HIV Infections
Conditions
Brief summary
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
Administered via subcutaneous (SC) injection
Tablets administered orally
DRUGEmtricitabine/tenofovir alafenamide (F/TAF)
Tablets administered orally
Administered via intramuscular (IM) injection
Administered orally
Sponsors
Gilead Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with LEN PrEP Persistence at Week 52 | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Uptake of PrEP: Proportion of Participants Who Decided to Use PrEP at Enrollment (Baseline) and Different Types of PrEP | 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 | Up to Week 104 |
| PrEP Coverage: Proportion of Days Protected by PrEP at Weeks 26, 52, 78, and 104, Overall and by PrEP Type | Up to Week 104 |
| PrEP Persistence: Mean Duration of PrEP Use | 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 | 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 | 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 | Up to Week 104 |
| PrEP Interruptions Assessed by Time Between Injections for Participants Initiating LEN PrEP who had to Re-initiate LEN PrEP | 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 | 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 | 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 | Up to Week 104 |
| Proportion of Participants with Receipt of First LEN PrEP Injection on the Same Day as Enrollment in the Study | Enrollment up to Week 104 |
Countries
United States
Contacts
CONTACTGilead Clinical Study Information Center
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed