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

Study acronym: INCLUSION
StatusRecruiting
PhasePhase 4
Started2026-01-13
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jan 5, 2027 → Jul 31, 2027
Primary endpoint added 3 → 4 primary endpoints
See other at-risk trials from Duke University

Amendment history

2026-08-24
Study Status, Outcome Measures, Contacts/Locations v2
Primary endpoint(s) modified3 to 4 entries
WasNumber of participants who provided identification of barriers to providing lenacapavir at a Latine community-based organization, Number of participants who provided identification of facilitators to providing lenacapavir at a Latine community-based organization, Number of participants who provided recommendations to address barriers to providing lenacapavir at a Latine community-based organization
NowAcceptability of the intervention measured by questionnaire, Feasibility of the intervention measured by programmatic indicators, Sustainability of the intervention, The persistence on lenacapavir among participants receiving care at El Centro Hispano at 12 months.
Primary completion pushed: 2027-01-05 → 2027-07-31
Completion moved earlier: 2028-01-05 → 2027-07-31
Secondary endpoints2 to 7 entries
AcceptabilityPersistence asat 6 months Adherence Retention Continuation Patient Satisfaction measured by the numberquestionnaire Quality of participants who answered "yes" to select modified acceptability questions from Abbreviated Acceptability Rating Profile (AARP) Number of providers who found the intervention feasible asLife measured by thequestionnaire Safety Programmeasured Sustainabilityby AssessmentAdverse Tool (PSAT)events
Study sitescontacts updated at 1 of 1 site
2026-01-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-01-05→confirmed 2026-01-13
Study sitesdetails revised at 1 of 1 site
2025-10-15
Original filing
Duke University
455 trials monitored
See 53 trials at risk
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 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 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-26