RecruitingPhase 4NCT07210125

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

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

Sponsor

Kelley-Ross & Associates, Inc.

Enrollment

75 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

HIV

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a long-acting HIV prevention injection called Lenacapavir — given every 6 months — can be safely and effectively delivered through a community pharmacy setting rather than a clinic, making PrEP (pre-exposure prophylaxis) more accessible. **You may be eligible if...** - You are 18 or older and weigh at least 35 kg - You have tested HIV-negative - You are willing to undergo all required study procedures and follow-up visits **You may NOT be eligible if...** - You have HIV or your HIV status is unknown - You take medications that significantly reduce Lenacapavir levels in the body (as listed in the FDA prescribing information) - You do not meet the criteria for management under the relevant pharmacy authority agreement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenacapavir 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.

OTHERStandard 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.