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New treatment option for HIV Prevention
Official title Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
ClinicalTrials.gov ID: NCT07218211
What this study is testing
What is Lenacapavir long-acting?
Lenacapavir long-acting is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hiv prevention.
Also referred to as Yeztugo, Lenacapavir injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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 .
You likely can't join if
- 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...
- 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...
- Individuals taking a medication with a significant interaction with lenacapavir will be excluded from the study.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.