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

PHASE4RecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

September 16, 2025

Primary Completion Date

March 31, 2027

Study Completion Date

June 30, 2027

Conditions
HIV
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.

Trial Locations (1)

98122

RECRUITING

Kelley-Ross Pharmacy, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Kelley-Ross & Associates, Inc.

OTHER