablets.
Locations (22)
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