NCT05514509

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	APRETUDE	Available as intramuscular injection.
DRUG	Cabotegravir tablet	Available as marketed orally administered tablets.

Timeline

• Start date: 2022-10-28
• Primary completion: 2025-09-02
• Completion: 2025-09-02
• First posted: 2022-08-24
• Last updated: 2026-02-09

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study