NCT05374525

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

A Phase 4, Randomized, Open-label, Two-arm Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-volume Pre-exposure Prophylaxis (PrEP) Sites in the U.S. for HIV Uninfected MSM and Transgender Men ≥ 18

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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. PSPs who choose to opt for 1-month oral lead-in (OLI) will receive cabotegravir tablets for PrEP at Month 1 followed by APPRETUDE intramuscular (IM) injections on Month 2, 3 and every two months thereafter up to Month 13. PSPs who opt for Direct to injections (DTI) will receive APPRETUDE IM injections on Month 1, 2 and every two months thereafter up to Month 12. Month 6/7 refers to Month 6 (DTI)/ Month 7 (OLI). Month 12/13 refers to Month 12 (DTI)/ Month 13 (OLI).

Conditions

• HIV Infections

Interventions

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

Timeline

• Start date: 2022-05-18
• Primary completion: 2024-08-08
• Completion: 2024-08-08
• First posted: 2022-05-16
• Last updated: 2025-12-15
• Results posted: 2025-12-15

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study