A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT05514509

Run by

ViiV Healthcare

People needed

370

Starts

2022-10-28

Expected to finish

2025-09-02

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Participant must be ≥18 years of age, at the time of signing the informed consent.
• 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

You may not qualify if…

• HIV indeterminate or positive test result during screening.
• A participant of concurrent interventional clinical or implementation science study at any time during the study.
• Cis-gender or Transgender male

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.