Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Lenacapavir long-acting for HIV Prevention

The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.

Official registry: https://clinicaltrials.gov/study/NCT07218211 · Duke University · enrollment listed as 100

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Lenacapavir long-acting. The registry lists allocation as na. The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW).

They plan to enroll about 100 people at Durham. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

INCLUSION - Enhancing PrEP Uptake and Retention Among Latine Transgender Women and Gay, Bisexual, and Other Men Who Have Sex With Men in the South Using Long-Acting Injectable PrEP

Interventions: Lenacapavir long-acting

Primary outcome (registry wording): Acceptability of the intervention measured by questionnaire

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Men only
  • Participants must be assigned male sex at birth
  • Report sexual activity with a someone assigned male at birth OR identify as GBM or TGW; be HIV-negative
  • Identify as Hispanic and/or Latine
  • Be 18 years or older
  • Weigh at least 77 lbs (35 kg) by self-reported weight
  • Interested in PrEP and willing to undergo the study procedures

Public study contact (from the registry)

Iris Navarro Clinical Research Coordinator

919-660-3940

inclusion@duke.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07218211 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07218211?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07218211?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary