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

• Status: Not yet recruiting
• Trial end date: 2024-02-06
• Target enrollment: 0
• Participant gender: Male

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 and high-volume PrEP sites in the United States for men who have sex with men (MSM) and Transgender men ≥ 18 years of age. There are two types of participants in the study. Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available Cabotegravir PrEP via prescription from the PrEP provider at the corresponding site. Staff Study Participants (SSPs) will refer to site staff who are involved in administrative and clinical aspects of offering and administering PrEP to PSPs and will participate in the staff study assessments.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ViiV Healthcare
• Treatments: Cabotegravir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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