Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
Recruiting
Phase 4Interventional Study
HIV PreventionHIV Pre-exposure ProphylaxisHIV Prevention ProgramHIV Prevention and CareHIV Pre-exposure Prophylaxis Use
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
100 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 able to provide informed consent in English or Spanish .
* Be 18 years or old…
Inclusion Criteria:
* 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 able to provide informed consent in English or Spanish .
* 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.
Exclusion Criteria:
* Individuals living with HIV.
* Individuals assigned female sex at birth will be excluded.
* Individuals who are currently taking oral PrEP from another source and are not willing to switch to lenacapavir for PrEP for the duration of the study will also be excluded.
* Individuals who report a history of severe renal or hepatic disease or with clinical stigmata of either disease on physical exam as assessed by a study clinician will be excluded.
* Individuals taking a medication with a significant interaction with lenacapavir will be excluded from the study.
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