Boosting long-acting injectable PrEP use among Latine gay/bisexual men and transgender women in the South

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a mixed-methods hybrid type 3 implementation program that tests a culturally tailored, community-delivered lenacapavir injection program while collecting clinical outcomes. Duke University and El Centro Hispano will integrate lenacapavir delivery on-site and use El Centro Hispano Peer Navigators to provide culturally congruent support for PrEP uptake, adherence, and persistence among Latine GBM and TGW. The primary outcome is persistence on lenacapavir compared with historical persistence at the Duke PrEP Clinic, and the study will use both quantitative measures and qualitative interviews to identify barriers and facilitators. Eligible participants are HIV-negative Latine individuals assigned male at birth who are interested in PrEP and able to consent in English or Spanish.

Why it matters

Who can join: the full rules

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.

Where it's running

• El Centro Hispano
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Tonia Poteat, PhD — Duke University Medical Center - Professor in the School of Nursing
• Study coordinator: Iris Navarro Clinical Research Coordinator
• Email: inclusion@duke.edu
• Phone: 919-660-3940

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.