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

NCT07210125 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: IN-US-974-7746
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Keywords

HIV PrEP; Lenacapavir; Pharmacist-managed PrEP,; L4P; Pre-exposure prophylaxis; community pharmacy PrEP

Outcome Measures

Primary Outcomes (3)

• Retention Rate

  Calculated by dividing the number of participants present in the study at 1 year by the number of individuals enrolled

  1 year

• Adherence Rate

  Collected as the proportion of injections that are successfully administered during each target injection window period over 1 year

  1 year

• Persistence

  Measured as the length of time a person remains on L4P for over 1 year

  1 year

Secondary Outcomes (4)

• Patient acceptability of a pharmacist managed L4P service.

  1 year

• Pharmacist Acceptability of a pharmacist managed L4P service

  1 year

• Visit Frequency between people receiving PrEP visits every 3 months versus every 6 months.

  1 year

• STI Positivity Rates in 6-month versus 3-month PrEP monitoring visits.

  1 year

Other Outcomes (6)

• L4P initiations

  1 year

• Time to first injection

  1 year

• HIV seroconversions

  1 year

Study Arms (2)

AIM 1: lenacapavir for PrEP managed by pharmacists

EXPERIMENTAL

prospective observational study enrolling 75 subjects into the cohort to report on the feasibility and acceptability of a pharmacist-managed L4P in a community pharmacy setting. This will be done as a longitudinal, observational, mixed methods study to report on experiences of operating this service for 1 year.

Drug: Lenacapavir long-acting

AIM 2: retrospective cohort study to assess the impact on PrEP visits every 3 months vs. every 6 mon

EXPERIMENTAL

The 75 subjects who provided informed consent will be retrospectively case control matched to a cohort of people for age, gender identity, insurance status, postal code, predictors of STI risk, number of partners, genders of partners, condomless sex, receptive anal sex. Adjustments will be made to matching ratio if all matches are not found.

Drug: Lenacapavir long-acting; Other: Standard of Care (SOC)

Interventions

Lenacapavir long-acting DRUG

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.

AIM 1: lenacapavir for PrEP managed by pharmacists; AIM 2: retrospective cohort study to assess the impact on PrEP visits every 3 months vs. every 6 mon

Standard of Care (SOC) OTHER

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.

AIM 2: retrospective cohort study to assess the impact on PrEP visits every 3 months vs. every 6 mon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older at the time of screening
• weight greater than or equal to 35kg
• HIV-negative status
• Willing to provide informed consent and undergo all required study procedures

You may not qualify if:

• Unknown or positive HIV status
• Coadministration of drugs that significantly decreases lenacapavir concentrations according to the FDA package insert
• Any participant that do not meet criteria for management under the CDTA

Sponsors & Collaborators

• Kelley-Ross & Associates, Inc.: lead
• Gilead Sciences: collaborator

Study Sites (1)

Kelley-Ross Pharmacy

Seattle, Washington, 98122, United States

Location

Related Publications (1)

• Groot Bruinderink ML, Boyd A, Coyer L, Boers S, Blitz L, Brand JM, Gotz HM, Stip M, Woudstra J, Yap K, Vermey K, Matser A, Feddes AR, Jongen VW, Prins M, Hoornenborg E, van Harreveld F, Schim van der Loeff MF, Davidovich U. Online-Mediated HIV Pre-exposure Prophylaxis Care and Reduced Monitoring Frequency for Men Who Have Sex With Men: Protocol for a Randomized Controlled Noninferiority Trial (EZI-PrEP Study). JMIR Res Protoc. 2023 Nov 8;12:e51023. doi: 10.2196/51023.

  PMID: 37938875 BACKGROUND

Related Links

• Centers for Disease Control and Prevention. Advancing team based care through collaborative practice agreements: a resource and implementation guide for adding pharmacists to the care team. Atlanta, GA, USA: Centers for Disease Control and Prevention, U.
• Gilead Sciences, Inc. (n.d.). Yetztugo™ (lenacapavir) tablets for oral use: Prescribing information

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Aim 1 is a prospective observational study enrolling 75 subjects into the cohort to report on the feasibility and acceptability of a pharmacist-managed L4P in a community pharmacy setting. Aim 2 is a retrospective matched cohort study to assess the differences in retention and STI positivity rates between groups.

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 7, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after last patient, last visit for 1 year, for 1 year
• Access Criteria: Access will be granted following review of a written proposal and execution of a data use agreement

Locations

US (1)