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Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

ConditionHIV Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGilead Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial population

People who need or want HIV prevention services identified and engaged through routine clinical practice

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Lenacapavir Injection

    Drug

    Administered via subcutaneous (SC) injection

  • Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

    Drug

    Tablets administered orally

  • Emtricitabine/tenofovir alafenamide (F/TAF)

    Drug

    Tablets administered orally

  • Cabotegravir (CAB)

    Drug

    Administered via intramuscular (IM) injection

  • Lenacapavir Tablet

    Drug

    Administered orally

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: LEN PrEP2 interventions
Group B: Other PrEP3 interventions

Trial outcomes

Primary outcomes

1

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

1

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)
2

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
3

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
4

PrEP Persistence: Mean Duration of PrEP Use

Time frame
Up to Week 104

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gilead Sciences

Lead sponsor

Source ClinicalTrials.gov
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