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

This 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. The study will be conducted as a longitudinal, observational, mixed methods evaluation of the operation of this service for 1 year using existing pharmacy clinic models and infrastructure. The investigators will also conduct a retrospective cohort study to assess the impact on PrEP visits every 3 months versus every 6 months. All subjects must meet all eligibility criteria to participate in the study. Subjects will have the opportunity to start or switch to commercially available L4P. PrEP initiation will be defined as subjects starting PrEP who have not taken PrEP for the previous 3 months. All FDA-approved PrEP products indicated for each individual will be offered, and each patient will have the opportunity to participate in the study. Patients interested in initiating will be offered the opportunity to enroll and provide informed consent. Initiation of L4P will be based on medical, laboratory, and coverage qualifications.

Patients on L4P will be managed by a pharmacist provider utilizing a CDTA based on the DHHS Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the FDA-approved label for lenacapavir. L4P will be administered on Day 1, Day 2 (oral loading dose only), and every six months thereafter. Subjects will be followed for 12 months, and electronic health record data will be collected retrospectively throughout the study duration. Subjects will be given a survey 4 to 6 weeks after initiation and at study end. Subjects will have the option to discontinue participation at any time for any reason, and standards of care for discontinuation will be followed. Participants who do not meet criteria for management under the CDTA (positive HIV screening, pregnancy, or other complicated health conditions) will be referred to an existing primary care provider or the clinic medical director for further management. Referrals for substance use treatment, mental health, and primary care services will also be provided. At the end of the study, each patient will complete a survey and be offered the option to continue commercially available L4P.

L4P will be administered by the pharmacist provider. A pharmacist training program will be created by the study team and completed by all pharmacists providing L4P services. Pharmacies are health care settings, and all safety measures will be followed for the administration of L4P. These measures include informed consent and counseling on risks versus benefits, post-injection observation, policies and procedures in place for emergency services and allergic reactions. Access to epinephrine and diphenhydramine will be onsite. All pharmacist providers will have CPR and blood-borne pathogen training. Pharmacists who enroll in the study and provide informed consent will be given a survey at study start and end. The pharmacist surveys will be validated psychometric assessments measuring implementation outcomes often considered "leading indicators" of implementation success: Acceptability of Intervention (AIM), Intervention Appropriateness Measure (IAM), and Feasibility Intervention Measure (FIM).

A pharmacy technician will assist with administrative tasks such as scheduling, billing, prior authorizations, benefit verification, and patient assistance programs. Specific attention will be given to overcoming billing barriers. Commercial drug product will be utilized in this study. To create a sustainable program after funding ceases, real-world reimbursement programs, such as insurance and patient assistance programs, will be used to reimburse pharmacist time for performing these clinical services and for the reimbursement of commercial drug product. Uninsured patients will have the opportunity to participate. The pharmacy technician will assist patients in enrolling in state and commercial drug assistance programs to cover service and medication costs.

The study intervention is divided into two aims. For Aim 1, the investigators will conduct 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. This will be conducted as a longitudinal, observational, mixed methods evaluation of operating this service for 1 year. The primary objective is feasibility as measured by retention. Additional feasibility outcomes include adherence, persistence, and seroconversion collected through EHR review. Secondary outcomes include acceptability (as determined by subject and provider surveys), STI rates, HIV seroconversions, reasons for discontinuation, and pharmacist and patient perspectives on barriers and facilitators. 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 differences in retention and STI positivity rates between groups. All participants will be able to undergo testing in between monitoring visits. The primary outcome measure will be adherence to PrEP medication as measured by the proportion of participants who successfully attend their PrEP monitoring visits over 12 months. Secondary outcomes include visit frequency and STI positivity rate. Visit frequency will be measured as the overall number of PrEP visits and in-between STI visits per person-year.

Inclusion criteria

• 18 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

Exclusion criteria

• 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