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ACTIVE NOT RECRUITING
NCT07210125
PHASE4

Implementation and Deliver of Lenacapavir for PrEP in a Community Pharmacy Setting

Sponsor: Kelley-Ross & Associates, Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, single center study to evaluate implementation of a pharmacist-managed delivery of L4P in a community pharmacy setting and the impact of twice-yearly vs. quarterly PrEP visits on STI rates.

Official title: Implementation and Delivery of Lenacapavir for PrEP in a Community Pharmacy Setting

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2025-09-16

Completion Date

2027-06-30

Last Updated

2026-04-02

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Lenacapavir long-acting

Until recently, only oral formulations of PrEP were available. With the availability of long-acting PrEP injectables, new strategies will need to be developed to deliver this new treatment option. The availability of L4P offers an opportunity to expand PrEP access outside traditional healthcare settings. However, data on the feasibility and acceptability of L4P in community pharmacies is lacking. Community pharmacies are ideal for L4P due to their accessibility and the ability to utilize both pharmacy and medical billing for reimbursement of medication and clinical services, unlike traditional healthcare settings. Pharmacists are one of the most highly accessible healthcare professionals in the community. There are over 60,000 community pharmacies across the U.S. The study will evaluate implementation outcomes (feasibility, acceptability), real-world effectiveness, and whether L4P can be used for same day starts or treatment switches.

OTHER

Standard of Care (SOC)

In aim 2, subjects enrolled in the L4P cohort will have the option of conducting STI testing every 6 months versus every 3 months. A retrospective matched cohort study will be conducted to assess the differences in retention and STI positivity rates between groups. All participants will be able to get tested in between monitoring visits.

Locations (1)

Kelley-Ross Pharmacy

Seattle, Washington, United States