Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

Official title

Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)

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.

Interventions

• Drug Lenacapavir Injection
  Administered via subcutaneous (SC) injection
• Drug Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
  Tablets administered orally
• Drug Emtricitabine/tenofovir alafenamide (F/TAF)
  Tablets administered orally
• Drug Cabotegravir (CAB)
  Administered via intramuscular (IM) injection
• Drug Lenacapavir Tablet
  Administered orally

Primary outcome measures

• Proportion of Participants with LEN PrEP Persistence at Week 52 [Time frame: Week 52]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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:

• Selects LEN PrEP as their chosen PrEP method; OR,
• Selects a different PrEP method or chooses not to start or continue PrEP.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

United States · 31 centers

• UAB 1917 Research Clinic — Birmingham
• Pacific Oaks Medical Group — Beverly Hills
• Ruane Clinical Research Group Inc. — Los Angeles
• Family Health Centers of San Diego — San Diego
• UC San Diego (UCSD) AntiViral Research Center (AVRC) — San Diego
• Mills Clinical Research — West Hollywood
• Vivent Health — Denver
• Bliss Health — Orlando
• … and 23 more centers

Identifiers

NCT: NCT07473778 · GS-US-528-7614

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗