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

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

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.

Inclusion criteria:

• 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

Exclusion criteria:

• 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