Status:

COMPLETED

A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States

Lead Sponsor:

ViiV Healthcare

Conditions:

HIV Infections

Eligibility:

MALE

18+ years

Phase:

PHASE4

Brief Summary

This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low ...

Eligibility Criteria

Inclusion

  • Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
  • No prior history of receiving CAB PrEP
  • HIV negative test result at screening
  • Capable of giving signed informed consent form

Exclusion

  • HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP
  • A participant of concurrent interventional clinical or implementation science study at any time during the study

Key Trial Info

Start Date :

May 18 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 8 2024

Estimated Enrollment :

287 Patients enrolled

Trial Details

Trial ID

NCT05374525

Start Date

May 18 2022

End Date

August 8 2024

Last Update

December 15 2025

Active Locations (17)

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Page 1 of 5 (17 locations)

1

GSK Investigational Site

Los Angeles, California, United States, 90036

2

GSK Investigational Site

San Francisco, California, United States, 94102

3

GSK Investigational Site

Washington D.C., District of Columbia, United States, 20005

4

GSK Investigational Site

Miami, Florida, United States, 33140