Clinical Trial

Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP

Study acronym: INCLUSION
Recruiting Phase 4
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-10-15.
Status change: Not Yet Recruiting → Recruiting 2026-01-29
Trial Details
NCT Number NCT07218211
Lead Sponsor Duke University
Collaborators: Gilead Sciences
Conditions HIV Prevention, HIV Pre-exposure Prophylaxis, HIV Prevention Program, HIV Prevention and Care, HIV Pre-exposure Prophylaxis Use
Enrollment 100 participants
Start Date 2026-01-13
Primary Completion 2027-01-05 (estimated)
Study Completion 2028-01-05 (estimated)
Updated on ClinicalTrials.gov 2026-02-02