Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

Gilead Sciences3,000 enrolled

Overview

The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP. The primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

HIV Infections

Interventions

Lenacapavir InjectionDRUG

Administered via subcutaneous (SC) injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of screening study procedures; * Willing and able to comply with all study requirements; * Presents at a study site needing or wanting PrEP for HIV prevention as determined by local clinical practice guidelines and institutional protocols, including new PrEP users (PrEP naïve) and current or former users of oral (emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®; F/TDF) or emtricitabine/tenofovir alafenamide (coformulated; Descovy®; F/TAF)) or injectable (LEN or cabotegravir (CAB)) PrEP who indicate interest in discussing PrEP methods that they are clinically eligible to receive; * Eligible for LEN PrEP per standard of care procedures, for example, being HIV-1 negative at screening using a Food and Drug Administration (FDA) approved/cleared test for diagnosis of acute or primary HIV-1 infection; * After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods: 1. Selects LEN PrEP as their chosen PrEP method; OR, 2. Selects a different PrEP method or chooses not to start or continue PrEP. Key Exclusion Criteria: * Any other indication not already listed above that would make the participant ineligible for LEN PrEP at enrollment according to local guidelines, organizational protocols, US Prescribing Information (USPI) for the PrEP product, and/or Center for Disease and Control (CDC) guidance. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (38)

UAB 1917 Research Clinic

Birmingham, Alabama, United States

RECRUITING

Pacific Oaks Medical Group

Beverly Hills, California, United States

RECRUITING

Ruane Clinical Research Group Inc.

Los Angeles, California, United States

RECRUITING

Family Health Centers of San Diego

San Diego, California, United States

Outcomes

Primary Outcomes

Proportion of Participants with LEN PrEP Persistence at Week 52

LEN PrEP persistence at Week 52 is defined as the proportion of participants receiving a LEN injection at enrollment who had an on-time injection at Week 26 and an on-time Week 52 visit ('on time' is defined as ≤ 28 weeks from the last injection).

Time frame: Week 52

Secondary Outcomes

Uptake of PrEP: Proportion of Participants Who Decided to Use PrEP at Enrollment (Baseline) and Different Types of PrEP

Time frame: Baselines (Day 1, date of the first LEN/CAB injection or oral PrEP prescription)

PrEP Persistence: Proportion of Participants who Persistently Used PrEP at Weeks 26, 78 and 104, Overall and by PrEP Type

Time frame: Up to Week 104

PrEP Coverage: Proportion of Days Protected by PrEP at Weeks 26, 52, 78, and 104, Overall and by PrEP Type

Time frame: Up to Week 104

PrEP Persistence: Mean Duration of PrEP Use

Time frame: Up to Week 104

PrEP Continuation: Proportion of Participants who Continued to Use PrEP at Week 26, 52, 78, and 104, Overall and Specific Types of PrEP

Time frame: Up to Week 104

PrEP Interruptions Assessed by Proportion of Participants who Adopted/Continued PrEP at Enrollment and Experienced Interruptions at Different Time Points at Week 26, 52, 78, and 104

Time frame: Up to Week 104

PrEP Interruptions Assessed by Proportion of Participants who Needed one or More LEN PrEP Re-initiations who Adopted/Continued LEN PrEP at Enrollment, at Week 26, 52, 78, and 104

Time frame: Up to Week 104

PrEP Interruptions Assessed by Time Between Injections for Participants Initiating LEN PrEP who had to Re-initiate LEN PrEP

Time frame: Week 26, Week 52, Week 78, and Week 104

Switching (Any Switch): Proportion of Participants Who Use any PrEP Method Different from the PrEP Method Adopted/Continued at Enrollment, at Weeks 26, 52, 78, and 104

Time frame: Week 26, Week 52, Week 78, and Week 104

Switch (Switch to LEN PreP): Proportion of Participants Switching to LEN PrEP among Participants who did not Initiate LEN PrEP at Enrollment, at Weeks 26, 52, 78, and 104

Time frame: Week 26, Week 52, Week 78, and Week 104

Time to First LEN Injection: Days From Enrollment and Choice of LEN PrEP to First Dose of LEN Injection as PrEP

Time frame: Up to Week 104

Proportion of Participants with Receipt of First LEN PrEP Injection on the Same Day as Enrollment in the Study

Time frame: Enrollment up to Week 104

Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

Overview

Conditions

Interventions

Eligibility

Locations (38)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts