drugset / Trial / NCT05514509

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

NCT05514509

Phase 4 Completed 370 enrolled ViiV Healthcare
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-10-28
Primary completion
2025-09-02
Completion
2025-09-02

Drugs

EvaluationDrugModalityDoseRoute
Background Cabotegravir Small molecule Intramuscular